Ex Parte Tuma et alDownload PDFPatent Trial and Appeal BoardSep 17, 201211356737 (P.T.A.B. Sep. 17, 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. 11/356,737 02/17/2006 Gregor Tuma SCHWP0241USA 3671 7590 09/17/2012 RENNER, OTTO, BOISSELLE & SKLAR, LLP Nineteenth Floor 1621 Euclid Avenue Cleveland, OH 44115-2191 EXAMINER DANEGA, RENEE A ART UNIT PAPER NUMBER 3736 MAIL DATE DELIVERY MODE 09/17/2012 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte GREGOR TUMA, MARIO SCHUBERT, FRANK GRUENSCHLAEGER, and MARTIN HAIMERL __________ Appeal 2011-004810 Application 11/356,737 Technology Center 3700 __________ Before LORA M. GREEN, FRANCISCO C. PRATS, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a method for determining a characteristic axis of a body structure. The Examiner entered rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part. STATEMENT OF THE CASE To ensure correct function of an artificial hip joint, “and to enable a long service life for the artificial joint, the femoral component of the artificial hip joint should be positioned in the bone structure of the femur in a particular position with respect to the shaft axis and the femur neck axis” Appeal 2011-004810 Application 11/356,737 2 (Spec. 1). Because two-dimensional x-ray images can be inadequate for determining the three-dimensional coordinates required to correctly position such implants, “computer tomography (CT) recordings of the body structure in question are often generated. However, CT recordings subject the patient to a significantly higher radiation exposure relative to the two-dimensional x-ray recordings mentioned above” (id. at 2). The Specification discloses “a method for determining characteristic axes of a body structure, such as for determining the three-dimensional position of the femur neck axis or the shaft axis of the upper leg bone or femur” (id.). Preferably, “two or more two-dimensional recordings [are] produced from different directions of each of a first area of the body structure and optionally also a second, different area of the body structure. The recordings, for example, can be two-dimensional x-ray recordings of the areas of the body structure” (id.). From these images, the “position of a characteristic axis, such as the position of the shaft axis, for example, can be determined automatically, manually or by means of an image processing algorithm” (id.). In one embodiment, the “position of the shaft axis and, with the aid of a generic model, the position of the femur neck axis can be determined, for example, by rear-projection from preferably at least two recordings of the femur neck and the shaft of a femur respectively” (id. at 4). Thus, “it is no longer necessary to obtain a CT recording” (id.). Claims 1-13 and 40 stand rejected and appealed (App. Br. 2). Claim 1 is representative reads as follows (emphasis added): 1. A method for determining a characteristic axis of a body structure, comprising: Appeal 2011-004810 Application 11/356,737 3 comparing each of at least two two-dimensional mappings of an area of the body structure with a generic model of the area in question, said generic model containing information on the position of the characteristic axis; ascertaining a mapping protocol for mapping the generic model onto the respective mappings of the area; using the ascertained mapping protocol to map the position of the characteristic axis in the generic model onto each of the at least two two-dimensional mappings of the area of the body structure; and back-projecting the at least two two-dimensional mappings of the area of the body structure to determine a three-dimensional position of the characteristic axis. The following rejections are before us for review: (1) Claims 1, 3-7, 11-13, and 40, under 35 U.S.C. § 103(a) as obvious over Bras1 (Ans. 3-5); (2) Claim 2, under 35 U.S.C. § 103(a) as obvious over Bras and Shimura2 (Ans. 5-6); and (3) Claims 8-10, under 35 U.S.C. § 103(a) as obvious over Bras and Krause3 (Ans. 7-9). DISCUSSION The Examiner found that Bras described a process substantially as recited in claims 1 and 40, except that “Bras doesn’t expressly teach the axis is positioned from the generic model onto the two images. However, Bras teaches retro projecting areas of interest, such as contours onto the images as 1 A. Le Bras et al., Personalised 3D reconstruction of proximal femur from low-dose digital biplanar radiographs, 1256 INTERNATIONAL CONGRESS SERIES 214-219 (2003). 2 Shimura, U.S. Patent App. Pub. No. 2003/0176860 A1 (published September 18, 2003). 3 Krause et al., U.S. Patent No. 6,711,432 B1 (issued March 23, 2004). Appeal 2011-004810 Application 11/356,737 4 well as using the method to determine characteristic axes of the femur” (Ans. 4). The Examiner reasoned, therefore, that an ordinary artisan would have considered it obvious to “back-project those characteristics of interest onto the two dimensional images to find the three dimensional characteristic of interest based on this approach” (id.). Appellants contend that “Bras does not teach back projecting two- dimensional mappings of the area of the body” as required by claim 1 (App. Br. 6). Rather, Appellants urge, given Bras’ disclosure that its “‘algorithm performs an elastic deformation of the generic object to fit its 3D retro- projected contours with the contours identified on both radiographs,’. . . [c]learly, retro-projection as disclosed in Bras applies to the ‘generic object’, and not the radiographs (i.e., the alleged two-dimensional mappings)” (id. at 7-8 (quoting Bras 216)). Appellants reason, therefore, that “Bras does not teach or suggest back-projecting the at least two two-dimensional mappings of the area of the body structure to determine a three-dimensional position of the characteristic axis as set forth in claim 1” (id.; see also Reply Br. 2-3). 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. Appellants’ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner’s prima facie case as to claim 1. Bras describes a process of producing a three-dimensional reconstruction of a proximal femur from low dose biplanar radiographs (see Appeal 2011-004810 Application 11/356,737 5 Bras 214 (abstract); see also id. at 215 (“The low dose digital X-ray device EOTM performs a linear scanning of each femur in two different incidences (posterior-anterior 0° and lateral views).”). As required by claim 1, using an ascertained mapping protocol, “the NSCC algorithm,” Bras compared a “3D generic model” to anatomic contour features identified in the radiographs (see id. at 216). Bras also discloses using the mapping protocol to fit the structures identified in the 3D generic model onto the contours identified in the radiographs (id. (“[T]he NSCC algorithm performs an elastic deformation of the generic object to fit its 3D retro-projected contours with contours identified on both radiographs.”)). Given Bras’ disclosure that its methods are useful for calculating hip axis length, which would be useful “for planning of surgical acts or computed assisted surgery” (Bras 214 (abstract); see also id. at 219), we discern no error in the Examiner’s finding that a surgeon of ordinary skill would have been prompted to apply Bras’ methodology to map the location of a characteristic axis in the generic model onto the two dimensional radiographs, as also required by claim 1. As to the back-projecting step at issue, we note Bras’ disclosure that “[a]n iterative control of the reconstructed models is performed by visualizing the retro-projection of the 3D reconstructed model on the real femoral contours seen on both radiographs” (id. at 216-17 (emphasis added)). As Bras explains, “[i]f the retro-projected contours are close to the real radiograph contours, the 3D model is accepted. If not, contours are modified in order to match the retro-projected model contours with the radiograph contours” (id. at 217). Appeal 2011-004810 Application 11/356,737 6 Thus, while it may be true that Bras’ process involves a retro- projection of the 3D generic object, Bras’ retro-projection itself includes or at least suggests the use of both of the two radiographs, as required by claim 1. Appellants do not point to any specific language in claim 1, or to any clear or specific supporting disclosure which defines or explains the back- projecting step, that would exclude a combined retro-projection of the 3D generic model and the two-dimensional radiographs to determine the three- dimensional position of a characteristic axis, as suggested by Bras. Appellants’ arguments therefore do not persuade us that the Examiner erred in finding that Bras suggests the claimed back-projecting step. Thus, as Appellants’ arguments do not persuade us that the Examiner failed to make out a prima facie case of obviousness as to claim 1, we affirm the Examiner’s rejection of that claim over Bras. As they were not argued separately, claims 3-6, 11, and 12 fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii). Appellants’ arguments also fail to persuade us that the preponderance of the evidence does not support the Examiner’s prima facie case as to claim 7. Claim 7 recites “the method according to claim [1, further comprising extracting contours of the body structure,] wherein extracting includes using the method of orthogonal curves” (App. Br. 16). Appellants argue that Bras “is silent with respect to using orthogonal curves to extract the contours” (id. at 9). The Examiner finds, however, that “since curves are extracted using two images taken at perpendicular angles to each other, to create a three dimensional model, the model [in Bras] will be based on using orthogonal curves or curves from each perpendicular image” (Ans. 8). Appeal 2011-004810 Application 11/356,737 7 Appellants do not dispute the Examiner’s finding. Moreover, Appellants’ Specification discloses that the use of orthogonal curves was a known edge detection method (see Spec. 3-4). Appellants’ arguments do not, therefore, persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion of obviousness as to claim 7. We therefore also affirm the Examiner’s obviousness rejection of claim 7 over Bras. As to claim 13, which depends from claim 1, Appellants reiterate their argument, discussed above, that Bras retro-projects the contours of the generic object, rather than the two radiographs, and urge, therefore, that “[i]f Bras does not perform retro-projection on the alleged two-dimensional mappings (i.e., the radiographs), it follows that Bras also does not produce a three-dimensional body structure by back-projecting the two-dimensional mappings” (App. Br. 10). Furthermore, Appellants argue, “the cited text of Bras is silent with respect to calculating boundary lines or boundary areas of such three-dimensional body structure model from back-projected body contour mappings” (id.). We are not persuaded. As discussed above, Appellants’ arguments do not convince us that claim 1 fails to encompass the retro-projecting steps described in Bras. Moreover, given Bras’ production of a 3D model in which “contours are generated as if they were projected on postero-anterior and lateral radiographs” (Bras 216 (Fig. 1 caption)), we discern no error in the Examiner’s finding that Bras’ method includes a step of generating a three- dimensional model as required by claim 13. Also, given the use of the NSCC algorithm to retrofit the contours from the generic 3D model to the Appeal 2011-004810 Application 11/356,737 8 radiographs, we are not persuaded that Bras’ method fails to include claim 13’s calculation of boundary lines from back-projected contour mappings. We therefore also affirm the Examiner’s rejection of claim 13 as obvious over Bras. We agree with Appellants, however, that the Examiner has not adequately explained why an ordinary artisan would have considered claim 40 to be obvious over Bras. Claim 40 recites, “[t]he method according to claim 1, further comprising using an intersecting line of back-projection planes ascertained from back-projecting the at least two two-dimensional mappings of the area to define the three-dimensional position of the characteristic axis” (App. Br. 16-17). As the Examiner points to no clear or specific teaching in Bras suggesting that a characteristic axis should be defined using an intersecting line of the back-projection planes of the two two-dimensional mappings, we reverse the Examiner’s rejection of claim 40 over Bras. The Examiner rejected claim 2 over Bras and Shimura, reasoning that an ordinary artisan would have considered it obvious to use Bras’ method to calculate the position of a second characteristic axis, in view of Shimura’s teaching of determining the location of two characteristic axes when performing prosthesis deployment surgery (see Ans. 5-6). Like claim 40, however, claim 2 requires the second axis’ position to be determined using a “calculation comprising an intersecting straight line of the back-projection planes of the central axes of the body contours in the two-dimensional mappings” (App. Br. 15). Because the Examiner points to no clear or specific teaching in either Bras or Shimura suggesting that a characteristic axis should be defined using an intersecting line of the back-projection Appeal 2011-004810 Application 11/356,737 9 planes of the two two-dimensional mappings, we reverse the Examiner’s rejection of claim 2 over those references. The Examiner also rejected claims 8-10, which all depend directly or ultimately from claim 1, as obvious over Bras and Krause (Ans. 7-9). The Examiner conceded that Bras did not expressly teach pre-registering landmarks on the body before generating the mappings, as required by claim 8 (id. at 6). To address that deficiency, the Examiner cited Krause as teaching “a method of identifying characteristic axes during robotic surgery in which the body part had preregistered landmarks to assist a surgeon or robot in comparing the actual body with the model during surgery” (id. (citing Krause, col. 5, ll. 15-25)). Based on these teachings, the Examiner concluded that an ordinary artisan would have considered it obvious “to pre- register landmarks on the body structure in Bras in order to use the method in robotic guided surgeries” (id.). Appellants argue that Krause discloses registering the markers “to a pre-surgical 3D model. A pre-surgical model infers that image data (e.g., any two-dimensional recording) used to construct such model has already been obtained” (App. Br. 14). Thus, Appellants urge, it cannot reasonably be concluded that “combining the teachings of Bras and Krause results in pre-registering the body structure before generating the at least two two- dimesnional [sic] mappings. Instead, and assuming Bras and Krause are combined as suggested by the Examiner, it is logical to conclude such registration occurs after the mappings are obtained” (id.). The Examiner responds that “Krause specifically contemplates images taken of the patient after marker registration or placement to calculate, or Appeal 2011-004810 Application 11/356,737 10 adjust, the final surgical plan” (Ans. 9 (citing Krause, abstract)). Thus, the Examiner urges, since “Bras’s 3-D model exists even before the x-ray images are taken, the methods of Krause can be used to further accurately define landmarks on the model, the x-ray images, and the body for use during surgery” (id.). We find that the Examiner has the better position. Claim 8 recites “[t]he method according to claim 1, further comprising pre-registering the body structure before generating the mappings” (App. Br. 16). Thus claim 8 encompasses placement of anatomical registration markers before the mapping protocol recited in claim 1 is used to map the position of the characteristic axis in the generic model onto the two two-dimensional mappings. We acknowledge that Krause describes using “an IR marker system . . . during surgery . . . [which] allows the surgeon to more accurately follow the surgical plan” (Krause, col. 5, ll. 16-25). As the Examiner points out, however, Krause more broadly discloses a computer aided orthopedic surgery method that involves using software to generate a 3D model of the relevant area of the body (id. at abstract). Specifically, Krause discloses that the “software model is used to generate a surgical plan, including placement of multifunctional markers, for performing the surgical procedure. After the markers are placed on the patient, an updated image of the patient is taken and used to calculate a final surgical plan for performing the remainder of the surgical procedure” (id.). Given Krause’s disclosure of placing registration markers before taking updated images of the patient, and before calculating the final surgical plan, we are not persuaded that the Examiner erred in finding that Appeal 2011-004810 Application 11/356,737 11 Krause would have suggested to an ordinary artisan practicing Bras’ methods that it would be useful to pre-register anatomical features in the body structure of interest before mapping it, so as to assist in the preparation of Bras’ ultimate mapping protocol. Thus, as Appellants’ arguments do not persuade us that the preponderance of the evidence fails to support the Examiner’s prima facie case as to claim 8, we affirm the Examiner’s rejection of that claim over Bars and Krause. Claims 9 and 10 fall with claim 8 as they were not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii). SUMMARY We affirm the Examiner’s rejection of claims 1, 3-7, and 11-13 as obvious over Bras. However, we reverse the Examiner’s rejection of claim 40 as obvious over Bras. We also reverse the Examiner’s rejection of claim 2 as obvious over Bras and Shimura. However, we affirm the Examiner’s rejection of claims 8-10 as obvious over Bras and Krause. 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-IN-PART lp Copy with citationCopy as parenthetical citation