Ex Parte de Villiers et alDownload PDFPatent Trial and Appeal BoardAug 25, 201411829056 (P.T.A.B. Aug. 25, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MALAN DE VILLIERS and DAVID HOVDA __________ Appeal 2012-005309 Application 11/829,056 Technology Center 3700 __________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. PAULRAJ, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an intervertebral prosthesis. The Examiner rejected the claims on anticipation/obviousness grounds. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Background “[T]he invention relates to restoration of spinal motion with a prosthetic disc for intervertebral insertion, such as in the lumbar and cervical spine” (Spec. ¶ 1). “Many [prior art] prosthetic discs use protruding anchors 1 Appellants identify the Real Party in Interest as SpinalMotion, Inc. (see App. Br. 3). Appeal 2012-005309 Application 11/829,056 2 to anchor the endplates to the adjacent vertebra,” and “[w]hile elongate fins, keels and other anchors have generally been successful in anchoring endplates to vertebra, clinical trials with large numbers of patients have shown that in rare cases the endplates of the implanted prosthetic disc can slip, causing patient discomfort and requiring surgical intervention” (id. at ¶ 2). “Another rare complication can arise with the elongate anchors when prosthetic discs are placed in adjacent intervertebral spaces on opposite ends of a vertebra, referred to as ‘stacking’” (id.). “The vertebra positioned between the adjacent prosthetic disks can split possibly as a result of grooves cut in the same plane on the upper and lower surfaces of the vertebra” (id.). The Claims Claims 1–22 and 28–33 are on appeal. Independent claims 1 and 28 are representative, and read as follows: 1. An intervertebral prosthesis comprising: an upper component adapted to engage an upper vertebra; a lower component adapted to engage a lower vertebra; a row of discrete pillars extending from an outer surface of at least one of the upper component or the lower component and including pillars of different average heights arranged to form an elongate anchor structure having an increasing height relative to the outer surface from at least one end of the anchor structure toward a center of the anchor structure, the row of pillars adapted to enter a groove formed in the upper vertebra or the lower vertebra and wherein the upper component and the lower component are adapted to engage each other or an intermediate member to form an articulate joint between the vertebrae. 28. An improved intervertebral prosthesis of the type including a first component adapted to engage a first vertebra, a second component adapted to engage a second vertebra, and an anchor on at least one of the first and second components which is axially oriented over a length of the component and is adapted to enter a groove formed in at least one of the vertebrae, the App App impr distr plura new bein anch the a towa obvi FF1. FF2. 2 Lak 3 Eis eal 2012-0 lication 11 ovement c ibuted ove lity of anc bone grow g of differe or structur t least one rd a cente The Issu The Exa ous over th Lakin (Laki Figur in et al., U ermann et 05309 /829,056 omprising r the lengt hors prov th relative nt averag e having a componen r of the an e miner has e combin is directe n, Title) (e e 1 of Lak S 7,780,6 al., US 20 a plurality h on the at ide an incr to a singl e heights a n increasin t from at chor struct rejected th ation of La FINDIN d to an “in mphasis o in is repro 76 B2, iss 04/022067 3 of axially least one eased surf e anchor, a nd are arra g height r least one e ure. e claims u kin2 and E GS OF FA tervertebr mitted). duced belo ued Aug. 2 0 A1, pub aligned, componen ace area to t least som nged to fo elative to nd of the a nder 35 U isermann CT al implant w: 4, 2010. lished No spaced-apa t, wherein receive a e of the a rm an elo an outer su nchor stru .S.C. § 10 .3 ation appa v. 4, 2004 rt anchors the nd engage nchors ngate rface of cture 3(a) as ratus” . App App FF3. FF4. eal 2012-0 lication 11 “With prost artifi verte impla Figur “FIG inclu col. 2 Lakin Tu altern 60 w to an enhan impla the ar taper pegs insert posit Alter the p 05309 /829,056 reference hesis 10 m cial disc pr bral bodie nt.” (Lak e 7 of Lak . 7 is simp de a plural , ll. 13–15 discloses rning to t ative artif ith one or adjacent v ced bone ntation so tificial dis ed or non- 62 may be ion and/or ioned alon natively, th late. The p to the sim ay include osthesis m s 16 and 18 in, col. 2, in is repro lified side ity of pegs ). : he simplifi icial disc p more keels ertebral bo ingrowth b as to prov c prosthes tapered sid angled an resist mig g an anteri e pegs 62 egs 62 ma 4 plified vi first and ay be imp and refer ll. 55–59.) duced belo view of an according ed side vi rosthesis m or pegs 6 dy. The p etween ad ide resista is. The pe es. The to d/or taper ration. Th or-posteri may be p y be used ew of FIG second pla lanted bet red to as a w: other artif to the pre ew of FIG ay includ 2 for fixat egs 62 ma jacent peg nce to mig gs 62 may p surface ed to facili e pegs 62 or centerli laced anyw as the sole . 1, an arti tes 12 and ween adja n interver icial disc sent teach . 7, an e a plate ion relativ y allow fo s 62 after ration of include s of the tate may be ne. here on structure ficial disc 14. The cent tebral prosthesis ings” (id., e r App App FF5. FF6. eal 2012-0 lication 11 for fi used fixati (Id. a Figur “FIG prost accor Lakin A one o fixati in the prost 44 an The s poste show cente 05309 /829,056 xation to t in combin on structu t col. 4, ll. e 6A of L . 6A is a si hesis inclu ding to the discloses n alternativ r more ou on relative simplifie hesis 40 m d a pair of ingle keel rior center n in FIG. 6 rline. The he adjacen ation with res. 20–33.) akin is rep mplified f ding at lea present te : e artificia twardly ex to an adja d front vie ay include keels 46 a 42 may be line of the ) or dispo pair of kee 5 t vertebral one or mo roduced be ront view st one pla achings” l disc pros tending ke cent verte w of FIG. a single k nd 48 on positione correspon sed at a gi ls 46 and bodies or re keels or low: of another te with spa (id. at col. thesis 40 m els to prov bral body. 6, the artif eel 42 on a second p d on the a ding plate ven distan 48 on the may be other artificial d ced apart 1, ll. 63–6 ay includ ide As show icial disc a first plat late 50. nterior- 44 (as ce from th other plate isc keels 5). e n e e Appeal 2012-005309 Application 11/829,056 6 50 may be spaced equally from the centerline or otherwise spaced from the centerline. A greater separation between the pair of keels 46 and 48 may provide additional stability for the artificial disc prosthesis 40 and thereby facilitate multi-level procedures, because of the interdigitation of alternative keels. The prosthesis 40 may alternatively include two or more spaced apart keels extending from both plates. For example, the prosthesis 40 may include three keels extending from both plates. It will be understood that the prosthesis 40 may be a two piece prosthesis or a three piece prosthesis. (Id. col. 3, ll. 42–60.) FF7. Lakin teaches that “[t]he keels may vary in length in the anterior- posterior direction. The keels may have a leading edge and may be a constant height throughout the entire length.” (Id. col. 3, ll. 61– 63.) Lakin also teaches that “the keels may taper in the anterior- posterior direction,” that “the taper may be limited to a forward/anterior portion of the keel,” or “[a]lternatively, any portion of the keel may be tapered along its length in the anterior- posterior direction.” (Id. col. 4, ll. 8–15.) FF8. Eisermann is directed to a “prosthetic device for insertion into a spondylosed intervertebral space” (Eisermann, Abstract). App App FF9. FF10 eal 2012-0 lication 11 Figur “FIG latera disclo . Eiser A keel 5 beari 05309 /829,056 e 4a of Ei . 4a is an i l insertion sure” (id. mann disc flange me 8 of articu ng surface sermann is sometric v according at ¶ 15). loses: mber or k lar compo 48. In on 7 reproduce iew of an to one em eel 68, con nent 42, e e embodim d below: articulatin bodiment figured sim xtends fro ent, the k g prosthet of the pre ilar to th m the eel 68 ic joint for sent e Appeal 2012-005309 Application 11/829,056 8 extends along the transverse axis T and is offset from the center of the bearing surface 48. Such an embodiment would accommodate insertion of the prosthetic joint 40 using a lateral approach. (Id. at ¶ 98.) FF11. Eisermann discloses: In some embodiments, one or both of the keels 58, 68 may include a sharp forward edge, illustrated by edge 68a of FIG. 4. By having such an edge, insertion of the keel into the associated vertebral body is facilitated. Also, the edge 68a can be of sufficient sharpness that the adjacent vertebral bodies do not require a slot for receiving the keel 68, discussed in greater detail below. (Id. at ¶ 100.) PRINCIPLES OF LAW “Section 103(a) forbids issuance of a patent when ‘the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting 35 U.S.C. § 103(a)). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” Id. at 416. “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. Appeal 2012-005309 Application 11/829,056 9 ANALYSIS Claims 1 and 13 Claims 1 and 13 recite an intervertebral prosthesis including among other elements, “pillars of different average heights arranged to form an elongate anchor structure having an increasing height relative to the outer surface from at least one end of the anchor structure toward a center of the anchor structure” (Cls. 1, 13). We find that the Examiner has made a prima facie showing of obviousness for these claims based on the cited teachings of the prior art (Ans. 5–7; FF1–11). With respect to these independent claims, Appellants argue that “[i]n the event that one of ordinary skill in the art was to take the teachings of Eisermann et al. and apply those teachings to Lakin et al., the resulting implant would have a plurality of pegs with each of the pegs having a taper,” but assert that “[h]owever, neither reference teaches pillars of different heights” (App. Br. 11–12). In support, Appellants point to Fig. 39 of Eisermann to argue that Eisermann “did contemplate a multiple part anchor structure and that anchor structure did not meet the claimed ‘pillars of different average heights . . .’” (id. at 12). Appellants also argue that the Examiner relies upon an incorrect reading of Eisermann because “it is the sharp forward edge (tapering in the width direction) that facilitates insertion of the keel into the associated vertebral body” (id. at 10). We are not persuaded by Appellants’ arguments. Eisermann plainly discloses that an advantage of including the “sharp forward edge” (68a in Fig. 4a) is that “[b]y having such an edge, insertion of the keel into the associated vertebral body is facilitated,” and “the edge 68a can be of Appeal 2012-005309 Application 11/829,056 10 sufficient sharpness that the adjacent vertebral bodies do not require a slot for receiving the keel 68” (FF11). This is similar to the advantage of the rows of pillars with increasing height identified in Appellants’ Specification, which states: In specific embodiments, the pillars are shaped and arranged to facilitate insertion into the groove so that the pillars of a row will fit tightly in the groove, for example where the row of pillars is driven into the groove with force. For example, the row of pillars can include pillars of increasing height along the row so that the row presents pillars of increasing height to the groove as the row is advanced distally into the groove. (Spec. ¶ 11.) Contrary to Appellants’ characterization of the Eisermann reference, we find that the increasing height of edge 68a, and not merely the tapering width, facilitates insertion of the prosthesis between an upper and lower vertebra. Furthermore, Lakin itself also discloses that “[t]he keels may have a leading edge,” and that the pegs may include tapered sides (FF4, FF7). As such, we agree with the Examiner that one skilled in the art would have found it obvious to superimpose the overall shape of the keel (including sharp edge 68a) taught by Eisermann onto the spaced-apart pegs (i.e., pillars) taught by Lakin (Ans. 6–7). The advantage of such a combination is that the resulting prosthesis would allow for enhanced bone ingrowth between adjacent pegs, while also facilitating the insertion of the prosthesis between the vertebra. We find this to be a clear example of a “combination of familiar elements according to known methods [yielding] no more than ... predictable results.” KSR, 550 U.S. at 416. Appeal 2012-005309 Application 11/829,056 11 Appellants’ focus on the embodiment shown in Fig. 39 of Eisermann is unavailing. In particular, Appellants argue that “[t]o fabricate such a construct from the disclosures of Lakin and Eisermann is clearly hindsight reconstruction of the invention without any basis in the prior art,” and “[t]his hindsight reconstruction is particularly egregious in this situation where both Lakin (FIG. 7) and Eisermann (FIG. 39) show multiple pillars or multiple keels having the same height” (Reply Br. 3). We do not find the rejection to be based on hindsight reconstruction because the prior art provided express motivation to include a sharp/tapered edge in the keel to facilitate insertion of the prosthesis. Moreover, the fact that Eisermann disclosed an alternative embodiment in Fig. 39 that did not include a sharp edge for multiple keels does not negate the obviousness of the claimed invention. The mere disclosure of alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (the “mere disclosure of alternative designs does not teach away”); see also In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (“just because better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes”). Accordingly, we affirm the obviousness rejection of claims 1 and 13. Appellants do not present separate arguments for claims 2–4, 6–8, 10–12, 14–19, 21, 22, and 31–33. Therefore, those claims fall with their respective independent claims. 37 C.F.R. § 41.37(c)(1)(vii). Claim 5 Dependent claim 5 recites that “each pillar has a height and several pillars have substantially the same height” (Cl. 5). With respect to this claim, Appellants argue that “Lakin et al. and Eisermann et al. either alone Appeal 2012-005309 Application 11/829,056 12 or in any reasonable combination do not teach or suggest pillars of both increasing heights and pillars of the same height” (App. Br. 13). We disagree. The superimposition of the shape of the keel taught in Fig. 4a of Eisermann onto the pegs taught by Lakin would result in pillars of both increasing height and pillars of the same height. As noted by the Examiner, “there would be no reason for tapering all of the pillars of Lakin in view of Eisermann and his rationale because once the leading group of tapered pillars has penetrated the bone slot, the need for a taper has been obviated as the keel has already been inserted into the intervertebral space” (Ans. 10). We therefore affirm the rejection of claim 5. Claim 9 Dependent claim 9 recites that “at least some of the pillars have a vertical recess on a distal surface” (Cl. 9). The Examiner finds that this feature is satisfied by the recess between the adjacent pillars taught by Lakin (Ans. 11). Appellants argue that this feature is not taught or suggested by the combination, and that “[t]he space between pillars may be a recess, but it is clearly not ‘a recess on a distal surface’” (Reply Br. 4). We do not agree with Appellants’ claim interpretation, as there is nothing in the claim language to suggest that “a vertical recess on a distal surface” cannot be the recess between the adjacent pegs taught in Fig. 7 of Lakin. Moreover, we find nothing in either the claim language or the Specification to indicate that the “distal surface” must be the surface of the pillars as opposed to the claimed “outer surface of at least one of the upper component or the lower component” from which the pillars extend. The only reference in the Specification to a “vertical recess” is the statement that: “At least some of the pillars have a vertical recess on a distal surface. The Appeal 2012-005309 Application 11/829,056 13 vertical recess provides space into which bone can grow to anchor the implant, and the recess does not initially engage bone recess as the pillar is advanced distally into the groove” (Spec. ¶ 11). This does not suggest that the vertical recess must be different than the gaps between the rows of pillars, or that the “distal surface” must be on the surface of the pillars. To the contrary, the Specification elsewhere identifies “distal end 108” as the portion of the prosthesis “that leads as the implant is advanced into the intervertebral space” (id. at ¶ 26). Under our broadest reasonable interpretation of the claim 9, we find that the recess between the pillars taught by Lakin satisfies the “vertical recess” requirement. In re Am. Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (“During examination, ‘claims . . . are to be given their broadest reasonable interpretation consistent with the specification, and . . . claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.’”) (Citations omitted.) We therefore affirm the rejection of claim 9. Claim 20 Dependent Claim 20 recites that “the rows of pillars are offset from each other to avoid vertebral splitting” (Cl. 20). For this claim, the Examiner points to the embodiment in Fig. 6A of Lakin showing spaced apart keels (Ans. 7–8; FF5–6). Contrary to Appellants’ unsupported assertion, we find this to be a clear disclosure of pillars that are offset from each other as required by the claim. Appellants’ discussion of Figures 6 and 9 of Eisermann is not relevant since the Examiner did not rely upon those alternative embodiments to support the obviousness rationale (App. Br. 13– 14). We therefore affirm the rejection of claim 20. Appeal 2012-005309 Application 11/829,056 14 Claim 28 Claim 28 is a Jepson claim that claims as the improvement a plurality of spaced-apart anchors with “at least some of the anchors being of different average heights and are arranged to form an elongate anchor structure having an increasing height relative to an outer surface of the at least one component . . . ” (Cl. 28). Thus, the “anchors” recited in this claim are similar to the “pillars” recited in claims 1 and 13. The Examiner rejected this claim as obvious based on the same combined teachings of Lakin and Eisermann (Ans. 5–7). Because Appellants’ argument for this claim is similar to those discussed above with respect to claims 1 and 13, we also affirm the obviousness rejection of claim 28. Appellants do not present separate arguments for dependent claims 29 and 30. Therefore, those claims fall with claim 28. 37 C.F.R. § 41.37(c)(1)(vii). SUMMARY We affirm the claim rejections 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 cdc Copy with citationCopy as parenthetical citation