Ex Parte ViswanathanDownload PDFPatent Trial and Appeal BoardDec 17, 201410977466 (P.T.A.B. Dec. 17, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RAJU R. VISWANATHAN ____________ Appeal 2012-006927 Application 10/977,4661 Technology Center 3700 ____________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and AMANDA F. WIEKER, Administrative Patent Judges. WIEKER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a control for a remote navigation system, and a method of operating such a system. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 According to Appellant, the real party in interest is Stereotaxis, Inc. (App. Br. 2). Appeal 2012-006927 Application 10/977,466 2 STATEMENT OF THE CASE Claims 1–32 are on appeal.2 Independent claim 1 is representative and reads as follows: 1. A control for a remote navigation system including an orientation controller that orients the distal end of a medical device in an operating region in a subject, and a length controller that extends and retracts the distal end of the medical device, to navigate the distal end of the medical device to a selected destination in response to user inputs, the control interrupting operation of at least one of the orientation controller and the length controller when the user inputs would cause the orientation controller and the length controller to navigate the distal end of the medical device to one of a plurality of predetermined restricted locations. Independent claim 8 recites a control for a remote navigation system that overrides at least one controller when a user’s input would navigate the medical device to a location “outside of a plurality of predetermined target locations.” Independent claims 14, 21, 27, and 30 recite methods for operating a remote navigation system and include limitations similar to those of claims 1 and 8. THE ISSUE The Examiner rejected claims 1–32 under 35 U.S.C. § 103(a) as obvious over Werp3 (Ans. 4–6).4 2 Claims 1–59 are pending and claims 33–59 are withdrawn (App. Br. 2). 3 Werp et al., US 6,015,414, issued Jan. 18, 2000. 4 On September 6, 2011, Appellant filed a Terminal Disclaimer in response to a double patenting rejection (App. Br. 2). The Examiner did not include the double patenting rejection in the “Grounds of Rejection” of the Answer (Ans. 4) and, therefore, we do not treat it here. Appeal 2012-006927 Application 10/977,466 3 Appellant relies on the arguments presented with respect to independent claims 1, 8, 14, 21, 27, and 30 for all claims (App. Br. 10–12). We focus our analysis, therefore, on claims 1, 8, 14, 21, 27, and 30, and the dependent claims stand or fall with those claims. 37 C.F.R. § 41.37(c)(1). The Examiner finds that Werp discloses an apparatus and method for magnetically steering a metal-tipped catheter to a desired endpoint within human tissue, achieved by selecting a desired path of catheter travel, inserting and advancing the catheter through the tissue, determining actual positions of the magnetic tip of the catheter within the tissue, determining and storing correction vectors that represent the difference between the actual location of the magnetic tip and the desired path, and applying a magnetic field adjusted to achieve movement of the magnetic tip of the catheter along the desired path (Ans. 4). The Examiner finds that Werp does not explicitly disclose preventing navigation of the device to restricted locations, but concludes that “it would be obvious to one of ordinary skill in the art that by determining specific vectors related to the path of travel of the medical device, the device is navigated along the desired path and prevented from navigating to restricted locations” (id. at 5). The issue is: Does the evidence of record support the Examiner’s conclusion that the claims are obvious in view of Werp? FINDINGS OF FACT FF1. Werp discloses a remote navigation system and method for controlling movement of a flexible catheter with a magnetic tip “through a medium which may be living tissue such as a human brain” (Werp at Abstract, ll. 1–7). Appeal 2012-006927 Application 10/977,466 4 FF2. Werp’s Figures 5 and 6 are reproduced below: FIG. 5–6 present block diagrams of portions of a Magnetic Stereotaxis System in accordance with the invention (id. at col. 5, ll. 14–18). FF3. Werp discloses a medical device, e.g., “a catheter 34 with metal tip 36 having a magnetic implant 30 inside” (id. at col. 12, ll. 61–63). FF4. Werp discloses a length controller, stating that “[p]ush wire 32 is operatively coupled to a motor in an advancement mechanism 52 that a surgeon may control by issuing commands at a console 54 . . . . To fully automate catheter movement, advancement mechanism 52 may also be Appeal 2012-006927 Application 10/977,466 5 controlled by the processor” (id. at col. 12, l. 65–col. 13, l. 1; col. 13, ll. 17– 19). Werp discloses that the length controller “push[es] the magnetic tip of the catheter through the medium” (id. at col. 4, ll. 3–4). FF5. Werp discloses a control and an orientation controller, stating that “[c]onsole 54 contains a processor such as a digital computer responsive to operator commands input through operator control 58 and to cameras 20 for controlling a power supply (not shown) that supplies currents to coil terminals 24 to generate the required magnetic fields” (id. at col. 13, ll. 12– 17). Werp further discloses that the generated magnetic fields are “effective to guide the mechanically-pushed catheter tip in a predetermined direction” (id. at col. 3, ll. 46–49). FF6. Werp discloses that a surgeon “plan[s] a path through the tissue of patient 50 . . . to a point at which treatment is to be delivered . . . then activates the system by issuing appropriate commands through console 54” (id. at col. 13, ll. 25–32). FF7. Werp discloses that, in response to the issued commands, “processor inside console 54 computes positions of metal tip 36 . . . and the coil currents necessary to move metal tip 36 along the desired path . . . and applies the computed currents to the coils while advancement mechanism 52 advances metal tip 36 through the tissue” (id. at col. 13, ll. 33–39). FF8. Werp discloses that the system also: determin[es] . . . correction vectors (the correction vectors representing differences between locations on the desired path and the actual positions of the magnetic tip), stor[es] values of correction vectors in a memory, and appl[ies] a magnetic field adjusted to achieve movement of the magnetic tip at least approximately along the desired path, the adjustment depending upon at least one stored set of values of correction vectors Appeal 2012-006927 Application 10/977,466 6 (Id. at col. 3, ll. 54–62; see also id. at col. 13, ll. 39–41, 48–54). FF9. Werp discloses that the “processor will have a representation of a planned or predetermined path stored in its memory. At any location or locations where the planned path deviates from a straight line in front of a then-present location of the seed, a program stored in the computer provides an added correction vector” (id. at col. 7, ll. 25–33). FF10. Werp discloses that movement of the catheter through the tissue “continues until the endpoint of the path is reached” (id. at col. 13, ll. 41–42) or, alternatively, “the surgeon may intervene by stopping movement of the catheter or by changing its course before the originally planned endpoint is reached” (id. at col. 13, ll. 46–48). FF11. Werp discloses that magnetically guided catheters “could be used to deliver dopamine to the affected regions of the brain with minimal indiscriminate distribution of the neurotransmitter to the surrounding tissue, thereby lessening attendant side effects” (id. at col. 2, ll. 30–35). PRINCIPLES OF LAW “An examiner bears the initial burden of presenting a prima facie case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) (citation omitted). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). ANALYSIS We adopt the Examiner’s findings regarding the scope and content of the prior art (Ans. 4–8; FF1–FF11) and we agree that the claimed control Appeal 2012-006927 Application 10/977,466 7 and method for a remote navigation system would have been obvious in view of Werp. We address Appellant’s arguments below. First, Appellant argues that “[c]hanging course does not necessarily mean that the ‘originally planned endpoint’ is a ‘predetermined restricted location’” (App. Br. 11). We do not understand the Examiner to interpret the originally planned endpoint of Werp as the predetermined restricted location required by claim 1. Rather, the Examiner describes Werp’s system as restricting movement of the medical device to a predetermined, desired path, wherein travel along the desired path is achieved by “calculating parameters regarding the restricted locations, storing the parameters, and navigating the device based on the predetermined parameters” (Ans. 5). The Examiner then continued on to state: the distal end of the catheter is advanced through tissue and is advanced until the endpoint of the predetermined path is reached, where the operator may even intervene and stop movement of the catheter by changing its course before originally planned endpoint is reached based on the predetermined calculations related to the path of the device through tissue. Even though Werp et al. do not explicitly teach of preventing navigation to restricted locations, it would be obvious to one of ordinary skill in the art . . . . (Id.). Indeed, rather than finding that the originally planned endpoint is a restricted location, we agree with the Examiner’s finding that Werp teaches travel on a desired path, that such travel is achieved through the calculation of correction vectors and the application of adjusted magnetic fields, that such travel continues until an end point is reached or travel is stopped or altered by a surgeon, and that although Werp fails to explicitly teach Appeal 2012-006927 Application 10/977,466 8 preventing navigation to a restricted location, such a limitation would have been obvious over Werp’s teaching of correction vectors (id.; see also FF7– FF9). Appellant’s argument is, therefore, unpersuasive. Appellant also contends that Werp’s disclosure of changing course “does not render it obvious that a control might interrupt the operation of an orientation controller and/or length controller . . . as recited in claim 1” (App. Br. 11). It appears that Appellant also contends that Werp does not render it obvious that a controller overrides the operation of at least one controller, as recited in claim 8 (see id. at 11, ll. 2–4). We understand that Werp does not explicitly state that the control “interrupts” or “overrides” operation of a controller (see Ans. 6–7). Werp, however, discloses that when a medical device deviates from a predetermined, desired path, the system’s control applies an adjusted magnetic field to move the device back onto the desired path (FF8, FF9; id.). We agree with the Examiner that this disclosure, read in light of Appellant’s Specification, describes “interrupting” or “overriding.” Specifically, Appellant describes “interrupting” or “overriding” as “block[ing] further operation of the controllers or alternatively . . . modify[ing] the operation of the medical navigation system to navigate to the closest point [‘that is not in one of the plurality of restricted locations’ or ‘within one of the permitted locations’]” (Spec. ¶ 4, ll. 9–12; ¶ 5, ll. 5–7). Given Appellant’s usage of these terms, we agree with the Examiner’s conclusion that by applying an adjusted magnetic field (i.e., by “modifying the operation of the medical navigation system . . .”), Werp satisfies claims 1 and 8. Appeal 2012-006927 Application 10/977,466 9 Appellant also contends that the Examiner’s interpretation of “a plurality of predetermined restricted locations,” which appears in claims 1 and 14, is overly broad (App. Br. 11; Reply Br. 11–12). We disagree. The Examiner interprets this phrase as referring to locations that are “not the predetermined path” (Ans. 6). Appellant’s Specification supports this interpretation. Appellant describes “restricted” locations as those “into which the user does not wish to navigate the distal end of the medical device” (Spec. ¶ 37, ll. 11–14; see also id. ¶ 2, ll. 4–6; ¶ 6, ll. 7–9; ¶ 18, ll. 3–8). In other words, locations through which medical device travel is not desired are “restricted.” We conclude, therefore, that the Examiner’s interpretation of “a plurality of predetermined restricted locations” as locations that are not on the predetermined, desired path is proper in light of the Specification. In the Reply Brief, Appellant makes several additional arguments directed to the Examiner’s interpretation (Reply Br. 11–12). First, Appellant contends that under the Examiner’s interpretation, Werp must store “all points conceivably reachable by the medical device that did not fall on the ‘predetermined path’” and must update that information each time the device veers off the path, resulting in a waste of resources (Reply Br. 11). We are not persuaded. Werp’s system already identifies locations that are not on the predetermined path when determining correction vectors (FF8, FF9). We do not agree, therefore, that the Examiner’s interpretation would result in a waste of resources. Appellant also contends that because Werp allows movement of the device “approximately along the desired path,” Werp “apparently allows the Appeal 2012-006927 Application 10/977,466 10 device tip to be moved to a location that is neither ‘predetermined’ nor ‘restricted’ as defined by the Office” (Reply. Br. 11–12). We do not perceive the ambiguity argued by Appellant. In Werp’s system, a device is in a “restricted” location when it is off the predetermined, desired path, such that correction vectors are determined (FF8, FF9). Alternatively, when a device is on the predetermined desired path, even if “approximately” on the desired path, correction vectors need not be determined (FF7). Therefore, we see no ambiguity in this interpretation. Appellant also argues that a location, “even though ‘predetermined’ as taught by Werp, might nevertheless lead the device tip into a location in the patient where the device could cause complications. Such a location could not be considered a ‘restricted location’ under the Office’s interpretation.” (Reply Br. 12). We are not persuaded. Appellant does not cite any evidence supporting this argument, which appears to be purely speculative. Indeed, Werp discloses that the predetermined, desired path on which the device travels is selected by a surgeon and terminates at a desired treatment location (FF6). Appellant has presented no evidence suggesting that the locations selected by a surgeon as ideal for device travel and treatment may, nonetheless, cause complications. Further, there is no requirement in claim 1 that limiting movement to restricted locations will necessarily avoid any complications resulting from the treatment. Regarding claims 8 and 21, Appellant briefly argues that the Examiner did not state how Werp discloses “a plurality of predetermined target locations” (App. Br. 11). Appeal 2012-006927 Application 10/977,466 11 We disagree. The Examiner describes that Werp discloses selecting a desired path on which a catheter will travel and applying an adjusted magnetic field to achieve movement of the catheter along that desired path (Ans. 4; see also id. at 5, ll. 11–13; 6, ll. 7–10). We agree with the Examiner, therefore, that Werp teaches “a plurality of predetermined target locations,” e.g., the desired path. Finally, Appellant argues: Although a physician might use predetermined parameters in navigating a device, many other factors can and do affect the movement of the device through the subject. The claimed control and methods can provide valuable oversight capabilities to a physician who is in the middle of an operation. Applicant respectfully submits that it would not have been obvious to modify Werp et al. in the manner urged by the Examiner without using Appellants’ claims as a guide. (App. Br. 12). It appears that Appellant attempts to argue that the claimed invention provides unexpected results, but without providing any evidence. “It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984); see also In re Wood, 582 F.2d 638, 642 (CCPA 1978) (“Mere lawyer’s arguments . . . unsupported by objective evidence, are insufficient to establish unexpected results”). As to Appellant’s conclusory statement that the claimed invention would not be obvious without engaging in impermissible hindsight, we are not persuaded. The Examiner presented a fact-based rationale for concluding that the claims would be obvious to one of ordinary skill in the Appeal 2012-006927 Application 10/977,466 12 art (Ans. 4–6; see also id. at 6–8). Although the Examiner did not make a specific finding regarding the level of skill in the art, the field of endeavor encompasses brain surgery and biomedical engineering (FF1). We agree with the Examiner’s conclusion that one of ordinary skill in these relevant arts would find it obvious to prevent navigation of Werp’s device into restricted locations, because Werp explicitly discloses determining correction vectors in order to automatically and continuously move a medical device from an undesired location to a predetermined, desired path of travel. One skilled in the art need not resort to hindsight to find such limitations obvious in light of Werp’s disclosure (see, e.g., FF8, FF9, FF11). We thus affirm the rejection of claims 1, 8, 14, 21, 27, and 30 under 35 U.S.C. § 103(a) as obvious. Because claims 2–7, 9–13, 15–20, 22–26, 28, 29, 31, and 32 fall with the independent claims, we affirm the rejection of those claims as well. 37 C.F.R. § 41.37(c)(1). SUMMARY We affirm the rejection of claims 1–32 on appeal. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Ssc Copy with citationCopy as parenthetical citation