Ex Parte Pianca et al

Patent Trial and Appeal BoardAug 22, 2017

13427679 (P.T.A.B. Aug. 22, 2017)

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. 13/427,679 03/22/2012 Anne Margaret Pianca BSNC-1-165.2 4716 50638 7590 08/22/2017 Boston Scientific Neuromodulation Corp. c/o Lowe Graham Jones 701 Fifth Avenue Suite 4800 Seattle, WA 98104 EXAMINER WEHRHEIM, LINDSEY GAIL ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 08/22/2017 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 ANNE MARGARET PIANCA and ROGER CHEN ____________ Appeal 2015-008283 Application 13/427,6791 Technology Center 3700 ____________ Before PHILIP J. HOFFMANN, MATTHEW S. MEYERS, and ROBERT J. SILVERMAN, Administrative Patent Judges. SILVERMAN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–14, 21, and 22. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “The real party in interest for this appeal is Boston Scientific Neuromodulation Corporation. Boston Scientific Neuromodulation Corporation, the assignee of the present patent application, is a wholly- owned subsidiary of Boston Scientific Corporation.” Appeal Br. 2. Appeal 2015-008283 Application 13/427,679 2 ILLUSTRATIVE CLAIM 1. An implantable lead anchor comprising: a body having an outer surface, a top end, a front side, a first end, a second end opposite to the first end, wherein the body is made of metal or rigid plastic, the body defining a lead slot configured and arranged to receive a lead inserted laterally into the lead anchor along the lead slot, the lead slot defining an elongated opening extending along the front side of the body and open at the outer surface of the body along an entire length of the front side of the body from the first end to the second end, and a transverse lumen extending from the top end of the body and intersecting the lead slot; a separate exterior member disposed around at least a portion of the outer surface of the body, the exterior member being formed of a biocompatible material and defining a transverse opening through which the transverse lumen is accessible and a lateral opening through which the lead slot is accessible; and a fastener disposed in the transverse lumen, the fastener configured and arranged for fastening the received lead to the lead anchor by engaging a portion of the lead, wherein the lead anchor is configured and arranged to be slidable along the lead prior to fastening the lead to the lead anchor using the fastener. CITED REFERENCES The Examiner relies upon the following references: Mueller US 4,632,670 Dec. 30, 1986 Pohndorf US 5,036,862 Aug. 6, 1991 Belden et al. US 5,957,968 Sept. 28, 1999 (hereinafter “Belden”) Jenkins US 6,606,523 B1 Aug. 12, 2003 Appeal 2015-008283 Application 13/427,679 3 REJECTIONS I. Claims 1, 2, 6–14, 21, and 22 are rejected under 35 U.S.C. § 103(a) as unpatentable over Mueller, Pohndorf, and Belden. II. Claims 3–5 are rejected under 35 U.S.C. § 103(a) as unpatentable over Mueller, Pohndorf, Belden, and Jenkins. FINDINGS OF FACT We rely upon and adopt the Examiner’s findings stated in the Non- Final Office Action at pages 3–15 and the Answer at pages 3–7, except as stated otherwise in the Analysis below. Additional findings of fact may appear in the Analysis below. ANALYSIS The Appellants present several arguments for error in the rejection of independent claim 1 and rely upon these same arguments as to dependent claims 2–14, 21, and 22. See Appeal Br. 7–13, 16. In addition, the Appellants present separate arguments for dependent claims 7 and 9. See id. at 14–15. For the reasons provided below, these arguments are not persuasive of error. Accordingly, we sustain the Examiner’s decision rejecting claims 1–14, 21, and 22 under 35 U.S.C. § 103(a). Independent Claim 1 1. “implantable” The Appellants argue that Mueller, alone or in combination with Pohndorf and Belden, fails to teach or suggest claim 1’s “implantable” lead anchor. Appeal Br. 7–8. In particular, the Appellants point out that Mueller is designed to sit on a patient’s skin, rather than inside a patient’s body. Id. at 7 (citing Mueller, col. 2, ll. 35–36). Appeal 2015-008283 Application 13/427,679 4 The Examiner maintains that, even if regarded as a limitation (despite being recited in the claim preamble, seemingly as a statement of purpose or intended use, per MPEP § 2111.02(II)), Mueller is capable of “implanta[tion],” even if not stated explicitly therein, and, in any event, the “implantable” feature is nevertheless taught by Pohndorf. Answer 3–4 (citing Pohndorf, col. 2, ll. 14–32, col. 3, ll. 20–29, col. 4, ll. 53–59). Furthermore, were the rejection of claim 1 regarded as being over Pohndorf, in view of Mueller and Belden, such a change in the order of references would not amount to a new ground of rejection. Id. at 4 (citing MPEP § 1207.03(a)(II)). The Appellants’ Reply Brief urges that the term “implantable” limits the scope of claim 1, that the Examiner’s reliance on Pohndorf constitutes a new ground of rejection, and that “significant structural differences” preclude reliance on Pohndorf to modify Mueller. Reply Br. 3–4. The Appellants’ arguments are unpersuasive. Even if “implantable” limits claim scope, the Appellants do not explain why the rejection might not rely upon Pohndorf for such teaching. Although “significant structural differences” (Reply Br. 4) allegedly undermine Mueller’s combination with Pohndorf, the Appellants neither identify such differences nor explain why they would impair the combination. Further, the Appellants provide no basis for the position that relying on Pohndorf for the “implantable” teaching might constitute a new ground of rejection. Indeed, “where the relevant factual inquiries underlying an obviousness determination are otherwise clear, characterization by the examiner of prior art as ‘primary’ and ‘secondary’ is merely a matter of presentation with no legal significance.” In re Mouttet, 686 F.3d 1322, 1333 (Fed. Cir. 2012). In any event, even if Appeal 2015-008283 Application 13/427,679 5 the Examiner’s Answer were to invoke a new ground of rejection, the Appellants waived the option to re-open prosecution, in such regard; by submitting a Reply Brief, the Appellants elected to maintain the Appeal. See 37 C.F.R. § 41.39(b). 2. A “body . . . made of metal or rigid plastic” The Appellants argue that Mueller employs a flexible material, such that its principle of operation would be altered, if modified to meet the “rigid plastic or metal” feature of claim 1, in view of Belden (which employs interlocking pieces). Appeal Br. 8–9 (citing Mueller, col. 2, ll. 1–4, 45–47; Belden, Fig. 1, elements 22, 24). If modified per the rejection, the Appellants contend, Mueller’s suture tab would lack the flexibility needed to allow it to close. Id. at 8. The Examiner maintains that the modification (providing “rigid plastic” material, per Belden, to Mueller) would not change Mueller’s principle of operation, because Belden discloses the use of a coated harder plastic that possesses some degree of flexibility, so as to allow the interlocking capability. Answer 4–5 (citing Belden, col. 4, ll. 49–63, Figs. 3–4). But the Appellants, in the Reply Brief, contend that “[o]nly a small degree of flexibility” is needed for Belden’s interlocking components, whereas Mueller’s suture tab “must be much more flexible.” Reply Br. 5. Yet, the Appellants do not offer any evidentiary support for such an assertion of inadequate flexibility. Attorney argument in briefing cannot take the place of evidence. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Further, as the Examiner points out, claim 1 does not define Appeal 2015-008283 Application 13/427,679 6 the degree of “rigid[ity]” needed and the Appellants’ argument does not explain why Belden’s teaching, in this regard, might be inadequate. Answer 4. Accordingly, the Appellants’ argument is not persuasive of error. 3. The “body defining . . . a lead slot configured and arranged to receive a lead inserted laterally into the lead anchor along the lead slot” The Appellants argue that Pohndorf cannot include (or be modified to include) the recited “lead slot configured and arranged to receive a lead inserted laterally,” without changing Pohndorf’s principle of operation. Appeal Br. 9. Yet, the Examiner’s Answer shows that the Appellants’ assertion rests upon a misunderstanding of the rejection, which does not rely upon the supposed modification of Pohndorf; rather, Pohndorf is included in the rejection to show that it was known in the art to use a suture tab over a “lead” and a “transverse lumen that intersects with a lead slot.” See Answer 5. Accordingly, this argument is unpersuasive of error. 4. A “separate exterior member disposed around at least a portion of the outer surface of the body” The rejection relies upon Belden’s technique of coating or overmolding a sleeve material with a biocompatible plastic, in combination with Mueller, to provide the claimed “separate exterior member disposed around at least a portion of the outer surface of the body.” See Non-Final Act. 5 (citing Belden, col. 3, ll. 29–38, col. 4, ll. 49–65). The Appellants acknowledge that Belden teaches coating or overmolding a member with silicone rubber, polyurethane, or other softer Appeal 2015-008283 Application 13/427,679 7 biocompatible plastic to reduce tissue irritation. Appeal Br. 9 (citing Belden, col. 3, ll. 34–36). Yet, the Appellants contend that Belden’s coating/overmolding and Mueller’s suture tab are made of identical material, such that there would be no design rationale or motivation for a person of skill in the art to combine Mueller and Belden, per the rejection. Id. at 9–10; Reply Br. 7. The Appellants’ argument is not persuasive. As the Examiner finds, Mueller discloses multiple embodiments employing different biocompatible materials, including PVC, urethane, and silicone. Non-Final Act. 3 (citing Mueller, col. 2, ll. 1–5); Answer 5. Therefore, the combined teachings of Mueller and Belden do not require using identical materials for both the “body” and the “exterior member.” Further, the rejection relies upon Belden’s teachings of both a “rigid” material for the “body,” as well a coated or overmolded “exterior member.” See Answer 5–6. Moreover, the Appellants do not address the Examiner’s stated reason for combining Belden with Mueller — namely, to provide “a more effective anchoring system that promotes biocompatibility such as reduced tissue irritation.” Non-Final Act. 5. 5. A “body defining . . . a transverse lumen” and an “exterior member . . . defining a transverse opening through which the transverse lumen is accessible” The Appellants argue that none of the references teach or suggest the claimed “body defining . . . a transverse lumen” and an “exterior member . . . defining a transverse opening through which the transverse lumen is accessible.” See Appeal Br. 10–11. Specifically, the Appellants emphasize that the screw fastener and corresponding aperture of Pohndorf’s Appeal 2015-008283 Application 13/427,679 8 lead anchor are both covered, when the device is assembled, leaving no opening for access to the fastener, such that Pohndorf lacks an “exterior member” with “a transverse opening through which the transverse lumen is accessible.” Id. The Appellants’ argument is unpersuasive, because the rejection relies upon Pohndorf, in combination with Belden and Mueller, for the limitation at issue — not Pohndorf alone. See Non-Final Act. 5; Answer 6. “[O]ne cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). Specifically, the rejection applies Pohndorf’s teaching of a fastener (and corresponding aperture through which it is disposed) to an anchor having the two-layer configuration disclosed in Belden (forming the “body” and “exterior member,” as discussed in the previous section), so as to yield both the “body defining . . . a transverse lumen” as well as the “exterior member” (i.e., the coating/overmolding or outer layer, per Belden) that “defin[es] a transverse opening through which the transverse lumen is accessible.” See Non-Final Act. 5; Answer 6. 6. The “lead anchor is configured and arranged to be slidable along the lead prior to fastening the lead to the lead anchor using the fastener” The Appellants argue that the combination of Pohndorf, Mueller, and Belden is improper, because it would change Pohndorf’s principle of operation, and because Pohndorf teaches away from the claimed “lead anchor” that is “slidable along the lead prior to fastening the lead to the lead anchor using the fastener.” Appeal Br. 11–13; Reply Br. 9–11. According to the Appellants, Pohndorf explicitly warns of the dangers and Appeal 2015-008283 Application 13/427,679 9 disadvantages of an anchor that slides relative to the lead and is designed to form a non-sliding relationship between the anchor and the lead. See Appeal Br. 11–13; Reply Br. 9–10. This argument is not persuasive of error in the rejection. As an initial matter, the rejection relies upon Mueller, not Pohndorf, for the teaching of an anchor that is “slidable,” relative to the object being anchored, “prior to” the application of a fastener. Non-Final Act. 3 (citing Mueller, col. 2, ll. 14– 40). Moreover, the Appellants misunderstand Pohndorf. As the Examiner finds, rather than teaching away from the claimed “slidable” feature, Pohndorf teaches it. See Answer 6. Indeed, Pohndorf discloses an anchor that is positionable relative to the lead and is then fixed in place by a screw fastener, in order to prevent sliding thereafter. See Non-Final Act. 13–14 (citing Pohndorf, col. 4, ll. 15–28). Dependent Claim 7 Dependent claim 7 recites, in part, “a plurality of ridge elements arranged adjacent to each other in a series.” According to the Non-Final Office Action (pages 7 and 15), Pohndorf’s disclosed circumferential grooves (elements 22 in Figure 6) meet the identified limitation of claim 7, because — in regard to the interpretation of the term “adjacent” — the Examiner maintains that “the grooves only need to be next to one another” to satisfy the claim (Non-Final Act. 15). The Appellants argue that Pohndorf’s circumferential grooves are not “adjacent to each other,” per claim 7; rather, they are “spaced apart” and “separated by a substantial portion” of Pohndorf’s cover 69. Appeal Br. 14. The Appellants do not propose an alternative construction of the term Appeal 2015-008283 Application 13/427,679 10 “adjacent,” but assert that the Examiner’s interpretation is “not reasonable as it renders the term essentially meaningless” (id.), “it ignores the plain meaning of the term ‘adjacent’ and is inconsistent with the specification and the disclosure of Pohndorf” (Reply Br. 13). We agree with the Examiner’s determination the term “adjacent” — under its broadest reasonable construction — may be satisfied by elements next to each other. See WEBSTER’S NEW TWENTIETH CENTURY DICTIONARY (2d ed. 1979) (“[L]ying near or close (to something); bordering upon.”) Thus, Pohndorf’s grooves may form claim 7’s “ridge elements arranged adjacent to each other in a series.” Dependent Claim 9 Like claim 7, dependent claim 9 also relates to “ridge elements,” reciting, in part, “a plurality of first ridge elements arranged adjacent to each other in a first series” and “a plurality of second ridge elements arranged adjacent to each other in a second series.” The Non-Final Office Action identifies Pohndorf’s circumferential grooves (element 22) as satisfying the recited “ridge elements” and states that the recitation of two “series” thereof merely requires a duplication of parts, which is well-known in the art and has been held to involve only routine skill in the art. Non-Final Act. 9–10 (citing St. Regis Paper Co. v. Bemis Co., Inc., 549 F.2d 833 (7th Cir. 1977)). Further, additional grooves would provide better retention of the anchor, employing the technique of Pohndorf. Id. at 10; Answer 7. The Appellants argue that Pohndorf’s grooves, as in regard to claim 7 (discussed above), do not meet the claim 9’s “adjacent” feature. Appeal Br. Appeal 2015-008283 Application 13/427,679 11 14; Reply Br. 12–13. Further, the Appellants contend that it would not be obvious to duplicate Pohndorf’s grooves, so as to form claim 9’s two “series” of “ridge elements,” as there would be no need to do so. Appeal Br. 14; Reply Br. 12–13. The Appellants’ argument is not persuasive of error. The alleged failure of Pohndorf to teach “adjacent” elements is addressed above, in regard to claim 7. As to the two “series” of “ridges,” the Examiner identifies the legal principle that a duplication of essential working parts generally involves only routine skill in the art (Non-Final Act. 10), but the Examiner does not rely exclusively thereon. In addition, the Examiner presents the fact-based reasoning that Pohndorf’s grooves (for retaining sutures) enable more secure attachment of the anchor (id.) and that “[a]dditional grooves 22 would provide further retention as already defined by Pohndorf” (Answer 7). DECISION We AFFIRM the Examiner’s decision rejecting claims 1–14, 21, and 22 under 35 U.S.C. § 103(a). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED