Rainer Graumann et al.Download PDFPatent Trials and Appeals BoardAug 19, 201913285493 - (D) (P.T.A.B. Aug. 19, 2019) 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. 13/285,493 10/31/2011 RAINER GRAUMANN 2011P10334 6074 27350 7590 08/19/2019 LERNER GREENBERG STEMER LLP Box SA P.O. BOX 2480 HOLLYWOOD, FL 33022-2480 EXAMINER FERNANDEZ, KATHERINE L ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 08/19/2019 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): boxsa@patentusa.com docket@patentusa.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte RAINER GRAUMANN, GERHARD KLEINSZIG, YOSHITO OTAKE, and JEFFREY SIEWERDSEN __________ Appeal 2017-010151 Application 13/285,493 Technology Center 3700 __________ Before ERIC B. GRIMES, RYAN H. FLAX, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants1 submit this appeal under 35 U.S.C. § 134 involving claims to a method for localization of a structure including, inter alia, steps of acquiring a preoperative 3D computer-tomography (CT) image and an intraoperative two dimensional (2D) x-ray image. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Party in Interest as The Johns Hopkins University and Siemens Aktiengesellschaft. Br. 1. Appeal 2017-010151 Application 13/285,493 2 STATEMENT OF THE CASE Appellants’ “invention relates to a method for localization and identification of a structure in a projection image with a system having a known system geometry.” Spec. ¶ 2. The Specification explains that “[w]rong site surgery is a surprisingly common error in medical practice with major ramification to the patient and healthcare system.” Id. ¶ 3. Using spinal surgery as an example, the Specification further explains that a wrong site surgery may involve a procedure that is performed at the wrong level, such as at an incorrect one of the vertebrae, which can otherwise have a similar visual and radiographic appearance. Id. According to the Specification, the described invention overcomes disadvantages of known localization and identification methods and “significantly decreases the number of wrong-level surgeries and . . . is independent of the surgeon’s ability to localize and/or identify a target level in the body.” Id. ¶ 4. Claims 1, 3, and 8 are on appeal.2 Claim 1, the only independent claim, is illustrative and reads as follows: 1. A method for localization and identification of a structure with a system having a known system geometry, the method comprising the following steps: 2 Appellants’ brief (see, e.g., Br. 1, 10) indicates that claim 9 was finally rejected and is subject to this appeal. Claim 9, however, was newly submitted via amendment dated April 28, 2016. And the Examiner indicated in the August 10, 2016 Final Rejection that claim 9 was directed to a non- elected invention and was, accordingly, withdrawn from consideration on the merits. Final Act. 2–3; 37 C.F.R. § 1.142(b). Claim 9 is, thus, not part of the final rejection on appeal and will not be further considered by the Board in this decision. Appeal 2017-010151 Application 13/285,493 3 a) acquiring a preoperative 3D computer-tomography (CT) image of a structure; b) preprocessing the 3D CT image to generate a volume image by segmenting the structure in the 3D CT image; c) acquiring an intraoperative two dimensional (2D) X-ray image; d) preprocessing the 2D X-ray image to obtain a line integral of a linear attenuation coefficient from 2D image intensity values to generate a fixed image; e) estimating an approximate pose of the structure; f) calculating a digitally reconstructed radiograph (DRR) using: the volume image, the estimated approximate pose and the system geometry; g) comparing the calculated DRR and the fixed image by a similarity measure based on gradient information; h) updating the estimated approximate pose in order to increase the similarity measure; i) repeating steps f) to h) until the similarity measure reaches a criterion of optimization and then displaying the estimated approximate pose to represent a localized and identified structure, wherein in each repetition of step f), the updated estimated approximate pose that was previously calculated in a most recent performance of step h) is used as the estimated approximate pose; and j) overlaying the calculated DRR from a last repetition of step f) onto the fixed image. Br. 9–10 (Claims App’x). Appeal 2017-010151 Application 13/285,493 4 The claims stand rejected as follows: Claims 1 and 3 under 35 U.S.C. § 103(a) as obvious over Khamene,3 Edic,4 Raanes,5 Pluim,6 and Cosman.7 Final Act. 3–11; Ans. 2–10. Claim 8 under 35 U.S.C. § 103(a) as obvious over Khamene, Edic, Raanes, Pluim, Cosman, and Boese.8 Final Act. 11–12; Ans. 10–11. DISCUSSION Claims 1 and 3 Appellants do not separately argue the patentability of claims 1 and 3. Our discussion, thus, focuses on independent claim 1. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Khamene discloses a method having all the limitations of claim 1, with four exceptions. Final Act. 3–6. First, the Examiner finds that Khamene discloses step (d)’s preprocessing of the intraoperatively acquired 2D x-ray image to form a fixed image,9 but does not specify that the image processing involves obtaining a line integral of a linear attenuation coefficient from 2D image intensity values. Id. at 6. 3 Khamene et al., US 2006/0188139 A1, published Aug. 24, 2006. 4 Edic et al., US 2004/0120449 A1, published June 24, 2004. 5 Raanes et al., US 2009/0003523 A1, published Jan. 1, 2009. 6 Josien P. W. Pluim et al., Image Registration by Maximization of Combined Mutual Information and Gradient Information, 19:8 IEEE TRANSACTIONS ON MEDICAL IMAGING 809–814 (2000). 7 Cosman, US 2002/0065461 A1, published May 30, 2002. 8 Boese et al., US 7,689,019 B2, issued Mar. 30, 2010. 9 According to the Examiner, a “fixed image” is represented by a segmented 2D-distance map or a “real segmented projection image” in Khamene. Final Act. 4 (citing Khamene ¶¶ 17–19, 30). Appeal 2017-010151 Application 13/285,493 5 According to the Examiner, however, that deficiency is remedied by Edic, which the Examiner finds teaches a successful means of image generation involving preprocessing and calibration to obtain a line integral of linear attenuation coefficients from 2D image intensity values. Final Act. 7 (citing Edic ¶ 31); see also Ans. 17 (“The processed data was then used to successfully formulate/generate an image with improved temporal resolution.”) (citing Edic, Abstract, ¶¶ 30–31). The Examiner reasons it would have been obvious to use this known and successful x-ray image preprocessing technique, which the Examiner finds provides improved resolution, in Khamene’s method. Final Act. 6–7; Ans. 16–17. Second, the Examiner finds that, although Khamene discloses, as in claim 1’s step (g), comparing the calculated DRR (a simulated 2D projection image reconstructed from a 3D CT image) and the fixed image (from an intraoperatively acquired 2D x-ray image) based on a similarity measure, Khamene does not specify that the measure is based on gradient information. Final Act. 5 (citing e.g., Khamene ¶¶ 16, 18–19, 25–30, and Fig. 2). The Examiner finds, however, that Pluim teaches that gradient information is a useful similarity measure for registration of clinical images. Final Act. 8–9 (citing Pluim, Abstract, 810, 813). Because Pluim teaches that use of gradient information provides a more robust and accurate similarity measure, the Examiner reasons it would have been obvious to use gradient information for the similarity measure of Khamene. Id.; see also Ans. 12– 13; Pluim 809 (“Image gradients by themselves have been shown to be useful registration criteria”). Appeal 2017-010151 Application 13/285,493 6 Third, although the Examiner finds that Khamene discloses that its system may include a display, the Examiner states that Khamene does not specifically teach step (i)’s “displaying” the estimated approximate pose to represent a localized and identified structure as recited in claim 1. Final Act. 6 (citing Khamene ¶ 14); see also Khamene Fig. 1 (structure 116 (display unit)). Nevertheless, the Examiner finds that Raanes describes image-guided radiation treatment systems that involve comparing 2D in-treatment x-ray images with 2D digitally reconstructed radiographs (DRRs) derived from 3D pre-diagnostic treatment images (see Raanes ¶¶ 5–6) and discloses displaying information, such as 2D or 3D representations, on a display to assist the user. Final Act. 8; Raanes ¶ 91. According to the Examiner, it would have been obvious to display the estimated approximate pose (i.e., a 2D representation) based on the combined teachings of Khamene and Raanes in order to provide a user presentation and allow the user to visually assess the structure of interest. Final Act. 8. Fourth and finally, the Examiner finds that although Khamene’s method seeks to closely match the synthetic projection image (DRR) to the fixed image (generated from an intraoperative x-ray image), Khamene does not disclose “overlaying” the DRR and fixed image as in claim 1’s step (j). Final Act. 6. The Examiner turns to Cosman, finding it teaches a surgical positioning system that uses reconstructed radiographs (DRRs) in comparison with actual x-ray images taken intraoperatively. Final Act. 9 (citing Cosman ¶ 68, Fig. 4). According to the Examiner, Cosman teaches the use of “overlay analysis” and that “[b]ased on the comparative images (i.e. overlaid images) from such reconstructed and actual X-ray views, Appeal 2017-010151 Application 13/285,493 7 further patient/beam corrective movements . . . may be made/planned.” Id. The Examiner concludes it would have been obvious to overlay Khamene’s DRR images onto a fixed image projection, as suggested by Cosman, to provide a comparative image that can be used for corrective movements (e.g., of the patient) during an operation. Final Act. 9–10. We agree with, and adopt, the Examiner’s findings and conclusion that claim 1 would have been obvious over Khamene, Edic, Raanes, Pluim, and Cosman. Final Act. 4–11. On the record here, we credit and agree with the Examiner’s findings that Khamene teaches the method of claim 1, but for those distinctions discussed above. Final Act. 4–5 (identifying where Khamene teaches or suggests the limitations of each of steps (a)–(i) of claim 1); see, e.g., Khamene ¶¶ 16–19, 30, Fig. 2. Those distinctions are, however, known image processing and display techniques, for assessment and comparison of x-ray, CT, DRR, and other clinical images, as evidenced by the remaining references. And the Examiner has provided technical reasoning, drawn largely from the prior art of record, to explain why the skilled artisan would have included those techniques in Khamene’s method to arrive at the claimed subject matter. Appellants first argue that “Pluim concerns registering one three- dimensional image with another three-dimensional image” and the “method disclosed in Pluim is only applicable to registering a three-dimensional image with another three-dimensional image.” Br. 4. According to Appellants, there is no teaching “in Pluim [that] could be used to register a three-dimensional image with a two-dimensional image as is the case in Khamene.” Id. Moreover, Appellants contend, it is not clear from Pluim Appeal 2017-010151 Application 13/285,493 8 how one would even make the required calculations between a three- dimensional and two-dimensional space, “[n]or is there any teaching or suggestion that such a result would be valid or give advantageous results.” Id. at 4–5. Appellants’ argument is unpersuasive. Appellants’ argument misconstrues the rejection, the claims, and the prior art. Ans. 11–12. The Examiner is not suggesting Pluim’s teachings be used to register a 3D image with a 2D image; rather the “Examiner is suggesting that the gradient information be used for the similarity metric . . . to compare the 2D DRR and the 2D fixed image disclosed by Khamene.” Id. As the Examiner explains in detail (with supporting evidence), a DRR is a two-dimensional image that is derived from a 3D CT image. Id. at 12 (citing, e.g., Khamene ¶ 30); see also Raanes ¶ 5 (disclosing that DRRs are “2D digitally reconstructed radiographs (DRRs) derived from three dimensional (3D) pre- treatment diagnostic imaging data of the patient”). The Examiner also cites disclosure in Pluim teaching more generally that “[i]mage gradients by themselves have been shown to be useful registration criteria.” Ans. 13 (citing Pluim 809). And, the Examiner explains that Pluim teaches that gradient information can be determined in individual “slices”—2D images. Ans. 13 (citing Pluim Fig. 2). Appellants provide no persuasive argument or evidence to the contrary.10 10 Appellants did not file a Reply Brief here to respond further to the Examiner’s Answer. Moreover, insofar as the Appellants’ argument suggests there would be something unclear or difficult for the skilled person in applying Pluim’s teachings to Khamene, which otherwise discloses claim 1’s step (g) of comparing a DRR and fixed image based on a similarity Appeal 2017-010151 Application 13/285,493 9 Appellants also argue the rejection is “logically flawed” because “Khamene discloses a system and method for two-dimensional to three- dimensional registration.” Br. 5. Putting aside that Appellants state (twice) in their briefing that Khamene relates to registering a three-dimensional image with a two-dimensional image,11 Appellants’ argument fails to identify what, if any, actual limitation(s) of claim 1 are allegedly missing in Khamene or the art as combined. The Examiner has explained, for example, where Khamene teaches obtaining a 3D CT image, how that is processed to generate a volume image, from which a synthetic/simulated 2D projection image (DRR) is constructed, and also where Khamene discloses acquiring an intraoperative 2D x-ray image, and the Examiner has explained why that further processed x-ray image meets the “fixed image” limitation of claim 1, against which the calculated DRR is compared. Final Act. 4; Ans. 3–4, 6–7; see, e.g., Khamene ¶¶ 16–19, 30. Appellants do not persuasively demonstrate error in the Examiner’s findings. Appellants also contend that Raanes and Cosman “do not contain anything” to suggest modifying Khamene’s method of alleged two- measure, that argument is undercut by the Specification itself. The Specification makes only a passing mention to “gradient information” as a useful similarity measure and cites Pluim as support. Spec. ¶ 30 (“One possible similarity measure that can be used here is gradient information proposed by Pluim et al.”). If use of gradient information, as taught in Pluim, in a method of 2D to 2D or 3D to 2D registration was beyond the skilled artisan’s normal capabilities, one would expect a more complete explanation in the Specification, not simply a citation to Pluim. 11 See Br. 4 (“. . . to register a three-dimensional image with a two- dimensional image as is the case in Khamene”) (emphasis added), 5 (same). Appeal 2017-010151 Application 13/285,493 10 dimensional to three-dimensional registration. Br. 5–6. This argument fails for the reasons above—the Examiner has explained sufficiently on this record where Khamene discloses the steps of claim 1 and Appellants do not show otherwise. As for whether the skilled artisan would have considered the teachings of Raanes and Cosman, we agree with the Examiner here that, because each of Khamene, Raanes, and Cosman relate to acquiring and using diagnostic images (DRRs, x-ray images) for interventional radiation treatments, the skilled person had reasons for considering the teachings of each reference. Ans. 14–15. The reasons for combining the relevant teachings are discussed above. Lastly, Appellants state that they “believe the person of ordinary skill in the art would not have obtained any suggestion to have modified the preprocessing step in Khamene by obtaining a line integral of a linear attenuation coefficient from 2D image intensity values,” as taught in Edic. Br. 6–7. According to Appellants, “[t]his is due to the fa[c]t that Khamene needs to segment the 2D x-ray projection so that the distance map can be extracted.” Id. at 7. On this record, we are unpersuaded. The Examiner explains why the proposed modification of the art (incorporating Edic’s preprocessing technique) is consistent with Khamene’s method and teaching. Ans. 16 (explaining that “in Khamene, the segmentation process follows after a full unsegmented [pre-processed] image is generated,” and “preprocessing of the 2D X-ray image to generate a fixed image is considered to encompass the processing steps that occur prior to generating the ‘real segmented projection images’ (i.e. fixed image) which is compared to the calculated Appeal 2017-010151 Application 13/285,493 11 DRR.”). Appellants do not provide any argument or evidence to demonstrate that the Examiner’s reasoning is technically flawed or otherwise incorrect. For the above reasons, we determine that the preponderance of the evidence on this record supports the Examiner’s conclusion that claim 1 would have been obvious over Khamene, Edic, Raanes, Pluim, and Cosman. Claim 3 was not argued separately and falls with claim 1. Claim 8 The Examiner rejected claim 8 over Khamene, Edic, Raanes, Pluim, Cosman, and Boese. Final Act. 11–12. According to the Examiner, Boese discloses acquiring images with a C-arm device, and the Examiner concludes it would have been obvious to use a C-arm device to acquire x- rays in the method suggested by the combined references. Id. Appellants do not provide separate, substantive argument related to claim 8. Appellants contend claim 8 is patentable “for the reasons given above with regard to claim 1.” Br. 7. Appellants’ arguments on claim 1 are unpersuasive as already explained. We adopt the Examiner’s findings and conclusion of obviousness for claim 8 on this record. Final Act. 11–12. Conclusion of Law The preponderance of the evidence on this record supports the Examiner’s conclusion that claims 1, 3, and 8 would have been obvious. SUMMARY We affirm the rejections for obviousness on appeal. Appeal 2017-010151 Application 13/285,493 12 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 Copy with citationCopy as parenthetical citation