PACESETTER, INC.

Patent Trials and Appeals Board

Mar 16, 2022

2021003966 (P.T.A.B. Mar. 16, 2022)

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. 15/017,283 02/05/2016 Kwangdeok Lee A13P1003USD1(013-0382US1) 1350 152583 7590 03/16/2022 Pacesetter, Inc. The Small Patent Law Group, LLC 1423 Strassner Dr. Suite 100 Brentwood, MO 63144 EXAMINER SURGAN, ALEXANDRA L ART UNIT PAPER NUMBER 3795 NOTIFICATION DATE DELIVERY MODE 03/16/2022 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): ASJM_Patents@abbott.com docket@splglaw.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KWANGDEOK LEE, EDWARD KARST, MICHAEL E. BENSER, ROHAN MORE, CRAIG HEWITT, STUART ROSENBERG, FUJIAN QU, and HODA RAZAVI Appeal 2021-003966 Application 15/017,283 Technology Center 3700 ____________ Before NINA L. MEDLOCK, KENNETH G. SCHOPFER, and BRADLEY B. BAYAT, 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 1-10. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 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 Pacesetter, Inc. Appeal Br. 3. Appeal 2021-003966 Application 15/017,283 2 BACKGROUND The Specification states that the “disclosure relates generally to techniques for characterizing an area in a body,” and more particularly “to characterizing vascular branches.” Spec. ¶ 2. CLAIMED SUBJECT MATTER Claim 1 is the only independent claim on appeal and recites: 1. A method for characterizing a region of interest (ROI) comprising: advancing a tool through one or more locations within the ROI: and at each of the one or more locations within the ROI: collecting vibratory motion data using an electromagnetic sensor for sensing vibratory motion, wherein the electromagnetic sensor is embedded on the tool; applying a processor to extract one or more of cardiac vibratory motion data or respiratory vibratory motion data from the collected vibratory motion data to obtain residual vibratory motion data at the one or more locations; applying a processor to generate geometric data of a geometric data set of the ROI based on the residual vibratory motion data; and determining a cross-sectional area dimension at the one or more locations based on the geometric data set. Appeal Br. 29. Appeal 2021-003966 Application 15/017,283 3 REJECTIONS 1. The Examiner rejects claims 1-5 and 7-10 under 35 U.S.C. § 103 as unpatentable over Dobak2 in view of Rosenberg.3 2. The Examiner rejects claim 6 under 35 U.S.C. § 103 as unpatentable over Dobak in view of Rosenberg and Tesfayesus.4 DISCUSSION Claims 1, 3-5, and 7 With respect to claim 1, the Examiner finds that Dobak teaches a method as claimed except that Dobak does not teach generating geometric data and determining a cross-sectional area dimension as claimed. Non- Final Act. 3 (citing Dobak Figs. 24, 28; ¶¶ 106, 108, 109, 124, 194, 235, 247-250). The Examiner relies on Rosenberg to cure these deficiencies. Id. at 3-4 (citing Rosenberg Fig. 10; ¶¶ 154, 155, 159, 160). The Examiner determines that it would have been obvious to modify Dobak in view of Rosenberg “to allow a user to observe a relationship between the vibrator[y] motion data and the cardiac anatomy.” Id. at 4 (citing Rosenberg ¶ 160). We agree with and adopt the Examiner’s findings and determination regarding the rejection of claim 1. See Non-Final Act. 3-4; see also Ans. 3- 15. As discussed below, we are not persuaded of reversible error with respect to the rejection of claim 1. Appellant first argues that there would be no reason to modify Dobak based on Rosenberg. Appeal Br. 9-10. In support, Appellant asserts that “a cross sectional area dimension is irrelevant and meaningless to Dobak,” and 2 Dobak, III, US 2008/0021336 A1, pub. Jan. 24, 2008. 3 Rosenberg et al., US 2011/0054559 A1, pub. Mar. 3, 2011. 4 Tesfayesus et al., US 2012/0197340 A1, pub. Aug. 2, 2012. Appeal 2021-003966 Application 15/017,283 4 “cross-sectional area would not inform Dobak’s user of any information useful to Dobak.” Id. at 10, 12. Appellant explains that Dobak teaches using acceleration sensor data to characterize displacement and vibration in the left ventricle (LV), “using the motion data to characterize the different phases of the LV cycle for analyzing LV function.” Id. at 12. According to Appellant, Dobak’s mapping system senses LV motion for optimizing cardiac resynchronization therapy (CRT) lead placement. Thus, Appellant asserts that “the cross-sectional area would not inform Dobak’s user of a preferred LV target pacing zone.” Id. We are not persuaded of error by this argument. As an initial matter, we note that Dobak and Rosenberg are both directed to processes in which optimal CRT lead placement is determined. For example, Dobak teaches a “a method for multiple catheter repositionings in the LV or coronary sinus or great cardiac vein to map the motion of the LV for identifying the optimal pacing region.” Dobak ¶ 28. Similarly, Rosenberg teaches a method that “aim[s] to facilitate lead implantation” by, for example, allowing a clinician to “view a map of pacing parameters [in order to] readily decide to locate a lead in a region with appropriate pacing parameters.” Rosenberg ¶ 26. Further, as the Examiner explains, Rosenberg specifically discusses a process similar to that described in Dobak and indicates that mapping a cross-sectional area would provide an improvement over that process. Ans. 4-5 (citing Rosenberg ¶ 26). The Examiner further explains that, in light of this teaching, “Rosenberg specifically teaches that it would be beneficial to provide additional visual information to the user in order to find an optimal pacing site.” Id. at 5. We agree with this assessment by the Appeal 2021-003966 Application 15/017,283 5 Examiner, and thus, we disagree with Appellant’s argument that there would be no reason to modify Dobak based on Rosenberg. Next, Appellant argues that Rosenberg does not teach generating a geometric data set as claimed. Appeal Br. 15. Appellant indicates that the Examiner’s reliance on Rosenberg is misplaced because the “operations of Figure 10 do not generate a geometric data set of an ROI based on vibratory motion and do[ ] not use the geometric map to determine a cross-sectional area dimension at a location.” Id. Appellant asserts that this figure shows a process for mapping phrenic nerve stimulation and patient discomfort and “has nothing to do with a cross sectional area dimension at a location.” Id. We are not persuaded of error by this argument for the reasons provided by the Examiner. See Ans. 6-9. In particular, the Examiner explains: Rosenberg teaches using a catheter/lead with electrodes thereon to deliver energy to heart tissue in vivo. Rosenberg teaches upon delivery of this energy, using an accelerometer to detect vibratory motion such as the involuntary contraction of the diaphragm via stimulation of the phrenic nerve. Rosenberg teaches using a processer (computerized storage and display system, paragraph [0092] for example) to generate specific position data of the catheter/lead based on sensed electrical potentials in the x, y, and z directions, and saving this position data with the vibratory motion data from the accelerometer. The specific position of an object in space meets the plain meaning of geometric as set forth above, therefore Rosenberg teaches applying a processor to generate geometric data. Rosenberg teaches a plurality of these specific positions are generated, which meets the plain meaning of a geometric data set. This data set is based on the vibratory motion data indicating the location of the phrenic nerve, which is a region of interest. Collectively, Rosenberg teaches, ‘applying a processor to generate geometric data of a geometric data set of the ROI based on the residual vibratory motion data.’ Appeal 2021-003966 Application 15/017,283 6 Rosenberg further teaches generating a contour (‘an outline especially of a curving or irregular figure: shape,’ merriam-webster.com) based on the multi-dimensional set of discrete points, scaling these contours to the model of the heart, and then displaying the cross-sectional depiction of the contour in the manner shown in FIG. 10. It is noted that the claim requires ‘determining a cross-sectional area dimension’ not ‘measuring’ the dimension. As set forth above, to determine is to ‘fix the boundaries of.’ Rosenberg's disclosure of generating a contour based on the discrete data points meets the plain meaning of ‘determining a cross-sectional area dimension’ because the shape of the contour dictates the shape of the cross-sectional area. The shape of the cross-sectional area, in turn, fixes the boundaries of any measure in length, breadth or thickness (the three dimensions of space); scope, extent (also fig); or size of the cross sectional area. Ans. 8-9. The cited portions of Rosenberg are consistent with the Examiner’s findings. See Rosenberg Figs. 5, 10; ¶¶ 21, 22, 95, 152, 154, 155, 159. Finally, Appellant argues that Dobak does not teach obtaining residual vibratory motion data. Appeal Br. 16. Here, Appellant asserts that the claim requires that the residual vibratory motion data cannot include either cardiac vibratory motion data or respiratory vibratory motion data. Id. at 16-17. Given this interpretation, Appellant argues that the LV acceleration signals used in Dobak’s method are cardiac signals and cannot be considered residual vibratory motion data as claimed. Id. at 17. We are not persuaded. We agree with the Examiner that, when reasonably broadly construed, the claim does not require that the residual vibratory motion data are separate and distinct from both cardiac vibratory motion data and respiratory vibratory motion data. Ans. 12. The language itself requires only that vibratory motion data are collected and then “one or Appeal 2021-003966 Application 15/017,283 7 more of cardiac vibratory motion data or respiratory motion data” are extracted from the vibratory motion data to obtain residual vibratory motion data. The language thus indicates that only one or the other of cardiac or respiratory motion data need be extracted to obtain residual vibratory motion data. Further, we disagree with Appellant’s contention that the Specification supports Appellant’s more narrow interpretation of the claim. The cited portions of the Specification are consistent with the claim language requiring only that one or both of cardiac or respiratory motion data are extracted to obtain residual data. See Spec. ¶¶ 41, 44. Finally, the requirements of the dependent claims are not consistent with Appellant’s interpretation. Specifically, claims 8-10 each requires that cardiac vibratory motion data are extracted and excluded from the residual vibratory motion data. Appeal Br. 30. If the cardiac vibratory motion data were already required to be excluded from the residual data in claim 1, it is not clear how these dependent claims would further limit claim 1. We also agree with the Examiner regarding the finding that Dobak discloses determining residual vibratory motion data in the form of data related to mitral valve regurgitation. Ans. 11 (citing Dobak ¶¶ 235, 247- 250). Appellant does not specifically address the Examiner’s findings regarding the cited portions of Dobak beyond maintaining that the claim requires a narrower interpretation of residual vibratory motion data. See Appeal Br. 16-17. As discussed, we disagree with Appellant’s interpretation. Further, the Examiner explains that Dobak at least suggests filtering out other vibrational motion data, and we agree for the reasons provided by the Examiner. Ans. 11. Appeal 2021-003966 Application 15/017,283 8 Based on the foregoing, we are not persuaded of error in the rejection of independent claim 1. Appellant does not raise separate arguments regarding the rejection of dependent claims 3-5, and 7, and thus, we are also not persuaded of error in the rejection of those claims for the same reasons. Accordingly, we sustain the rejection of claims 1, 3-5, and 7. Claim 2 Claim 2 depends from claim 1 and requires “determining a size of a lead for permanent placement within the ROI based on the geometric data set.” Appeal Br. 29. The Examiner finds that Dobak teaches such a determination. Non-Final Act. 4 (citing Dobak ¶¶ 214-216). Appellant argues that the cited paragraphs have nothing to do with determining size of a lead. Appeal Br. 21. We are persuaded by Appellant’s argument. The Examiner asserts that the claim requires only that a lead size is determined and does not require selection of a lead from one or more options, and that this can be done as a mental step performed by medical personnel. Ans. 15-16. The Examiner explains that because Dobak teaches the use of a 2-3 mm lead, a determination has been made regarding the lead size for permanent placement of the lead. Id. Although this may be true, the claim further requires a determination of lead size “based on the geometric data set.” The Examiner has not explained how the determination to use a 2-3 mm catheter in Dobak is based on a geometric data set. Accordingly, we are persuaded of error and do not sustain the rejection of claim 2. Appeal 2021-003966 Application 15/017,283 9 Claims 8-10 Claims 8-10 each ultimately requires that the residual vibratory motion data do not include or differ from cardiac vibratory motion data. See Appeal Br. 30. The Examiner finds that Dobak teaches extracting cardiac vibratory motion data to obtain residual vibratory motion data such that the residual data are different from and do not include the cardiac data. Non- Final Act. 5. Appellant argues that a modification of Dobak to extract cardiac vibratory motion data from the vibratory data to obtain residual vibratory motion data “would render Dobak in operative [sic] and unsuited for its intended purpose.” Appeal Br. 22-24. Appellant asserts that “[t]he primary, and virtually only information, that Dobak uses to identify a preferred LV pacing site is movement of the left ventricular wall,” and that removing such cardiac motion data from Dobak’s vibratory motion data would be illogical and would leave Dobak with “no basis to identify the preferred LV pacing site.” Id. We are not persuaded of error for the reasons provided by the Examiner. See Ans. 16-17. As the Examiner explains, the rejection does not rely on any modification of Dobak regarding these claim requirements. Id. As discussed above, the Examiner relies on Dobak’s teaching of the use of vibration motion related to mitral vale regurgitation as the claimed residual vibratory motion data, and the Examiner explains that Dobak teaches filtering the data such that cardiac vibratory motion data are extracted. Appellant’s argument does not address these findings. Further, given these findings, we disagree with Appellant’s contention that Dobak uses only left ventricular movement in determining a preferred pacing cite. Based on the foregoing, we sustain the rejection of claims 8-10. Appeal 2021-003966 Application 15/017,283 10 Claim 6 Claim 6 recites: The method of claim 5, further comprising confirming at least one dimensional value associated with the ROI by counting, using a processing device, a number of pixels of a visual image of the ROI, wherein the visual image is one of a fluoroscopic image, an X-ray image, a computed tomography scan, a computed axial tomography scan, a magnetic resonance imaging image, or an ultrasound image. Appeal Br. 30. With respect to this claim, the Examiner further relies on modifying the combination of Dobak and Rosenberg based on Tesfayesus.5 Non-Final Act. 5. The Examiner finds, Tesfayesus et al. teaches a method of confirming at least one dimensional value associated with an ROI by counting a number of pixels of a visual image of the ROI (para [0030]), the visual image being one of a fluoroscopic image, an X-ray image, a computed tomography scan, a computed axial tomography scan, a magnetic resonance imaging image, or an ultrasound image (paragraph [0028]). Id. The Examiner determines it would have been obvious to modify Dobak and Rosenberg based on the teachings of Tesfayesus “in order to provide a quantitative scale.” Regarding this rejection, Appellant argues that “Tesfayesus does not teach or suggest that the visual image is” one of the types required by the claim; that Tesfayesus only describes endoscopy; and one of “ordinary skill in the art would not look to endoscopy to produce the imaging disclosed in claim 6.” Appeal Br. 26. We are not persuaded of error by this argument. 5 We note that the Examiner misidentifies Rosenberg as “Brock et al.” in the body of this rejection. We consider this a harmless, inadvertent error. Appeal 2021-003966 Application 15/017,283 11 Although Tesfayesus discusses the use of naso-endoscopy for imaging, Tesfayesus teaches the use of alternative imaging techniques including fluoroscopy, x-ray imaging, and x-ray computed tomographyk, which are all listed in the claim. Tesfayesus ¶ 28. Thus, contrary to Appellant’s assertion, Tesfayesus teaches the use of visual images from several of the types listed in claim 6. Accordingly, we sustain the rejection of claim 6. CONCLUSION We AFFIRM the rejections of claims 1 and 3-10. We REVERSE the rejection of claim 2. In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1-5, 7-10 103 Dobak, Rosenberg 1, 3-5, 7- 10 2 6 103 Dobak, Rosenberg, Tesfayesus 6 Overall Outcome 1, 3-10 2 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136 (a). See 37 C.F.R. § 1.136 (a)(l)(iv). AFFIRMED IN PART