Ex Parte Aram et alDownload PDFBoard of Patent Appeals and InterferencesMar 13, 201211171180 (B.P.A.I. Mar. 13, 2012) 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. 11/171,180 06/30/2005 Luke Aram 1671-0337 6029 28078 7590 03/13/2012 MAGINOT, MOORE & BECK, LLP CHASE TOWER 111 MONUMENT CIRCLE SUITE 3250 INDIANAPOLIS, IN 46204 EXAMINER SNOW, BRUCE EDWARD ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 03/13/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte LUKE ARAM, DAN AUGER, ADAM HAYDEN, and JORDAN LEE __________ Appeal 2010-009896 Application 11/171,180 Technology Center 3700 __________ Before TONI R. SCHEINER, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to methods of configuring and implanting prostheses. The Examiner entered rejections for new matter, anticipation, and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse the anticipation rejections. We affirm the new matter rejection, however. We also affirm the obviousness rejection, except as to one claim. Appeal 2010-009896 Application 11/171,180 2 STATEMENT OF THE CASE Appellants invented a method of configuring a prosthesis for use in total knee replacement procedures (see Spec. 1). In one embodiment, the invention provides distinct, separate components for resurfacing the knee- facing portion of the femur (see Figures 43 and 44). The components may be deployed by attaching them to the femur, and to each other, using connectors, such as screws (id.; see also Spec. 37). The connectors may be made of resilient materials (Spec. 39; see also Figures 48A and 48B). Claims 9-20 stand rejected and appealed (App. Br. 2). Claims 9 and 14, the independent claims, illustrate the appealed subject matter and read as follows: Claim 9. A method of configuring a prosthesis system comprising: selecting one of a plurality of first components in a kit for replacing a first surface portion of a bone, each of the plurality of first components including a bone contacting side configured to be placed against the bone; selecting one of a plurality of second components in the kit for replacing a second surface portion of the bone; and connecting the selected first component to the selected second component with a first resilient connector, the first resilient connector formed from a material other than material used to form the second component. Claim 14. A method for implanting a prosthesis system comprising: making an incision; selecting a first component having a bone mounting surface, a bone surface replacement surface, a first side adjacent to the bone mounting surface and adjacent to the bone surface replacement surface, and a second side adjacent to the bone mounting surface and adjacent to the bone surface replacement surface; Appeal 2010-009896 Application 11/171,180 3 selecting a second component having a bone mounting surface, a bone surface replacement surface, and a side adjacent to the bone mounting surface and the bone surface replacement surface; connecting the first component and the second component with a resilient connector, the resilient connector of a material different from material included in the second component, such that the first side of the first component is in opposition to the side of the second component; inserting the connected first component and second component through the incision; and mounting the first and the second component on a bone such that the bone mounting surface of the first component and the bone mounting surface of the second component are in opposition to the bone. The following rejections are before us for review: (1) Claims 9-20, under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Ans. 4); (2) Claims 9, 10, 12, 14, and 18-20, under 35 U.S.C. § 102(e) as anticipated by White1 (Ans. 4-6); and (3) Claims 9-11 and 13-20, under 35 U.S.C. § 102(e) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Johnson2 (Ans. 6-7). WRITTEN DESCRIPTION/NEW MATTER The Examiner found that claims 9-20 recite “subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention” (Ans. 4). Specifically, 1 U.S. Patent App. Pub. No. 2006/0116770 A1 (published June 1, 2006). 2 U.S. Patent App. Pub. No. 2005/0278034 A1 (published December 15, 2005). Appeal 2010-009896 Application 11/171,180 4 the Examiner contended that Appellants added “the new limitation, ‘the first resilient connector formed from a material other than material used to form the second component’ to both independent claims (similar language for claim 14)” (id.). However, the Examiner urged, Appellants “failed to indicate where support could be found in the original disclosure,” and the Examiner was unable to find support for the inserted language (id.). Appellants contend that “[m]aterials used in forming condylar components are well known. Specifically, the femoral components are made of a hard material such as stainless steel or chromium cobalt alloy. (See, e.g., U.S. Patent No. 3,878,566 at column 3, line 56, et seq.)” (App. Br. 8). In contrast to the Examiner’s position, Appellants argue, “the resilient connectors, as disclosed at page 39, lines 8-15 of Appellants’ specification, are made of suitable resilient materials which include nitinol, polyurethanes, elastomers and liquid metals” (id.). Thus, Appellants reason, “the materials specifically identified are different from, and more resilient than, the materials known by those of ordinary skill in the art to be used in forming femoral components” (id.). Further, Appellants argue, the Specification “need not disclose what is well-known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public” (id. (citing. In re Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991))). We find that the Examiner has the better position. While we agree with Appellants that a disclosure may be enabling even if it does not describe what is already well known, Buchner, 929 F.2d at 661, the Examiner’s written description rejection presents a different issue than the enablement rejection discussed in Buchner. See Ariad Appeal 2010-009896 Application 11/171,180 5 Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1340 (Fed. Cir. 2010) (“We now reaffirm that § 112, first paragraph, contains a written description requirement separate from enablement . . . .”) (emphasis added). As stated in TurboCare Div. of Demag Delaval Turbomachinery Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001): The written description requirement and its corollary, the new matter prohibition of 35 U.S.C. § 132, both serve to ensure that the patent applicant was in full possession of the claimed subject matter on the application filing date. When the applicant adds a claim or otherwise amends his specification after the original filing date . . ., the new claims or other added material must find support in the original specification. It is well settled, however, that “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, where the disclosure does not provide word-for-word support for claimed subject matter, “a description that merely renders the invention obvious does not satisfy the requirement.” Ariad v. Lilly, 598 F.3d at 1352. Thus, as the Federal Circuit has explained, “the written description must include all of the limitations . . ., or the applicant must show that any absent text is necessarily comprehended in the description provided and would have been so understood at the time the patent application was filed.” Hyatt v. Boone, 146 F.3d 1348, 1354-55 (Fed. Cir. 1998) (emphasis added). Here, Appellants’ arguments do not persuade us that an ordinary artisan would have understood that the Specification describes the second Appeal 2010-009896 Application 11/171,180 6 bone surface-replacing component of the inventive prosthesis as necessarily being made of a different material than the resilient connector. It is undisputed that the limitation at issue does not find literal textual support in the disclosure. Moreover, page 39 of the Specification simply does not state what materials are to be used to make the non-connector components of the inventive prostheses, and Appellants point to no other portion of the disclosure explaining what those components are to be made of. Thus, while it might be true that ordinary artisans would have understood what materials would be useful to make knee prostheses, Appellants have directed us to no portion of the Specification that would have led an ordinary artisan to unequivocally conclude that the non- connector components of the inventive prostheses were to be made of any particular material. We are therefore not persuaded that the Specification would have led an ordinary artisan to necessarily conclude that the disclosure included an embodiment in which the non-connector components were composed of materials different than the materials used to make the connectors. While the Specification might have made it obvious to make the prostheses using a combination of different materials as claimed, descriptive support cannot be demonstrated merely by showing that the limitations at issue would have been obvious from the alleged supporting disclosure. See Ariad v. Lilly, 598 F.3d at 1352. In sum, Appellants’ arguments do not persuade us that the Examiner erred in rejecting claims 9-20 under 35 U.S.C. § 112, first paragraph. We therefore affirm that rejection. Appeal 2010-009896 Application 11/171,180 7 ANTICIPATION – WHITE The Examiner rejected claims 9, 10, 12, 14, and 18-20 as anticipated by White (Ans. 4-6). Among other reasons, Appellants traverse the Examiner’s finding of anticipation because, “in order to anticipate claim 9, the formed prosthesis must be configured for placement on a single bone, with both of the components providing a replacement surface for the bone on which they are positioned” (App. Br. 12). The Examiner responds that White’s device is capable of fulfilling the intended uses and functional limitations recited in the claims (Ans. 9-10). In particular, the Examiner urges, White’s three-piece intra-vertebral prosthesis provides a replacement surface for the vertebra it replaces, and the pieces of the device that correspond to the first and second components of the claimed device are “fully capable of contacting a remaining rear portion of the replaced vertebrae bone 72 with a bone contacting side” (id. at 10 (citing White, Figure 8)). Further, the Examiner notes, “entire bone 72 was not removed. It would be advantageous to leave as much of the bone 72 as possible to help fuse vertebrae 70 and 74” (id. at 11 (citing White, Figure 8)). As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Appeal 2010-009896 Application 11/171,180 8 While we have carefully considered the Examiner’s position, we are not persuaded that the Examiner has adequately explained why White describes a method having all of the claimed features. We agree that “‘[f]unctional’ terminology may render a claim quite broad . . .[;] a claim employing such language covers any and all embodiments which perform the recited function.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). Thus, functional limitations directed to an intended use of an apparatus claim do not serve to distinguish the claimed apparatus from prior art apparatuses inherently capable of performing the claimed function. See In re Schreiber, 128 F.3d 1473, 1478-79 (Fed. Cir. 1997) (holding prior art apparatus anticipatory because it was inherently capable of performing the claimed function). We also agree that claim 9 recites a relatively simple method in which two components are a connected to each other using a resilient connector made of a material different from that used to form one of the components. Claim 9 does, however, state that the first component is “for replacing a first surface portion of a bone” and also includes “a bone contacting side configured to be placed against the bone” (App. 29 (emphasis added)). Thus, we interpret claim 9 as reciting a method that uses a component capable not only of replacing the surface of a bone, but also capable of contacting the same bone whose surface is being replaced. As seen in the embodiments discussed above, this may be accomplished by a component that is shaped to conform to the bone, or cover it, so as to provide a replacement surface, such as performed in a total knee replacement (see Appellants’ Figures 43 and 44). Appeal 2010-009896 Application 11/171,180 9 In contrast, the Examiner’s anticipation rejection of claim 9 is based on the finding that White’s device is configured such that one or the other end portions of the device would contact a portion of removed vertebra 72, if that vertebra was not fully removed (see Ans. 10-11). However, White explicitly states that its “vertebral replacement device 10 can be placed between vertebra 70 and vertebra 74 after removal of vertebra 72” (White [0070] (emphasis added)). Thus, contrary to the Examiner’s position, White describes total, rather than partial, removal of the vertebra to be replaced. We are therefore not persuaded that the Examiner has adequately explained why White’s device is capable of providing both a replacement surface for a bone, and also contact the bone whose surface is replaced. While the Examiner urges that partial removal of the vertebra would be advantageous, and would result in contact between an end component of the device and the partially removed bone, the Examiner points to no portion of White that explicitly or inherently discloses replacement of a partially removed vertebra in that manner. Nor does the Examiner point to any embodiment showing that one of the end portions of White’s device, when connected to the other two portions, would necessarily be capable of contacting a portion of a bone, while also providing a replacement surface for that bone. In sum, as we are not persuaded that the Examiner has adequately explained why White describes a method that uses components capable of performing as required by claim 9, we reverse the Examiner’s anticipation rejection of that claim, and its dependents, over White. As claim 14 recites a process requiring similarly configured components, we also reverse the Appeal 2010-009896 Application 11/171,180 10 Examiner’s anticipation rejection of that claim, and its dependents, over White. ANTICIPATION – JOHNSON The Examiner rejected claims 9-11 and 13-20 as anticipated by or, in the alternative, as obvious over Johnson (Ans. 6-7). Appellants argue that the Examiner erred in finding that Johnson anticipates the rejected claims, because the Examiner has not shown that the connectors joining Johnson’s femoral surface replacing components are necessarily formed of a material different than the material forming the components themselves, as required by independent claims 9 and 14 (App. Br. 22-24). The Examiner responds that the claims do not recite “that the material used to form the connector is a different type of material used to form second component. Material can not be in two places at one time. It is impossible that the material forming the connector is the same of the material forming the second component” (Ans. 13-14). Further, the Examiner urges, Johnson “teaches in claim 22, ‘at least one of the components includes a CSTi coating’” (id. at 14). Therefore, the Examiner reasons “one . . . component is formed with a coating and the other is not. This also inherently fulfills the language, ‘the first resilient connector formed from a material other than the material used to form the second component’” (id.). Claim 9 recites connecting first and second bone resurfacing components with a “first resilient connector formed from a material other than material used to form the second component” (App. Br. 29). Claim 14 Appeal 2010-009896 Application 11/171,180 11 similarly requires the resilient connector to be formed “of a material different from a material included in the second component” (id. at 30). We are not persuaded that an ordinary artisan would have considered it reasonable to interpret two components, such as two bricks, with identical chemical compositions, to be composed of different materials simply because the two bricks were separate from each other. Thus, we are also not persuaded that Johnson’s connection mechanisms 54 were necessarily formed of a different material than that forming mating components 12 and 14, merely because those pieces are not contiguous (see Johnson, Figure 5). Moreover, the fact that one or the other of Johnson’s components can have a particular coating (Johnson, p. 8 (claim 22)) does not persuade us that the component having that coating is “formed from” the coating material as recited in claim 9, or that the coating is “included in” the component (emphasis added) as claim 14 requires. Thus, as we are not persuaded that Johnson describes a process having all of the features of independent claims 9 and 14, we reverse the Examiner’s anticipation rejection of those claims, and their dependents, over Johnson. OBVIOUSNESS – JOHNSON The Examiner alternatively concluded that claims 9-11 and 13-20 would have been obvious to an ordinary artisan (Ans. 7). Specifically, the Examiner posited that an ordinary artisan would have considered it obvious to “have tried a material such as a plastic for the third body such that it would snap into a component[] made of, for example, an alloy material with predictable results” (id.). The Examiner reasoned that, in view of the snapping engagement mechanism Johnson described as being useful in its connectors, an ordinary artisan would have reasoned that plastic would be a Appeal 2010-009896 Application 11/171,180 12 suitable material for achieving that functionality, and that the “resilient material such as plastic would be a different material than the well known metal/alloy materials used in the art for the articulating components” (id. at 14-15). Appellants’ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion of obviousness. Appellants initially argue that the Examiner “failed to provide a clear articulation as to why one of ordinary skill in the art would find a resilient connector to be obvious for use with the device of Johnson” (id. at App. Br. 24). We are not persuaded. As seen in Figure 5 of Johnson, Johnson discloses a knee replacement system that includes two bone resurfacing components 40 and 12, as required by claim 9. As also required by claim 9, the two components are joined using a “connection mechanism” 54 that matingly engages a connector 28 (Johnson [0059]; see also id. at Fig. 5). As the Examiner pointed out (Ans. 6), Johnson discloses that its resurfacing components can be joined together by configuring the connection mechanisms 54 such that they “snap[p]ingly engage” their mating part (Johnson [0060]). While it may be true that Johnson does not expressly state that resilient connectors would useful for providing the snapping engagement, we agree with the Examiner that an ordinary artisan would have reasonably inferred that resilient connectors would be suitable for achieving the snapping connection functionality described by Johnson, and that it would be suitable to form such resilient connectors of a different material than that used to form the hard articulating surfaces of the resurfacing components. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, Appeal 2010-009896 Application 11/171,180 13 418 (2007) (The obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”); see also id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an automaton.”). Appellants argue that a resilient connector “would not guarantee the fit required by the device of Johnson. Moreover, a resilient connector would allow for movement between the adjacent components” (App. Br. 24). Further, Appellants argue, if the components are placed closely together as Johnson teaches, “the components joined with resilient connectors could rub together, resulting in undesired generation of friction debris as discussed in the Appellants’ specification at page 4, lines 2-9. One of ordinary skill in the art would not attempt to use a connector that would generate friction debris” (id.). We do not find these arguments persuasive. While page 4 of the Specification may discuss the problem of frictional debris caused by rubbing components, given Johnson’s express disclosure of using a snapping engagement mechanism, we are not persuaded that an ordinary artisan would have failed to adopt that connection technique using resilient connectors. Moreover, Appellants point to no specific evidence suggesting that an ordinary artisan would have expected that using resilient connectors to achieve Johnson’s snapping connection would provide an inadequate fit, or would allow excessive component movement such that undesired friction debris would result. It is well settled that argument of counsel is not an adequate substitute for actual evidence. See In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997). Appeal 2010-009896 Application 11/171,180 14 In sum, because Appellants’ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner’s prima facie case of obviousness as to claim 9, we affirm the Examiner’s obviousness rejection of that claim over Johnson. As Appellants based their arguments regarding claims 10, 11, 13, 14-18, and 20 on the same arguments discussed above as to claim 9 (see App. Br. 25-26), we affirm the Examiner’s obviousness rejection of those claims over Johnson as well. Appellants argue that the Examiner failed to make out a prima facie case of obviousness as to claim 19 because the Examiner did not “identify any structure or disclosure of Johnson which could be considered to be a spacer as recited in claim 19” (App. Br. 27). The Examiner responds that, “[r]egarding claim 19, ‘selecting a resilient connector with an integrated spacer’ does not infer that the components are spaced for each other. The spacing between components can be none. The integrated spacer is the length of the resilient connector” (Ans. 15). Claim 19 recites “[t]he method of claim 18, wherein selecting the resilient connector comprises selecting a resilient connector with an integrated spacer.” We do not agree with the Examiner that a positive recitation of a connector with a “spacer” is reasonably interpreted as encompassing a device that provides no spacing between the components joined by the connector. Rather, in our view, an ordinary artisan would have interpreted claim 19 as requiring the practitioner to select a resilient connector having some integrated structure, such as an integrated washer or similar element, that provided spacing between the two components being joined by the resilient Appeal 2010-009896 Application 11/171,180 15 connector (see, e.g., integrated spacer 862 shown in Appellants’ Figure 49B). As the Examiner points to no connector having such a structure, we reverse the Examiner’s obviousness rejection of claim 19 over Johnson. SUMMARY We affirm the Examiner’s rejection of claims 9-20, under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. We reverse the Examiner’s rejection of claims 9, 10, 12, 14, and 18- 20, under 35 U.S.C. § 102(e) as anticipated by White. We also reverse the Examiner’s anticipation rejection of claims 9-11 and 13-20 over Johnson. However, we affirm the Examiner’s alternative obviousness rejection of claims 9-11, 13-18, and 20 over Johnson. We reverse the Examiner’s obviousness rejection of claim 19 over Johnson. TIME PERIOD 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 dm Copy with citationCopy as parenthetical citation