Ex Parte Mostafavi et alDownload PDFBoard of Patent Appeals and InterferencesAug 27, 201210664213 (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. 10/664,213 09/16/2003 Hassan Mostafavi 005513P021 3361 7590 08/27/2012 Daniel E. Ovanezian BLAKELY, SOKOLOFF, TAYLOR & ZAFMAN LLP Seventh Floor 12400 Wilshire Boulevard Los Angeles, CA 90025-1026 EXAMINER CWERN, JONATHAN ART UNIT PAPER NUMBER 3737 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 HASSAN MOSTAFAVI, LARRY D. PARTAIN, ALEXANDER SLOUTSKY, and PETER MUNRO __________ Appeal 2011-009683 Application 10/664,213 Technology Center 3700 __________ Before DONALD E. ADAMS, LORA M. GREEN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of claims directed to a method of imaging markers and determining coordinates, to an apparatus, and to a system. The Patent Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-009683 Application 10/664,213 2 STATEMENT OF THE CASE The invention relates to the field of medical devices and procedures and, in particular, to localization of targets within a body. (Spec. 1, ¶ [0001].) Claims 1, 3, 5-16, 49, 51-58, 62-79, and 81-89 are pending and rejected. (App. Br. 4.) Claim 1 illustrates the subject matter and reads: 1. A method, comprising: imaging a plurality of markers in a first imaging modality, wherein at least a plurality of the markers are implanted completely internally in a body; determining first coordinates of the plurality of markers relative to a first beam isocenter and internal to the body; imaging the plurality of markers in a different second imaging modality; and determining second coordinates of the plurality of markers relative to a second beam isocenter and internal to the body, wherein at least a plurality of said markers are implanted in soft tissue of the body, wherein the first beam isocenter is a planned treatment beam isocenter and the second beam isocenter is a treatment machine beam isocenter at a time of treatment, and wherein the first imaging modality is CT and the second imaging modality is one of kilo volt (kV) and mega volt (MV) imaging. Claims 1, 3, 5-7, 13-14, 16, 49, 51-58, 62, 76-77, 82-84, and 87-89 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mate, 1 Cosman, 2 and Jaffray. 3 Claims 8-9, 12, 78-79, and 81 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, Jaffray, and Jang. 4 1 Timothy P. Mate et al., US 2002/0193685 A1, Dec. 19, 2002. 2 Eric R. Cosman, US 2002/0065461 A1, May 30, 2002. 3 David A. Jaffray et al., US 2003/0007601, Jan. 9, 2003. 4 Ben K. Jang, US 5,757,953, May 26, 1998. Appeal 2011-009683 Application 10/664,213 3 Claims 10 and 11 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, Jaffray, Jang, and Gerig. 5 Claims 15, 63-72, and 74 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, Jaffray, and Fitzpatrick. 6 Claims 73 and 75 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, Jaffray, Fitzpatrick, and Carol. 7 Claims 85 and 86 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, Jaffray, and Ishikawa. 8 The rejections of independent claims 1, 49, and 54, and dependent claims 62-64, 82, and 88 are appealed. (App. Br. 4, III.) The appealed claims were addressed in two rejections: (I) appealed claims 1, 49, 54, 62, 82 and 88 were included in the rejection over Mate, Cosman, and Jaffray; and (II) appealed claims 63 and 64 were included in the rejection over Mate, Cosman, Jaffray, and Fitzpatrick. As the rejections of claims 3, 5-16, 51-53, 55-58, 62, 76-79, and 81-89 were not appealed, those claims may be cancelled. Ex parte Ghuman, 2008 WL 2109842 *2 (BPAI 2008) (precedential) (“If upon filing an appeal brief, the applicant limits the claims to be considered on appeal, then it is the practice of the Patent and Trademark Office to treat the claims not pursued in the appeal brief as having been withdrawn from the appeal”). In any event, the failure to appeal is a waiver under Ex parte Frye, 2010 WL 889747 *4 (BPAI 2010) (precedential) (“If an appellant fails to present arguments on a particular 5 Lee H. Gerig, US 5,446,548, Aug. 29, 1995. 6 J. Michael Fitzpatrick et al., US 6,073,044, June 6, 2000. 7 Mark P. Carol, US 5,622,187, April 22, 1997. 8 Akira Ishikawa et al., US 6,398,710 B1, June 4, 2002. Appeal 2011-009683 Application 10/664,213 4 issue—or, more broadly, on a particular rejection—the Board will not, as a general matter, unilaterally review those uncontested aspects of the rejection”). OBVIOUSNESS Findings of Fact 1. We adopt the Examiner‟s findings concerning the scope and content of the prior art. 2. The Examiner directed attention to prior art paragraphs, some of which are reproduced in part here for convenient reference. 3. Mate disclosed: Figures 11 and 12 illustrate a feedback portion 80 of the monitoring assembly 44 that provides feedback data to an operator about, as an example, the position of the markers 30, the target isocenter 40 and the machine isocenter 22. The feedback portion 80 is a display monitor that provides pictorial, graphical, or textual information to the operator. Other feedback portions 80, such as graphical display devices, auditory feedback devices, or visual feedback devices can be used in alternate embodiments. In one embodiment, the computer controller 38 contains imaging data, such as from a CT, MRI, or ultrasound imaging system, that defines the shape and size of the target 12 within the body 14. The imaging data also defines the locations of each marker 30 in or around the target 12. The computer controller 38 uses the imaging data to provide a simulated model of the target, the markers, and the target isocenter. This simulated model is displayed on the feedback portion 80 as shown in Figure 11 in phantom lines. The simulated model is also displayed overlaying the machine isocenter 22, so the simulated target isocenter 40 is coincident with the machine isocenter. The simulated target and simulated markers can also display how the actual target needs to be Appeal 2011-009683 Application 10/664,213 5 positioned and oriented three-dimensionally for the particular radiation therapy to be applied to the target. (Mate 6, ¶ [0060], emphasis added.) 4. Mate‟s Figures 11 and 12 are reproduced here: Appeal 2011-009683 Application 10/664,213 6 5. Mate further explained: The monitoring assembly 44 also receives and displays information from the computer controller 38 to show the actual locations of the markers 30 and target isocenter 40 relative to the machine isocenter 22, and relative to the simulated target and markers. Accordingly, the feedback portion 80 allows the operator to determine the actual position of the markers relative to the simulated markers, and the target isocenter 40 relative to the machine isocenter 22 substantially in real time while the patient 16 is on the support table 76 (Figure 1). The patient 16 and support table 76 can be repositioned until the target 12 is properly oriented for the selected radiation therapy. (Id., ¶ [0061], emphasis added.) 6. Mate further explained: In addition to accurately tracking and monitoring the position of the target 12 relative to the machine isocenter 22, the system 10 is also usable to monitor the status of the target, such as a tumor or the like, in a patient's body 14 over time. . . . Images of the tumor 90 and markers 30 are obtained by CT, MRI, ultrasound, or other imaging technique over time. From these multiple images of the tumor 90 and markers 30, the position of the markers relative to the tumor can be compared and tracked. Accordingly, a doctor can use the markers 30 in the multiple images as a reference tool to determine whether the tumor has shrunk, grown, moved, or otherwise changed within the patient's body. (Id., ¶ [0062].) 7. Mate further explained: Thus, doctors can track the status of tumors or other targets within the body over time to determine, as an example, the effectiveness of radiation therapy, whether additional treatments are needed, or whether a change in tumor growth has occurred or whether the radiation treatment plan needs to be altered. Appeal 2011-009683 Application 10/664,213 7 (Id., ¶ [0063].) 8. Cosman taught that “diagnostic X-rays from machines 80 and 81 or high energy X-rays for portal imaging can be used to visualize internal anatomy such as bones and/or radiopaque index markers placed on the skin or implanted in bones or tissue within the patient prior to treatment.” (Cosman 6, ¶ [0067].) 9. Jaffray disclosed: A number of techniques have been developed to reduce uncertainty associated with systematic and/or random variations in lesion location resulting from interfraction and intrafraction errors. These include patient immobilization techniques (e.g., masks, body casts, bite blocks, etc.), off-line review processes (e.g., weekly port films, population-based or individual-based statistical approaches, repeat computerized tomography scans, etc.), and on-line correction strategies (e.g., pre-ports, MV or kV radiographic or fluoroscopic monitoring, video monitoring, etc.). (Jaffray 1, ¶ [0008].) I. Claims 1, 49, and 54 Appellants present their arguments for claims 1 (a method), 49 (an apparatus), and 54 (a system) under separate headings, but the arguments are the same. We address these arguments together. Appellants contend that “the cited references do not teach or enable” the claimed method. (App. Br. 10.) Appellants (i) contend the Examiner misread Cosman to teach “imaging a plurality of the markers that are implanted completely internally in a body as required by claim 1” (id. at 12); and (ii) “traverse that Mate teaches or can be combined with anything that Appeal 2011-009683 Application 10/664,213 8 teaches imageable markers, or markers other than ones that are located (but not imaged) by being RF excitable” (id. at 11-12). These contentions are unpersuasive because the evidence supports the Examiner‟s findings. First, Cosman taught that internally implanted markers could be used in addition to externally imaged markers. (FF 8.) The markers would have been implanted prior to treatment, but the imaging can be done interoperatively, as Cosman explained in paragraphs 65-68, and as the Examiner explains. (Ans. 4 and 13.) Second, Mate described imaging its markers, and illustrated the imaging with display drawings. (FF 2-4.) Appellants‟ arguments to the contrary appear to simply contradict the evidence. Appellants further contend “the references cannot be properly combined to teach the limits of claim 1” and argue that the rejection‟s logic is unreasonable: After reading Mate and Cosman it is unreasonable that a person would consider combining the RF-excitable internal marker, location determination system of Mate in addition to the camera external marker imaging system of Cosman, but then not using the RF-excitable markers required by each embodiment of Mate, because the result is simply imaging external markers using the camera of Cosman. Second, it is hard to imagine why a person would redundantly locate external markers by using the external imaging system of Cosman and then locate RF- excitable markers using the imaging system of Mate, other than only to read on Appellants claims. (Id. at 12-13.) According to Appellants, it is unclear how the “un-imaged” RF marker system of Mate would calculate positions relative to the “external camera imaged marker system of Cosman,” and the combination is not enabled. (Id. at 13.) First, the Examiner found that improving accuracy would have motivated a person of skill in the art to use more than one Appeal 2011-009683 Application 10/664,213 9 imaging modality. Appellants‟ arguments don‟t show the motivational finding was erroneous. Second, Appellants‟ characterization of Mate‟s markers as “un-imaged” is wrong. Third, the allegation that the combination is not enabled is only an allegation. Both Mate and Cosman described how to image markers, and Cosman described imaging multiple marker systems, implanted and external. Appellants haven‟t shown that the combination would have required undue experimentation in view of the detailed disclosures both references provided. Appellants also argue that a practitioner would not add MV treatment imaging of Jaffray to pre-treatment imaging of Cosman since they are different modes of imaging. One skilled in the art would not use x-ray to image external markers of Cosman since visible light camera would be sufficient. It would unnecessarily over-radiate the patient and does not provide any benefit (other than only reading on the claims; e.g., kV imaging is superior to MV imaging for pre-treatment imaging). (Id.) The fact that they are different modes of imaging suggests that their combination would not have been considered redundant. Instead, increasing accuracy would have been the benefit. Although Mate and Cosman each aimed for accurate alignment of target and machine isocenters, and Jaffray said that a number of techniques had been developed “to reduce uncertainty” (Jaffray 1, ¶ [0008]), Appellants assert that increasing accuracy of alignment was not recognized as a result effective variable. (App. Br. 14.) This argument is unpersuasive because it is contrary to the evidence. Mate‟s patent was entitled “Guided Radiation Therapy System,” and the first sentence of its Abstract reads “[a] system and method for accurately locating and tracking the position of a target, such as a Appeal 2011-009683 Application 10/664,213 10 tumor or the like, within a body.” Cosman addressed the “need … in relation to the treatment of internal anatomical targets, specifically to position and maintain such targets with respect to a beam or isocenter of a linear accelerator (LINAC) X-ray treatment machine” (Cosman 1, ¶ [0008]), and explained that with its invention “the beam B can be positioned and maintained to collimate at the desired target” (id. at 2, ¶ [0024]). All three references evidence that a person of ordinary skill in the art knew that accuracy was an important goal. In short, the benefits alleged for the claimed invention would have been the expected benefits of the treatment planning and delivery suggested by Mate, Cosman, and Jaffray. Claim 62 Claim 62 limits the method of claim 1 by further comprising: adjusting a position of a target volume within the body relative to a treatment beam using the plurality of internal markers imaged using the first imaging modality having an external source and the second imaging modality having an external source. Appellants contend that the “references do not contemplate the limits required by claim 62,” but only repeat the arguments that Mate is limited to RF sensors, that Cosman only taught external markers, and that Jaffray‟s teaching cannot be properly combined with the Mate and Cosman teachings. (App. Br. 19-20.) These arguments remain unpersuasive for the reasons discussed above concerning claim 1, and as the Examiner responded (Ans. 12). Claim 82 Claim 82 further limits the method of claim 1 by reciting: Appeal 2011-009683 Application 10/664,213 11 wherein the first beam isocenter is determined at a treatment planning machine during a treatment planning stage, the second beam isocenter is a treatment machine beam isocenter during a treatment, and the treatment planning machine and the treatment machine are different machines. Appellants contend that “the references do not teach . . . the first beam isocenter is determined at a treatment planning machine during a treatment planning stage, the second beam isocenter is a treatment machine beam isocenter during a treatment, and the treatment planning machine and the treatment machine are different machines.” (App. Br. 20.) The rejection found: “Cosman teaches the use of preoperative CT scanning ([0064]) and the use of interoperative CT scanning as well ([0065]). These imaging systems are located on different machines, one being used for planning the treatment and one being used for the actual treatment.” (Ans. 4-5.) The evidence supports the Examiner‟s finding, and we agree with the Examiner‟s response to this argument. (See Ans. 13.) Claim 88 Claim 88 limits the method of claim 1 by reciting: wherein the first beam isocenter is a planned isocenter determined at a planning machine at a time of planning using an image from the first imaging modality, wherein the second beam isocenter is a treatment machine beam isocenter of a treatment machine at a time of treatment, and wherein the second imaging modality is arranged to provide an image of the patient at the treatment machine. Appellants contend that the references do not teach the features of claim 88, and reiterate their view that the reference teachings are so limited that they fail to teach or suggest the features of claim 1. (App. Br. 21.) The Appeal 2011-009683 Application 10/664,213 12 argument is unpersuasive because Cosman disclosed using different machines for planning and treatment, as discussed with respect to claim 82, above. We also agree with the Examiner‟s response to this argument. (See Ans. 13.) II. Claims 63 and 64 were rejected, with other claims, over Mate, Cosman, Jaffray, and Fitzpatrick. The Examiner found that Fitzpatrick disclosed a method for determining the location in physical space of a point of a fiducial marker, and that a rigid body transform is necessary to register and align the coordinate systems of two imaging modalities. (Ans. 7-8.) The Examiner found that when using two imaging modalities, as suggested by Mate, Cosman, and Jaffray, the rigid body transform Fitzpatrick taught using would “allow for the two imaging spaces to be properly registered and aligned, and thus the markers in the two images to be aligned. This will allow for the proper positioning adjustment to be determined and executed.” (Id. at 8.) The Examiner thus concluded it would have been obvious “to have used a rigid body transform technique as taught by Fitzpatrick et al., in the combined system of Mate et al., Cosman, and Jaffray et al.” (Id.) Claim 63 limits the method of claim 1 by further comprising: estimating an adjustment to at least one of the body and a treatment beam in a treatment session, based on a determination of any change of spacing between imaged markers implanted in a target, over a course of multiple treatment sessions, and based on a number of visible markers in the imaged markers. Claim 64 limits the method of claim 1 by further comprising: estimating a number of positioning images needed for the treatment session based on a determination of any change of spacing between Appeal 2011-009683 Application 10/664,213 13 imaged markers implanted in a target, over a course of treatment, and based on the number of visible markers in the image. Appellants present the same arguments for claims 63 and 64, albeit under separate headings. We consider the arguments together. Appellants agree that “Fitzpatrick teaches registering two arbitrarily oriented three dimensional images is to align the coordinate systems of the two images (col. 1, lines 42-58),” but contend that “Fitzpatrick only teaches that the accurate selection and comparison of views of identical areas in images that have been obtained by imagers at different times or by images obtained essentially at the same time.” (App. Br. 22.) Appellants argue that “Fitzpatrick does not provide any description of what is meant by „different times;‟ or whether different imagers or machines are used at different times.” (Id.) Thus, Appellants contend that the references do not “contemplate” the limits required by claim 63. The Examiner responds that Mate showed that markers can be imaged over time to determine if they moved, and the radiation plan can be adjusted accordingly. (Ans. 13-14, citing Mate ¶¶ [0060]-[0063].) The evidence supports that finding. (FF 6, 7.) When the combined teachings of the references are taken together, it is apparent that a person of ordinary skill in the art would have appreciated the “different times” Fitzpatrick alluded to would be a matter of a doctor‟s judgment for tracking the status of the tumor, as explained by Mate: “doctors can track the status of tumors or other targets within the body over time.” (FF 7.) Appellants‟ arguments are therefore unpersuasive. Appeal 2011-009683 Application 10/664,213 14 SUMMARY We affirm the rejection of claims 1, 49, 54, 62, 82 and 88 under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, and Jaffray. We affirm the rejection of claims 63 and 64 under 35 U.S.C. § 103(a) as unpatentable over Mate, Cosman, Jaffray, and Fitzpatrick. 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 cdc Copy with citationCopy as parenthetical citation