Ex Parte Williams et alDownload PDFBoard of Patent Appeals and InterferencesJan 19, 201010402123 (B.P.A.I. Jan. 19, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Ex parte LYTTON WILLIAMS and SUI-KAY WONG ____________________ Appeal 2009-006582 Application 10/402,123 Technology Center 3700 ____________________ Decided: January 19, 2010 ____________________ Before LINDA E. HORNER, STEVEN D.A. McCARTHY, and FRED A. SILVERBERG, Administrative Patent Judges. SILVERBERG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Lytton Williams et al. (Appellants) seek our review under 35 U.S.C. § 134 of the final rejection of claims 50-55, 61-71 and 103-106. We have jurisdiction under 35 U.S.C. § 6(b) (2002). Appeal 2009-006582 Application 10/402,123 2 SUMMARY OF DECISION We REVERSE. THE INVENTION Appellants’ claimed invention is directed to an intervertebral disc replacement device that can be implanted in a spine (Spec. 2: ¶¶ [0006] and [0007]). Claims 50, 55 and 62, reproduced below, are representative of the subject matter on appeal. 50. An intervertebral implant system comprising: a first anchor plate comprising a bone- engaging surface configured to face toward and be secured to a first vertebral body adjacent to an intervertebral space; a second anchor plate configured to be secured to a second vertebral body adjacent to the intervertebral space, wherein the second anchor plate is formed separately from the first anchor plate; and a first intermediate component rigidly attachable to the first anchor plate independently of any conical pres-fitted interface, the first intermediate component comprising a concave body having a concave recess shaped to articulate with a convex surface to permit postoperative relative motion between the first and second anchor plates; and a coupling device actuatable between an attached position, in which the coupling device is positioned to block removal of the concave body from the first anchor plate, and a detached position, in which the coupling device is positioned to avoid blocking removal of the Appeal 2009-006582 Application 10/402,123 3 concave body from the first anchor plate, without requiring detachment of the first anchor plate from the first vertebral body and without requiring access to the bone-engaging surface. 55. The intervertebral implant system of claim 50, wherein the first intermediate component further comprises a convex body having the convex surface, wherein the convex body is configured to be at least one of attached to and detached from the second anchor plate without requiring detachment of the second anchor plate from the second vertebral body. 62. An intervertebral implant system comprising: a first anchor plate comprising a bone- engaging surface configured to face toward and be secured to a first vertebral body adjacent to an intervertebral space; a second anchor plate configured to be secured to a second vertebral body adjacent to the intervertebral space; a first intermediate component having a substantially rigid structure, wherein the first intermediate component is rigidly attachable to the anchor plates to perform a first function; and a second intermediate component having a substantially rigid structure, wherein the second intermediate component is rigidly attachable to the anchor plates to perform a second function; wherein the first and second intermediate components are interchangeably attachable to the anchor plates; wherein the first and second functions are different; wherein the bone-engaging surface is shaped to abut the first vertebral body without requiring Appeal 2009-006582 Application 10/402,123 4 removal of a substantial amount of bone tissue from the first vertebral body. THE REJECTIONS The Examiner relies upon the following as evidence of unpatentability: Boyd US 5,425,773 Jun. 20, 1995 Eisermann US 2003/0204261 A1 Oct. 30, 2003 Coates US 6,899,735 B2 May 31, 2005 The following rejections by the Examiner are before us for review: 1. Claims 62-71, 105 and 106 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2. Claims 50-55, 61-66, 69-71 and 103-106 are rejected under 35 U.S.C. § 102(b) as being anticipated by Boyd. 3. Claims 55, 62-67, 69-71, 105 and 106 are rejected under 35 U.S.C. § 102(e) as being anticipated by Eisermann. 4. Claims 55, 62, 63, 65-71 and 105 are rejected under 35 U.S.C. § 102(e) as being anticipated by Coates. ISSUES The issues before us are: (1) whether the Examiner erred in finding that the limitation “without requiring removal of a substantial amount of bone tissue from the first vertebral body” as called for in claim 62 is not supported by Appellant’s Specification or Drawings as required by the written description requirement of 35 U.S.C. § 112, first paragraph (Reply Appeal 2009-006582 Application 10/402,123 5 Br. 5, App. Br. 5); (2) whether the Examiner erred in finding that Boyd describes a coupling device that is actuatable between an attached position and a detached position without requiring access to the bone engaging surface as called for in independent claim 50 (Reply Br. 8, App. Br. 7); (3) whether the Examiner erred in finding that Boyd describes an intermediate component rigidly attachable to the anchor plates as called for in independent claim 62 (Reply Br. 9, App. Br. 8); (4) whether the Examiner erred in finding that Eisermann and Coates are available as prior art against claim 55 (Reply Br. 12, 15; App. Br. 8, 11); (5) whether the Examiner erred in finding that Eisermann describes a bone-engaging surface shaped to abut the first vertebral body without requiring removal of a substantial amount of bone tissue from the first vertebral body as called for in independent claim 62 (Reply Br. 12, App. Br. 11); and (6) whether the Examiner erred in finding that Coates describes a second intermediate component rigidly attachable to the anchor plates as called for in independent claim 62 (Reply Br. 15, App. Br. 12). ANALYSIS Rejection of claims 62-71, 105 and 106 under 35 U.S.C. § 112, first paragraph Claim 62 calls for, inter alia, “wherein the bone-engaging surface is shaped to abut the first vertebral body without requiring removal of a substantial amount of bone tissue from the first vertebral body.” Appellants contend that the limitation “without requiring removal of a substantial amount of bone tissue from the first vertebral body” as called for in claim 62 is fully supported by Appellants’ disclosure, specifically in Provisional Application 60/368,783, which is incorporated by reference Appeal 2009-006582 Application 10/402,123 6 (Reply Br. 5, App. Br. 6). Appellants further contend that “[n]o removal of bone tissue or ‘tissue of the endplates of the vertebral bones’ is disclosed.” (Reply Br. 7). In support thereof, Appellants reference page 13 of Provisional Application 60/368,783, which describes that (1) “[t]he anchoring elements 18 are preferably introduced into vertebrae V1 and V2 without first creating one of [sic] more holes in the vertebrae for the anchoring elements 18” and (2) that “[c]are should be taken not to violate the endplates E1 and E2.” (App. Br. 6). In further support thereof Appellants contend that “one skilled in the art would also understand that in this instance, ‘substantial’ does not have any special meaning and therefore carries its common meaning as ‘of ample or considerable amount quantity, size etc.’” (Reply Br. 7). The Examiner found that the limitation “without . . . body” is not supported by Appellants’ Specification or Drawings (Ans. 4). The Examiner further found in regard to Appellants’ invention, that it is “difficult to conclude that such a method does not require removal of bone tissue.” (Ans. 9). The Examiner still further found that Appellants’ Specification does not define how much a “substantial amount” is (Ans. 9). Appellants’ Application on appeal was filed on March 28, 2003, and incorporated by reference in its entirety Provisional Application 60/368,783, filed on March 30, 20021. Appellants’ Specification describes that “[d]ebris, such as osteophytes or residual disc material may be removed from the disc space.” Spec. 20, ¶ 1 See page 1, paragraph [0001] of Appellants’ Specification. Appeal 2009-006582 Application 10/402,123 7 [0084].2 “With the disc space cleared of debris, the components of the intervertebral device 10 may be inserted in the patient’s spine.” (Spec. 20, ¶ [0085]) (emphasis added). Further, Provisional Application 60/368,783, page 13 states that the integrity of the endplates E1 and E2 is a concern. We find that Appellants’ proffered definition of “substantial” is consistent with its ordinary meaning3. A person having ordinary skill in the art would understand the phrase “substantial amount,” as called for in claim 62 and in light of the ordinary meanings of the words used in the phrase, to refer to a considerable amount. A person having ordinary skill in the art would understand that the removal of debris and residual material, while also maintaining the integrity of the endplates, is not the removal of a considerable amount, that is, a substantial amount of bone tissue from the first vertebral body. Therefore, we find that the limitation “without requiring removal of a substantial amount of bone tissue from the first vertebral body” as called for in claim 62 is fully supported by Appellants’ original disclosure. See Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002) (“[T]he written description requirement is satisfied by the patentee’s disclosure of ‘such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.’”). Accordingly, we conclude that Appellants have demonstrated that the Examiner erred in rejecting claim 62 as failing to comply with the written 2 Citations to the “Spec.” are to the Substitute Specification, filed on May 16, 2005. 3 The ordinary meaning of the word “substantial” includes “considerable in quantity, significantly great.” MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY (10th ed. 1996). Appeal 2009-006582 Application 10/402,123 8 description requirement of 35 U.S.C. § 112, first paragraph. Appellants have likewise demonstrated error in the Examiner’s rejection of claims 63- 71, 105 and 106, which depend from claim 62. Rejection of claims 50-55, 61-66, 69-71 and 103-106 under 35 U.S.C. § 102(b) as being anticipated by Boyd Regarding independent claim 50: Claim 50 calls for, inter alia, a coupling device actuatable between an attached position and a detached position without requiring access to the bone-engaging surface. Appellants contend that Boyd does not describe a coupling device actuatable between an attached position and a detached position without requiring access to the bone-engaging surface as called for in claim 50, as Boyd’s screw 78 is only accessible to be actuated from the space directly adjacent to the bone-engaging surface 76 (App. Br. 7). The Examiner contends that prior to implantation, Boyd’s device is actuatable between an attached position and a detached position (Ans. 9). Boyd describes, inter alia, an insert cup 170 having an engaging surface 176, and a screw (coupling device) 78 counter-sunk in the engaging surface 176 of the insert cup 170 (col. 8, l. 54-col. 9, l. 20; and figs. 18-20). We find that in Boyd, regardless of whether the device is implanted, the only access to the screw head is by way of the engaging surface 176. Therefore, Boyd does not describe a coupling device actuatable between an attached position and a detached position without requiring access to the bone-engaging surface as called for in claim 50. Appellants have likewise demonstrated error in the Examiner’s rejection of claims 51- 55, 61, 103 and 104, which depend from claim 50. Appeal 2009-006582 Application 10/402,123 9 Regarding independent claim 62: Claim 62 calls for, inter alia, “a first intermediate component . . . rigidly attachable to the anchor plates to perform a first function; and a second intermediate component . . . rigidly attachable to the anchor plates to perform a second function; wherein the first and second intermediate components are interchangeably attachable to the anchor plates.” Appellants contend: (1) that Boyd does not describe a first and second intermediate component as called for in claim 62 (App. Br. 8); (2) that claim 62 is intended to and “explicitly requires the first intermediate [component] to be attachable simultaneously to the plates (plural) to perform a function” (Reply Br. 9); (3) that “[i]f the intent had been that the intermediate component could be attachable to either plate to perform a first function, the claim would have been written that way” (Reply Br. 9); and (4) that neither of Boyd’s components 24, 44 are capable of simultaneously attaching to both of the anchor plates (Reply Br. 9). The Examiner contends: (1) that claim 62 does not require that the intermediate components be attachable to both of the anchor plates at the same time (Ans. 10-11); and (2) that Boyd describes a first intermediate component 24 and a second intermediate component 44, wherein the intermediate components 24, 44 are interchangeably attachable to each one of the anchor plates (Ans. 10-11). Appellants have stated that claim 62 is intended to and “explicitly requires the first intermediate [component] to be attachable simultaneously to the plates (plural) to perform a function.” (Reply Br. 9). Appeal 2009-006582 Application 10/402,123 10 Claim 62 calls for a first intermediate component performing a first function when the first component is attachable to the anchor plates, that is, plural anchor plates and not an anchor plate. In view of the anchor plates being called for in claim 62 in the plural, a person having ordinary skill in the art would understand the language “attachable to the anchor plates” as called for in claim 62 as requiring the first intermediate component to be capable of being attached simultaneously to both of the anchor plates to perform the first function, and the second intermediate component to be interchangeable with the first intermediate component and likewise capable of being attached simultaneously to both of the anchor plates to perform the second function. We will also interpret claim 62 in that manner. See Toro Co. v. White Consolidated Indus., Inc., 199 F.3d 1295, 1299 (Fed. Cir. 1999) (In judicial “claim construction” the court must achieve the same understanding of the patent, as a document whose meaning and scope have legal consequences, as would a person experienced in the technology of the invention. Such a person would not rely solely on a dictionary of general linguistic usage, but would understand the claims in light of the specification and the prior art, guided by the prosecution history and experience in the technologic field.). See also In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (holding that when construing claim terminology in the United States Patent and Trademark Office, claims are to be given their broadest reasonable interpretation consistent with the specification, reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art.). Appeal 2009-006582 Application 10/402,123 11 Boyd describes an upper assembly (anchor plate) 20, a lower assembly (anchor plate) 22, a first member (first component) 24 and a second member (second component) 44 (col. 4, l. 57-68; col. 5, ll. 12-28). Boyd shows in Figure 3 that the first and second members 24, 44 can only be attached to one of the assemblies at a time. Therefore, Boyd does not describe a first intermediate component attachable simultaneously to both of the anchor plates, and a second intermediate component attachable simultaneously to both of the anchor plates as called for in claim 62. Appellants have likewise demonstrated error in the Examiner’s rejection of claims 63-66, 69-71, 105 and 106, which depend from claim 62. Rejection of claim 55 under 35 U.S.C. § 102(e) as being anticipated by Eisermann or Coates Regarding claim 55: Claim 55 calls for, inter alia, that both the concave body and the convex body are attachable and detachable. Appellants contend that: (1) the present invention claims priority to Provisional Application 60/368,783, filed March 30, 2002 (Reply Br. 4, 12, 15; App. Br. 8, 11); (2) Provisional Application 60/368,783 describes and shows in the last two figures the invention called for in claim 55, that is, that both the concave body and the convex body are attachable and detachable (App. Br. 8, 11); (3) the invention called for in claim 55 is entitled to the filing date of the Provisional Application 60/368,783, that is, March 30, 2002 (Reply Br. 4, 12; App. Br. 8); and (4) Eisermann and Coates are not available as prior art against claim 55 (Reply Br. 12, 15). The Examiner contends that: (1) Provisional Application 60/368,783 does not describe in one embodiment that both the concave and convex Appeal 2009-006582 Application 10/402,123 12 inserts are removable (Ans. 12, 14); (2) the invention called for in claim 55 is only entitled to a filing date of March 28, 2003; and (3) both Eisermann and Coates are available as prior art against the invention called for in claim 55 (Ans. 12, 15). Appellants’ Application on appeal was filed on March 28, 2003. Appellants’ Specification claims the benefit of the earlier-filed Provisional Application 60/368,783, filed March 30, 2002. Eisermann’s invention, filed on October 30, 2003, contains a claim for the benefit of an earlier-filed provisional application filed April 25, 2002. Coates’ invention was filed on October 2, 2002. A non-provisional application shall have the same effect as though it was filed on the date of the provisional application to which benefit has been claimed. 35 U.S.C. § 119(e)(1). We find that Provisional Application 60/368,783, in particular, the last two figures, describes and shows, in one embodiment, that both the concave body and the convex body (1) are attached to the anchor plates by being slid into ‘T’ slots and (2) are secured to the anchor plates by two screws. In particular, the next to last figure of the provisional application contains the wording “[m]ovement subassembly slide into ‘T’ slots in this direction & then secure with 2 screws.” The last figure of the provisional application denotes the convex body as an “upper movement convex half” and part of the concave body as a “lower movement half.” Since the concave body and the convex body are held in place by screws, we find that both the concave body and the convex body are attachable and detachable. Thus, we find that Provisional Application 60/368,783 describes the invention called for in claim 55. Appeal 2009-006582 Application 10/402,123 13 Therefore, the invention called for in claim 55 is entitled to the benefit of the filing date of March 30, 2002, the filing date of the provisional application. The claim 55 filing date of March 30, 2002 predates both Eisermann’s priority date of April 25, 2002 and Coates’ filing date of October 2, 2002. Accordingly, both Eisermann and Coates are not available as prior art against claim 55. Therefore, we conclude that Appellants have demonstrated that the Examiner erred in rejecting claim 55 as being anticipated by Eisermann and as being anticipated by Coates. Rejection of claims 62-67, 69-71, 105 and 106 under 35 U.S.C. § 102(e) as being anticipated by Eisermann Claim 62 calls for, inter alia, that the bone-engaging surface is shaped to abut the first vertebral body without requiring removal of a substantial amount of bone tissue from the first vertebral body. Appellants contend: (1) that Eisermann does not describe shaping the bone-engaging surface without requiring removal of a substantial amount of bone tissue from the first vertebral body as called for in claim 62 (Reply Br. 12); (2) that Eisermann’s system requires removal of a substantial amount of bone tissue from the first vertebral body, as is evidenced by Eisermann’s elongate recesses 300 (Reply Br. 12; App. Br. 11); and (3) that since Eisermann describes in paragraph [0058] that recesses 300 are formed by reaming, drilling and chiseling; substantial amounts of bone tissue are being removed from the vertebral bodies (Reply Br. 13). The Examiner found that: It is true, Eisermann shows removal of some bone tissue from the endplates in fig. 14 in order to Appeal 2009-006582 Application 10/402,123 14 provide a flush fit with the implant anchor plates. This removal shown in fig. 14 however is not considered by the examiner to be a “substantial amount”, as only a small portion of the vertebral endplate surface is removed compared to the entire endplate (Vu or Vl [sic, VL]). (Ans. 13). Eisermann describes that to accommodate the insertion of the disc prosthesis 20 within the intervertebral space S, preparation of the upper and lower vertebrae VU, VL is required. (p. 6, col. 1, ¶ [0057]). Eisermann’s intervertebral space S is enlarged by forming elongate openings or recesses 300. (p. 6, col. 1, ¶ [0057]). Eisermann’s elongate recesses 300 are formed by reaming, while other methods of forming the recesses 300 are also contemplated, e.g., drilling and chiseling. (p. 6, col. 1, ¶ [0058]). A person having ordinary skill in the art would understand that the limitation “without requiring removal of a substantial amount of bone tissue from the first vertebral body” called for in claim 62 is not broad enough to cover reaming, chiseling and drilling. Therefore, we conclude that Appellants have demonstrated that the Examiner erred in rejecting claim 62 as being anticipated by Eisermann. Appellants have likewise demonstrated error in the Examiner’s rejection of claims 63-67, 69-71, 105 and 106, which depend from claim 62. Rejection of claims 62, 63, 65-71 and 105 under 35 U.S.C. § 102(e) as being anticipated by Coates Claim 62 calls for, inter alia, first and second intermediate components performing different functions, and being rigidly and interchangeably attachable to the anchor plates. Appeal 2009-006582 Application 10/402,123 15 Appellants contend that Coates does not describe a second intermediate component rigidly attachable to the anchor plates as called for in independent claim 62 (Reply Br. 15, App. Br. 12). Appellants further contend that Coates’ additional inserts 70a do not perform a second function as they are nothing more than a duplicate of the first insert 70a (Reply Br. 16). The Examiner contends that in Coates, the different sized or shaped additional inserts 70a or fusion inserts 70b are a second intermediate component which is rigidly attachable to the anchor plates (Ans. 15). The Examiner further contends that Coates’ fusion inserts 70b are rigidly attachable by rigid stabilizers or by bone growth (Ans. 15). Coates’ describes: (1) two types of inserts 70, an articulating insert 70a and a fusion insert 70b (col. 3, ll. 1-51); (2) that other forms of the inserts 70 may be employed without departing from the broadest forms of the present invention (col. 3, ll. 25-32); (3) that “while fusion-type inserts 70b may be readily removable immediately after installation, the insert 70b may become fixed in place over time” (col. 5, ll. 11-14); and (4) means to promote the fusion process of insert 70b (col. 5, ll. 14-17). We find that Coates only describes two types of inserts 70, an articulating type 70a performing a first function and a fusion type 70b performing a second function. We find that while Coates’ articulating type of insert 70a may take different forms, or be of a different size or shape, all of the articulating inserts will articulate, and therefore, will all perform the same function. Further, Coates’ fusion type inserts 70b may also be of different size or shape, but will all perform the same function of fusing (fig. 2). Appeal 2009-006582 Application 10/402,123 16 We find that replacing an articulating insert 70a (a first intermediate component) with another articulating insert 70a will not provide a second intermediate component having a different function as called for in claim 62. Since Coates has denoted inserts 70b as fusion inserts and describes means to promote the fusion process, Coates intends that the inserts 70b become fixed in place. Therefore, we find that Coates’ inserts 70b are not interchangeably attachable to the anchor plates as called for in claim 62. Assuming arguendo that one could consider the insert 70b to be interchangeably attachable since it is removable immediately after installation, Coates further describes and shows an aperture 60 closed off by arms 52 and linking bridge member 58 to hold insert 70b in a mating relationship to the baseplate 20 (col. 2, ll. 49-64, col. 4, ll. 56-59; and fig. 1). Further, Coates describes that “[o]nce the proper insert 70 has been selected and installed, the surgeon may add an optional flexible or rigid element (not shown) secured to the exterior of the mounting sections 30 of the two baseplates 20, if desired.” (col. 4, l. 65-col. 5, l. 1). We find that the Examiner has misinterpreted Coates’ fusion insert 70b, in view of the addition of the rigid element, as being rigidly attachable to the anchor plates. As Coates’ rigid element is secured to the mounting sections 30, not the insert 70b, Coates’ insert 70b is only secured to the baseplates 20 by a mating relationship (fig. 1). Therefore, Coates’ fusion insert 70b is not rigidly attachable to the anchor plates as called for in claim 62. Therefore, we conclude that Appellants have demonstrated that the Examiner erred in rejecting claim 62 as being anticipated by Coates. Appeal 2009-006582 Application 10/402,123 17 Appellants have likewise demonstrated error in the Examiner’s rejection of claims 63, 65-71 and 105, which depend from claim 62. CONCLUSIONS Appellants have established that the Examiner erred in finding that the limitation “without requiring removal of a substantial amount of bone tissue from the first vertebral body” as called for in claim 62 is not supported by Appellant’s Specification or Drawings as required by the written description requirement of 35 U.S.C. § 112, first paragraph. Appellants have established that the Examiner erred in finding that Boyd describes a coupling device that is actuatable between an attached position and a detached position without requiring access to the bone engaging surface as called for in independent claim 50. Appellants have established that the Examiner erred in finding that Boyd describes an intermediate component rigidly attachable to the anchor plates as called for in independent claim 62. Appellants have established that the Examiner erred in finding that Eisermann and Coates are available as prior art against claim 55. Appellants have established that the Examiner erred in finding that Eisermann describes a bone-engaging surface shaped to abut the first vertebral body without requiring removal of a substantial amount of bone tissue from the first vertebral body as called for in independent claim 62. Appellants have established that the Examiner erred in finding that Coates describes a second intermediate component rigidly attachable to the anchor plates as called for in independent claim 62. Appeal 2009-006582 Application 10/402,123 18 DECISION The decision of the Examiner to reject claims 50-55, 61-71 and 103- 106 is reversed. REVERSED mls MEDICINELODGE INC. 124 SOUTH 600 WEST LOGAN, UT 84321 Copy with citationCopy as parenthetical citation