Ex Parte Lall et alDownload PDFPatent Trial and Appeal BoardOct 11, 201714605144 (P.T.A.B. Oct. 11, 2017) 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. 14/605,144 01/26/2015 Terrence Lall 046079.00020 2868 34661 7590 CHARLES N. QUINN FOX ROTHSCHILD LLP 997 Lenox Drive, Bldg. #3 Lawrenceville, NJ 08648 EXAMINER SMITH, RUTH S ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 10/13/2017 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): ipdocket @ foxrothschild. com cquinn @ foxrothschild. com dmcgregor @ foxrothschild. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TERRENCE LALL and JAMES A. IONSON Appeal 2016-007296 Application 14/605,1441 Technology Center 3700 Before RICHARD J. SMITH, TAWEN CHANG, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a dual modality endocavity imaging and treatment system. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We AFFIRM, but designate the affirmance as a new ground of rejection. 1 According to Appellants, the real party in interest is Gamma Medical Technologies LLC. App. Br. 2. Appeal 2016-007296 Application 14/605,144 STATEMENT OF THE CASE The Specification states: “In medical imaging applications, two technologies are generally used: ultrasound and nuclear medical imaging.” Spec. 14. The Specification discloses that ultrasound technology “enables a very compact design of a probe and is powerful in revealing the anatomical structures of the organs” but is “not an ideal tool in cancer detection and diagnosis because the ultrasound technology can only generate anatomical images, whereas functional images are needed. . . .” Id. In contrast, “nuclear medical imaging techniques have the capacity to provide the desirable functional images,” but are “bulky and can only be integrated into an external detection system.” Id. 1 5. Asa result, “since the detectors of such external systems are located far away from the imaged organs, they have a poor detection efficiency and low spatial resolution, which limit such detector’s ability to pinpoint the exact positions of cancerous tissues in a small organ.” Id. According to the Specification, a compact device has been developed to address the problems with nuclear radiation detection, but it is “primarily designed for diagnosis of cancer and other abnormalities in an imaged organ.” Id. ]Hf 6—7. Further according to the Specification, it is therefore “highly desirable to develop a dual modality probe that integrates the benefits of both radiation imaging and ultrasound imaging for the purpose of enabling targeted biopsies and treatment of diseases, including cancer.” Id. 17. The Specification states that “the invention relates to a novel dual modality probe that has an integrated solid-state semiconductor detector, ultrasound device and a method of using such probe to enable targeted biopsies and treatment of disease(s).” Id. 13. 2 Appeal 2016-007296 Application 14/605,144 Claims 1—5 and 7—13 are on appeal. Claim 1 is illustrative and reads as follows (emphasis added to highlight limitations at issue): 1. A dual modality endocavity imaging and treatment system, comprising: a housing; a nuclear detector system housed within the housing, the nuclear detector system defining a first origin of a first three- dimensional coordinate system and configured for detecting nuclear radiation imaging data as three-dimensional coordinate positions relative to the first origin; an ultrasound detector system housed within the housing, the ultrasound detector system defining a second origin of a second three-dimensional coordinate system and configured for detecting ultrasound imaging data as three-dimensional coordinate positions relative to the second origin; a needle supported by the housing and adjustably positionable relative thereto, the needle having a radiation signature; and a data processing module configured to receive the nuclear radiation imaging data which includes first three- dimensional coordinate system data on the position of the needle and the ultrasound imaging data which includes second three- dimensional coordinate system data on the position of the needle; combine the nuclear radiation imaging data with the ultrasound imaging data utilizing coordinate transformation to co-register points of the first and second three dimensional coordinate systems; and to generate and output an image showing the relative position of the needle and an endocavity object of interest. App. Br. 10. 3 Appeal 2016-007296 Application 14/605,144 The claims stand rejected as follows: Claims 1—5 and 7—13 were rejected under 35 U.S.C. § 103(a) as obvious over the combination of Kimchy,2 Nagler,3 Fujio,4 Glossop,5 Thornton,6 Dries,7 Grass8 and/or Barth.9 In the Examiner’s Answer, the Examiner withdrew the pending rejection of claims 1—4 and 7—13 under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. Ans. 4. This issue is thus no longer a part of this appeal. FINDINGS OF FACT 1. Kimchy discloses: The present invention successfully addresses the shortcomings of the presently known configurations by providing imaging apparatus, comprising a first device, for obtaining a first image, by a first modality, selected from the group consisting of SPECT, PET, CT, an extracorporeal gamma scan, an extracorporeal beta scan, x-rays, an intracorporeal gamma scan, an intracorporeal beta scan, an intravascular gamma scan, an intravascular beta 2 Kimchy et al., US Patent No. 7,652,259 B2, issued Jan. 26, 2010 (“Kimchy”). 3 Nagler et al., US Patent Publication No. 2004/0204646 Al, published Oct. 14, 2004 (“Nagler”). 4 Fujio et al., US Patent No. 5,873,828, issued Feb. 23, 1999 (“Fujio”). 5 Glossop et al., US Patent Publication No. 2007/0055128 Al, published Mar. 8, 2007 (“Glossop”). 6 Thornton, US Patent Publication No. 2004/0049109 Al, published Mar. 11, 2004 (“Thornton”). 7 Dries et al., US Patent Publication No. 2013/0187911 Al, published July 25,2013 (“Dries”). 8 Grass et al., US Patent Publication No. 2012/0207373 Al, published Aug. 16, 2012 (“Grass”). 9 Barth et al., US Patent Publication No. 2005/0058326 Al, published Mar. 17, 2005 (“Barth”). 4 Appeal 2016-007296 Application 14/605,144 scan, and a combination thereof, and a second device, for obtaining a second, structural image by a second modality, selected from the group consisting of a three-dimensional ultrasound, an MRI operative by an internal magnetic field, an extracorporeal ultrasound, an extracorporeal MRI operative by an external magnetic field, an intracorporeal ultrasound, an intracorporeal MRI operative by an external magnetic field, an intravascular ultrasound, and a combination thereof, and wherein the apparatus further includes a computerized system, configured to construct an attenuation map, for the first image, based on the second, structural image. Additionally, the computerized system is configured to display an attenuation-corrected first image as well as a superposition of the attenuation-corrected first image and the second, structural image. Furthermore, the apparatus is operative to guide an in-vivo instrument based on the superposition. Kimchy col. 15,11. 35—57. 2. Kimchy discloses: In accordance with another embodiment of the present invention, the nuclear-radiation probe may be a three-dimensional system such as SPECT or PET, and the ultrasound probe may be a three- dimensional ultrasound system. Id. at col. 23,11. 32-35. 3. Dries discloses “a method of[] displaying a multi dimensional image and an annotation located therein.” Dries 11. 4. Dries discloses: A person skilled in the art will appreciate that the method may be applied to multi-dimensional image data, e.g. two- dimensional (2-D), three-dimensional (3-D) or four-dimensional (4-D) images, acquired by various acquisition modalities such as, but not limited to, standard X-ray Imaging, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Nuclear 5 Appeal 2016-007296 Application 14/605,144 Medicine (NM). Id. 141. 5. Grass discloses: [A] method of three-dimensional analysis of lesions represented by image data, comprising: detecting individual lesions and three-dimensional positions of the individual lesions, based on the image data; and detecting a cluster of lesions, based on three dimensional position information of lesions, and associating at least some of the individual lesions with the cluster of lesions, based on the three-dimensional positions of the individual lesions. Grass H 25-27. 6. Grass discloses: When applying this system, the three-dimensional positions of the individual lesions of a cluster of lesions become available. These three-dimensional positions may be used to derive information about the nature of the lesions. The relative positions of the lesions within the cluster may be used as an indication of a particular disease. Grass 1 8. 7. Grass discloses: A person skilled in the art will appreciate that the method may be applied to multi-dimensional image data, e.g. two- dimensional (2-D), three-dimensional (3-D) or four-dimensional (4-D) images, acquired by various acquisition modalities such as, but not limited to, standard X-ray Imaging, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Nuclear Medicine (NM). Id. 141. 6 Appeal 2016-007296 Application 14/605,144 8. Barth discloses “a system and a procedure for virtually representing the inside of the body.” Barth | 5. 9. Barth discloses that “[t]he previously recorded 3D data record preferable is recorded with a high-resolution imaging modality e.g. with magnetic resonance tomography, computed tomography, ultrasound, positron-emission tomography or nuclear medicine procedures.” Id. 111. ANALYSIS We limit our analysis to claim 1 because the claims were not argued separately. In finding the pending claims obvious, the Examiner found that Kimchy disclosed a “dual modality endocavity imaging and treatment system” comprising “a nuclear detector system . . . configured for detecting nuclear radiation imaging data” and “an ultrasound detector system ... for detecting ultrasound imaging data.” Final Act. 3.10 The Examiner acknowledged that Kimchy did not disclose, inter alia, “that the nuclear image data and the ultrasound image data is three-dimensional data.” Id. at 4.* 11 The Examiner found, however, that Dries, Grass and/or Barth “each disclose that ultrasound image data and nuclear image data can be provided as three-dimensional data.” Id. Based on these teachings, the Examiner concluded that it would have been obvious “to have further modified 10 Office Action mailed July 17, 2015 (“Final Act.”). 11 The Examiner also found that Kimchy failed to disclose “that the needle is supported by the housing” and “using the needle in the images as one of the fiducials.” Final Act. 4. The Examiner found that these elements would have been obvious in view of Nagler, Fujio, Glossop and Thronton. As Appellants do not present argument that these elements would have been nonobvious, we do not address them here. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). 7 Appeal 2016-007296 Application 14/605,144 Kimchy et al such that the imaging systems each provide three-dimensional image data as such is a well-known expedient in the art used to provide a more accurate view of a region of interest.” Id. Appellants argue that the prior art identified by the Examiner does “not disclose the use of three-dimensional gamma data to determine the position of an object” and instead relates “only to the morphology of a specimen with a known location.” App. Br. 6. Appellants contend that the disclosures of 3-D imaging in Dries, Grass, and Barth have “nothing to do with using 3-D to find the location of the organ. ...” and “therefore there would be no reasonable basis to combine these teachings with Kimchy et al. and arrive at the present invention.” Id. at 6—7. We are not persuaded. Kimchy discloses a system that uses a dual modality probe system comprising a nuclear detector and an ultrasound detector to provide the location of a tumor so a biopsy needle can be guided to the tumor. FF1; see also, App. Br. 6 (discussing Kimchy). Kimchy expressly states that the “nuclear-radiation probe may be a three-dimensional system such as SPECT or PET, and the ultrasound probe may be a three-dimensional ultrasound system.” FF2. In addition, Grass also expressly discloses “detecting individual lesions and three dimensional positions of the individual lesions” and using the “relative positions of [] lesions ... as an indication of a particular disease.” FF5 & FF6. Grass teaches that this can be done using three dimensional ultrasound and nuclear imaging data. FF7. Accordingly, the prior art does disclose the use of three-dimensional data to determine the position of an object. Given that Kimchy expressly discloses an embodiment that uses a three dimensional nuclear-radiation system and a three-dimensional 8 Appeal 2016-007296 Application 14/605,144 ultrasound system (FF2), it appears that no modification to Kimchy would be necessary in order to meet the claim requirement that the nuclear image data and the ultrasound image data is three-dimensional data. Accordingly, we are not persuaded by Appellants’ argument that there would be no reasonable basis to combine the teachings of Dries, Grass and Barth with the teachings with Kimchy to arrive at the claimed system. Moreover, to the extent it would have been necessary to incorporate the use of three-dimensional data in an embodiment of Kimchy’s dual modality system to arrive at the claimed system, we find that the preponderance of the evidence supports the Examiner’s conclusion that the use of three-dimensional data was “a well-known expedient in the art used to provide a more accurate view of a region of interest.” Final Act. 4; FF3—9. Appellants have not provided persuasive argument or evidence to the contrary. Nor have Appellants provided persuasive evidence or argument that the differences (if any) between the claimed three dimensional data and the three dimensional data disclosed in Dries, Grass and/or Barth are such as to render the use of three dimensional data in Kimchy’s dual modality system nonobvious. Appellants’ attempt to distinguish Dries, Grass and/or Barth based on how their data is used is unconvincing, particularly in light of Grass’ disclosure that its method can be used to show relative positon. See, FF5 & FF6. Accordingly, we agree with the Examiner that it would have been obvious to use three dimensional data in Kimchy’s dual modality system because it would have “provide[d] a better, more accurate understanding of the location of that target.” Ans. 5. For the reasons set forth herein, we affirm the Examiner’s rejection of claim 1. Claims 2—5 and 7—13 fall with claim 1 because the claims were not 9 Appeal 2016-007296 Application 14/605,144 argued separately. Because our affirmance relies upon facts and arguments that differ from those used by the Examiner,12 we designate our affirmance as setting forth a new ground of rejection. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under §41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of 12 Although the Examiner and this panel both find the claimed imaging system to be obvious over prior art including Kimchy, the Examiner’s position appears to accept Appellants’ premise that the prior art does not disclose the use of three-dimensional data to determine position. Ans. 3—5. In contrast, our affirmance does not accept this premise. 10 Appeal 2016-007296 Application 14/605,144 rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the MPEP § 1214.01. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R. §§ 41.50(f), 41.52(b). AFFIRMED; 37 C.F.R, $ 41.50(B) 11 Copy with citationCopy as parenthetical citation