Ex Parte 6969390 et al

Patent Trial and Appeal BoardMay 20, 2013

95000448 (P.T.A.B. May. 20, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE 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. 95/000,448 05/18/2009 6969390 101.0056-13REX 9508 22882 7590 05/20/2013 MARTIN & FERRARO, LLP 1557 LAKE O'PINES STREET, NE HARTVILLE, OH 44632 EXAMINER CLARK, JEANNE MARIE ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 05/20/2013 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ NUVASIVE, INC. Requester, Appellant v. Patent of WARSAW ORTHOPEDIC, INC. Patent Owner, Respondent ____________________ Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B21 Technology Center 3900 ____________________ Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON and DANIEL S. SONG, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING NuVasive (hereinafter "Requester") requests reconsideration under 37 C.F.R. Â§ 41.79 (hereinafter "Req." or "Request") of our New Decision Under 37 C.F.R. Â§ 41.77(f) mailed September 29, 2012 (hereinafter "New Dec." or "New Decision"). We grant-in-part the Request to the extent that we 1 Issued November 29, 2005 to Michelson (hereinafter "'390 patent"). Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 2 consider the Requester's arguments and modify the original Decision in the manner set forth infra. The details of the reexamination history of the '390 patent resulting in the issuance of the New Decision is set forth therein (New Dec. 2-3) but a brief discussion of the history of the appeal is helpful for the purposes of this Rehearing. During the reexamination of the '390 patent, the Examiner declined to adopt various obviousness rejections proposed by the Requester and the Requester appealed to the Board in Appeal 2010-007339. We disagreed with the Requester that "one of ordinary skill in the art would 'modify' the screw of Lowery by removing a portion of the screw head as suggested by the Appellant." (Original Decision mailed October 21, 2010 (hereinafter "Orig. Dec." or "Original Decision") 12). We nonetheless found the independent claims obvious based on the combination of Lowery and Surer, Surer disclosing an implant screw having the recited screw head configuration (Orig. Dec. 7-8). While we generally agreed with the Appellant's assertion that the screw head shape is a design choice, in reversing the Examiner's refusal to reject the claims, we specifically stated that "the substitution of the screw of Surer for the screw in the plating system of Lowery is merely a predictable variation of Lowery that a person of ordinary skill can implement." (Orig. Dec. 12). We further stated that "one of ordinary skill would recognize that the screw of Lowery, when substituted by the screw of Surer, would yield substantially the same result." (Orig. Dec. 13). Thus, we reversed the Examiner's refusal to reject the independent claims of the '390 patent based Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 3 on the combination of Lowery and Surer, and denominated our reversal as a new ground under 37 C.F.R. Â§ 41.77(b). In response to the Original Decision by the Board, the Patent Owner requested reopening of prosecution under 37 C.F.R. Â§ 41.77(b)(1) and amended the claims to submit new independent claims 46 and 47 similar to the rejected independent claims, but further reciting specific limitations with respect to the screw including: "said upper facing surface of said upper portion having a recess configured to cooperatively engage a driver instrument adapted to insert said screw into the vertebral body,"; "said tip being configured to be one of self-tapping and including a cutting flute,"; "said first shaft portion being generally cylindrical, said second shaft portion being generally conical and having a larger diameter proximate said head and smaller diameter adjacent said first shaft portion,"; and "said thread having an outer diameter that is generally uniform along at least a substantial portion of each of said first and second shaft portions." (See generally, Request to Reopen Prosecution, filed November 22, 2010). The Requester proposed 45 new rejections for these amended claims (see generally, Third Party Request Comments (filed February 2, 2011) 11). In the New Decision, we declined to adopt any of the properly submitted new Proposed Rejections, and declined to consider rejections that were deemed to improperly extend beyond the scope of the Board's Original Decision. It is the New Decision for which the Requester presently seeks reconsideration. Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 4 I. A. Combination of Lowery, Surer and Davne (Issues 4 and 5) The Requester argues that in the New Decision, the Board made a fact finding that was not urged by the parties and erred in finding that "it appears more likely than not that the screws of Lowery and Surer did not exhibit the screw breakage issues identified and addressed by Davne in providing the tapered root diameter of design 'd.' considering the increased diameter at the shoulders, and thus, increased strength provided thereby." (Req. 2 quoting New Dec. 25-26). The Requester argues that this finding is erroneous because it is inconsistent with the background section of the '390 patent which describes a second generation of plating systems as including Lowery, and subsequently mentions that "screw breakage continues to be experienced and occurs most commonly at the junction of the screw to the posterior aspect of the plate." (Col. 2, ll. 46-54; col. 3, ll. 7-9). In reconsidering the record, we agree with the Requester that we overlooked the background of the '390 patent in the New Decision which fairly suggests that the screw breakage is experienced in the screw disclosed in Lowrey. Consequently, we modify the New Decision and withdraw therefrom the portion beginning with "Whereas the Requester refers to the disclosure of Davne" on page 25 and ending with "and is inadequate to support the conclusion of obviousness. See KSR, 550 U.S. at 418, 421" on page 26. However, having withdrawn the above portion of the New Decision and having reconsidered the matter, we decline to alter our ultimate decision to not adopt the Requester's proposed rejection. In particular, the proposed rejection relies on the combination of Lowery, Surer and Figure 1D of Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 5 Davne (Third Party Request Comments (filed February 2, 2011) 11). In suggesting the combination, the Requester asserts that: it would have been obvious in view of Davne to modify the screw shaft shape of Lowery/Surer so as to have a generally conical upper portion and a generally cylindrical lower portion for a screw shaft so as to reduce screw breakage issues. Also, a skilled artisan would have been prompted to incorporate the first and second shaft portions (as taught by Davne) to the resulting screw of Lowery and Surer because it is merely "[c]ombining prior art elements according to known methods to yield predictable results." MPEP Â§ 2143(A); KSR, 82 U.S.P.Q.2d at 1395 ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results."). (Id. at 11-12, emphasis added). As noted by the Requester, in its Background of the Invention section, the '390 patent discusses problems and breakage in prior art plating systems, and further explains that second generation of plating systems has been developed or proposed in response the those problems (col. 2, ll. 27-48). This second generation of plating systems included the plating system of Lowery, as well as numerous others such as Morscher, Synthes, Danek Orion, Codman Shurtleff, and Smith Nephew Richards, among others (col. 2, ll. 48-53). While the background of the '390 patent also states that screw breakage continues to be experienced, it specifically highlights that Synthes and Smith Nephews Richard systems are particularly vulnerable to the breakage problem (col. 3, ll. 7-14). The screw of Lowery is not specifically highlighted as being particularly vulnerable to breakage. Turning to Davne which is relied upon by the Requester for disclosing a conical portion, Davne specifically states: Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 6 The most recent modification tapered the root diameter (Figure 1D) in this junctional area, and when breakage occurs, it is at the end of the taper. (Davne S187, col. 2, emphasis added). Thus, the screw of Davne also experiences breakage in use. In view of Davne's disclosure, the Requester's asserted reason (Req. 4) for incorporating the conical portion of Davne in the combination of Lowery and Surer is not well founded, and is likely to be based on impermissible hindsight which utilizes the claims of the '390 patent as a template. Similar considerations apply to the Requester's assertion that a person of ordinary skill in the art "would have been prompted to incorporate the first and second shaft portions (as taught by Davne)" and that the invention merely combines prior art elements according to known methods (Third Party Request Comments (filed February 2, 2011) 12). Such broad and generalized assertions of obviousness set forth by the Requester are not adequate rationales to combine the prior art elements because they are not supported by fact-based reasoning. While we agree with the Requester that specific motivation to combine is not required for obviousness (Req. 4), the law is also clear that "a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." KSR Intâ€™l v. Teleflex, Inc., 550 U.S. 398, 418 (2007). In this regard, the "factfinder should be aware . . . of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning." Id. at 421. The Requester further argues that "the changes between the Lowery/Surer combination and the added limitations are nothing more than Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 7 predictable design variations that are well within the skill of the art." (Req. 4). However, the evidence of record which demonstrates many different plating systems that incorporate plates and screws having various different shapes and configurations tend to indicate the contrary, i.e., that such designs are not mere predictable variations with results varying in the degree of success. In our view, the Requester's assertion that it would be nothing more than predictable design variations to arrive at the claimed plating system having screws with the recited features is based on impermissible hindsight. While we consider the above discussion sufficient for the purposes of this Rehearing, we nonetheless briefly address the other unpersuasive arguments. Both unamended and amended claims required the root diameter of a first shaft portion to be less than the root diameter of the second shaft portion. The Requester disagrees with the Board's finding of fact that the shoulder of the screws in Lowery is greater than the diameter of the rest of the screw shaft (Req. 3). However, Figure 5 of Lowery shows a slightly larger shoulder and drawings can be relied upon for what they reasonably show. Moreover, the Requester has itself asserted that Lowery discloses this limitation.2 2 See, e.g., Requester's Appeal Brief (filed November 12, 2009) in Appeal 2010-007339, page 6 stating "Lowery discloses â€¦ all of the limitations of claim 1, except the specifically claimed two-portion shape of the screw head"; and pages 7-8 which omits this limitation in stating: "To be clear about what feature of [unamended] claim 1 is missing from Lowery, it is the combination of the following limitations of claim 1 for the screw head: 1) that the head's lower portion be wider than the upper portion, 2) that each one of the head's lower portion and the head's upper portion has an upper Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 8 The Requester also argues that Surer's "increased diameter of the screw shoulder is not at a location that would address the known prior art problem of screw breakage at the junction of the posterior, or bottom, of the plate" because the increased shoulder resides "primarily within, and in some cases, entirely within, the plate itself and not at the junction of the bottom of the plate." (Req. 3-4, citing Figures 2 and 3 of Surer). However, Figure 1 of Surer which shows the greatest level of detail of the screw illustrates that at the junction of the bone and plate, the screw shaft has the increased diameter of the shoulder (Surer, Fig. 1). B. Combination of Lowery, Surer, Frigg and Orion (Issue 6) The Requester again points out, and we agree, that we overlooked the background discussion in the '390 patent with respect to Lowery (Req. 5). Consequently, we also modify the New Decision and withdraw the portion beginning with "Similar to our discussion supra with respect to Davne" on page 28 and ending with "or direct our attention to the disclosure of Frigg in support of its assertion" also on page 28. However, having withdrawn the above portion of the New Decision and having reconsidered the matter, we decline to alter our ultimate decision to not adopt the Requester's proposed rejection for the additional reasons set forth in the New Decision (New Dec. 28). The Requester argues that contrary to the Board's finding, the conical transition region of Frigg is "proximate" the screw head as required by the facing surface, and 3) that the lower portion's upper facing surface be 'at least in part in a plane that crosses the mid-longitudinal axis of the screw.'" Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 9 claims because that is a relative term "and the portion of the screw shaft that the claim requires to be 'proximate' the screw head is in fact nearer to the screw head [in Frigg] than the portion of the screw (the lower portion) that is proximate the distal tip of the screw." (Req. 5-6). We remain unpersuaded. We consider it unreasonable to read "proximate" to encompass a significant intervening cylindrical portion such as that disclosed in Frigg, especially given that the plating system screws are necessarily limited in size by virtue of their application. Thus, we find that Frigg does not disclose a conical transition region that is proximate the screw head. The Requester also asserts that "the upper portion of the screw shaft being generally tapered or generally cylindrical is a matter of predictable design choice." We find this predictable design choice argument to be unpersuasive and likely to be based on hindsight using the claims at issue as a template. See KSR, 550 U.S. 418, 421. C. Combination of Lowery, Surer, Blair and Orion (Issues 7 and 8) The Requester again points out that we overlooked the background discussion in the '390 patent relative to Lowery (Req. 6). We agree and we further modify the New Decision to withdraw the portion on page 30beginning with "Moreover, both Lowery and Surer already provide" and ending with "addressed by the teaching of Blaire which is relied upon by the Requester." However, having withdrawn the above portion of the New Decision and having reconsidered the matter, we decline to alter our ultimate decision to not adopt the Requester's proposed rejection for the additional reasons set forth in the New Decision (New Dec. 29-30). Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 10 The Requester also argues that "although the upper portion of the screw shaft in Blair is indeed generally cylindrical, it is manifestly well- known, for example in view of the Orion plate reference, that all or portion of a screw shaft may be tapered" and so, the changes are routine design changes and obvious design variations (Req. 6-7). Again, we consider the Requester's proposed rejection to be based on impermissible hindsight that utilizes the claims of the '390 patent as a template in modifying the screw of Lowery/Surer. See KSR, 550 U.S. 418, 421. D. Combination of Lowery, Surer, Allard and Orion (Issues 9 and 10) The Requester argues that the Board's application of Allard is based on improperly narrow interpretation of the limitation "generally cylindrical" as requiring a "perfectly cylindrical structure" and that the Board's finding regarding Allard is contrary to the figures therein (Req. 7-8). However, we observe that the New Decision does not require a perfectly cylindrical structure as asserted. Instead, we found Allard's disclosure to be, at best, ambiguous and stated: However, we find that Figure 7 appears [to] illustrate that the shaft of the screw of Allard is tapered and generally conical throughout its entire length (FF 15). At best, Allard is ambiguous about the shape of the shaft which is being depicted with respect to a generally cylindrical portion. There is certainly no express disclosure in Allard of a generally cylindrical shaft portion together with a generally conical shaft portion as noted by the Examiner (Determination 28). In view of the absence of such express disclosure - either in words or by drawing - we simply do not have sufficient evidence that would have guided one of ordinary skill in the art to have selected, without Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 11 hindsight, a screw shaft with the required conical and cylindrical portions. (New Dec. 32, emphasis added). The Requester also argues that the claims do not require the first shaft portion to be of any particular length or percentage and thus, "only a small portion of the distal portion of the screw shaft" need be generally cylindrical (Req. 7-8). However, we do not consider such interpretation to be reasonable as it allows the limitation to be rendered meaningless since a miniscule portion of a conical section could be taken and characterized as cylindrical Moreover, we consider the Requester's proposed rejection to be based on impermissible hindsight that utilizes the claims of the '390 patent as a template in modifying the screw of Lowery/Surer. See KSR, 550 U.S. 418, 421. Thus, in view of the above in addition to the reasons set forth in the New Decision (New Dec. 32-34), we decline to modify our decision not to adopt the proposed rejection. II. Grounds Based on the Combination of Surer and Oxland As noted supra, in the Original Decision, the Board reversed the Examiner's refusal to reject the original independent claims of the '390 patent subject to appeal in Appeal 2010-007339, and denominated the reversal as new grounds of rejection under 37 C.F.R. Â§ 41.77(b). (See Orig. Dec. 12-14). The rejection entered by the Board was based on the combination of Lowery and Surer (id.). Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 12 Of the Requester's 45 newly proposed rejections for the amended claims, Proposed Rejections V.A.1) through D.4) were based on the combination of Surer and Oxland (see generally, Third Party Request Comments (filed April 11, 2011) 29-33; Third Party Request Comments (filed February 2, 2011) 64-110). In the New Decision, we declined to consider these rejections because they improperly extend beyond the scope of the Board's decision under 37 C.F.R. Â§ 41.77 (New Dec. 35). The Requester argues that the Board erred as a matter of law in refusing to consider these newly proposed rejections that are based on the combination of Surer and Oxland (Req. 8-11). We disagree. The Requester asserts that the rejections were directed to "the [patent] owner's response [i.e. the newly amended claims]" but the Board did not provide analysis or citation that supports its refusal to review the newly proposed rejections based on the combination of Surer and Oxland (Req. 8- 9). The Requester further asserts that it has complied with the rules which "limit the scope of a patent owner's response (amendment or new evidence) and a requester's comments (limited to issues raised by Board's opinion or owner's response)," and observes that there is "no provision in Â§ 41.77 that suggests it is appropriate for the Board to refuse to consider properly submitted comments." (Req. 10-11). The Requester misstates the rules. The pertinent portion of the rules states: Such written comments [of any requester] must be limited to the issues raised by the Board's opinion reflecting its decision and the owner's response. (See 37 C.F.R. Â§ 41.77(c), emphasis added). Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 13 Thus, the rule is clear the Requester's comments be limited to issues raised by the Board in its decision "and" the Patent Owner's response, not merely based on the Board's opinion "or" the Patent Owner's response as asserted. These rejections (Proposed Rejections V.A.1 through D.4) go beyond the rejection entered by the Board because the primary reference Surer relied upon in the newly proposed rejections of the Requester differs from that of the entered new ground of rejection, and the application of the secondary references including Oxland differs from the original rejections on appeal. Thus, because these newly proposed rejections are based on the combination Surer and Oxland and substantively differ from the rejection entered by the Board in its new ground, they cannot be said to be limited to the issues raised by the Board's decision. As explained in the New Decision and maintained herein, Rejections relying on such a combination were not at issue in the '7339 Decision. Hence, the newly Proposed Rejections V.A.1) to D.4) improperly extend beyond the scope of the New Ground of Rejection entered by the Board and are not proper under the provisions of 37 C.F.R. Â§ 41.77. (New Dec. 35). Under the Requester's reasoning, there is no limit to what can be presented by the Requester because anything can be argued to be in response to the Patent Owner's response, thereby rendering the language of the rule meaningless. The other newly proposed rejections based on the combination of Lowery and Surer, including those that relied on additional new prior art (Proposed Rejections IV.A.1 through G4) are proper in that they are in Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 14 response to the Patent Owner's response (i.e., the added limitations via the amendment) and the Board's entered new ground. As such, these newly proposed rejections have been addressed in the New Decision and above in this Decision on Request for Rehearing. The Requester further asserts that the Board did not provide analysis or citation that supports its refusal to review the newly proposed (Req. 9). While the explanation in the New Decision and its reference to the pertinent rules appear to be clear, we have further clarified the New Decision in our discussion herein. The Requester points out that the Examiner fully considered the newly proposed rejections3 and argues that it should not be deprived of Board review (Req. 10). However, we observe that it is the Board that has jurisdiction over the grant of the Patent Owner's request to reopen, and the entry of the Requester's comments under 37 C.F.R. Â§Â§ 41.77(b)(1) and 41.77(c). Thus, while the Examiner's Determination is helpful to the Board in "reconsider[ing] the matter and issu[ing] a new decision" under 37 C.F.R. Â§ 41.77(f), the Board is not bound or restricted thereby. Finally, the Requester argues that the Board's position of not reviewing "properly raised proposed rejections" denies due process (Req. 11). However, as discussed above, the newly proposed rejections based on the combination of Surer and Oxland are not "properly raised." The other newly proposed rejections were "properly raised," and thus, were addressed by the Board. 3 We observe that the Examiner, upon considering these proposed rejections, still declined to adopt them (see generally, Examiner's Determination mailed March 10, 2011). Appeal 2012-004133 Reexamination Control 95/000,448 Patent US 6,969,390 B2 15 CONCLUSIONS We agree with the Requester that we overlooked the background discussion of Lowery in the specification of the '390 patent. Correspondingly, we modify the New Decision as noted supra. However, as also explained supra, we decline to modify the New Decision as to its result and decline to enter the Requester's proposed rejections. Thus, the Request for Reconsideration is Granted-In-Part. GRANTED-IN-PART PATENT OWNER: MARTIN & FERRARO, LLP 1557 LAKE Oâ€™PINES STREET, NE HARTVILLE, OH 44632 THIRD PARTY REQUESTER; FISH & RICHARDSON P.C. PO BOX 1022 MINNEAPOLIS, MN 55440-1022