Smith & Nephew, Inc. et al.

Patent Trials and Appeals Board

Feb 1, 2022

2021004166 (P.T.A.B. Feb. 1, 2022)

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. 14/891,699 11/17/2015 Philip CARDAMONE PT-5398-US- PCT/PH022101 1013 103738 7590 02/01/2022 Smith & Nephew, Inc. (Troutman Pepper) ATTN: Sabrina Chambers 7135 Goodlett Farms Parkway Cordova, TN 38016 EXAMINER WOLF, MEGAN YARNALL ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 02/01/2022 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): Patents.Dept.US@smith-nephew.com docketingpgh@pepperlaw.com smith-nephew_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILIP CARDAMONE, MANUEL MILLAHN, and MARTIN IMMERZ Appeal 2021-004166 Application 14/891,699 Technology Center 3700 Before JENNIFER D. BAHR, MICHAEL J. FITZPATRICK, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 4, 6, 10, 13, and 21-24. A hearing was held on January 24, 2022. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real parties in interest as Smith & Nephew Inc., Smith & Nephew Asia Pacific Pte, Limited, and Smith & Nephew Orthopaedics AG. Appeal Br. 3. Appeal 2021-004166 Application 14/891,699 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to “an adjustable endoprosthesis comprising a first member, a second member and a coupling device for generating a movement of the second member relative to the first member.” Spec., p. 1. Claim 1 is illustrative of the claimed subject matter. 1. A tibial component of an adjustable knee joint endoprosthesis, the tibial component comprising: a first member that is connectable to an associated patient’s tibia via at least one of a press-fitted connection or a cemented connection; a second member configured to cooperate with a femoral component of the adjustable knee joint endoprosthesis, the second member comprising a first portion and a second portion that are independently movable with respect to each other; a first coupling section adjustably connecting the first portion to the first member, wherein the first coupling section is configured to cause the first portion to translate, rotate, or a combination thereof relative to the first member when actuated; a second coupling section adjustably connecting the second portion to the first member, wherein the second coupling section is configured to cause the second portion to translate, rotate, or a combination thereof relative to the first member when actuated; and a tracking reference coupled to at least one of the first member or the second member, wherein the tracking reference is configured to be tracked by a medical navigation system to determine a spatial positon of the at least one of the first member or the second member to determine a geometry of the endoprosthesis. Appeal 2021-004166 Application 14/891,699 3 THE REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Gustilo US 5,733,292 Mar. 31, 1998 Cohen US 6,454,806 B1 Sept. 24, 2002 Whiteside US 2003/0153978 A1 Aug. 14, 2003 Hauri US 2009/0222089 A1 Sept. 3, 2009 Claypool US 2012/0158152 A1 June 21, 2012 Colwell, JR (“Colwell”) US 2013/0066432 A1 Mar. 14, 2013 THE REJECTIONS The rejections before us on appeal are: I. Claims 1, 4, 6, 10, and 21 stand rejected under 35 U.S.C. § 103 as being unpatentable over Colwell, Hauri, and Whiteside. II. Claims 1, 6, 10, and 21-23 stand rejected under 35 U.S.C. § 103 as being unpatentable over Claypool, Hauri, and Whiteside. III. Claim 13 stands rejected under 35 U.S.C. § 103 as being unpatentable over Claypool, Hauri, Whiteside, and Gustilo. IV. Claim 24 stands rejected under 35 U.S.C. § 103 as being unpatentable over Claypool, Hauri, Whiteside, and Cohen. OPINION Rejection I Regarding independent claim 1, the Examiner finds that Colwell discloses, inter alia, a tibial component of an adjustable knee joint endoprosthesis comprising a first member (i.e., first portions 202, 302, 402, 502), a second member (i.e., second portions 212, 312, 412, 512), and first Appeal 2021-004166 Application 14/891,699 4 and second coupling sections (i.e., transducers/actuators 208, 418, 518, 608) adjustably connecting the first member to the second member. Final Act. 4 (citing Colwell ¶¶ 25, 71, Figs. 5-10). The Examiner determines that Colwell fails to disclose that the second member comprises independently movable first and second portions, as claimed, and the Examiner relies on Hauri for teaching “a trial tibial prosthesis in the same field of endeavor” (Ans. 3 (emphasis added)), “wherein a second member comprises two unconnected sectors 7 and 9 . . . that are each independently moveable with respect to each other for the purpose of allowing the bearings to take up different end positions in force equilibrium with the surrounding capsule and ligament structure” (Final Act. 4) (citing Hauri ¶ 11, Fig. 6B). The Examiner specifically finds that because Hauri discloses that “‘[t]he invention includes the basic concept of providing a ligament-tensioning device that is fully insertable into the joint in question, thus making it possible to close the joint capsule again after insertion’, . . . it is reasonable to consider the device of Hauri to be a tibial component/endoprosthesis since the device of Hauri replaces a missing proximal surface of the tibia and is placed inside the body.” Ans. 5 (citing Hauri ¶ 8). The Examiner reasons that it would have been obvious to modify Colwell’s single-piece second member to have independently movable first and second portions, as taught in Hauri, “to allow the portions to achieve different end positions and balance with the surrounding capsule and ligament structure.” Final Act. 4; Ans. 4. Appellant defines “endoprosthesis” as “‘an artificial device [used] to replace a missing bodily part that is placed inside the body.’” Appeal Br. 8; see also Repy Br. 4 (“The key is whether the device replaces the missing Appeal 2021-004166 Application 14/891,699 5 bodily part.”). Appellant argues that the Examiner’s reliance on Hauri for disclosing an endoprosthesis is in error, as Hauri’s ligament-tensioning devices “are not used to replace a missing bodily part that is placed inside the body,” as disclosed in Colwell, and “otherwise left within the patient’s body.” Appeal Br. 8-9; see also Reply Br. 3 (“ligament tensioners are regularly used in orthopaedic surgical procedures and do not replace the bone or portion thereof”). Appellant submits that because the Examiner fails “to recognize that Hauri does not in fact disclose an endoprosthesis,” the Examiner (i) “[fails] to explain why Hauri’s teachings that are not directed to an endoprosthesis are nonetheless applicable to the claimed tibial component of an endoprosthesis”; and (ii) “fails to articulate a reasoning with rational underpinning as to why a person of ordinary skill in the technical field would have found it obvious to combine the elements from Colwell’s knee balancing apparatus and Hauri’s ligament-tensioning device [as claimed].” Id. at 9. We are persuaded by Appellant’s argument. First, we accept Appellant’s definition of an endoprosthesis as an artificial device used to replace a missing bodily part that is placed inside the body. For example, Colwell discloses that “joint balancing apparatus 100 can be a temporary, permanent, or semi-permanent implant configured to replace a joint,” and thus, Colwell discloses an endoprosthesis or an artificial device (i.e., joint balancing apparatus 100) used to replace a bodily part (i.e., a joint) that is placed inside the body (i.e., as a permanent implant). Colwell ¶ 25. Hauri discloses a “[l]igament-tensioning device for activation of the ligament and/or capsule system in the implantation of a joint implant.” Appeal 2021-004166 Application 14/891,699 6 Hauri, Abstract (emphasis added). As relied on by the Examiner, Hauri discloses that [t]he invention includes the basic concept of providing a ligament-tensioning device that is fully insertable into the joint in question, thus making it possible to close the joint capsule again after insertion. For that purpose, in particular the bearing plates are to be dimensioned to match the joint in question-for example a knee joint-and projecting parts (such as, for example, handgrips/levers or hydraulic lines which projecting the prior art) are to the greatest possible extend to be avoided. In that respect the invention includes the concept of providing purely internal drive means or internal displacement means for the relative displacement of the opposing bearing plates. Hauri ¶ 8. We do not agree with the Examiner that Hauri’s teaching of fully inserting Hauri’s ligament-tensioning device into the joint necessarily means that Hauri’s ligament-tensioning device replaces part of the joint and is placed within the body as an implant. In sum, although structurally similar to Colwell’s joint balancing apparatus (or an endoprothesis), a preponderance of the evidence does not support the Examiner’s finding that Hauri’s ligament-tensioning device is, by definition, an endoprosthesis; rather, Hauri teaches that Hauri’s ligament-tensioning device is used as a medical instrument in the selection of an endoprosthesis. Thus, as argued by Appellant, the Examiner’s reasoning is based on a factual error. As such, the Examiner does not explain why a person of ordinary skill in the art, when seeking to select an endoprothesis that balances a knee joint, as disclosed in Colwell, would look to Hauri’s ligament-tensioning device, which has drive means for separately positioning first and second portions of a bearing plate relative to condyles of a femur (see, e.g., Hauri ¶ 11), to Appeal 2021-004166 Application 14/891,699 7 achieve different end positions and balance with the surrounding capsule and ligament structure relative to Colwell’s joint balancing apparatus, as reasoned by the Examiner. Accordingly, we cannot sustain the Examiner’s rejection of independent claim 1, and claims 4, 6, 10, and 21 depending therefrom. Rejection II Regarding claim 1, the Examiner finds that Claypool discloses, inter alia, an endoprosthesis placement system comprising a tibial component of an adjustable knee joint endoprosthesis including a first member (i.e., base component 34J) and a second member (i.e., tibial bearing component 32J), and first and second coupling sections adjustably connecting the first member to the second member (i.e., sections lateral wedge 41J and medial wedge 43J). Final Act. 6-7 (citing, e.g., Claypool, 17A-C); see also, e.g., Claypool ¶ 124. The Examiner determines that Claypool fails to disclose that the second member comprises independently movable first and second portions, as claimed, and the Examiner again relies on Hauri for teaching “an endoprosthesis.” Final Act. 7. The Examiner reasons that it would have been obvious to modify Claypool’s single-piece second member to have independently movable first and second portions, as taught in Hauri, “to allow the portions to achieve different end positions and balance with the surrounding capsule and ligament structure.” Final Act. 4; id. at 7; see, e.g., Claypool ¶ 124; Ans. 4-6. Appellant submits that “[the Examiner] uses Hauri in combination with Claypool in the same manner as the combination of Hauri and Colwell. Appeal Br. 14. The Appellant, again, argues that “Hauri is not in fact an endoprostheses,” and therefore, the Examiner (i) fails to explain why Appeal 2021-004166 Application 14/891,699 8 Hauri’s teachings that are not directed to an endoprosthesis are nonetheless applicable to the claimed tibial component of an endoprosthesis; and (ii) fails to articulate a reasoning with rational underpinning as to why a person of ordinary skill in the technical field would have found it obvious to combine the elements from Claypool’s knee balancing apparatus and Hauri’s ligament-tensioning device. Id. at 15; see also Reply Br. 3-6. We are persuaded by Appellant’s argument for essentially the same reason as stated supra, namely, that the Examiner’s finding that Hauri discloses an endoprosthesis is in error and thus, the Examiner’s reasoning lacks sufficient factual support. Accordingly, we cannot support the Examiner’s rejection of independent claim 1, and claims 6, 10, and 21-23 depending therefrom. Rejection III Regarding independent claim 13, the Examiner relies on “Claypool in view of Hauri,” for disclosing “the invention substantially as claimed and discussed [relative to independent claim 1],” wherein claim 13 recites, in relevant part, “the second member comprising a first portion and a second portion that are independently movable with respect to each other.” Final Act. 9; Appeal Br. 18 (Claims App.). Appellant argues that the Examiner’s reliance on Gustilo does not remedy the deficiencies of the Examiner’s findings relative to Hauri, and reasoning relative to Claypool and Hauri. Appeal Br. 15. Although Gustilo addresses both “knee prosthesis systems hav[ing] a comparable number of trial inserts” (Gustilo 1:66-67) and “devices that assist with balancing the soft tissues by attachment to the knee from the outside and holding the tibia and femur apart,” such as “spreaders” (id. at Appeal 2021-004166 Application 14/891,699 9 2:41-51), evidencing that Claypool and Hauri’s fields of use are known to be related and readily available to a person of ordinary skill in either field of use as distinguished by Appellant, we agree with Appellant that Gustilo does not cure the Examiner’s reliance on Hauri for disclosing an endoprosthesis. Accordingly, we do not sustain the Examiner’s rejection of claim 13. Rejection IV Regarding claim 24, which depends from independent claim 1, the Examiner relies on “Claypool in view of Hauri,” for disclosing “the invention substantially as claimed and discussed [relative to independent claim 1].” Final Act. 10; Appeal Br. 20 (Claims App.). Appellant argues, and we agree, that the Examiner’s reliance on Cohen does not remedy the deficiencies of the Examiner’s findings relative to Hauri, and reasoning relative to Claypool and Hauri. Appeal Br. 15-16. Accordingly, we do not sustain the Examiner’s rejection of claim 24. Appeal 2021-004166 Application 14/891,699 10 CONCLUSION The Examiner’s rejections of claims 1, 4, 6, 10, 13, and 21-24 are reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 6, 10, 21 103 Colwell, Hauri, Whiteside 1, 4, 6, 10, 21 1, 6, 10, 21- 23 103 Claypool, Hauri, Whiteside 1, 6, 10, 21- 23 13 103 Claypool, Hauri, Whiteside, Gustilo 13 24 103 Claypool, Hauri, Whiteside, Cohen 24 Overall Outcome 1, 4, 6, 10, 13, 21-24 REVERSED