Medtronic, Inc.Download PDFPatent Trials and Appeals BoardJul 19, 20212020004517 (P.T.A.B. Jul. 19, 2021) 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. 15/363,178 11/29/2016 Darren A. Janzig 0134.000714US02 4914 64619 7590 07/19/2021 MEDTRONIC, INC. (NEURO/MRG) 710 MEDTRONIC PARKWAY NE MS-LC340 MINNEAPOLIS, MN 55432-5604 EXAMINER BERTRAM, ERIC D ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 07/19/2021 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): ptodocketing@mrgs.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 DARREN A. JANZIG, ANDREW J. THOM, CHRIS J. PAIDOSH, BRAD C. TISCHENDORF, and GERALD G. LINDNER Appeal 2020-004517 Application 15/363,178 Technology Center 3700 ____________ Before ANTON W. FETTING, MICHAEL C. ASTORINO, and ROBERT J. SILVERMAN, Administrative Patent Judges. SILVERMAN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s decision rejecting claims 1–3, 7–13, and 15–23. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Medtronic, Inc. Appeal Br. 3. Appeal 2020-004517 Application 15/363,178 2 ILLUSTRATIVE CLAIM The claimed subject matter relates to “lead connectors” for electrical connections that may be used, for example, in “[i]mplantable active medical devices, such as cardiac rhythm management devices (pacemakers and defibrillators) and a variety of implantable muscle/nerve stimulators.” Spec. 1, ll. 8–9. Claims 1 and 13 are the independent claims in the Appeal. Claim 1 illustrates the subject matter at issue: 1. A method of forming a medical device lead connector comprising: sputtering a metallization layer that has a thickness in a range from 10 nanometers to less than 1 micrometer onto only a diffusion bond area portion of an electrically insulating ring; diffusion bonding the electrically insulating ring between a first electrically conducting contact ring and a second electrically conducting contact ring to form an aligned joined element; and joining a plurality of aligned joined elements in axial alignment to form a lead connector having a lead aperture. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Callol et al. (“Callol”) US 6,174,329 B1 Jan. 16, 2001 Janzig et al. (“Janzig”) US 2008/0208278 A1 Aug. 28, 2008 Floyd et al. (“Floyd”) US 2010/0179627 A1 July 15, 2010 O.M. Akselsen, Diffusion bonding of ceramics, 27 Journal of Materials Science 569 (1992) (“Akselsen”) I.I. Gab et al., Metal-To-Sapphire Brazed and Diffusion Bonded Windows for Optics, Ultra-High Vacuum Technics and Electronics for Maintenance at Temperatures 77–800 K, Proc. Int’l Conf. High Temperature Capillarity (June 29–July 2, 1997, Cracow, Poland) (N. Eustathopoulos & N. Sobczak, eds.) (“Gab”) Appeal 2020-004517 Application 15/363,178 3 REJECTIONS I. Claims 1–3, 7–13, and 15–23 are rejected under 35 U.S.C. § 103(a) as unpatentable over Janzig, Gab, Floyd, and Callol. II. Claims 1–3, 7–13, and 15–23 are rejected under 35 U.S.C. § 103(a) as unpatentable over Janzig, Askelsen, Floyd, and Callol.2 RELATED CASES At the time the Appeal Brief was filed in the present case, a Notice of Appeal had been filed in at least the related U.S. Application 13/088,913 (see Spec. 1), wherein the Board issued a Decision on September 30, 2016 (Appeal 2015-001305). The Appellant fails to identify this related Appeal. See Appeal Br. 3. We remind the Appellant and counsel to review prior and pending proceedings before the Board, as well as any other qualifying matters, so as to ensure that all related cases, within the scope of 37 C.F.R. § 41.37(c)(1)(ii), are identified. Representations to the Office are subject to the requirements of, e.g., 37 C.F.R. §§ 1.56, 11.18, and 11.303. FINDINGS OF FACT The findings of fact relied upon, which are supported by a preponderance of the evidence, appear in the following Analysis. ANALYSIS Each of Rejection I (based on the combination of Janzig, Gab, Floyd, and Callol) and Rejection II (based on the combination of Janzig, Askelsen, 2 We regard the Examiner’s mistaken inclusion of claim 6 in Rejection II as inadvertent. See Final Act. 7. Claim 6 is canceled. See Appeal Br., Claims App. 1. Appeal 2020-004517 Application 15/363,178 4 Floyd, and Callol) is applied to all claims in the Appeal (claims 1–3, 7–13, and 15–23). Claims 1 and 13 are the independent claims in this Appeal. With respect to each of Rejection I and Rejection II, the Appellant asserts error in the rejection of independent claims 1 and 13. Appeal Br. 8–14. In rejecting claims 1 and 13, the Examiner cites Janzig’s teaching of a “metallization layer” and relies upon Callol to teach the recited “sputtering” technique, for creating the “metallization layer.” Final Act. 4–9. According to the Examiner: [I]t would have been obvious to a PHOSITA at the time of the applicant’s invention to use sputtering to add the metallization layer of Janzig as Callol teaches that this is a known method of doing so at the time of the applicant’s invention and would have resulted in the recited structure of Janzig without affecting its operation. Additionally, the metallization layer additionally provides the benefit of protecting the medical device ([Callol] Col. 4, lines 33–48). Id. at 6. See also id. at 8–9. The Appellant does not dispute that the cited references teach all the limitations of claims 1 and 13, but the Appellant argues that the Examiner failed to provide an adequately supported reason for combining the above- identified teachings of Janzig and Callol. See Appeal Br. 8–12. The Appellant contends (see Appeal Br. 10–11) that the Examiner does not provide sufficient evidence for the position that Callol’s sputtering technique may be used to provide Janzig’s metallization layer, “without affecting [Janzig’s] operation” (Final Act. 6). According to the Appellant, none of the cited references teach or suggest that a metallization layer formed by sputtering would be suitable to use with the claimed “diffusion Appeal 2020-004517 Application 15/363,178 5 bonding” of claims 1 and 13. Appeal Br. 10–11. The only support for the Examiner’s position, the Appellant argues, is found in the Appellant’s Specification, such that “the Examiner’s reasoning is based on impermissible hindsight.” Id. at 11. Janzig teaches an “electrically insulating ring . . . metallized on opposing edges.” Janzig ¶ 51. The Examiner points out that, although Janzig does not teach how the metallized layer is formed, “it must be applied in some way.” Answer 8. Janzig indicates that the lead connector (which includes the “electrically insulating ring”) “can be formed by any useful method.” Janzig ¶¶ 50–51. See id. Figs. 4A, 4B, 5, 6. Further, as the Examiner finds, “Callol teaches that sputtering is a known method for applying a metallization layer to an implantable medical device, and is equivalent to a myriad of other techniques.” Answer 8. Indeed, Callol states: “A metallic coating . . . can be applied by electroplating, evaporation, plasma-vapor deposition, cathodic-arc deposition, sputtering, ion implantation, electrostatically, electrochemically, a combination of the above, or the like.” Callol col. 6, ll. 35–39. But the existence of the “sputtering” technique in the prior art — notwithstanding its lack of inconsistency [compatibility] with Janzig — is not sufficient to establish a reason for employing this technique for creating a metallization layer for use with Janzig’s insulating ring and other features. Thus, as the Examiner maintains, “the metallization layer additionally provides the benefit of protecting the medical device,” because Callol teaches the protective attribute of a sputtered metallic layer. Final Act. 6. See also id. at 9 (“[S]puttering the metallization layer additionally provides the benefit of protecting the medical device”) (citing Callol col. 4, ll. 33–48). Appeal 2020-004517 Application 15/363,178 6 The Appellant disputes the Examiner’s position that Callol’s teaching of a protective layer provides an adequate reason for combining the identified teachings of Janzig and Callol. See Appeal Br. 9–10. The Appellant argues: Callol describes coating a stent with a protective layer to protect from scratches, flaking, galvanic corrosion, and to improve both blood and bio-compatability [sic]. Callol abstract. Janzig as modified by the Examiner has insulating rings of sapphire or ceramic (Office Action at page 5). The Examiner has not provided any evidence that sapphire or ceramics used in Janzig are subject to scratches, flaking, and galvanic corrosion, or that the bio-compatability [sic] of the sapphire or ceramics would be improved by the sputtered metallization layer of Callol. Furthermore, the metallization layer is only sputtered onto a diffusion bond area portion as recited in claim 1 or only onto planar surfaces as recited in claim 13. As shown in FIG. 6 of the present specification . . . , such surfaces are not exposed after the diffusion bonding process. Therefore, the benefits asserted by the Examiner would not be realized even if such metallization could provide these benefits. Appeal Br. 9. As to the significance of adding a protective layer to Janzig’s insulating ring, the Examiner states: “all materials can be scratched by a material harder than it, so the additional, sputtered layer of Callol would add an additional layer of protection to help prevent scratching.” Final Act. 2. However, as the Appellant points out (see Appeal Br. 9), Janzig does not reflect any particular vulnerability of its insulating ring. By contrast, Callol relates specifically to “coatings applied to stents to make them radiopaque and coatings to protect the stent and the radiopaque layer.” Appeal 2020-004517 Application 15/363,178 7 Callol col. 1, ll. 8–10. As Callol explains, such radiopaque coatings are notoriously delicate: The radiopaque layer is thin, in one preferred embodiment it is about 1.0 to 50 microns thick. Since the layer is so thin, it is subject to scratching or flaking when the stent is being delivered intraluminally. Accordingly, it is an object of the invention to protect the stent and particularly the radiopaque layer with a more durable protective layer that is resistant to scratching and general mishandling. Id. col. 1, l. 66 – col. 2, l. 5. See also id. col. 4, ll. 29–31 (“[T]he radiopaque coating is prone to scratching and handling mishaps resulting in scratches, a chipped coating, flaking, or other defects.”) Furthermore, the other conundrum, identified by the Appellant (see Appeal Br. 9), concerns whether the protective benefits of Callol would be inconsistent with claim 1’s limitation of providing the “metallization layer” “onto only a diffusion bond area portion of an electrically insulating ring.” In view of this feature, the purportedly protective metallization would be applied only to the portion of the insulating ring that would be “diffusion bond[ed]” to an “electrically conducting contact ring” — i.e., a portion that is “not exposed after the diffusion bonding process” and, therefore, cannot benefit from any protection that a metallized layer might provide. Id. A similar issue applies to claim 13, which also limits the sputtered metallization layer to only a portion of the insulating ring, reciting: “sputtering a metallization layer . . . onto only planar surfaces of an electrically insulating sapphire or a ceramic ring.” In response, the Examiner maintains that the addition of Callol’s metallized layer would provide a benefit to the combined teachings of the other references: Appeal 2020-004517 Application 15/363,178 8 [T]he metallization la[y]er is necessarily added prior to bonding, and thus the metallization layer will be open to the environment prior to bonding with the conducting contact ring. During this time, Callol makes clear that a metallization layer with a thickness of 10 nanometers can act as a protective layer. Answer 9. Yet, the Examiner identifies no support for the finding that Janzig’s insulating ring would face an appropriate hazard after addition of the metallized layer, but prior to bonding with an electrically conductive contact ring. Moreover, the Examiner’s analysis does not alleviate the peculiarity that the proposed combination would add a protective layer only to the portion of the insulating ring (e.g., claim 1’s recitation of “only a diffusion bond area portion of an electrically insulating ring”) that would be least in need of protection, based upon the present record — whereas no protective layer would be afforded to the remainder of the insulating ring. In reviewing an Examiner’s determinations, the Board “must examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made.” In re Nuvasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016) (quoting Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (internal quotation marks and citation omitted)). These principles apply to the determination of a reason to combine the teachings found in the prior art (see id. at 1383), which — as the Supreme Court has emphasized — require “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). Appeal 2020-004517 Application 15/363,178 9 In the rejections in this Appeal, the Examiner’s findings do not adequately support the stated reason for combining the prior art teachings, as discussed above. Therefore, we do not sustain the rejections of independent claims 1 and 13, along with their respective dependent claims, under 35 U.S.C. § 103(a). CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 7–13, 15–23 103(a) Janzig, Gab, Floyd, Callol 1–3, 7–13, 15–23 1–3, 7–13, 15–23 103(a) Janzig, Akselsen, Floyd, Callol 1–3, 7–13, 15–23 Overall Outcome 1–3, 7–13, 15–23 REVERSED Copy with citationCopy as parenthetical citation