Ex Parte Karczmar et alDownload PDFPatent Trial and Appeal BoardFeb 17, 201612531495 (P.T.A.B. Feb. 17, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/531,495 09/16/2009 Gregory Karczmar 38107 7590 02/19/2016 PHILIPS INTELLECTUAL PROPERTY & STANDARDS P. 0. Box 3001 BRIARCLIFF MANOR, NY 10510 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 2007P00613WOUS 1415 EXAMINER NEGARESTAN, FARSHAD ART UNIT PAPER NUMBER 3768 NOTIFICATION DATE DELIVERY MODE 02/19/2016 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): debbie.henn@philips.com marianne.fox@philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GREGORY KARCZMAR, SHUNMUGAVELU SOKKA, and CHARLES A. PELIZZARI Appeal2014-001151 Application 12/531,495 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JACQUELINE T. HARLOW, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL 1 This is an appeal under 35 U.S.C. § 134 involving claims 1, 3-8, 12- 18, 20, 21, and 23-28 (App. Br. 9). Examiner entered rejections under 35 U.S.C. §103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. STATEMENT OF THE CASE Appellants' invention relates to "systems and methods for enhancing the conspicuity of target tissue regions to allow for improved image 1 Appellants identify the Real Party in Interest as Koninklijke Philips Electronics, N.V. (App. Br. 2). Appeal2014-001151 Application 12/531,495 guidance associated with radiotherapy treatment and surgery" (Spec. 1 :6-8). Independent claims 1, 20, and 24 are representative and reproduced in the Claims Appendix of Appellants' Appeal Brief. Claims 1, 3, 4, 12-17, 20, 21, and 23-25 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen,2 Fraser,3 and Nields.4 Claims 5 and 26 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, and Vaezy. 5 Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, Vaezy, and Suri.6 Claims 6, 7, and 27 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, and Dayton.7 Claim 18 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, Vaezy, and Meier. 8 Claim 28 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, and Ruchala. 9 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 2 Saracen, US 2006/0004281 Al, published Jan. 5, 2006. 3 Fraser, US 2006/0293598 Al, published Dec. 28, 2006. 4 Nields et al., US 2008/0033420 Al, published Feb. 7, 2008. 5 Vaezy et al., US 6,716,184 B2, issued Apr. 6, 2004. 6 Suri, US 6,718,055 Bl, issued Apr. 6, 2004. 7 Dayton et al., US 2005/0084538 Al, published Apr. 21, 2005. 8 Meier et al., US 2006/0058648 Al, published Mar. 16, 2006. 9 Ruchala et al., US 2007/0195929 Al, published Aug. 23, 2007. 2 Appeal2014-001151 Application 12/531,495 FACTUAL FINDINGS (FF) FF 1. Saracen suggests "[a]n apparatus and method to track the movement of a pathological anatomy in real-time during radiation treatment," that an "electromagnetic field may be generated by a transmitter positioned near the patient," and that "[d]uring radiation treatment, the position of the external reference objects is correlated with the internal markers to follow the motion of a pathological anatomy in real-time" (Saracen Abstract, i-f 62; see also Ans. 3--4, 6-7). FF 2. Fraser suggests that "[h]igh intensity focused ultrasound (HIFU) for medically treating tumors is automatically administered under robotic control in dosage intervals that alternate with ultrasonic imaging intervals," "a HIFU apparatus" that includes "a HIFU transmitter[] and a three- dimensional or '3-D' ultrasonic imaging transceiver," and that "ultrasonically high-contrast markers" are "formed by applying HIFU to 'bum' them in" (Fraser Abstract, i-fi-121, 30; see also Ans. 4, 7). FF 3. Nields suggests that [a] thermal ablation system is operable to perform thermal ablation using an x-ray system to measure temperature changes throughout a volume of interest in a patient. Image data sets captured by the x-ray system during a thermal ablation procedure provide temperature change information for the volume being subjected to the thermal ablation. Intermediate image data sets captured during the thermal ablation procedure may be fed into a system controller, which may modify or update a thermal ablation plan to achieve volume coagulation necrosis targets. The thermal ablation may be delivered by a variety of ablation modes including radiofrequency ablation, microwave therapy, high intensity focused ultrasound, laser ablation, and other interstitial heat delivery methods. Methods of performing 3 Appeal2014-001151 Application 12/531,495 thermal ablation using x-ray system temperature measurements as a feedback source are also provided. (Nields Abstract; see also Ans. 4, 7.) FF 4. Nields suggests that "[e]lastography and/or ARFI may be used to detect changes within the VOI due to the application of thermal ablation," that "[t]hese changes may indicate temperature or other changes in the VOI such as coagulation," and that "[ o ]nee these changes surpass a predetermined level, an x-ray CT image may be triggered" (Nields i-f 36; see also Reply Br. 4). FF 5. Nields suggests a method for performing thermal ablation within a VOI in a patient that includes capturing a baseline digital image of the VOI, capturing a temperature differential digital image of the VOI and registering the temperature differential digital image to the baseline digital image. . . . [T]he baseline digital image and the temperature differential digital image may be registered to a single external coordinate system. . . . [S]oftware may be employed to register the temperature differential digital image to the baseline digital image without the use of artificial fiducial markers .... [T]he software may be able to use internal structures within the images as natural fiducial markers and register the images by aligning those natural fiducial markers. (Nields ,-r 61.) ANALYSIS The combination of Saracen, Fraser, and Nields: Appellants' independent claim 1 requires, inter alia, "a MRI-guided HIFU system for generating ablation markings on a target tissue region" and "wherein the markings generated on the target tissue region by the MRI- guided HIFU are visible in the image generated by the imaging system" (Appellants' claim 1). Appellants' independent claim 20 requires, inter alia, 4 Appeal2014-001151 Application 12/531,495 "generating ablation markings which are visible by an imaging system on the target tissue region by ablating the target tissue region with a MRI- guided HIFU system" (Appellants' claim 20). Appellants' independent claim 24 requires, inter alia, "delivering HIFU to the target locations to generate ablation markings which are visible with a CT imaging system at the target locations" and "with the CT imaging system, imaging the target tissue region to generate CT images in which the ablation markings are visible" (Appellants' claim 24). Based on the combination of Saracen, Fraser, and Nields, Examiner concludes that, at the time of Appellants' invention was made, it would have been prima facie obvious to "combine the HIFU system for generating ablation marking as taught by Fraser with the radiotherapy system of Saracen to non-invasively mark the target tissue region for motion tracking" (Ans. 4, 8). We are not persuaded. Notwithstanding Examiner's assertion to the contrary, Nields, at best, suggests that "[a] thermal ablation system is operable to perform thermal ablation using an x-ray system to measure temperature changes throughout a volume of interest in a patient" (FF 3), "changes may indicate temperature or other changes in the VOI such as coagulation," and that "[ o ]nee these changes surpass a predetermined level, an x-ray CT image may be triggered" (FF 4), and "software may be able to use internal structures within the images as natural fiducial markers and register the images by aligning those natural fiducial markers" (FF 5). Therefore, we are not persuaded by Examiner's assertion that "Nields teaches that ablations caused by HIFU [] can be detected by x-ray imaging" (Ans. 4, 7; cf App. Br. 9, Reply Br. 4). Further, as Appellants point out, "[t]he Examiner has ostensibly retracted a 5 Appeal2014-001151 Application 12/531,495 reference at this late stage of prosecution (Examiner's Answer) and maintained his rejection without presenting a reference to support his newly presented assertions regarding what is 'old and well-known' in the art, or requires 'only routine skill"' (Reply Br. 3; see FF 3-5; cf Ans. 12 ("However, reliance on the reference ofNields is not necessary as ablation markings taught by Fraser are tissue scars made by ablating the tissue with HIFU, and it is old and well-known that tissue scars are visible with CT or X-ray imaging.")). In sum, Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Saracen, Fraser, and Nields suggest "wherein the markings generated on the target tissue region by the MRI-guided HIFU are visible in the image generated by the imaging system," "generating ablation markings which are visible by an imaging system on the target tissue region by ablating the target tissue region with a MRI-guided HIFU system," or "with the CT imaging system, imaging the target tissue region to generate CT images in which the ablation markings are visible." The combination of Saracen, Fraser, Nields, and Vaezy: Based on the combination of Saracen, Fraser, Nields, and Vaezy, Examiner concludes that, at the time Appellants' invention was made, it would have been obvious to "apply the HIFU contrast agent technique of Vaezy in the system of Saracen in view of Fraser and Nields to enhance the visibility of the generated markings" (Ans. 8). Examiner, however, failed to establish that Vaezy, makes up for the deficiency in the combination of Saracen, Fraser, and Nields discussed above. 6 Appeal2014-001151 Application 12/531,495 The combination of Saracen, Fraser, Nields, Vaezy and Suri: Based on the combination of Saracen, Fraser, Nields, Vaezy, and Suri, Examiner concludes that, at the time Appellants' invention was made, it would have been obvious to "apply the gadolinium x-ray contrast agents as taught by Suri in the system of Saracen in view of Fraser and Nields further in view of Vaezy to enhance the diagnostic utility" (Ans. 9). Examiner, however, failed to establish that Vaezy and Suri, make up for the deficiency in the combination of Saracen, Fraser, and Nields discussed above. The combination of Saracen, Fraser, Nields, and Dayton: Based on the combination of Saracen, Fraser, Nields, and Dayton, Examiner concludes that, at the time Appellants' invention was made, it would have been obvious to "apply low power ultrasound as taught by Dayton in the system of Saracen in view of Fraser and Nields to increase leakage of contrast agent into the tissue by increasing permeability of the cell membranes (e.g. vascular)" (Ans. 9-10). Examiner, however, failed to establish that Dayton, makes up for the deficiency in the combination of Saracen, Fraser, and Nields discussed above. The combination of Saracen, Fraser, Nields, Vaezy and Meier: Based on the combination of Saracen, Fraser, Nields, Vaezy, and Meier, Examiner concludes that, at the time Appellants' invention was made, it would have been obvious to "apply the gold fiducials (beads) as taught by Meier in the system of Saracen in view of Fraser and Nields further in view of Vaezy to enhance the radiation intensity" (Ans. 10). Examiner, however, failed to establish that Vaezy and Meier, make up for 7 Appeal2014-001151 Application 12/531,495 the deficiency in the combination of Saracen, Fraser, and Nields discussed above. The combination of Saracen, Fraser, Nields, and Ruchala: Based on the combination of Saracen, Fraser, Nields, and Ruchala, Examiner concludes that, at the time Appellants' invention was made, it would have been obvious to "mark the radiation risk areas as taught by Ruchala in the method of Saracen in view of Fraser and Nields to avoid exposing a particularly vulnerable area to radiation" (Ans. 11 ). Examiner, however, failed to establish that Ruchala, makes up for the deficiency in the combination of Saracen, Fraser, and Nields discussed above. CONCLUSION OF LAW The preponderance of the evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1, 3, 4, 12-17, 20, 21, and 23-25 under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, and Nields is reversed. The rejection of claims 5 and 26 under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, and Vaezy is reversed. The rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, Vaezy, and Suri is reversed. The rejection of claims 6, 7, and 27 under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, and Dayton is reversed. 8 Appeal2014-001151 Application 12/531,495 The rejection of claim 18 under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, Vaezy, and Meier is reversed. The rejection of claim 28 under 35 U.S.C. § 103(a) as unpatentable over the combination of Saracen, Fraser, Nields, and Ruchala is reversed. REVERSED 9 Copy with citationCopy as parenthetical citation