Ex Parte Tuma et alDownload PDFBoard of Patent Appeals and InterferencesAug 27, 201211122758 (B.P.A.I. Aug. 27, 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. 11/122,758 05/05/2005 Gregor Tuma SCHWP0205USA 4694 46140 7590 08/27/2012 DON W. BULSON (BRAI) RENNER, OTTO, BOISSELLE & SKLAR, LLP 1621 EUCLID AVENUE - 19TH FLOOR CLEVELAND, OH 44115 EXAMINER HARVEY, JULIANNA NANCY ART UNIT PAPER NUMBER 3733 MAIL DATE DELIVERY MODE 08/27/2012 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 GREGOR TUMA and CHRISTIAN WENDE __________ Appeal 2011-001732 Application 11/122,758 Technology Center 3700 __________ Before TONI R. SCHEINER, ERIC GRIMES, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a tracking system for an intramedullary pin. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE The Specification discloses that intramedullary pins are used to treat “fractures in long bones. Intramedullary pins include fixing holes or bores at the proximal and distal ends” to receive screws that attach the pin to the Appeal 2011-001732 Application 11/122,758 2 bone (Spec. 1: 16-20). The Specification states that “[o]ne problem with conventional intramedullary pins is that the … pin is deformed by the shape of the long bone” and thus the position of the distal fixing bore is unknown (id. at 1: 21-26). The Specification discloses “a deformation detection device that extends along the intramedullary pin” and communicates with a navigation system (id. at 3: 6-13). Claims 1-6, 8-10, 24, and 25 are on appeal. Claim 1 is representative and reads as follows: 1. A tracking system for an intramedullary pin whose spatial position is determined and/or tracked in image-guided surgery, said intramedullary pin having a proximal end and a distal end, comprising: a reference device configured for attachment to the proximal end of said intramedullary pin; a medical navigation system configured to locate said reference device and to determine an orientation of said intramedullary pin from the proximal end based on the location of the reference device; and a deformation detection device configured to detect deformations of said intramedullary pin and communicate the deformations to said navigation system, wherein said deformation detection device is a fiber optic structure that detects deformations on the basis of differences in light transmit times. The claims stand rejected under 35 U.S.C. § 103(a) as follows: • Claims 1-4, 24, and 25 in view of Smothers,1 Fuimaono,2 and Todoroki;3 • Claim 5 in view of Smothers, Fuimaono, Todoroki and Elstrom;4 1 Smothers et al., Patent Application Publication US 2003/0181918 A1, Sept. 25, 2003 2 Fuimaono et al., Patent Application Publication US 2003/0114846 A1, June 19, 2003 3 Todoroki, JP 2001-330415A, Nov. 30, 2001 Appeal 2011-001732 Application 11/122,758 3 • Claims 8 and 9 in view of Smothers, Fuimaono, Todoroki, and Barrick; 5 • Claim 10 in view of Smothers, Fuimaono, Todoroki, and Fradenburgh;6 and • Claim 6 in view of Smothers and Kroll.7 I. Issue The Examiner has rejected claims 1-4, 24, and 25 as obvious in view of Smothers, Fuimaono, and Todoroki, and has rejected claim 5 as obvious in view of Smothers, Fuimaono, Todoroki and Elstrom. The same issue is dispositive for both rejections. The Examiner finds that Smothers discloses “a tracking system for an intramedullary pin (50) … comprising: a reference device (12) configured for attachment to the proximal end of the intramedullary pin; a medical navigation system configured to … determine an orientation of the intramedullary pin … based on the location of the reference device; and a deformation detection device … configured to detect deformations of the intramedullary pin” (Answer 4). The Examiner finds that Smothers also discloses that “the deformation detection device can be … infrared, visual, … or any other desired technique” (id. at 5), but fails “to disclose that the deformation detection device is a fiber optic structure” (id.). 4 Elstrom et al., US 5,540,691 A July 30, 1996 5 Barrick, Patent Application Publication US 2003/0055435 A1, Mar. 20, 2003 6 Fradenburgh et al., US 5,015,842 A, May 14, 1991 7 Kroll et al., US 6,005,955, Dec. 21, 1999 Appeal 2011-001732 Application 11/122,758 4 The Examiner finds that Fuimaono discloses “a deformation detection device comprising a fiber optic structure” (id.) and that Todoroki discloses “a fiber optic structure capable of detecting deformations on the basis of differences in light transmit times and that an advantage of such a structure is that is inexpensive and effective” (id.). The Examiner concludes that it would have been obvious to modify Smothers’ navigation system to have a fiber optic deformation detection device (id. at 5-6) because such a modification “is a simple substitution of one type of deformation detection device for another and a fiber optic structure that is capable of detecting deformations … is inexpensive and effective” (id. at 6). Appellants contend that Fuimaono and Todoroki are non-analogous art (Appeal Br. 8-14) and that the combination of Smothers and Fuimaono renders the device of Smothers unsatisfactory for its intended purpose (id. at 15-17). The issue with respect to this rejection is: Has the Examiner provided an adequate basis for concluding that the tracking system of claim 1 would have been obvious to a person of ordinary skill in the art based on the cited references? Findings of Fact 1. Smothers discloses that “[i]ntramedullary nailing is well known in the art and essentially entails aligning two or more segments of bone … about a rod or nail that fits down the medullary canal of the fractured bone” (Smothers 1, ¶ 0003). 2. Smothers discloses an instrument “for aligning fractured segments of a bone. The instrument may include at least an elongated body and a Appeal 2011-001732 Application 11/122,758 5 reference coupled to the elongated body for enabling the instrument to be located by the image-guided surgical navigation system.” (Id. at 2, ¶ 0018.) 3. Smothers discloses that the instrument can be “a flexible reducer … having one or more location elements … to assist determining the physical relationship of at least certain parts of the flexible portion with respect to a reference” (id. at 3, ¶ 0020). 4. Smothers discloses that the term reducer refers to “to any instrument used to assist with the alignment of bones” (id. at 5, ¶ 0059). 5. Smothers discloses that “a surgeon may desire to use a flexible reducer if the bone fracture to be aligned or reduced is so misaligned that a rigid reducer is not workable or would be particularly difficult to use” (id. at 6, ¶ 0065). 6. Smothers discloses that a flexible reducer “presents a challenge to the use of the image-guided systems … because the flexible elongated portion 52 will not necessarily remain in a fixed position with respect to the reference 12 … in order to provide … accurate cues about its physical position” (id. at 6, ¶0069). 7. Smothers’ Figure 21 shows reference 12 attached to the proximal end of flexible reducer 50 (id. at Fig. 21). 8. Smothers discloses that “[f]lexible reducer 50 is consequently provided with one or more location elements 75 … [that] assist the determination … of the physical relationship of the flexible elongated portion 52 with respect to reference 12” (id. at 6, ¶ 0070). 9. Smothers discloses that a “location element 75 may be provided at or near the tip 54 of flexible elongated portion 52, at or near the middle of App App flexi elon comp porti refer by … array capa Figu the h comp 2, ¶ expa the s eal 2011-0 lication 11 ble elonga gated porti 10. Smo onent or d on 52 to b ence 12” ( 11. Smo infrared, 12. Fuim with two bilities” (F 13. Figu re 2 shows ousing, an 14. Fuim rises five 0019). 15. Fuim nd and con pines 20 a 01732 /122,758 ted portion on 52, or a thers disc evice that e sensed, d id. at 6, ¶ thers disc visual, … aono disc or more lo uimaono re 2 of Fu a “perspe d the dista aono disc spines 20 aono disc tract the e re bowed o 52, at mu ny combi loses that “ permits th etected, im 0071). loses that “ or any oth loses “a c cation sen 1, ¶ 0001). imaono is ctive view l end of th loses that or arms m loses that lectrode a utwardly” 6 ltiple posi nation of t [l]ocation e physica aged, or location e er desired atheter hav sors to pro shown bel of the bas e catheter “basket-sh ounted … the “expan ssembly, s (id.). tions alon hese posit element 7 l position mapped w lements 7 technique ing a bask vide impr ow: ket shape body” (id aped elec around an der is mo o that, in t g the flexi ions” (id.) 5 may be of flexible ith respect 5 may be s ” (id.). et-shaped oved map d electrode . at 1, ¶ 00 trode assem expander ved longit he expand ble . any elongated to ensed … electrode ping assembly 11). bly 18 22” (id. at udinally to ed positio , n Appeal 2011-001732 Application 11/122,758 7 16. Fuimaono discloses that the “catheter further includes two location sensors 32 and 34 for providing location information about each of the ring electrodes on the electrode assembly 18” (id. at 2, ¶ 0025). 17. Fuimaono discloses that “one of the location sensors 32 and 34 can comprise a bend sensor, which generates signals responsive to a bend radius of the spines 20” (id. at 3, ¶ 0028). 18. Fuimaono discloses that a “bend sensor can comprise … a fiber[ ]optic sensor, wherein the bend radius is determined by measuring the loss and/or back-reflection of light in an optical fiber, as is also known in the art” (id.). 19. Fuimaono discloses that the “coordinates of the distal sensor 32, relative to those of the proximal sensor 34, are determined and taken together with other known information pertaining to the curvature of the spines 20.… This information is used to find the positions of the ring electrodes 28 mounted on the spines 20.” (Id. at 3, ¶ 0029.) Analysis Claim 1 is directed to tracking system for an intramedullary pin whose spatial position is determined or tracked in image-guided surgery. The system comprises, among other things, a reference device configured for attachment to the proximal end of the intramedullary pin, a medical navigation system configured to locate the reference device, and a fiber optic deformation detection device configured to detect deformations of the intramedullary pin, based on differences in light transmit times, and communicate the deformations to the navigation system. Appeal 2011-001732 Application 11/122,758 8 Smothers discloses a tracking system for a flexible reducer such as an intramedullary pin or nail (FFs 2-4) that comprises a reference device for attachment to the proximal end of the reducer (FF 7), a medical navigation system configured to locate the reference device (FF 2), and a deformation detection device (location element 75; FFs 9-11) configured to detect deformations of the reduction device. Fuimaono discloses a basket shaped electrode assembly with spines that can be moved into a flexed position. Fuimaono discloses that electrodes are located on the spines and that the bend radius of the spines can be determined with the use of a fiber optic sensor that measures the loss and/or back-reflection of light in an optical fiber. Fuimaono discloses that the position of the electrodes in a patient’s body can be determined using bend sensors and the coordinates of sensors located at the distal and proximal ends of the basket. In view of these disclosures, it would have been obvious to one of ordinary skill in the art to modify Smothers’ flexible intramedullary reducer to comprise a fiber optic deformation or bend sensor, as disclosed in Fuimaono, because Smothers discloses the need to determine the deformation of its reducer and Fuimaono discloses that fiber optic bend sensors can be used to determine the deformation of an medical device within the body. Appellants argue that Fuimaono cannot be properly combined with Smothers because the references are non-analogous art (Appeal Br. 9). Appellants argue that Fuimaono is concerned with mapping electrical activity in the heart, and therefore is not in the same field of endeavor as Smothers (id.). Appellants also argue that Fuimaono is not pertinent to the Appeal 2011-001732 Application 11/122,758 9 invention of Smothers because Smothers does not identify any specific need or problem with its deformation detection system and thus “there is no reason for the person having ordinary skill in the art to look to non- analogous art (i.e., Fuimaono …) for a solution to a non-existent need or problem” (id. at 10). We are not persuaded by Appellants’ argument that Fuimaono is non- analogous art. Even when prior art is not in the same field of endeavor as the claimed invention, it is still analogous prior art if it is “reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). Thus, the question is not whether Smothers identified a problem with its deformation detection system, but whether Fuimaono would have commended itself to an inventor trying to solve the same problem addressed by Smothers; specifically, detecting deformation of an intramedullary pin. Since Fuimaono’s disclosure relates to the use of a fiber optic detection system to determine the degree of curvature of a medical device component within the body so that the coordinates of the device can be determined, we find that Fuimaono is analogous prior art because it would have logically commended itself to those skilled in the art considering the problem addressed by Smothers. Appeal 2011-001732 Application 11/122,758 10 Appellants also argue that the cited references cannot be properly combined because the combination would render Smothers’ device unsatisfactory for its intended purpose (Appeal Br. 15). Appellants argue that the bend sensor of Fuimaono only detects bends near the sensor, and thus Fuimaono “does not indicate how such sensor can detect bends away from the sensor itself” (id. at 16). This argument is not persuasive. Smothers discloses that the flexible reducer can have location elements or sensors at various points along its length (FF 9). Thus, the combined disclosures of Smothers and Fuimaono would have suggested to one of ordinary skill in the art fiber optic bend sensors placed at multiple locations along the flexible reducer, in order to detect deformation along its length. Appellants also argue that Todoroki is non-analogous art (Appeal Br. 9). However, since we conclude that the invention of claim 1 would have been obvious in view of Smothers and Fuimaono, as discussed above, we need not reach the question of whether Todoroki is non-analogous art. Conclusion of Law The Examiner has provided an adequate basis for concluding that the tracking system of claim 1 would have been obvious to a person of ordinary skill in the art based on the cited references. Claims 2-4, 24, and 25 fall with claim 1 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii). With regard to the rejection of claim 5 based Smothers, Fuimaono, Todoroki and Elstrom (Answer 6-7), Appellants have waived the opportunity to present additional arguments based on Elstrom. See Appeal Br. 17. Thus, we also affirm the rejection of claim 5. Appeal 2011-001732 Application 11/122,758 11 II. The Examiner has rejected claims 8 and 9 under 35 U.S.C. § 103(a) as obvious in view of Smothers, Fuimaono, Todoroki and Barrick. Claims 8 and 9 depend from claim 1 and further require that the fiber optic structure “comprises a structure with sequentially arranged fiber optic loops” (claim 8) or “comprises at least two loop structures orientated at an angle with respect to each other” (claim 9). The Examiner relies on Smothers, Fuimaono, and Todoroki as discussed above (Answer 7), and finds that Barrick discloses “a deformation detection device comprising fiber optic loops arranged in pairs of loops … [which] are sequential and oriented at an angle with respect to each other” (id.). The Examiner concludes that it would have been obvious to one of ordinary skill in the art to modify the device suggested by Smothers, Fuimaono, and Todoroki such that “the fiber optic structure comprises sequentially arranged fiber optic loops (claim 8) or at least two loops oriented at an angle with respect to each other (claim 9), as suggested by Barrick, as such a structure allows for deformation detection over the length of the device” (id. at 7-8). Appellants do not provide arguments disputing the rejection of claim 9 as obvious in view of Smothers, Fuimaono, Todoroki and Barrick (see Appeal Br. 18-20). Therefore, we summarily affirm the rejection of claim 9. With regard to claim 8, Appellants argue that “[o]ther than stating the sensor consists of paired loops, Barrick does not describe the sensor in any further detail … [and] does not illustrate the sensor in sufficient detail to Appeal 2011-001732 Application 11/122,758 12 enable a determination of whether or not the device includes sequential loops” (Appeal Br. 20). We agree with Appellants that the Examiner has not adequately shown that Barrick discloses or suggests “sequentially arranged fiber optic loops.” Barrick discloses a system for shaping orthopedic implants that comprises “a flexible fiber optic curvature sensor device … [which] is a tape used to determine the required three-dimensional shape of an orthopaedic implant” (Barrick 1, ¶ 0007). Barrick discloses that the “sensor relies on linear, bipolar modulation of light throughput in specially treated fiber optic loops sealed in laminations. The sensor consists of paired loops of optical fibers that have been treated on one side to lose light proportional to bending.” (Id.). Barrick does not disclose that the paired fiber optic loops are sequentially arranged, and the Examiner has not adequately explained why it would have suggested this limitation. Thus, we reverse the obviousness rejection of claim 8. III. The Examiner has rejected claim 10 under 35 U.S.C. § 103(a) as obvious in view of Smothers, Fuimaono, Todoroki, and Fradenburgh. Claim 10 depends from claim 1 and further requires that the “fiber optic structure comprises at least two loop structures orientated substantially perpendicular to each other.” The Examiner relies on Smothers, Fuimaono, and Todoroki as discussed above (Answer 8), and finds that Fradenburgh discloses “a fiber optic structure comprising at least two loop structures oriented substantially perpendicular to each other … to allow one to accurately determine a Appeal 2011-001732 Application 11/122,758 13 specific location” (id.). The Examiner concludes that it would have been obvious to modify Smothers’ device “such that the fiber optic structure comprises at least two loop structures oriented substantially perpendicular to each other, as suggested by Fradenburgh et al., as such a structure allows for accurate determination of a specific location” (id.). Appellants argue that Fradenburgh is nonanalogous art because it “is concerned with a damage detection system that incorporates optical fibers embedded in or on composite structures, such as composite structures that may be used in a space station” (Appeal Br. 21). We agree with Appellants that the Examiner has not shown that a person of ordinary skill in the art would have considered Fradenburgh to be analogous art with respect to Smothers and Fuimaono. Fradenburgh discloses that “space structures … will require a highly reliable structural monitoring system because of the potential vulnerability to micrometeor damage” (Fradenburgh, col. 1, ll. 24-30). Fradenburgh discloses a “fiber optic damage detection system [that] includes a plurality of optical fibers placed on or embedded in a composite matrix” (id. at col. 2, ll. 18-20) … such that an impact strike in one of the areas will upset two particular fibers and therefore pinpoint the location of damage within a defined area” (id. at col. 2, ll. 23-29). We agree with Appellants that the problem of detecting structural damage on a structure such as a space station is sufficiently different from the problem of detecting a bend in an intramedullary reducer that one of skill in the art would not look to Fradenburgh to solve the problem for detecting bends in a reducer. Thus, it is not the case that Fradenburgh “is reasonably Appeal 2011-001732 Application 11/122,758 14 pertinent to the particular problem with which the inventor is involved,” i.e., detecting deformation, i.e., bending, of a intramedullary pin, as compared to damage to a composite structure. In re Klein, 647 F3d 1343, 1348 (Fed. Cir. 2011) (quoting In re Bigio, 381 F.3d at 1325). We therefore agree with Appellants that Fradenburgh is non-analogous art. IV. The Examiner has rejected claim 6 under 35 U.S.C. § 103(a) as obvious in view of Smothers and Kroll. Claim 6 reads: 6. A tracking system for an intramedullary pin whose spatial position is determined and/or tracked in image-guided surgery, said intramedullary pin having a proximal end and a distal end, comprising: a reference device configured for attachment to the proximal end of said intramedullary pin; a medical navigation system configured to locate said reference device and to determine an orientation of said intramedullary pin from the proximal end based on the location of the reference device; and a deformation detection device configured to detect deformations of said intramedullary pin and communicate the deformations to said navigation system, wherein said intramedullary pin includes an interior cavity, and said deformation detection device extends in the interior cavity of said intramedullary pin. The Examiner relies on Smothers as discussed above (Answer 8-9). The Examiner finds that Smothers fails “to disclose that the intramedullary pin includes an interior cavity and the deformation detection device extends in the interior cavity of the intramedullary pin” (id. at 9). The Examiner finds that Kroll discloses “a transducer enclosed within a carrier … wherein the carrier may be hermetically sealed to protect the transducer from bodily fluids” (id.). The Examiner concludes that it “would have been obvious to one of ordinary skill in the art … for the [Smothers] deformation detection Appeal 2011-001732 Application 11/122,758 15 device, which may be a transducer …, to be located within a hermetically sealed interior cavity, as suggested by Kroll et al., as doing so can protect the deformation detection device from bodily fluids” (id. at 9). Appellants argue that Kroll “is simply disclosing that the sensor elements … are placed inside a sealed enclosure so as to protect them from fluids and/or contaminants” (Appeal Br. 25). Appellants argue that if Kroll’s teaching was applied to Smothers’ location sensor, “the skilled person simply would place the location sensor 75 within a carrier to protect them from bodily fluids. Such carrier would still reside on the elongated portion 52 of the intramedullary nail, as Kroll says nothing with regard to creating an interior cavity in a device.” (Id. at 26.) Appellants argue that “[p]resumably the transducer elements of Smothers’ location element 75 are already suitable for insertion into the body (e.g., they already are protected from bodily fluids)” (id. at 25). We agree with Appellants that the Examiner has not shown that the cited references would have made obvious a deformation detection device in the interior cavity of an intramedullary pin, as required by claim 6. Kroll discloses an “electromechanical transducer for an implantable hearing aid” (Kroll, abstract). Kroll discloses that a carrier may be used to attach the transducers to the ear (id. at col. 8, ll. 14-30). Kroll discloses that the carrier can be “hermetically sealed to protect any enclosed transducer elements and inertial mass from humidity and bodily fluids” (id. at col. 8, l. 67 to col. 9, l. 2). As recognized by Appellants, although Kroll suggests protecting a transducer from bodily fluids, the Examiner has pointed to nothing in Kroll to suggest any reason to place a deformation detection device within the Appeal 2011-001732 Application 11/122,758 16 interior cavity of an intramedullary pin. Thus, we reverse the rejection of claim 6 as being obvious in view of Smothers and Kroll. SUMMARY We affirm the rejection of claims 1-5, 9, 24, and 25 under 35 U.S.C. § 103(a). However, we reverse the rejection of claims 6, 8 and 10. TIME PERIOD FOR RESPONSE 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