Auris Health, Inc.Download PDFPatent Trials and Appeals BoardApr 1, 20212020002389 (P.T.A.B. Apr. 1, 2021) 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. 16/017,924 06/25/2018 David Burdick Berman AUR6055USNP1 5394 166068 7590 04/01/2021 Chang and Hale LLP, Auris Health, Inc. 4199 Campus Drive Suite 550 SUITE 550 Irvine, CA 92612 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 04/01/2021 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): eofficeaction@appcoll.com mail@changhale.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DAVID BURDICK BERMAN, CHRISTOPHER K. SRAMEK, HEDYEH RAFII-TARI, PRASANTH JEEVAN, and NICOLAS E. ROBERT ____________ Appeal 2019-002389 Application 16/017,924 Technology Center 3700 ____________ Before EDWARD A. BROWN, CARL M. DeFRANCO, and JAMES A. WORTH, Administrative Patent Judges. BROWN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks review under 35 U.S.C. § 134(a) of the Examiner’s decision rejecting claims 1, 3–12, 14–18, 20–24, and 26–30.2 Appeal Br. 5. 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 Auris Health, Inc., as the real party in interest. Appeal Br. 3. 2 Claims 2, 13, 19, and 25 are cancelled. Appeal Br. (Claims App.). Appeal 2020-002389 Application 16/017,924 2 CLAIMS “[Appellant’s] disclosure relates generally to systems and methods for the detection of electromagnetic (EM) distortion in [a] robotically-enabled medical system, and more particularly to detecting EM distortions which may affect EM based navigation systems used for navigation and localization of medical instruments within a patient.” Spec. ¶ 2. Claims 1, 12, 18, and 24 are independent. Claim 1, reproduced below, illustrates the claimed subject matter. 1. A system configured to detect electromagnetic (EM) distortion, the system comprising: a first EM sensor configured to generate a first set of one or more EM sensor signals in response to detection of an EM field, the first EM sensor configured for placement, in use, on a patient; an instrument comprising a second EM sensor and an image sensor, the second EM sensor and the image sensor located at a distal end of the instrument, the second EM sensor configured to generate a second set of one or more EM sensor signals in response to detection of the EM field, and the image sensor configured to generate an image signal; a processor; and a memory storing computer-executable instructions to cause the processor to: calculate one or more baseline values of one or more metrics at a first time based on EM sensor signals from the first set of one or more EM sensor signals corresponding to the first time, wherein the one or more metrics are indicative of a position of the first EM sensor at the first time, calculate one or more updated values of the one or more metrics during a time period after the first time based on EM sensor signals from the first set of one or more EM sensor signals corresponding to the time period after the first time, Appeal 2020-002389 Application 16/017,924 3 determine that a difference between the one or more updated values and the one or more baseline values is greater than a threshold value, determine that the EM field has been distorted in response to the difference being greater than the threshold value, in response to determining that the EM field has been distorted, reduce a weight value associated with the second EM sensor, and determine a position of the distal end of the instrument (i) based on a first image signal generated by the image sensor and weighted by the weight value associated with the image sensor and (ii) based on EM sensor signals generated by the second EM sensor and weighted by the reduced weight value associated with the second EM sensor. REJECTION3 Claims 1, 3–12, 14–18, 20–24, and 26–30 stand rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Final Act. 2. ANALYSIS The Examiner rejects claims 1, 3–12, 14–18, 20–24, and 26–30 as failing to comply with the written description requirement of 35 U.S.C. § 112(a) based on the determination that: The specification does not disclose the process, technique, equation or algorithm to [A] determine or set the effective 3 The rejection of claims 1, 3–12, 14–18, 20–24, and 26–30 under 35 U.S.C. § 112(b) as being indefinite has been withdrawn. Advisory Act. 3; Final Act. 4. Appeal 2020-002389 Application 16/017,924 4 threshold value. The specification does not disclose the process, technique, equation or algorithm to [B] “calculate an amount of the distortion in the EM field based on the one or more updated values and the one or more baseline values”. . . and [C]“calculate a mapping between a coordinate frame”. Without disclosing the processes, equations or algorithms to perform the claim limitations, applicant does not show possession of the invention. Ans. 4 (emphases added).4 We address the Examiner’s bases A–C below. A. “determine or set the effective threshold value” System claims 1 and 24 both recite “determine that a difference between the one or more updated values and the one or more baseline values is greater than a threshold value” (Appeal Br. 23 (Claims App.) (emphases added)); and claims 12 and 18, which are directed to a computer readable storage medium and a method, respectively, recite substantially the same language (id. at 26, 28). The test for sufficiency under the written description requirement of 35 U.S.C. § 112(a) “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). To have “possession,” “the specification must . . . show that the inventor actually invented the invention claimed.” Id. First, Appellant points out that none of the claims recites the language “determine or set the effective threshold value.” Appeal Br. 11. 4 The Examiner’s Answer indicates that the Examiner has withdrawn the rejection under this ground pertaining to the limitations “‘reduce a weight value’ and ‘determine a position of the distal end of an instrument.’” Ans. 3; see Final Act. 3. Appeal 2020-002389 Application 16/017,924 5 Second, Appellant submits that the Specification does provide written description support for the unclaimed language. Appeal Br. 11. Appellant explains that Figures 19A–19C show graphs of different metrics indicative of local EM distortion. Id. Appellant reproduces Figure 19A, illustrating a change in indicator value (Ind) metric. Id. at 11–12. This metric may be determined as a surgical instrument is passed through an endoscope. Id. at 12; see Spec. ¶ 127. Appellant explains that Figure 19A illustrates the change in the indicator value Ind, that is, “deviation from a baseline value (e.g., where the baseline value is set to 0),” resulting from five individual endoscope movement events at five different times. Appeal Br. 12–13 (citing Spec. ¶ 133). Appellant submits that based on a graph of, for example, indicator value Ind, and “selecting appropriate threshold values,” unacceptable deviations from the threshold value can be detected. Id. at 13 (citing Spec. ¶ 133). Appellant submits that in Figure 19A, “the threshold value is a value that is greater than noise at baseline.” Id. (citing Spec. ¶ 127 (“significantly higher than the noise in the change in [the] indicator value metric ΔInd”)). Appellant further contends: The specific threshold value selected by a user (i.e., how much higher than the noise at baseline) will vary depend on the level of EM field distortion deemed to be tolerable or acceptable by the user. The threshold value is a criteria set by the user for determining when deviations from the baseline are unacceptable, and would depend on factors that affect EM field distortion in general, e.g., operating room setup, environmental factors, the medical procedure. Id. (citing Spec. ¶ 109). Appellant has the better position. First, the Specification need only describe the invention, as claimed. See Amgen Inc. v. Hoechst Marion Appeal 2020-002389 Application 16/017,924 6 Roussel Inc., 314 F.3d 1313, 1333 (Fed. Cir. 2003). Accordingly, we agree with Appellant that “[t]here is no requirement that the specification disclose a process, technique, equation or algorithm for functionality that is not recited in the claim.” Appeal Br. 11. Claims 1 and 24 both require the processor to calculate the one or more baseline values and the one or more updated values of the one or more metrics, and to determine that a difference between these calculated values “is greater than a threshold value.” This determination would appear to involve simply comparing one value (“a difference”) to another value (“a threshold value”). Claims 1 and 24 do not, however, require the processor to “determine” or “set” “a threshold value,” or an “effective threshold value.” The same applies to claims 12 and 18. Second, Appellant has indicated where the Specification discloses how the “threshold value” is related to deviations from baseline values for various metrics, as well as factors that can be considered in selecting an appropriate threshold value. We are persuaded that the Specification reasonably conveys to persons skilled in the art that the inventors had possession of the feature “determine that a difference between the one or more updated values and the one or more baseline values is greater than a threshold value” recited in claims 1 and 24, and closely similar language in claims 12 and 18. B. “calculate an amount of the distortion in the EM field” Each of claims 3, 4, 14, 15, and 28 recites the limitation “calculate an amount of the distortion in the EM field based on the one or more updated values and the one or more baseline values,” and claims 20 and 21 recite closely similar language. Appeal Br. (Claims App.). Appeal 2020-002389 Application 16/017,924 7 Appellant contends that paragraph 178 of the Specification provides written support for this limitation. Appeal Br. 19. This paragraph discloses: the system may calculate the amount of distortion. The amount of EM field distortion may be proportional to the change in one or more of the calculated metrics. In this implementation, the system may calculate an amount of the distortion in the EM field based on one or more updated values calculated at a second time and one or more baseline values calculated a first time prior to the second time. Spec. ¶ 178 (emphasis added). Appellant asserts, “in some embodiments, the calculation of the amount of distortion can be based on the ‘EM field distortion [being] proportional to the change in one or more of the calculated metrics.’” Appeal Br. 19. Appellant submits that one skilled in the art would understand that two values being proportional to one another provides an algorithm for calculating one value given the other value, as “proportionality” is a well- defined mathematical concept defining the relationship between two values as being multiplicatively connected to a constant. Appeal Br. 19–20. Appellant further submits that one skilled in the art would recognize that the amount of EM field distortion can be determined by multiplying the change in one or more of the calculated metrics by a constant, which satisfies the requirement for a process, technique, equation, or algorithm as to the recited “calculate” limitation. Id. at 20. The Examiner responds that the Specification does not disclose how to obtain a constant and the criteria for selecting it. Ans. 6–7. Appellant replies that the claims do “not recite a constant, much less, ‘obtain[ing] a constant’ or ‘selecting a constant.’” Reply Br. 10. Appeal 2020-002389 Application 16/017,924 8 We agree with Appellant that the Specification is not required to disclose a process, technique, equation, or algorithm for obtaining or selecting a constant used in determining the amount of EM field distortion, as this is not recited in the rejected claims. Reply Br. 10. Further, we are persuaded that the disclosure in paragraph 178 of the Specification reasonably conveys to persons skilled in the art that the inventors had possession of the limitation “calculate an amount of the distortion in the EM field based on the one or more updated values and the one or more baseline values” recited in claims 3, 4, 14, 15, and 28, and closely similar language in claims 20 and 21. C. “calculate a mapping” Claims 8, 16, and 22 each recite the limitation “calculate a mapping between a coordinate frame of the EM field and a coordinate frame of the model based on at least one of: (i) the one or more baseline values and (ii) the one or more updated values.” Appeal Br. 25, 28, 30 (Claims App.). Appellant contends that this limitation has written description support in paragraphs 100 and 182 of the Specification. Id. Paragraph 100 discloses: The localization module 95 may use real-time EM tracking to generate a real-time location of the endoscope in a global coordinate system that may be registered to the patient’s anatomy, represented by the preoperative model. . . . These distances and orientations may be intra-operatively “registered” to the patient anatomy (e.g., the preoperative model) in order to determine the geometric transformation that aligns a single location in the coordinate system with a position in the pre- operative model of the patient’s anatomy. Once registered, an embedded EM tracker in one or more positions of the medical instrument (e.g., the distal tip of an endoscope) may provide real-time indications of the progression of the medical instrument through the patient’s anatomy. Appeal 2020-002389 Application 16/017,924 9 (Emphasis added). Paragraph 182 describes closely the “access” and “calculate” limitations in claims 8, 16, and 22. Appellant contends that one skilled in the art would understand that “determining ‘the geometric transformation that aligns a single location in the coordinate system with a position in the pre-operative model of the patient’s anatomy’[] is a process, equation, or algorithm for calculating ‘a mapping between a coordinate frame of the EM field and a coordinate frame of the model.’” Appeal Br. 21. Appellant also contends that determining a registration or mapping between two coordinate frames is a well-defined mathematical concept that enables the mapping of points in a first coordinate frame into a second coordinate frame. Id. In response, the Examiner acknowledges that the general concept of registration and mapping is well-known, but states that “in this specific invention the registration and mapping relies on baselines values and updated values. It is unknown to one of ordinary skill in the art how to register and map using baseline[] values and updated values.” Ans. 7. Appellant replies that claim 1 “define[s] that the ‘baselines values’ and the ‘updated values’ are values ‘of the one or more metrics.’” Reply Br. 12. Independent claims 12 and 18, from which claims 16 and 22 respectively depend, likewise define the baseline and updated values as in claim 1. See Appeal Br. 26–29 (Claims App.). Appellant submits the Examiner acknowledges that mapping between the position of a coordinate frame of an EM field and a coordinate frame of the model is well-known. Id. Thus, Appellant contends, the use of position metrics (i.e., the claimed baseline and updated values) within the EM field to determine the mapping is merely an application of such a registration. Id. Appellant submits that Appeal 2020-002389 Application 16/017,924 10 because the baseline and updated values can be position metrics within the coordinate frame of the EM sensor, these values can be mapped to the coordinate frame of the model. Id. Appellant’s contentions are persuasive. Claim 1, for example, recites that “the one more metrics are indicative of a position of the first EM sensor.” Accordingly, the recited baseline and updated values of the one or more metrics are likewise indicative of the position of the first EM sensor, and can be considered position metrics within the first EM sensor’s coordinate frame. Paragraphs 100 and 182 of the Specification disclose that such position values or metrics can be mapped to a coordinate frame of a model representative of a patient’s anatomy. We are convinced that the Specification reasonably conveys to persons skilled in the art that the inventors had possession of the “calculate a mapping” limitation recited in claims 8, 16, and 22. We do not sustain the rejection of claims 1, 3–12, 14–18, 20–24, and 26–30 as failing to comply with the written description requirement of 35 U.S.C. § 112(a). CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–12, 14– 18, 20–24, 26–30 112(a) Written Description 1, 3–12, 14– 18, 20–24, 26–30 REVERSED Copy with citationCopy as parenthetical citation