Ex Parte BertramDownload PDFPatent Trial and Appeal BoardFeb 10, 201412049674 (P.T.A.B. Feb. 10, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MORTON BERTRAM III __________ Appeal 2012-005681 Application 12/049,674 Technology Center 3700 __________ Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an arthroscopic surgical procedure for treating a defect in a knee joint. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 1 Appellant identifies the Real Party in Interest as Morton Bertram III (see App. Br. 1). Appeal 2012-005681 Application 12/049,674 2 Statement of the Case Background “Uni-compartmental knee procedures have therefore become more popular . . . however, in many case[s] this involves a 4-inch incision, significant soft tissue dissection, and significant morbidity for the patient” (Spec. 1, ll. 16-20). “This invention resides in an improved uni- compartmental implant including a shaft having a proximal end attached to a head and a distal end, and one or more raised portions spaced apart along the shaft to resist back-out” (Spec. 2, ll. 10-12). The Claims Claims 15-34 are on appeal. Independent claim 15 is representative and reads as follows: 15. An arthroscopic surgical procedure for treating a defect in a knee joint having a femoral side with medial and lateral condylar protrusions on respective sides of a patellofemoral groove and a tibial side with a platform against which the condylar protrusions articulate, the method comprising the steps of: identifying a region of eburnated bone associated with a knee joint; measuring the region; providing an implant having a shaft and a head with dimensions corresponding to the measured region, the head having a first side attached to the shaft and an opposing second side having a convex outer surface; reaming a central portion of the region to a specific depth corresponding to the shaft of the implant; over-reaming with a secondary reamer corresponding to the size of the head of the implant; and press fitting or cementing the implant into the reamed and over-reamed portion of the defect. Appeal 2012-005681 Application 12/049,674 3 The issues A. The Examiner rejected claims 15-34 under 35 U.S.C. § 103(a) as being obvious over Schwartz ʼ9422 (Ans. 4-5). B. The Examiner rejected claims 15-34 under 35 U.S.C. § 103(a) as being obvious over Schwartz ʼ3143 (Ans. 5). Because these rejections turn on the same issue, we will consider these rejections together. The Examiner finds that Schwartz ʼ942 teaches “an implant having a shaft and a head (Figure 2) that may be circular in form (page 9, lines 5-7; page 15, lines 3-5). Identifying and measuring a region of eburnated bone associated with a knee joint would have been immediately obvious, if not inherent” (Ans. 4). The Examiner finds that Schwartz ‘942 teaches “reaming and over-reaming steps would have been obvious from Figure 5 and page 16, line 24 et seq. A convex outer surface would have been an obvious variant in order to better conform to the articular surface being replaced” (Ans. 4). Appellant contends that “Claim 15 further includes the limitations of measuring the region and providing an implant having a shaft and a head portion with dimensions corresponding to the measured region (as amended) Schwartz et al. do not disclose or suggest such steps” (App. Br. 3). Appellant contends that “Figure 5 of Schwartz et al., is a cross section of a system which does not teach or suggest any method steps, and the section of Schwartz cited by the Examine[r] teaches away from reaming by disclosing, 2 Schwartz et al., WO 97/25942 A1, published Jul. 24, 1997. 3 Schwartz et al., US 6,468,314 B2, issued Oct. 22, 2002. Appeal 2012-005681 Application 12/049,674 4 instead, that the system can be pressed into . . . cancellous bone” (App. Br. 3). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that either Schwartz ʼ942 or Schwartz ʼ314 render the claims obvious? Findings of Fact 1. Figure 1 of Schwartz ʼ942 is reproduced below: “FIG. 1 is a fragmentary schematic view of a knee having therein a pair of assemblies of the cartilage repair system” (Schwartz ʼ942 7, ll. 8-9). Appeal 2012-005681 Application 12/049,674 5 2. Schwartz ʼ942 teaches “where only a single assembly 12 will be used, other configurations, such as a circular configuration, may be preferred” (Schwartz ʼ942 9, ll. 5-7). 3. Schwartz ʼ942 teaches that the “delivery unit 14 is configured and dimensioned to be mounted in both the area from which damaged or destroyed articular cartilage has been removed and the adjacent healthy cancellous bone area of the bone” (Schwartz ʼ942 8, ll. 5-8). 4. Figure 5 of Schwartz ʼ942 is reproduced below: “FIG. 5 is a sectional view thereof taken along line 5-5 of FIG. 3 and fragmentarily shows the cartilage repair system inserted into a bone” (Schwartz ʼ942 7, ll. 15-17). 5. Schwartz ʼ942 teaches that: Referring now to FIG. 5, after surgical removal of the damaged or destroyed articular cartilage, the elongate member 23 (extending downwardly from the concave Appeal 2012-005681 Application 12/049,674 6 bottom portion 30 of the support frame 22) is placed into the cancellous bone 74 through the sub-chondral bone plate 72 which is below the damaged articular cartilage area. The support frame 22 is supported by the sub-chondral bone plate 72. The elongate member 23 has a blunt bevelled bottom 40 so that the elongate member 23 can be placed easily into the cancellous bone 74, which is a soft region of the bone. The bottom 40 of the elongate cylindrical member 23 is blunt so that the bottom 40 does not break when the elongate cylindrical member 23 is placed inside the cancellous bone 74. When the elongate member 23 is 10 placed into the soft cancellous bone 74, the cancellous bone 74 is displaced by, and reforms around, the radially extending ribs 38 of the elongate member 23. (Schwartz ʼ942 16, l. 24 to 17, l. 12). 6. Schwartz ‘942 teaches that While the system 10 is illustrated in FIG. 1 as being used to regenerate damaged or destroyed articular cartilage on the femoral knee joint surface K, those skilled in the medical arts will readily appreciate that the system 10 is equally useful in other articular joints such as the shoulder, hip, and the like. The extent of the damaged or destroyed articular cartilage on the surface of the bone will determine whether the system 10 employs a single assembly 12 or a plurality of assemblies 12. (Schwartz ʼ942 8, ll. 16-24). 7. Schwartz ʼ7454 teaches: a drill/countersink 130 according to the present invention . . . . it will be appreciated that the distal end 132 of the drill/countersink 130 is similar to the elongate member 23. A central portion 134 of the drill/counter sink 4 Schwartz, R., US 5,632,745, issued May 27, 1997. Appeal 2012-005681 Application 12/049,674 7 130 has ribs 136 at an angle similar to the bottom 30 of the support frame 22 . . . Thus, the forward drill/countersink portion 132 provides an opening in the cancellous bone for the elongate number 23 while the central drill/countersink portion 134 provides a countersink opening for bottom 30 partially in the cancellous bone 74 and partially in the subchondral bone plate 72. (Schwartz ʼ745, col. 11, ll. 6-16). Principles of Law “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Analysis We begin by addressing the procedural issue of the Examiner’s citation of the Schwartz ʼ745 patent in the Examiner’s Answer. The Examiner should have clearly identified this as a New Grounds of Rejection, because “any rejection that relies upon any Evidence not relied upon in the Office action from which the appeal is taken (as modified by any advisory action) shall be designated by the primary examiner as a new ground of rejection.” 37 CFR § 41.39(a)(2). Appellant is then offered two choices, to reopen prosecution or to maintain the appeal by filing a Reply Brief which Appeal 2012-005681 Application 12/049,674 8 addresses the new grounds. See 37 CFR § 41.39(b). Appellant did not choose to reopen prosecution, and instead filed a Reply Brief which specifically responded to the Examiner’s Answer at page 6, almost quoting the first half of the Examiner’s sentence stating that “[t]he examiner does not believe it is necessary to show that reaming and over-reaming were quite common in the orthopedic implant arts at the time of the present invention, but in order to remove any doubt, reference is made to Schwartz, US 5,632,745” (Ans. 6; Reply Br. 2). Consistent with Kronig, we find that Appellant had a fair opportunity to respond to Schwartz ʼ745, since they responded to the first half of the sentence referencing Schwartz ʼ745 and were, therefore, reasonably aware of the Examiner’s reliance upon that reference and had the opportunity to respond to the reference in the Reply Brief. See In re Kronig, 539 F.2d 1300, 1302 (CCPA 1976) (“[T]he ultimate criterion of whether a rejection is considered ‘new’ in a decision by the board is whether appellants have had fair opportunity to react to the thrust of the rejection.”) We will, therefore, address the substantive issues on appeal. We begin by noting that “any arguments or authorities not included in the appeal brief will be refused consideration by the Board for purposes of the present appeal.” 37 CFR § 41.37(c)(1)(iv). This rule is in place so that the Board will be provided the benefit of the Examiner’s expertise in considering Appellant’s arguments. We will, therefore, only address the arguments presented in either the Appeal Brief or Reply Brief. Claim 15 Appellant presents two distinct arguments regarding claim 15. Appellant first contends that Schwartz ʼ942 “does not teach both techniques Appeal 2012-005681 Application 12/049,674 9 as implied by the Examiner, and certainly does not teach or suggest all of Appellant’s claim language, namely, ‘reaming a central portion of the region to a specific depth corresponding to the shaft of the implant and over- reaming with a secondary reamer corresponding to the size of the head of the implant’” (Reply Br. 1; cf. App. Br. 3). We are not persuaded. Schwartz ʼ942 teaches surgical removal of damaged tissue followed by insertion of an implant into cancellous bone (FF 5). In the Examiner’s Answer, the Examiner cites Schwartz ʼ745, who teaches the use of a drill to “ream” an opening in cancellous bone for insertion of an implant (FF 7). Schwartz ʼ745 also teaches that “the central drill/countersink portion 134 provides a countersink opening for bottom 30 partially in the cancellous bone 74 and partially in the subchondral bone plate 72” (Schwartz ʼ745, col. 11, ll. 14-16; FF 7). This action by a second drill with a countersink is reasonably interpreted as satisfying the “over- reaming” requirement of claim 15. We agree with the Examiner that the ordinary artisan, familiar with Schwartz ʼ942 and Schwartz ʼ745, would have found it obvious to incorporate the “reaming” and “over-reaming” steps since Schwartz ʼ745 teaches that this is a mode of insertion into cancellous bone (FF 7). Appellant’s second argument is that “[c]laim 15 further includes the limitations of measuring the region and providing an implant having a shaft and a head portion with dimensions corresponding to the measured region (as amended) Schwartz et al. do not disclose or suggest such steps” (App. Br. 3). Appeal 2012-005681 Application 12/049,674 10 We are not persuaded. Schwartz ʼ942 teaches that the “delivery unit 14 is configured and dimensioned to be mounted in both the area from which damaged or destroyed articular cartilage has been removed and the adjacent healthy cancellous bone area of the bone” (Schwartz ʼ942 8, ll. 5-8; FF 3). This is reasonably interpreted as a teaching by Schwartz ʼ942 to measure the region being surgically treated, particularly in light of the word “dimensioned”. We agree with the Examiner that the ordinary artisan would have found it obvious to measure the region, in order to ensure that the implant is “dimensioned to be mounted” in the proper location (FF 3). Claims 16-205 Appellant contends that the “Examiner still has not provided and substantive arguments as to why claims 16-21 stand rejected” (App. Br. 4). The Examiner responds that “the further limitations of these claims are inherent in the Schwartz et al. ʼ942 teaching” (Ans. 7). We find that the Examiner has the better position. Figure 1 of Schwartz ʼ942 shows the insertion of multiple devices at multiple locations in the knee joint, satisfying the requirement of claim 20 (FF 1). Figure 1 also shows the various structures of the knee into which the procedure can be performed which include the specific locations required by claims 16-19. Given the teaching by Schwartz ʼ942 that the ordinary artisan will recognize that the implant system may be used on knee joints or other joints (FF 5), we agree with the Examiner that application of the system to specific knee 5 We note that the phrase “procedure is performed” is duplicated in claim 20. Appeal 2012-005681 Application 12/049,674 11 structures would have been either inherent or obvious over Schwartz ‘942 (FF 5). Claims 21-24 Appellant contends that “Claim 21 adds to claim 15 that the implant ‘has a single, tapered shaft having a central longitudinal axis.’ Regardless of the Examiner’s unsupported argument that a bevel may be viewed as a taper,’ again the interpretation does not read on all of Appellant’s claim limitations” (App. Br. 4). The Examiner finds that in “regard to claim 21, the bevel 40 (page17, line 4; Figure 4) may be viewed as a taper” (Ans. 4). The Examiner finds that “tapering implant shafts (including successively smaller ribs) were widely known in the art at the time of the present invention” (Ans. 7). We find that Appellant has the better position. Even if bevel 40 in Figure 4 of Schwartz ʼ942 is treated as a taper, that taper would not satisfy the requirement for a “single, tapered shaft” in claim 21 because the bevel 40 is only a portion of the shaft and does not satisfy a claim that is reasonably interpreted to require the entire shaft to be tapered as shown in Figures 1-5 of the Specification. The Examiner finds that “Appellant does not even acknowledge . . . [that] tapering implant shafts (including successively smaller ribs) were widely known in the art at the time of the present invention” (Ans. 7). We find this argument fails to recognize that the burden of production is on the Examiner, not on Appellant. Fritch, 972 F.2d at 1265. The issue is not what the Examiner knows, the issue is whether the Examiner has established facts with evidence. In this particular situation, the Examiner Appeal 2012-005681 Application 12/049,674 12 must establish that tapered implant shafts were known, and include evidence supporting this position in the rejection. The Examiner did not provide such evidence in the rejection. In addition, there is a burden on the Examiner to explain why it would have been obvious to substitute the alleged “widely known tapered implant shafts” for the non-tapered shaft of Schwartz ʼ942. The Examiner provides no reason for such a substitution. “‘[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Claims 25, 26, and 34 Appellant contends that the “Examiner states that claims 25, 26 and 34 would be obvious without referring to any prior art or case citations. This is insufficient to establish plima facie obviousness. Claims 27, 28 have not been properly examined” (App. Br. 5). The Examiner finds that an “implant length lying within the range of ‘less than 50mm’ (instant claim 25) would have been obvious under routine analysis and/or experimentation in order to accommodate relatively small patients (including animals) and to minimize the amount of tissue removed (Schwartz et al. ʼ942: page 3, lines 23-27)” (Ans. 7). We find that Appellant has the better position. The Examiner’s reliance on page 3, lines 23-27 of Schwartz ʼ942 is unclear, since that portion of Schwartz provides no teachings regarding the size or dimensioning of implants. The Examiner also fails to provide evidence, as Appeal 2012-005681 Application 12/049,674 13 opposed to simply argument, that the size range would have been obvious to the person of ordinary skill. As we already noted, the burden of production of evidence is placed upon the Examiner. Fritch, 972 F.2d at 1265. Claims 29 and 306 Appellant contends that Schwartz ʼ942 “teaches away from the use of ceramic, chrome-cobalt alloy or other bio-compatible alloy, opting instead for bio-absorbable components” (App. Br. 5). The Examiner responds that “Appellant’s remarks do not address the specific obviousness rationale for this particular art, where biocompatible (and mechanically compatible) alloys are commonplace” (Ans. 8). We find that Appellant has the better position. The Examiner again failed to provide evidence that either ceramic or a chrome cobalt or other alloys were known, let alone known equivalents useful in the method of Schwartz ʼ942. Again, this may be a fact easily established by any number of prior art teachings, but the Examiner did not provide such evidence. Fritch, 972 F.2d at 1265. 6 Appellant contends that “claims 31-33 have not been properly examined” (App. Br. 5), but do not provide a separate heading or separate and specific argument for these claims. “[T]he failure of appellant to separately argue claims which appellant has grouped together shall constitute a waiver of any argument that the Board must consider the patentability of any grouped claim separately.” 37 CFR § 41.37(c)(1)(iv). Appeal 2012-005681 Application 12/049,674 14 Conclusion of Law The evidence of record supports the Examiner’s conclusion that either Schwartz ʼ942 or Schwartz ʼ314 renders claims 15-20 obvious. The evidence of record does not support the Examiner’s conclusion that either Schwartz ʼ942 or Schwartz ʼ314 renders claims 21-26, 29, 30, and 34 obvious. SUMMARY In summary, we affirm the rejection of claims 15-20 under 35 U.S.C. § 103(a) as being obvious over Schwartz ʼ942. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 27, 28, and 31-33, as these claims were not argued separately. We reverse the rejection of claims 21-26, 29, 30, and 34 under 35 U.S.C. § 103(a) as being obvious over Schwartz ʼ942. We affirm the rejection of claims 15-20 under 35 U.S.C. § 103(a) as being obvious over Schwartz ʼ314. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 27, 28, and 31-33, as these claims were not argued separately. We reverse the rejection of claims 21-26, 29, 30, and 34 under 35 U.S.C. § 103(a) as being obvious over Schwartz ʼ314. 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 lp Copy with citationCopy as parenthetical citation