Ex Parte Robinson

Patent Trial and Appeal BoardJul 31, 2015

11528175 (P.T.A.B. Jul. 31, 2015)

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. 11/528,175 09/26/2006 Janine C. Robinson S0134.0020 6262 109587 7590 08/03/2015 SPINAL KINETICS, INC. 595 N. Pastoria Ave. Sunnyvale, CA 94085 EXAMINER NELSON, CHRISTINE L ART UNIT PAPER NUMBER 3774 MAIL DATE DELIVERY MODE 08/03/2015 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 JANINE C. ROBINSON ____________ Appeal 2012-012105 Application 11/528,175 Technology Center 3700 ____________ Before STEFAN STAICOVICI, JILL D. HILL, and BRANDON J. WARNER, Administrative Patent Judges. WARNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Janine C. Robinson (“Appellant”)1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–3 and 8–22, which are all the pending claims. Appeal Br. 5. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellant, the real party in interest is Spinal Kinetics Inc. Appeal Br. 3. Appeal 2012-012105 Application 11/528,175 2 CLAIMED SUBJECT MATTER Appellant’s disclosed invention relates to a prosthetic intervertebral disc with a compressible core and at least one cast end plate. See Spec. ¶ 1. Claims 1, 8, and 20 are independent. Claim 1, reproduced below with emphasis added, is illustrative of the subject matter on appeal. 1. A prosthetic intervertebral disc comprising: a.) first and second end plates, wherein at least one of the end plates is a cast end plate, and b.) a compressible core member positioned between said first and second end plates and formed prior to casting of the at least one cast end plate, the compressible core member being wound with fibers that extend between and engage both the first and second end plates, and wherein the at least one cast end plate comprises a cast polymer having a form provided by causing the polymer to flow to the fibers of the wound compressible core member, by causing the polymer to solidify, and thereby casting the at least one cast end plates. EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: Bao US 5,534,028 July 9, 1996 Navarro US 5,534,030 July 9, 1996 Xavier US 6,063,121 May 16, 2000 Eberlein US 6,626,943 B2 Sept. 30, 2003 McClellan US 2007/0179621 A1 Aug. 2, 2007 Appeal 2012-012105 Application 11/528,175 3 REJECTIONS The following rejections are before us for review: I. Claims 1–3, 8–13, and 16–22 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Eberlein, Bao, Navarro, and McClellan. II. Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Eberlein, Bao, Navarro, McClellan, and Xavier. ANALYSIS As correctly noted by Appellant, the claims in this application are all in the nature of product-by-process claims. See Appeal Br. 11. Notably, the claimed prosthetic intervertebral disc requires more than just an end plate that is formed by casting; all the claims require that the cast end plate be formed by causing a polymer to flow to a core component of the disc and then causing the polymer to solidify or cure to thereby cast the end plate. See id. In other words, the claimed cast polymer end plate is not merely formed by casting an individual part in isolation, but is instead formed by casting the polymer plate with the core component so as to form a complementary whole. Specifically, independent claim 1 requires that the cast polymer end plate have “a form provided by causing the polymer to flow to the fibers of the wound compressible core member.” Appeal Br., Claims App. Independent claim 8 requires “causing the polymer to flow to the peripheral core member,” thereby “causing the peripheral core member to engage the at least one cast end plate.” Id. Similarly, independent claim 20 requires that Appeal 2012-012105 Application 11/528,175 4 “the peripheral core member is made adherent to the at least one cast end plate by causing that polymer to flow to the peripheral core member,” thereby “causing the peripheral core member to adhere to the at least one cast end plate.” Id. Critically, each of the independent claims includes structural features imparted by the recited casting process, which must be considered in a determination of patentability. See Appeal Br. 11–12. Rejections I and II both rely on a combination of teachings from Eberlein, Bao, Navarro, and McClellan to render obvious the prosthetic intervertebral discs as claimed. Ans. 4–7. Appellant asserts that none of the references discloses a prosthetic intervertebral disc having a cast polymer end plate that “engages or is made adherent to a component fiber or to a component peripheral core member through formation . . . of the end plate,” and that none of the references shows “a product-by-process end plate that conforms in shape to the pre-existing core member, the shape being formed due to the process polymer flow” to that core member during casting. Appeal Br. 13–14; see also Reply Br. 2–5. Appellant also argues that these rejections “fail to provide any consistent technical reasoning from the prior art or reasoned basis from general knowledge” as to why one of ordinary skill in the art would have combined the teachings of Eberlein, Bao, Navarro, and McClellan, “but instead simply provide[] a bare conclusion that [McClellan’s] procedure . . . could make such a structure,” such that the Examiner has not met the burden of establishing a proper prima facie case of obviousness. Reply Br. 3–4. We agree. Although we appreciate the Examiner’s finding that Eberlein discloses a prosthetic intervertebral disc that includes many conventional components (see Ans. 5–6), Appellant correctly observes that Eberlein’s end plates are Appeal 2012-012105 Application 11/528,175 5 pre-formed rather than being cast with any core component (see Appeal Br. 14). We note that the Examiner similarly acknowledges that Eberlein does not disclose end plates made by casting. See Ans. 6. The Examiner turns to Navarro for teaching that casting end plates is known (see id.), but this combination with Eberlein results only in end plates pre-formed by casting in isolation. The same shortcoming results from the Examiner’s reliance on Bao for teaching that casting polymers is known. See id. Even stretching Bao’s teaching of casting a polymer for a disc’s nucleus or core, as relied on by the Examiner, to encompass casting a polymer for a disc’s end plate still results in end plates pre-formed by casting in isolation. Finally, the Examiner relies on McClellan for teaching a mold process where a mesh can be integrally formed with a moldable material, stating that the mesh (asserted as being equivalent to the fibers of the compressible core member) would be pre-formed. See Ans. 6–7 (citing McClellan ¶ 18). As the requisite articulated reasoning for this combination, the Examiner states only that it would have been obvious “to utilize the process for making a fiber/mesh integral with a molded/cast material as taught by McClellan . . . as this would provide another alternative for production and may impart additional strength to the connection between the core and end plate.” Id. at 7 (emphasis added). Appellant argues that McClellan does not rectify the shortcomings of the teachings of Eberlein, Bao, and Navarro, and that the Examiner has therefore not established that the cited art would lead to a cast polymer end plate that would have a form produced when a flowable polymer is caused to flow to and contact a core component and then harden. See Appeal Br. 14–15. We agree with Appellant in that the Examiner has not provided Appeal 2012-012105 Application 11/528,175 6 adequate factual evidence or persuasive technical reasoning to explain how this “alternative for production,” stated as the reason for combining the molding process of McClellan with the structure of Eberlein, could actually be used to form the end plates of Eberlein. In particular, as Appellant correctly notes, Eberlein discloses pre- formed end plates that have a particular shape prior to any contact with a core component—these shapes define contact surfaces for interacting with the core component, which can change in area as a function of pressure on the spine. Appeal Br. 14; see Eberlein, Figs. 1–5; col. 4, ll. 2–59. This structure of Eberlein’s end plates would remain unchanged even if they were modified to be polymer end plates pre-formed by casting in isolation based on the teachings of Navarro and Bao, as proposed by the Examiner. What is unclear, however, is how McClellan’s molding process could be used as an alternative for production to form the structure of Eberlein’s end plates (even with the modifications proposed), because integrally forming a core component with moldable material end plates as stated (see Ans. 6–7) would eliminate Eberlein’s defined contact surfaces. The Examiner’s response to arguments provides no further explanation. See Ans. 7–8. Speculation and conjecture cannot form the basis for concluding obviousness. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“A rejection based on section 103 clearly must rest on a factual basis, and these facts must be interpreted without hindsight reconstruction of the invention from the prior art.”). Absent improper hindsight reconstruction, we fail to see a reasoned explanation based on a rational underpinning as to how or why McClellan’s molding process could be used as an alternative for Appeal 2012-012105 Application 11/528,175 7 production to form the structure of even modified Eberlein, and a reason for such use is not otherwise evident from the record. We note that Xavier is relied on by the Examiner in Rejection II for teaching an additional feature of a metallic stent member (see Ans. 7), but not to cure the above-noted deficiency with respect to the combination of Eberlein, Bao, Navarro, and McClellan. Accordingly, based on the record before us, we conclude that the Examiner has not met the burden of establishing a proper prima facie case of obviousness of the claimed subject matter. On this basis, we cannot sustain the rejection of independent claims 1, 8, and 20, or of any of their respective dependent claims. DECISION We REVERSE the Examiner’s rejections of claims 1–3 and 8–22. REVERSED em