2019004176 (P.T.A.B. May. 12, 2020)

Averbuch, Dorian

Patent Trials and Appeals BoardMay 12, 2020

2019004176 (P.T.A.B. May. 12, 2020)

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. 13/286,918 11/01/2011 Dorian Averbuch H-IL-00045DIV (1988-45DIV 5717 107146 7590 05/12/2020 Covidien LP 5920 Longbow Drive Mail Stop A36 Boulder, CO 80301-3299 EXAMINER TRAN, THO Q ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 05/12/2020 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): docket@carterdeluca.com rs.patents.two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DORIAN AVERBUCH Appeal 2019-004176 Application 13/286,918 Technology Center 3700 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and SUSAN L. C. MITCHELL, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The Examiner rejected the claims under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject the claims. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM, but designate the affirmance as NEW GROUND OF REJECTION. 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 Covidien LP. Appeal Br. 1. Appeal 2019-004176 Application 13/286,918 2 STATEMENT OF THE CASE The Examiner finally rejected claims 10 and 22–29 under pre-AIA 35 U.S.C. § 103(a) as obvious in view Edwards et al. (US 2009/0281566 A1, published Nov. 12, 2009) (“Edwards”) and Soper et al. (US 2006/0149134 A1, published July 6, 2006) (“Soper”). Final Act. 6, 11. Claim 10, the only independent claim on appeal, is reproduced below (bracketed numbers and letters have been added for reference to the limitations in the claim): 10. A method, comprising: [1] attaching at least one patient sensor to an exterior portion of a patient; [2] inserting a probe into the patient; and [3] executing a software application stored within a memory associated with a computer, which when executed performs the steps of: [a] acquiring a plurality of images of the patient's lungs; [b] generating an electromagnetic field; [c] detecting at least one field strength of the generated electromagnetic field with the at least one patient sensor; [d] monitoring the at least one field strength of the generated electromagnetic field with the at least one patient sensor to monitor locations of said at least one patient sensor in the generated electromagnetic field as said patient inhales and exhales; [e] determining a first location of said at least one patient sensor in the generated electromagnetic field using the monitored at least one field strength of the generated electromagnetic field, the first location corresponding to a first position between exhalation and inhalation of a breathing cycle of said patient; [f] determining a second location of said at least one patient sensor in the generated electromagnetic field using the monitored at least one field strength of the generated Appeal 2019-004176 Application 13/286,918 3 electromagnetic field, the second location corresponding to a second position between exhalation and inhalation of said breathing cycle of said patient; [g] selecting one of the plurality of acquired images corresponding to a position of said at least one patient sensor during said breathing cycle of said patient, wherein the selected one of the plurality of acquired images is an interpolated image corresponding to a position of said at least one patient sensor between maximum inhalation and maximum exhalation; [h] determining a real-time position of said probe in the generated electromagnetic field using at least one field strength of the generated electromagnetic field detected by the probe; [i] generating a real-time representation of a position of said probe within said patient's lungs as said probe is navigated through an airway of said patient; and [j] displaying the generated real-time representation of the probe and said selected one of the plurality of acquired images such that the selected one of the plurality of acquired images is superimposed over said real-time representation of said probe location within said patient’s lungs to register the real-time position of the sensor on the selected one of the plurality of acquired images. DISCUSSION The claimed method attaches a sensor to an exterior of a patient (step [1]). The method determines the sensor position on an acquired image of the lung during the breathing cycle of the patient by monitoring the field strength of an electromagnetic field with the sensor (steps [a]–[g]). A probe is also inserted into the patient (step [2]) and the method generates a real- time representation of a position of a probe within the patient’s lungs, as the probe is navigated through an airway of the patient, using the field strength of the generated electromagnetic (“EM”) field detected by the probe (steps, Appeal 2019-004176 Application 13/286,918 4 [h], [i]). In the last step of the method, the position of the probe is registered with the real-time position of the sensor on the acquired image of the lungs (step [j]). The Examiner found that Edwards describes attaching a sensor to a patient and inserting a probe into the patient as in steps [1] and [2] of claim 10. Final Act. 6. The Examiner further found that Edwards describes steps [a]–[g] of claim 10, but found that Edwards does not explicitly describe using a sensor which is attached to the exterior of the patient as required by step [1] of claim 10. Id. at 6–10 (citing paragraph 62 of Edwards for sensor placement). For the “exterior” limitation, the Examiner found that Soper describes an image guidance system that compensates for motion, such as respiration, and which places a sensor on the exterior of the body that detects electromagnetic fields. Id. at 11. The Examiner determined it would have been obvious to one of ordinary skill in the art to use Soper’s sensor in Edwards “because it amounts to the substitution of one known, equivalent element for another to obtain predictable results.” Id. Appellant contends that Soper does not describe placing a sensor on the exterior of a patient’s body that detects an electromagnetic field as required by the claim (“[c] detecting at least one field strength of the generated electromagnetic field with the at least one patient sensor”). Appeal Br. 6. Appellant argues that Soper discloses detecting the movement of the flexible endoscope within the patient using an electromagnetic field, but not using an electromagnetic field with the external sensor. Id. at 6–7. The Examiner responds that Soper discloses that “position sensors” are affixed to the thorax of a patient and the only other mention of “position sensors” in Soper is of a “position sensor” on the tip of a probe which Appeal 2019-004176 Application 13/286,918 5 detects an electromagnetic field. Ans. 3–4. Therefore, the Examiner concluded that the external sensor in Soper must be the same type of position sensor used for the probe and consequently capable of detecting an electromagnetic field. Ans. 4 (“the only logical interpretation of ‘position sensor’ in [0093] would be the same as that in the discussion of the ‘position sensor’ in the tip of the probe (an electromagnetic sensing type position sensor)”). Id. Edwards We begin with Edwards. Edwards discloses a sensor 24 that the Examiner cited to meet the limitations of the sensor affixed to the exterior of a patient (step [1] of claim 10) which detects and monitors the generated electromagnetic field (steps [c] and [d]). Final Act. 6. Edwards describes reference marker 24 as follows: The reference marker 24 is configured to be disposed in the region of the patient’s body where the IGI [image guided intervention] will be performed. Specifically, the reference marker 24 is configured to be disposed at an anatomic location within the body of the patient 10 that exhibits movement correlated to and/or associated with a movement of the target anatomy (i.e., the anatomy intended for IGI). In some embodiments, the reference marker 24 is configured to be disposed at a location internal to the body of the patient. A position, location, and/or orientation of the reference marker 24 is configured to be detected by the tracker 20, as described herein. In some embodiments, the reference marker 24 can be any suitable reference marker, such as any of the types described herein. In some embodiments, for example, the reference marker 24 is a non-tissue internal reference marker, also referred to as a “fiducial,” that is positioned within the body of the patient 10 and that is not made from the patient’s bodily tissue. Appeal 2019-004176 Application 13/286,918 6 Edwards ¶ 62. As explained in paragraph 62, the reference marker is disposed in the patient’s body. The Examiner pointed to the disclosure in this paragraph that “[i]n some embodiments, the reference marker 24 is configured to be disposed at a location internal to the body of the patient” as evidence that the marker could also be positioned externally, i.e., because in other embodiments it might positioned externally. However, we do not find this disclosure to disclose or suggest an external marker. Specifically, the paragraph refers to the marker several times as being within the body, and other parts of Edwards where marker 24 is discussed, it is also described as being within the body (Edwards ¶¶ 65, 71, 75, 77 (“internal reference marker 24”). In contrast, other types of markers are expressly disclosed as being “external” (¶ 61, “reference marker 22, also referred to herein as an external reference marker”) and contrasted with internal marker 24 (¶ 71, “using the positional information of the external reference marker 22 and the internal reference marker 24.”). Consequently, the Examiner’s finding that reference marker 24 can be an external marker is not supported by a preponderance of the evidence. However, Edwards teaches that reference marker 24 can be tracked using an electromagnetic field: In some embodiments, the tracker 20 includes an electromagnetic field generator configured to emit a series of electromagnetic fields, which are designed to reach a portion of the body of the patient 10 at which at least one of the reference markers 18, 22, 24 is disposed. The electromagnetic field can, for example, induce a voltage in the at least one of the reference marker 18, 22, 24 that can be monitored and translated into a coordinate position of the at least one of the reference marker 18, 22, 24. Appeal 2019-004176 Application 13/286,918 7 Edwards ¶ 59. Edwards teaches that reference marker 24 can be used to determine the position of target anatomy in a patient: Once the image is taken, an image most accurately depicting the target anatomy (e.g., the heart) at a particular moment in time can be ascertained by viewing the position of the internal reference marker 24 and selecting the image that was taken when the internal reference marker 24 was last in that particular location and orientation. Edwards ¶ 92. Thus, Edwards teaches that electromagnetic fields can be detected by a sensor (“reference marker 24”) and can be used to determine its position in a patient as required by steps [c], [d], [e], and [f] of claim 10. Final Act. 7–8. Soper Soper describes an external sensor: As shown in FIG. 7E, it is also contemplated that one or more other sensors 303 comprising, for example, position sensors, impedance electrodes, or strain gauges, can be affixed to the thorax of the patient to produce signals directly indicative of lung volume or deformation of the bronchial passages. The one or more motion sensors are coupled to a movement interface 305, which preprocesses the movement signals and supplies a processed movement signal to the processor in light source and processor 282. Alternatively, it may be preferable to employ a signal produced by one or more sensors that is a surrogate for determining the movement of the bronchial passages. For example, if the external signal is monitored while the flexible endoscope is at a known position, any change in the position of the flexible endoscope during breathing or movement of the chest can be empirically related to the external signal produced by the one or more sensors. Soper ¶ 93. Appeal 2019-004176 Application 13/286,918 8 Soper explains, that as shown in Figure 7E, the “position sensors” are attached to the thorax. In the same paragraph, Soper also refers to the sensors as “motion sensors.” This is consistent with the earlier description of Figure 7E which “illustrates how a plurality of motion sensors affixed to the thorax of a patient can be used to provide bodily function signals that can be employed to compensate for movement of the patient’s lungs and bronchial passage.” Soper ¶ 42. Thus, we understand that the “position sensors” are also “motion sensors.” Consistently, paragraph 93 of Soper further discloses that the motion or position sensors “are coupled to a movement interface 305, which preprocesses the movement signals and supplies a processed movement signal to the processor in light source and processor 282.” Soper ¶ 93 (reproduced above). There is no disclosure or suggestion in this paragraph that the position sensors monitor electromagnetic field strength as required by the claim (steps [c], [d]). Soper does not teach that the movement interface detects voltage induced by an electromagnetic field. The Examiner, however, interpreted the position sensor in paragraph 93 to be electromagnetic sensing because Soper also describes a position sensor that senses electromagnetic fields. Ans. 3–4. We do not agree with this interpretation. As found by the Examiner, Soper teaches: Flexible endoscope 24, which is shown in FIG.1B, includes a position sensor 84 with three orthogonal coils (not separately shown) that produce signals indicative of the position and orientation of rigid portion 26 of the flexible endoscope relative to an electromagnetic field source (not shown in this Figure), which is external to the patient’s body in this embodiment. The signals produced by the sensor are conveyed through electrical leads 86 to the interactive computer workstation and monitor, which processes the signal to determine the absolute position and orientation of the distal end of flexible endoscope 24 relative to the electromagnetic field source. Appeal 2019-004176 Application 13/286,918 9 Soper ¶ 64. The “position sensor” described in paragraph 64 produces signals which are “conveyed through electrical leads 86 to the interactive computer workstation and monitor.” The “position sensor” described in paragraph 93, on the other hand, is “coupled to a movement interface 305.” The latter sensor is also called a “motion sensor.” Soper ¶¶ 42, 93. Thus, the two position sensors are described by Soper to function differently. The preponderance of the evidence therefore does not support the Examiner’s finding that the external position/motion sensor described by Soper in paragraph 93 detects and monitors electromagnetic fields as required by rejected claim 10. Accordingly, the rejection cannot be sustained on this finding. New ground of rejection However, as explained in more detail below, the cited publications support the obviousness rejection, but for a different reason than given by the Examiner. The issue is whether it would have been obvious to one of ordinary skill in the art at the time of the invention to have monitored electromagnetic field strength with an external patent sensor and determine the sensor’s external location during breathing with this electromagnetic field information as required by claim 10 (see steps [1], [c], [d], and [e] of the claim).2 2 We agree with the Examiner’s findings that Edwards describes attaching a sensor to a patient and inserting a probe into the patient as in steps [1] and [2] of claim 10, and that Edwards describes steps [a]–[g] of claim 10, but for a sensor which is attached to the exterior of the patient as required by step [1] of claim 10. Final Act. at 6–10 (citations omitted). Appeal 2019-004176 Application 13/286,918 10 Soper teaches that breathing can be tracked using an external sensor: FIG. 7D illustrates a system . . . in which . . . an imaging device is shown imaging a plurality of markers applied to the chest of a patient to monitor breathing and movement. Soper ¶ 41. FIG. 7E illustrates how a plurality of motion sensors affixed to the thorax of a patient can be used to provide bodily function signals that can be employed to compensate for movement of the patient’s lungs. Soper ¶ 42. Therefore, as found by the Examiner, Soper monitors the movement of an external sensor as a patient inhales and exhales during breathing as required by step [d]–[f] of claim 10. See also Soper ¶¶ 91–93. Although the movement of the external sensor described by Soper is not detected with an electromagnetic field as required by claim 10 (steps [c]–[f]), Edwards, as already discussed, teaches that sensor (“reference marker 24”) detecting an electromagnetic field can be used to detect movement: The reference marker 24 is configured to be disposed in the region of the patient’s body where the IGI will be performed. Specifically, the reference marker 24 is configured to be disposed at an anatomic location within the body of the patient 10 that exhibits movement correlated to and/or associated with a movement of the target anatomy. Edwards ¶ 62. Edwards discloses that any suitable tracking system can be used to track its sensors. Edwards ¶ 59 (“The tracker 20 is configured to detect (or track) the positional information of at least one of the reference markers 18, 22, 24. The tracker 20 can be any suitable tracking system, including, but not Appeal 2019-004176 Application 13/286,918 11 limited to, an electromagnetic tracking system.”). Thus, Edwards teaches that movement tracking systems are interchangeable. Based on these disclosures, it would have been obvious to one of ordinary skill in the art at the time of the invention to use an external sensor to track breathing as disclosed by Soper, in which the tracking modality is electromagnetic detection, because Edwards teaches that such modality is effective to track changes in anatomical positions and that tracking systems are interchangeable. Employing an electromagnetic field to detect changes in the location of an anatomical part would have been an obvious use of a known technique for detecting changes in the part’s position. As held in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007): [I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. . . . [A] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions. The rejection of claim 10 as obvious in view of Edwards and Soper is affirmed. However, because our reasoning differs from the Examiner’s, we designate this as a new ground of rejection under 37 C.F.R. § 41.50(b). The Examiner’s rejections of dependent claims 22–29 did not depend on the erroneous finding. Final Act. 11. Appellant did not provide separate arguments for these claims. Appeal Br. 11–12. We therefore affirm the rejection of these clams for the reason given by the Examiner. 37 C.F.R. § 41.37(c)(1)(iv). CONCLUSION Appeal 2019-004176 Application 13/286,918 12 In summary: Claims Rejected 35 U.S.C. § Reference(s) /Basis Affirmed Reversed New Grounds 10 103 Edwards, Soper 10 10 22–29 103 Edwards, Soper 22–29 Overall Outcome 10, 22– 29 10 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 Appeal 2019-004176 Application 13/286,918 13 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)