Ex Parte ColvinDownload PDFPatent Trial and Appeal BoardAug 12, 201311120526 (P.T.A.B. Aug. 12, 2013) 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. 11/120,526 05/02/2005 Michael S. Colvin 1362009-2026 1875 50638 7590 08/12/2013 Boston Scientific Neuromodulation Corp. c/o Frommer Lawrence & Haug LLP 745 Fifth Ave NEW YORK, NY 10151 EXAMINER BERTRAM, ERIC D ART UNIT PAPER NUMBER 3766 MAIL DATE DELIVERY MODE 08/12/2013 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 MICHAEL S. COLVIN ____________ Appeal 2011-008591 Application 11/120,526 Technology Center 3700 ____________ Before EDWARD A. BROWN, RICHARD E. RICE and MITCHELL G. WEATHERLY, Administrative Patent Judges. RICE, Administrative Patent Judge. DECISION ON APPEAL Appeal 2011-008591 Application 11/120,526 2 STATEMENT OF THE CASE Michael S. Colvin (Appellant) seeks our review under 35 U.S.C. § 134 of the Examiner’s rejection of claims 1-10 and 12-22. App. Br. 5. Claim 11 has been canceled. Id. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. CLAIMED SUBJECT MATTER Claims 1, 12 and 19 are the independent claims on appeal. Claim 1 is reproduced below: 1. A device for stimulating tissue inside a patient’s body, comprising: a lead body that is configured and arranged to be substantially rigid outside the patient’s body and throughout a procedure for implantation of the lead into the patient’s body and then becomes non- rigid after completing the implantation procedure and upon exposure within the patient’s body, wherein the lead body is configured and arranged to maintain a same shape throughout implantation; and a plurality of stimulating electrodes disposed on the lead body. App. Br., Claims App’x. REFERENCES RELIED ON BY THE EXAMINER Mullett US 5,121,754 Jun. 16, 1992 Altman US 5,658,327 Aug. 19, 1997 Parker WO 97/10784 Mar. 27, 1997 Appeal 2011-008591 Application 11/120,526 3 THE REJECTIONS Claims 1-10 and 12-22 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Claims 1-4, 6-10, 19, 20 and 22 are rejected under 35 U.S.C. § 102(b) as being anticipated by Parker. Claims 5 and 8 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Parker and Altman. Claim 12 is rejected under 35 U.S.C. § 102(b) as being anticipated by Mullett. ANALYSIS Written Description Rejection Claims 1 and 19 are each directed to a device for stimulating tissue inside a patient’s body, and each require that “the lead body is configured and arranged to maintain a same shape throughout implantation.” Claim 12, which is directed to a method of treating body tissue, requires “implanting a lead body . . . into the body tissue without bending the lead body during the implantation.” The Examiner determines that these limitations “require the lead to be unable to move at all during implantation.” Ans. 3. In finding that the Specification does not describe this requirement, the Examiner notes statements in the Specification that “the lead should merely remain ‘substantially rigid’ throughout implantation” (id. at 4, referencing Spec. 1, l. 27 – 2, l. 2), “the ‘lead should remain sufficiently rigid during insertion of the lead into the body to allow the lead to be positioned without becoming too flexible’” (id., referencing Spec. 4, ll. 26-27) and “the lead ‘maintains sufficient rigidity’ during implantation” (id., referencing Spec. 7, ll. 11-12). Appeal 2011-008591 Application 11/120,526 4 The Examiner thus finds that, as described by the Specification, “some flexibility is ok, as long as it is not ‘too flexible.’” Id. In response to Appellant’s argument that the Specification also contains passages indicating that the lead is “rigid” outside the patient’s body and during insertion into the body (see, e.g., App. Br. 10), the Examiner’s position is that “[j]ust because something is rigid does NOT mean that it cannot be bent” and “[s]ince ‘rigid’ does not require something that cannot be bent, being rigid does not necessarily mean something will maintain a same shape or prevent bending, as required by amended claims 1 and 12.” Ans. 7-8. The purpose of the written description requirement in 35 U.S.C. § 112, first paragraph, is to “‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”’ Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (quoting In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)). “[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351. This test “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. The Examiner is correct that the Specification describes embodiments in which the lead body is configured and arranged to be only “substantially rigid” outside the patient’s body and during insertion into the patient’s body. E.g., Spec. 1, l. 27 – 2, l. 2 and 2, ll. 7-9. However, the Specification also describes other embodiments in which “[t]he lead body is rigid prior to and during insertion.” Id. at 2, ll. 4-6; see also id. at 3, ll. 1-2 and 5, ll. 5-6. Because the ordinary and customary meaning of “rigid” consistent with the Appeal 2011-008591 Application 11/120,526 5 Specification is “stiff” (incapable of or resistant to being flexed or bent),1 we determine that a person of ordinary skill in the art would recognize that Appellant was in possession of a lead body “configured and arranged to maintain a same shape throughout the implantation” (claims 1 and 19), as well as the step of “implanting a lead body . . . into the body tissue without bending the lead body during the implantation” (claim 12). Accordingly, we do not sustain the rejection of claims 1-10 and 12-22 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Anticipation Rejection – Parker Appellant argues claims 1-4, 6-10, 19 and 20 as a group. App. Br. 12- 15. We select claim 1 as representative of the group, and thus claims 2-4, 6- 10, 19 and 20 stand or fall with claim 1.2 Appellant argues claim 22 separately. Id. at 16. We discuss claims 1 and 22 below. Claim 1: In finding that Parker discloses all of the features recited in claim 1, the Examiner reasons that the ability of the lead to remain substantially rigid to prevent bending throughout a procedure is highly reliant on the type of procedure being done, and can be considered an intended use of the lead. Ans. 5. The Examiner notes that “[t]he method in which the lead is implanted is not claimed” and finds that Parker’s “lead is capable of being implanted in any way imaginable, including cutting a hole in the patient and 1 WEBSTER’S THIRD NEW INT’L DICTIONARY, UNABRIDGED, accessed at http://lionreference.chadwyck.com (last visited Jul. 29, 2013). 2 See 37 C.F.R. § 41.37(c)(1)(vii). Appeal 2011-008591 Application 11/120,526 6 dropping the rigid lead into the hole, at which point it will contact moisture and become less rigid.” Id. at 9. The Examiner explains that “[t]he fact that Parker discloses a certain method of implantation does not change the fact that the lead is capable of being implanted in different parts of the body using different implantation techniques.” Id. Appellant’s position is that the features related to the rigidity of the lead body in claim 1 are not recitations of intended use, but rather are structural features, “namely, the variable rigidity of the lead body and conditions under which the lead body is rigid or non-rigid.” App. Br. 12; see also Reply Br. 7-8. Appellant argues that “Parker does not have the recited rigidity properties.” App. Br. 12. Appellant points out that “Parker explicitly teaches that ‘[s]heath 18, while stiffer than carrier 10, must be sufficiently flexible so that it can be bent to conform to the shape of the cochlea.’” Id. at 13 (quoting Parker at p. 5, ll. 14-16 and referencing figs. 11 and 12); see also Reply Br. 8. Appellant argues that the Examiner’s reasoning that Parker is capable of inserting a lead body into a pre-cut hole without bending “is inconsistent with the disclosure of Parker . . . which requires the straight cochlear assembly to bend as it is implanted” and “even if this were medically possible or reasonable, the cochlear assembly would still necessarily bend because the cochlear assembly must assume the curvature of the cochlea so that the electrodes are in contact with the tissue.” App. Br. 13-14. Appellant also argues that “Parker does not teach or suggest implanting the lead elsewhere or in any other manner.” Reply Br. 8-9. On the record before us, we agree with the Examiner’s findings and ultimate determination of anticipation. The recitation of a lead body “configured and arranged to be substantially rigid to prevent bending of the Appeal 2011-008591 Application 11/120,526 7 lead body throughout a procedure for implantation of the lead into the patient’s body, wherein the lead body is configured and arranged to maintain a same shape throughout the implantation,” is a mere statement of intended use or functional limitation. See Ans. 5. Contrary to Appellant’s argument, there is no requirement for the function to be disclosed. See, e.g., In re Schreiber, 128 F.3d 1473, 1477-78 (Fed. Cir. 1997) (claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function or use); see also In re Swinehart, 439 F.2d 210, 213 (CCPA 1971) (“[W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.”). The Examiner reasonably found that Parker’s electrode assembly would be capable of performing the use or function recited in claim 1. See Ans. 9. Appellant has not provided sufficient argument or evidence to establish that this finding is in error. We do not agree with Appellant’s argument that Parker fails to teach or suggest implanting a lead elsewhere than the cochlea or in any other manner. See Reply Br. 8-9; see also Ans. 9; Parker, p. 1, ll. 11-12 and p. 7, ll. 15 – p. 8, l. 3. Parker specifically discloses “other implanted electrodes, such as the electrodes used in pacemakers.” Parker, p. 7, ll. 15-18. With respect to pacemakers, Parker discloses that the tines used to secure the distal end of the electrode to an internal cardiac wall are folded and maintained in a closed position by a bioabsorbable sheath during implantation and allowed to open and engage the cardiac wall upon Appeal 2011-008591 Application 11/120,526 8 dissolution of the sheath after implantation. Id., p. 7, ll. 19-23. Accordingly, Parker’s disclosure is not limited to implanting the lead in the cochlea. We are not informed on this record as to why such a sheath, when used for implanting electrodes in parts of the body other than the cochlea, would not be capable of performing the use or function recited in claim 1. Accordingly, we sustain the rejection of claim 1, and claims 2-4, 6-10, 19 and 20 as being anticipated by Parker. Claim 22: Claim 22 depends from claim 1 and additionally recites that “the lead body is configured and arranged to be straight throughout the implantation.” The Examiner finds that Parker’s lead is straight prior to implantation. Ans. 5 (referencing Parker, fig. 11). Otherwise, the Examiner’s position with respect to claim 22 is the same as for claim 1, i.e., that Parker’s lead is capable of maintaining a same shape throughout the implantation. Id. at 4-6. Appellant argues that “the lead of Parker is not straight throughout implantation because it must fit within the curved cochlea.” App. Br. 16. This argument does not persuade us that Parker’s sheath is incapable of maintaining a straight shape throughout implantation. For this reason, and those discussed supra in connection with claim 1, Appellant’s argument does not persuade us of error in the Examiner’s rejection. Accordingly, we sustain the rejection of claim 22 as being anticipated by Parker. Anticipation Rejection - Mullett The Examiner finds that Mullett discloses the method recited in claim 12. Ans. 6. Appellant disagrees and argues that “as clearly taught in the present patent application, the variable rigidity of the lead body, recited Appeal 2011-008591 Application 11/120,526 9 in the claims, arises as a property of the lead body itself, not from the insertion of another instrument, such as a stylet, into the lead body.” App. Br. 17. Appellant further argues that “[t]he lead body of Mullett is non-rigid prior to, during, and after implantation” and that “[i]t is the stylet, not the lead body, that is rigid” in Mullet. Id. Appellant’s argument is not commensurate with the scope of claim 12. We find nothing in the claim language or the Specification that precludes insertion or removal of a stylus into or out of the lead body to effect variable rigidity of the lead body. Contrary to Appellant’s argument based on selective passages from the Specification (id.), the Specification explicitly states that the variable rigidity of the lead body can arise, not only as a property of the lead body itself, but also from the insertion of another instrument, such as a stylus, into the lead body. See Spec. 3, ll. 16-22. As described in the Specification, a lumen may run longitudinally within the lead 202, and a stylus may be inserted into the lumen before implantation of the lead to help stiffen the lead during implantation and may be withdrawn after the lead is implanted in the desired location inside the body tissue. Id. Thus, Appellant’s Specification does not disclaim or disavow insertion or removal of a stylus into or out of the lead body to effect variable rigidity of the lead body. Accordingly, we sustain the rejection of claim 12 as being anticipated by Mullett. Obviousness Rejection – Parker and Altman Appellant argues that Altman does not address the deficiencies of Parker. For the reasons discussed supra with respect to claim 1, we sustain Appeal 2011-008591 Application 11/120,526 10 the rejection of claims 5 and 8 as being unpatentable over Parker and Altman. DECISION We reverse the rejection of claims 1-10 and 12-22 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. We affirm the rejection of claims 1-4, 6-10, 19, 20 and 22 under 35 U.S.C. § 102(b) as being anticipated by Parker. We affirm the rejection of claim 12 under 35 U.S.C. § 102(b) as being anticipated by Mullet. We affirm the rejection of claims 5 and 8 under 35 U.S.C. § 103(a) as being unpatentable over Parker and Altman. 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-IN-PART mls Copy with citationCopy as parenthetical citation