Ex Parte Sathyanarayana et al

Patent Trial and Appeal BoardAug 23, 2016

12563754 (P.T.A.B. Aug. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/563,754 09/21/2009 Shashidhar Sathyanarayana 79292 7590 08/24/2016 Boston Scientific Corporation c/o Lowe Graham Jones 701 Fifth Avenue Suite 4800 Seattle, WA 98104 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. 1362001-2003.2 7035 EXAMINER AKAR, SERKAN ART UNIT PAPER NUMBER 3737 MAILDATE DELIVERY MODE 08/24/2016 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 SHASHIDHAR SATHYANARA YANA and WENGUANG LI Appeal2014-005837 Application 12/563,754 Technology Center 3700 Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A. POLLOCK, Administrative Patent Judges. PERCURIAM DECISION ON APPEAL This is a decision on appeal 1 under 35 U.S.C. Â§ 134 from the Examiner's rejection of claims 1-22. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We reverse. STATEMENT OF THE CASE The Specification discloses "intravascular ultrasound (IVUS) imaging systems" and related methods. Spec. 1: 11-12. "An IVUS imaging system can include a control module (with a pulse generator, an image processor, 1 Appellants identify the Real Party in Interest as Boston Scientific Corporation (App. Br. 2). Appeal2014-005837 Application 12/563,754 and a monitor), a catheter, and one or more transducers disposed in the catheter." Spec. 2:2--4. The catheter "can be positioned in a lumen or cavity within ... a region to be imaged, such as a blood vessel wall." Spec. 2:4--6. The control module causes the transducers to generate "acoustic pulses that are transmitted through patient tissue." Spec. 2:7-8. "Reflected pulses ... are absorbed by the one or more transducers and transformed [in]to electric pulses ... [which] are delivered to the image processor and converted to an image." Spec. 2:8-11. The Specification discloses a method of evaluating tissue types in an IVUS image by "providing a tissue classifier comprising a plurality of detector arrays for each of a plurality of tissue types, where each detector array comprises a plurality of detectors." Spec. 2: 13-16. The method comprises comparing "an input IVUS spectrum of a region in the ... image to the tissue type-assigned IVUS spectra of each of the plurality of detectors for each of the plurality of detector arrays." Spec. 2: 19-22. "For each of the plurality of detectors of each of the plurality of detector arrays, it is determined whether the input spectrum corresponds to the tissue type of the detector based on the comparisons of the input spectrum to the ... spectra for that detector." Spec. 2:22-24. "This [process] is repeated for each region to be characterized in the ... image." Spec. 2:28-29. "A size of at least one of the tissue types in a selected portion of the ... image is determined using the tissue characterizations of the regions in the selected portion." Spec. 2:29-31. 2 Appeal2014-005837 Application 12/563,754 Claim 1 is representative of the claims on appeal and reads as follows (emphasis added): 1. A method of evaluating at least one tissue type in at least one intravascular ultrasound (IVUS) image, the method comprising: a) providing a tissue classifier comprising a plurality of detector arrays for each of a plurality of tissue types, wherein each detector array comprises a plurality of detectors and each detector comprises a plurality of tissue type-assigned IVUS spectra, wherein a plurality of the tissue type- assigned IVUS spectra of each detector correspond to a tissue type of the detector and a plurality of the tissue type-assigned IVUS spectra correspond to other tissue types; b) comparing an input IVUS spectrum of a region in the at least one intravascular ultrasound image to the tissue type-assigned IVUS spectra of each of the plurality of detectors for each of the plurality of detector arrays; c) determining, for each of the plurality of detectors of each of the plurality of detector arrays, whether the input spectrum corresponds to the tissue type of the detector based on the comparisons of the input spectrum to the tissue type-assigned spectra for that detector; d) for each of the plurality of detector arrays, combining results of the plurality of detectors of the detector array to produce an array result; e) combining the array results for the plurality of detector arrays to provide a tissue characterization of the region from the plurality of tissue types; t) repeating b) to e) for each region to be characterized in the at least one intravascular ultrasound image; g) determining a size of at least one of the tissue types in a selected portion of the at least one intravascular ultrasound image using the tissue characterizations of the regions in the selected portion; and h) displaying one or more of the at least one intra vascular ultrasound image with an indication of the tissue characterization of one or more regions of the at least one intra vascular ultrasound image that is displayed and an indication of the size of at least one of the tissue types in the selected portion of the at least one intra vascular ultrasound image that is displayed. Issue The Examiner has rejected claims 1, 7, 8, 12, 13, and 18-21 under 3 Appeal2014-005837 Application 12/563,754 35 U.S.C. Â§ 103(a) as obvious in view ofWatson.2 Ans. 2; Final Rejection (Final Rej.) 2--4. 3 The Examiner has also rejected claims 2-5, 14--16, and 22 in view of Watson and McLeod4, and claims 6, 9-11, and 17 under 35 U.S.C. Â§ 103(a) in view of Watson, McLeod, and Kawaguchi. 5 Ans. 2; Final Rej. 4--8. The issue presented is: Does the evidence of record support the Examiner's conclusion that Watson would have made obvious a method of evaluating at least one tissue type in at least one intravascular ultrasound (IVUS) image that comprises "determining a size of at least one of the tissue types in a selected portion of the at least one intra vascular ultrasound image using the tissue characterizations of the regions in the selected portion," as recited in each of independent claims 1, 12, and 18? Analysis We have reviewed Appellants' contentions that the Examiner erred in rejecting claims 1, 7, 8, 12, 13, and 18-21 as obvious over the cited art. App. Br. 9-11; Reply Br. 2---6. We agree with Appellants that the Examiner 2 Robin J. Watson et al., Classification of Arterial Plaque by Spectral Analysis of In Vitro Radio Frequency Intravascular Ultrasound Data, 26 Ultrasound in Med. & Biol. 73-80 (2000) ("Watson"). 3 Office Action mailed May 22, 2013. 4 Andrew L. McLeod et al., Classification of Arterial Plaque by Spectral Analysis in Remodelled Human Atherosclerotic Coronary Arteries, 30 Ultrasound in Med. & Biol. 155-159 (2004) ("McLeod"). 5 Ren Kawaguchi et al., Usefulness of Virtual Histology Intravascular Ultrasound to Predict Distal Embolization for ST-Segment Elevation Myocardial Infarction, 50 Journal of the American College of Cardiology 1641-1646 (2007) ("Kawaguchi"). 4 Appeal2014-005837 Application 12/563,754 has not adequately explained how Watson would have made obvious the inventions of the rejected claims. For emphasis, we highlight and address the following: FPL Watson discloses that "[i]ntravascular ultrasound (IVUS) is a useful tool in the examination of coronary arteries, and can provide reliable measurements of vessel dimensions and the location and severity of obstructive coronary plaques." Watson 73, left col. FF2. Watson discloses that, in a study to "test whether radio- frequency analysis of coronary plaques predicts the histological classification, r.f. data were collected using ... [an] intravascular ultrasound scanner." Watson, Abstract. FF3. Watson discloses that a "pullback scan of length approximately 40 mm was performed on each coronary artery, the catheter position being controlled by the PC via a stepper motor. Typically, approximately 200 scans, separated by 200 Âµm, were collected in each pullback." Watson 7 4, right col. FF4. "[R]egions-of-interest [ROis] from eight ... coronary arteries were selected and identified by histology as falling into one of seven different tissue types." Watson, Abstract. "These are loose fibrous tissue (n = 78), moderate fibrous tissue (n = 27), dense fibrous tissue (n = 33), microcalcification (n = 14), calcified plaque (n = 55), lipid/fibrous mixture (n = 51) and homogeneous areas of lipid pool (n = 29)." Watson, Abstract. Watson discloses that only 54% of the RO Is were correctly classified using these categories. Watson, Abstract. When the "data were reclassified using three broader tissue groups: (1) calcified plaque, (2) lipid pool and (3) a 5 Appeal2014-005837 Application 12/563,754 mixed fibrous category," 86% of the RO Is were correctly classifieds. Watson, Abstract. FF5. Watson discloses that the "results demonstrate the feasibility of using spectral features of IVUS signals to discriminate between calcified plaque, mixed fibrous tissue and lipid pools." Watson 78, right col. Appellants argue that Watson does not teach or suggest "determining the size of at least one of the tissue types, as recited in claim 1." App. Br. 10. Appellants argue that the instant rejection does not "demonstrate that Watson discloses 'determining a size of at least one of the tissue types in a selected portion of the at least one intra vascular ultrasound image using the tissue characterizations of the regions in the selected portion' as recited in the claims." App. Br. 10-11. The Examiner responds that Watson discloses the disputed limitation. Ans. 5---6. The Examiner finds that Watson "performs 'a pullback scan of length approximately 40 mm ... on each coronary artery, the catheter position being controlled by the PC via a stepper motor. Typically approximately 200 scans, separated by 200 Âµm were collected in each pullback'." Ans. 5---6, citing Watson 74, right col., see FF 3. The Examiner notes that, "while scanning the section of the vessel, the beginning of the tissue that contains histology is known and the end of the histological tissue is determined from the scan measurement." Ans. 6. The Examiner provides the following illustration: 6 Appeal2014-005837 Application 12/563,754 The illustration shows a blood vessel with a plaque in it and an inserted IVUS catheter that extends beyond the plaque. Ans. 6. The Examiner states that, as shown in the illustration, the IVUS device "scans the plaque area of 40 mm, the beginning and the end region of plaque is known therefore the size is determined." Ans. 6. The Examiner also cites the following paragraph from Watson as teaching the claim 1 limitation of determining the size of at least one tissue type: Two hundred ninety-nine ROis of length 64 sample points (approx. 0.2 mm) and width five scan-lines (approximately 0.3 mm at a distance of 2 mm from the transducer) were selected .... These regions were then analyzed in terms of their spectral content. The size of region was chosen to be sufficiently small to encompass a homogeneous area of tissue, and sufficiently large to allow a reasonable signal-to-noise ratio from averaging adjacent scan-lines Watson 75, cited by the Examiner at Ans. 6. We find that Appellants have the better argument. Claim 1 is directed to a method of evaluating a least one tissue type that comprises providing an IVUS tissue classifier that provides a plurality of detector arrays for a plurality of tissue types, and using the classifier to determine tissue characterizations of a region, i.e., determine tissue types in a region. Claim 1 further requires that a size of least one tissue type is determined from these tissue characterizations using the IVUS tissue classifier. Although the Examiner points to Watson's disclosure that a pullback scan of a length of 40 mm was performed on each coronary artery, this portion of Watson discloses that scans of coronary arteries were obtained to determine regions interest, but does not suggest that tissue characterizations were obtained 7 Appeal2014-005837 Application 12/563,754 using an IVUS tissue classifier or that a size of a particular tissue type was determined using the characterizations. See FF 3. The Examiner also points to Watson's disclosure, at page 75 (shown above), that relatively small regions of interest (RO Is) were chosen for spectral analysis so that the tissue would be homogeneous in the ROI. This portion of Watson also does not suggest that a size of a particular tissue type was determined using tissue characterizations of a region that were obtained with an IVUS classifier, as recited in claim 1. Thus, we agree with Appellants that the Examiner has not adequately explained how Watson would have made obvious the method of claim 1 with the step of "determining a size of at least one of the tissue types in a selected portion of the at least one intra vascular ultrasound image using the tissue characterizations of the regions in the selected portion." Thus, we reverse the rejection of independent claim 1 and dependent claims 7 and 8 under 35 U.S.C. Â§ 103(a) in view of Watson. The Examiner has also rejected independent claim 12 as obvious in view of Watson. Independent claim 12 is directed to a computer-readable medium having instructions that enable a device to "determin[e] a size of at least one of the tissue types in a selected portion of the at least one intravascular ultrasound image using the tissue characterizations of the regions in the selected portion." As discussed above with respect to claim 1, we have concluded that the Examiner has not adequately explained how Watson discloses determining the size of at least one tissue type using the tissue type characterizations. Thus, we reverse the rejection of independent claim 12 and dependent claim 13 under 35 U.S.C. Â§ 103(a) in view of Watson. 8 Appeal2014-005837 Application 12/563,754 The Examiner has also rejected independent claim 18 as obvious in view of Watson. Claim 18 is directed to a tissue classifier that comprises a processor that determines "a size of at least one of the tissue types in a selected portion of the at least one intravascular ultrasound image using the tissue characterizations of the regions in the selected portion." For the reasons discussed with respect to claims 1 and 12, we also conclude that the Examiner has not adequately explained how Watson would have made obvious the device of claim 18. Thus, we reverse the rejection of independent claim 18 and dependent claims 19-21under35 U.S.C. Â§ 103(a) in view of Watson. The Examiner has also rejected, under 35 U.S.C. Â§ 103(a), dependent claims 2-5, 14--16, and 22 in view of Watson and McLeod and claims 6, 9- 11, and 17 in view of Watson, McLeod, and Kawaguchi. Ans. 2; Final Rej. 4--8. For these rejections, the Examiner relies on Watson as discussed above with respect to independent claims 1, 12, and 18. Thus, we also reverse these rejections. Conclusion of Law The evidence of record does not support the Examiner's conclusion that Watson would have made obvious a method of evaluating at least one tissue type in at least one intravascular ultrasound (IVUS) image that comprises "determining a size of at least one of the tissue types in a selected portion of the at least one intra vascular ultrasound image using the tissue characterizations of the regions in the selected portion," as recited in independent claims 1, 12, and 18. 9 Appeal2014-005837 Application 12/563,754 SUMMARY We reverse the rejection of claims 1-22 under 35 U.S.C. Â§ 103(a). REVERSED 10