Walter KusumotoDownload PDFPatent Trials and Appeals BoardMar 29, 20222022000260 (P.T.A.B. Mar. 29, 2022) 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. 16/285,622 02/26/2019 Walter Kusumoto 18086.001 9802 41689 7590 03/29/2022 BRADLEY P. HEISLER HEISLER & ASSOCIATES 3017 DOUGLAS BOULEVARD, SUITE 300 ROSEVILLE, CA 95661 EXAMINER HOLMES, REX R ART UNIT PAPER NUMBER 3792 MAIL DATE DELIVERY MODE 03/29/2022 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 WALTER KUSUMOTO Appeal 2022-000260 Application 16/285,622 Technology Center 3700 ____________ Before JAMES P. CALVE, BRUCE T. WIEDER, and KENNETH G. SCHOPFER, Administrative Patent Judges. SCHOPFER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-22. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Walter Kusumoto. Appeal Br. 1. Appeal 2022-000260 Application 16/285,622 2 BACKGROUND The Specification describes the field of invention as relating “to methods for protecting sensitive bodily structures from thermal damage during ablation procedures upon a patient, such as cardiac ablation procedures.” Spec. 3. More particularly, the Specification states that the “invention relates to use of ultrasound thermometry to monitor tissue temperature and protect against damage to sensitive tissues nearby where an ablation procedure is being conducted.” Id. CLAIMS Claims 1 and 20 are the independent claims on appeal. Claim 1 is illustrative of the appealed claims and recites: 1. A method for ablation of bodily structures while protecting adjacent tissues from damage, the method including the steps of: placing an ablation tool adjacent to a target bodily structure to be ablated; locating an ultrasound probe within range of tissues to be protected; operating the ablation tool to ablate the target bodily structure; evaluating ultrasound probe data during said operating step to determine temperature changes of tissues to be protected, based at least partially on detection of changes in speed of sound within the tissues to be protected, the speed change associated with temperature change; and adjusting said operating step when said evaluating step detects undesirable temperature change in the tissues to be protected. Appeal Br. 9. Appeal 2022-000260 Application 16/285,622 3 REJECTIONS 1. The Examiner rejects claims 1-5, 11-13, 19, and 20 under 35 U.S.C. § 102(a)(1) as anticipated by Cosman.2 2. The Examiner rejects claims 14-18 under 35 U.S.C. § 103 as unpatentable over Cosman. 3. The Examiner rejects claims 6-10, 21, and 22 under 35 U.S.C. § 103 as unpatentable over Cosman in view of Eigil.3 DISCUSSION Anticipation We are persuaded of error in the anticipation rejection of claim 1 by Appellant’s argument that the Examiner has not shown that Cosman discloses an evaluating step as claimed. With respect to claim 1, the Examiner finds that Cosman discloses a method as claimed, and more specifically, that Cosman discloses evaluating ultrasound probe data at process step 2428 described in Cosman at paragraph 240. Final Act. 4. The Examiner also explains that Cosman “clearly discloses monitoring and controlling the ablation process using the sensed tissue temperature using ultrasound,” and “one cannot measure a lesion without monitoring the tissue to be protected as they are side by side on the image.” Id. at 2 (citing Cosman ¶ 178). The Examiner finds that the tissue to be protected is the tissue immediately next to the lesion being treated and “[b]y adjusting the lesion based on tissue temperature Cosman necessarily reads on the claimed monitoring of protected tissue otherwise the entire area 2 Cosman, Jr. et al., US 2015/0320481 A1, pub. Nov. 12, 2015. 3 Eigil et al., US 2017/0100091 A1, pub. Apr. 13, 2017. Appeal 2022-000260 Application 16/285,622 4 would be a lesion.” Id. at 2-3 (citing Cosman ¶¶ 47, 61, 62, 178, 201, 240). The Examiner also explains that because “ultrasound uses sound waves to produce images . . . using ultrasound to determine temperature necessitates using speed of sound changes to determine temperature.” Id. at 3. As an initial matter, we agree with Appellant that the claim step at issue requires determining changes in temperature in tissues that are to be protected while ablating other tissues, and that this determination is at least partially based on detecting a change in speed of sound within the tissues to be protected. See Appeal Br. 4. In responding to Appellant’s arguments, the Examiner states [i]f the Appellant wished to have the temperature data being detected based on changes of speed of sound they should have claimed that. However, what they actually claimed was evaluating ultra sound probe data to determine temperature changes, based at least partially on detection of changes in speed of sound. The claimed language is broad and does not require the speed of sound to be determined and then used to calculate the temperature. The claim language is silent as to how the temperature is calculated as long as it uses detected data that is based at least partially on changes of speed of sound. The language only requires that the ultrasound data is evaluated to determine temperature changes and that ultrasound data has to at least include detected changes in speed of sound. Ans. 8-9. The Examiner indicates that the claim does not require that “the temperature data being detected [is] based on changes of speed of sound.” Id. at 8. However, the claim specifically requires evaluating ultrasound data to determine temperature changes “based at least partially on detection of changes in speed of sound.” Appeal Br. 9. The Examiner explains that the claim does not require that the speed of sound is determined and then used to calculate temperature and that the claim is silent regarding how the Appeal 2022-000260 Application 16/285,622 5 temperature is calculated. Although the claim does not specify the process by which temperature changes are determined, we disagree that the claim is silent on this issue. See Appeal Br. 6. Rather, the claim requires that determining the temperature change is based at least partially on detected changes in speed of sound. Thus, we disagree with the Examiner’s statement that the claim only requires determining temperature change based on ultrasound data and that the ultrasound data only need to separately include detected changes in speed of sound. Rather, the claim requires that a detection of changes in speed of sound within the protected tissues is a factor in determining the temperature changes of those tissues. In light of this interpretation of the claim, we have reviewed the cited portions of Cosman and agree with Appellant that Cosman does not disclose evaluating ultrasound probe data to determine temperature changes in protected tissue “based at least partially on detection of changes in speed of sound within the tissues to be protected, the speed change associated with temperature change,” as recited in claim 1. Appeal Br. 4. Regarding the Examiner’s finding that this method step is disclosed in Cosman by process step 2428, we disagree. Step 2428 is a step in the flowchart depicted in Cosman’s Figure 24, which is described as a flow chart showing “a method for control of a HF ablation process using an internally cooled HF electrode, an automated controller, ultrasound imaging of the ablation process, and a real-time graphic display HF signal output parameters.” Cosman ¶ 78. Step 2428 is labeled “Evaluate and/or control the size and position of the ablation by ultrasound imaging.” Id. at Fig. 24. Cosman discloses that in this step ultrasound imaging data is presented so that the ablation process can be monitored and adjusted either manually or automatically. Id. ¶ 240. “For Appeal 2022-000260 Application 16/285,622 6 example, the controller can automatically process ultrasound data by image processing techniques to assess lesion size, the rate of lesion size growth, [and] maximum temperatures.” Id. Although this description suggests that an ablation process may be adjusted based on temperature data, Cosman does not disclose that temperature changes in tissues to be protected are determined based on detected changes in speed of sound within the tissues to be protected. Regarding the remaining portions of Cosman relied upon by the Examiner, we do not see any express disclosure regarding how temperature changes are calculated, regardless of the tissue at issue. However, the Examiner appears to indicate that the claimed process is inherent in Cosman: Since the ultrasound data was detected from human tissue that has varying densities, the detected data necessarily has changes in speed of sound. Further, since the data that is detected includes changes in speed of sound, and that data is used to determine the temperature of the tissue, it clearly reads on the claims. Ans. 7. We disagree. As Appellant explains, the claim requires detection of changes in speed of sound in tissue to be protected. Reply Br. 2. The Examiner appears to be relying on the fact that Cosman’s ultrasound data may inherently include detecting differences in the speed of sound between different issues of different densities. We agree with Appellant that detecting differences in the speed of sound between different tissue types is different than detecting a change in speed of sound within tissues to be protected and where the speed change is associated with temperature change, as is required by the claim. Id. As Appellant explains, in claim 1, “a change of speed of sound is occurring ‘within’ the tissues to be protected, different Appeal 2022-000260 Application 16/285,622 7 types of tissues with perhaps different densities are not being compared together.” Id. Based on the foregoing, we are persuaded of error in the anticipation rejection of claim 1. For the same reasons, we are persuaded of error in the anticipation rejection of dependent claims 2-5, 11-13, and 19. Independent claim 20 includes an evaluating step that is substantially the same as the evaluating step included in claim 1. See Appeal Br. 11. The Examiner relies on the same findings with respect to this limitation as those discussed above (Final Act. 4, 5-6; Ans. 9), and Appellant presents the same arguments as for claim 1 (see Appeal Br. 7-8). Thus, we are also persuaded of error in the rejection of claim 20 for the reasons discussed above. Accordingly, we do not sustain the rejection of claims 2-5, 11-13, 19, and 20. Obviousness In rejecting claims 6-10, 14-18, 21, and 22 as obvious, the Examiner relies on the same findings as above and does not provide further analysis or citation to evidence that would cure the deficiency in the anticipation rejection. Accordingly, for the reasons discussed, we also do not sustain the obviousness rejections. CONCLUSION We REVERSE the rejections of claims 1-22. In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-5, 11-13, 19, 20 102(a)(1) Cosman 1-5, 11- 13, 19, 20 14-18 103 Cosman 14-18 Appeal 2022-000260 Application 16/285,622 8 Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 6-10, 21, 22 103 Cosman, Eigil 6-10, 21, 22 Overall Outcome 1-22 REVERSED Copy with citationCopy as parenthetical citation