Ex Parte Donhowe et alDownload PDFPatent Trial and Appeal BoardMay 29, 201812613739 (P.T.A.B. May. 29, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/613,739 11/06/2009 51947 7590 05/31/2018 Patent Dept. - Intuitive Surgical Operations, Inc. 1020 Kifer Road Sunnyvale, CA 94086 FIRST NAMED INVENTOR Caitlin Quance Donhowe 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 ATTORNEY DOCKET NO. CONFIRMATION NO. NEOG755-200/US 6961 EXAMINER NEWTON, ALEXANDRA L ART UNIT PAPER NUMBER 3779 NOTIFICATION DATE DELIVERY MODE 05/31/2018 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): dana.ru bens tein @intusurg.com patent.group@intusurg.com natalie.hood@intusurg.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CAITLIN QUANCE DONHOWE, AMIR BELSON, KRISTOFFER JOHN DONHOWE, KENNETH ROBERT KRIEG, ERIC MICHAEL STORNE, THOMAS J. YORKEY, and JUN ZHANG Appeal2017-005188 1 Application 12/613,739 Technology Center 3700 Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. § 134 involving claims to a method of medical device path planning. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Our Decision refers to Appellants' Appeal Brief ("Appeal Br.," filed Aug. 13, 2016) and Reply Brief ("Reply Br.," filed Feb. 6, 2017), and the Examiner's Final Office Action ("Final Act." mailed March 14, 2016) and Answer ("Ans.," mailed Dec. 7, 2016). 2 Appellants identify the real party in interest as Intuitive Surgical Operations, Inc. (see App. Br. 2). Appeal2017-005188 Application 12/613,739 Statement of the Case Background "[C]onventional medical device path-planning is performed using medical imaging data usually CAT, X-ray, MRI, PET [or] fluoroscopy imaging data" (Spec. ,r 5). The Specification teaches: Unlike prior art methods that required path planning prior to use of a steerable medical device, waypoints of a steerable medical device are stored as the device is moved within a patient. The stored waypoints are an ordered sequence of locations. The ordered sequence of locations defines a safe path within the patient for moving an articulatable portion of the steerable medical device. (Spec. ,r 6). The Claims Claims 1, 3-7, 14, and 15 are on appeal. 3 Claim 1 is representative and reads as follows: 1. A method comprising: storing, by a controller, waypoints of a steerable medical device as the steerable medical device is moved towards a desired location in a patient, the waypoints being locations of the steerable medical device within the patient, wherein said stored waypoints comprise an ordered sequence of locations, wherein said ordered sequence of locations defines a safe path for moving an articulatable portion of said steerable medical device within the patient, wherein said articulatable portion comprises an articulatable segment, wherein the articulatable segment includes a serial combination of a plurality of links, 3 The Examiner indicates that "Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form" (Final Act. 5). 2 Appeal2017-005188 Application 12/613,739 and wherein each link in the plurality of links is coupled to another link in the plurality of links by a joint; constraining, by the controller as the steerable medical device is moved in the patient, said articulatable segment of said steerable medical device to maintain said articulatable segment within a boundary region enclosing said safe path, the boundary region being generated using the ordered sequence of locations, wherein a link in the articulatable segment deviating from the safe path remains within the boundary region. The Issues 4 A. The Examiner rejected claims 1, 3-5, 14, and 15 under 35 U.S.C. § I03(a) as obvious over Belson '912, 5 Belson '007, 6 and Webster7 (Final Act. 2--4). B. The Examiner rejected claims 6 and 7 under 35 U.S.C. § I03(a) as obvious over Belson '912, Belson '007, Webster, and Moll8 (Final Act. 5). A. 35 U.S.C. § 103(a) over Belson '912, Belson '007, and Webster The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that the prior art renders the method of the claims obvious? 4 We note that while the Examiner did not include Belson '007 in the statement of the rejection, the Examiner clearly relied upon this reference as recognized by Appellants (see App. Br. 6). 5 Belson et al., US 2006/0258912 Al, published Nov. 16, 2006. 6 Belson et al., US 6,610,007 B2, issued Aug. 26, 2003. 7 Webster et al., US 2009/0171271 Al, published July 2, 2009. 8 Moll et al., US 2007/0197896 Al, published Aug. 23, 2007. 3 Appeal2017-005188 Application 12/613,739 Findings of Fact 1. Belson '007 teaches the "method of the present invention involves inserting the distal end of the endoscope body into a patient, either through a natural orifice or through an incision, and steering the selectively steerable distal portion to select a desired path" (Belson '007 2:65 to 3 :2). 2. Figures 18-20 of Belson '007 are reproduced below: FIG, 20 A simplified representation of how the distance may be used to advance the device may be seen in FIG. 18. The endoscopic body 238 is advanced until the distal tip reaches a depth of L1, as measured from the midpoint of the datum speculum 234. At this depth, it is necessary for the user to selectively steer the tip to follow the sigmoid colon S such that the body forms a radius of curvature R1. Once the position and depth of this feature has been defined by the distal tip, any proximal segment that reaches this depth of L 1 can be commanded to configure itself in the same manner as the distal tip segment until it has achieved the correct combination of bends to negotiate the tum. As the body 238 is further advanced, as seen in FIG. 19, it will eventually reach the second major bend at a depth of L1+L2. Accordingly, as for L1, any segment that is advanced and reaches a depth of L 1 + L2 will likewise be commanded to execute a tum as defined by the distal tip being selectively steered when it first passed the second bend into the descending colon D. Again as the body 238 is further advanced, as shown in FIG. 20, any subsequent segment that is advanced to reach a 4 Appeal2017-005188 Application 12/613,739 depth of L1+L2+L3 will be commanded to execute and negotiate the tum to follow the transverse colon T, again where the original curve has been defined by the selectively steerable distal tip. (Belson '007 13:22--45). 3. Belson '007 teaches "electronic motion controller 140 controls the motion of the automatically controlled proximal portion 106 of the body 102. The electronic motion controller 140 may be implemented using a motion control program running on a microcomputer" (Belson '007 5: 19- 22). 4. Belson '007 teaches: "When the correct curve of the selectively steerable distal portion 104 for advancing the distal end 108 of the endoscope body 102 into the sigmoid colon S has been selected, the curve is logged into the memory of the electronic motion controller 140 as a reference" (Belson '007 10:35-39). Belson '007 teaches: "In this way, a three dimensional map of the colon or path may be generated and maintained for future applications" (Belson '007 10:46--48). 5. Belson '007 teaches the electronic motion controller 140 propagates the selected curves proximally or distally along the automatically controlled proximal portion 106 of the endoscope body 102 to maintain the curves in a spatially fixed position. This allows the endoscope body 102 to move through tortuous curves without putting unnecessary force on the wall of the colon C. (Belson '007 7:63 to 8:2). 6. Belson '912 teaches: There are numerous examples of articulating or bendable or steerable instruments used in a wide variety of industrial and medical applications. In general, the articulating instrument is 5 Appeal2017-005188 Application 12/613,739 directed to advance along a selected or desired pathway to accomplish a task such as inspection, repair, etc. The more convoluted the pathway, the higher degree of articulation, control, and flexibility needed to maneuver the instrument into the desired position. (Belson '912 ,r 3). 7. Figures lOA and lOE of Belson '912 are reproduced below: 192 ' FJG.10E FIG. 10A "The hinges, joints, or universal joints 182 to 192 may be connected together to form a segment 180, shown in FIG. lO(a), which may then be caused to bend in two axes, e.g., via the use of activated polymer material." (Belson '912 ,r 119). "In another alternative, as shown in FIG. lO(e), a continuous sleeve 188 may be placed around the circumference of a number of segments 190, 192 that may comprise the entire endoscope or a subset of the segments making up the endoscope" (Belson '912 ,r 121). 8. Belson '912 teaches: "Individually controllable pieces or lengths of activated polymer material, or individually controllable electrodes covering individual regions of activated polymer material, may be used to bend each of the segments individually in any desired direction" (Belson '912 ,r 121). 6 Appeal2017-005188 Application 12/613,739 9. Belson '912 teaches "[s]ome of the segments are steerable or controllable by a user (with or without computer controlled assistance) into or along a selected or desired pathway while others are electronically or computer controlled to follow the shape of the previously steered segments in a so called 'follow the leader' manner" (Belson '912 ,r 12). 10. Webster teaches "the physician determines a desired path from entry point 175 to surgical site 180. In doing so, the physician may identify a path through which active cannula 102 will travel, along with an error boundary around the path" (Webster ,r 65). 11. Webster teaches The physician may use user interface 155 to define the path and its error boundaries. In doing so, the physician may use a cursor to tag points within the registered image acquired in step 605. The software identifies the location of these selected points in the registered image and stores these locations in memory 152. (Webster ,r 66). 12. Webster teaches "the software computes a plurality of configurations for active cannula 102 that will enable active cannula to gradually achieve the final configuration computed in step 615, while not having the active cannula stray beyond the path and error boundaries determined by the physician" (Webster ,r 72). 13. Webster teaches: "Medical imaging system 160 may be of a type that provides 3-dimensional images with sufficient timeliness and sufficient frame rate to enable image-based feedback control of active cannula 102 by the software running on host computer 152" (Webster ,r 44). Principles of Law When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable 7 Appeal2017-005188 Application 12/613,739 solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." Id. at 416. Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 2--4; FF 1-12) and agree that the claims are obvious over the cited prior art. We address Appellants' arguments below. Claim 1 Appellants contend Belson describes that as the device is moved into the patient, the motion is done is such a way that the path of the leading segment is followed. Thus, once the path for the leading segment is defined, the path for each subsequent segment has the same coordinates that the leading segment had at that insertion depth. No calculations are needed, and no constraints on the trailing segments, other than restricting the shape of a segment to the shape of the preceding segment, are needed according to Belson. (App. Br. 9). We find this argument unpersuasive because Belson doesn't just teach a "follow the leader" approach but rather teaches two alternatives, the "follow the leader" approach as argued by Appellants (see App. Br. 8) and an individual control of segments approach, both of which appear consistent 8 Appeal2017-005188 Application 12/613,739 with claim 1 which broadly recites "constraining ... said articulatable segment of said steerable medical device to maintain said articulatable segment within a boundary region enclosing said safe path." However, even accepting Appellants' apparent position limiting claim 1 to an individual control of segments approach, Belson '912 explains "[s]ome of the segments are steerable or controllable by a user (with or without computer controlled assistance) into or along a selected or desired pathway while others are electronically or computer controlled to follow the shape of the previously steered segments in a so called 'follow the leader' manner" (FF 9). Belson '912 teaches how the user segments may be controlled because "[i]ndividually controllable pieces or lengths of activated polymer material ... may be used to bend each of the segments individually in any desired direction" (FF 8). Thus, Belson '912 does teach that individual segments may be user controllable, and would have motivated the use of Belson '007's three dimensional map of the colon with predefined curves with the individually controllable segments because of the desire expressed by Belson '007 to stay on a safe path and "move through tortuous curves without putting unnecessary force on the wall of the colon C" (FF 5). Appellants contend: Webster suggests at most that prior to using a surgical instrument, a surgeon can specify a path and an error boundary in a planning stage that is used to subsequently control the instrument. Webster fails to suggest anything about determining an error boundary using actual locations of a leading part of the active cannula. (App. Br. 10-11). 9 Appeal2017-005188 Application 12/613,739 We find this argument unpersuasive. Claim 1 recites "the boundary region being generated using the ordered sequence of locations." Claim 1 does not include any limitation that clearly requires determining the error boundary "using actual locations of a leading part of the active cannula" as argued by Appellants. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the outset because ... they are not based on limitations appearing in the claims."). Moreover, Webster teaches "image-based feedback control of active cannula 102 by the software running on host computer 152" (FF 13) and teaches the use of software to keep the cannula within error boundaries (FF 12). These teachings of Webster reasonably suggest using the actual location of the entire cannula with feedback control to avoid undesirable movements outside of the error boundaries that would injure the patient (see FF 10-13). Appellants reiterate their "follow the leader" argument regarding Belson '912, contending one of skill in the art in reading Belson would understand how to move all but the leading segment of the surgical device though the lumen. In particular, they would understand based on the teaching of Belson, that while the follow-the-leader may not exactly replicate the path of the leading segment, the follow-the-leader approach, without more, still resulted in the trailing segments being moved through the tortuous lumen without disturbing adjacent tissue or objects as taught by Belson. (App. Br. 11). We remain unpersuaded by this argument because, as already noted, Belson '912 suggests steering of cannula segments by direct user control (FF 9), Belson '912 suggests each cannula segment may be individually controllable (FF 8), and because Webster suggests controlling the cannula 10 Appeal2017-005188 Application 12/613,739 through the tortuous lumen to not "stray beyond the path and error boundaries determined by the physician" (FF 12). Thus, the ordinary artisan would have found it obvious to individually control any or all segments of a cannula to constrain that cannula to remain within the desired error boundaries because both Webster and Belson '007 recognize the need to avoid damaging adjacent tissues resulting in injury to the patient (FF 5, 12). Appellants contend neither Belson, Webster, nor the combination suggests a constraining act where a link of the articulatable segment deviating from the safe path is constrained to remain within the boundary region. Belson surrounds the segments in a polymer sheath and so constrains the links of segment to remain within the sheath, and the sheath determines the path that the links follow. Webster does not consider a segment that includes links. (App. Br. 13). Appellants further contend the "Examiner hypothesizes a problem that neither Belson nor Webster, as ones of skill in the art, considered" (id. at 14). Appellants contend "Belson, who was clearly aware of the conditions under which the device which be used and the likely failure modes, stated as quoted above: 'Using such a "follow-the-leader" type algorithm, the device may be advanced into tortuous lumens or paths without disturbing adjacent tissue or objects.' Belson, Paragraph [00086]" (id. at 14). We find these arguments unpersuasive. It is incorrect to state that Belson '912 is limited to "follow-the-leader" movements (see FF 9). While Belson '912 has an embodiment with a continuous sleeve as shown in Figure lOE, Belson '912 also shows an embodiment without the continuous sleeve in Figure lOA (FF 7). Belson '912 makes it clear that the sleeve is an 11 Appeal2017-005188 Application 12/613,739 alternative stating "In another alternative, as shown in FIG. lO(e), a continuous sleeve 188 may be placed around the circumference of a number of segments" and also stating "[i]n the variations where a continuous band or sleeve is used" (Belson '912 ,r 121). These statements indicate that Belson '912 envisions cannulas with and without sleeves, and therefore reasonably suggests segments not constrained by a sheath. Therefore, while Webster may not address linked segments, the ordinary artisan, concerned that the cannula of Belson '912 may "put[] unnecessary force" on adjacent tissues (FF 5) would reasonably have used Webster's teaching to prevent the "active cannula stray[ing] beyond the path and error boundaries determined by the physician" (FF 12). It is the combination of the teachings of Belson '912, Belson '007, and Webster that render claim 1 obvious, not any of the teachings alone. Claims 3 and 4 Appellants contend "[ w ]hile Webster indicates that the physician specifies an 'error boundary,' this error boundary is specified in the planning stage. There examiner has failed to cite any suggestion that the error boundary is generated as recited in Claims 1, 3, and 4" (App. Br. 15). We find this argument unpersuasive because Webster clearly teaches "image-based feedback control of active cannula 102 by the software running on host computer 152" (FF 13). The ordinary artisan would have found it obvious to control the cannula using the error boundaries disclosed by Webster (FF 12) in order to prevent impingement into undesirable locations as suggested by Belson '007 (FF 5) and Webster (FF 12). Appellants also contend: 12 Appeal2017-005188 Application 12/613,739 Even if the boundary region were extended, the Examiner has failed to explain how Belson would be modified to do other than follow-the-leader. Modification of Belson to constrain the path to other than the path of the leading segment would require a change in the control system of Belson, which is not even addressed in the rejection. (App. Br. 16). We find this argument unpersuasive for the reasons already given above that Belson '912 is not limited to the "follow-the-leader" algorithm but rather teaches "[ s Jome of the segments are steerable or controllable by a user (with or without computer controlled assistance) into or along a selected or desired pathway while others are electronically or computer controlled to follow the shape of the previously steered segments in a so called 'follow the leader' manner" (FF 9). The ordinary artisan would understand that the control system for user controlled segments would have been improved by using the control software and error boundaries disclosed by Webster (FF 12-13) in order to prevent patient injury (FF 5). Claims 5, 14, and 15 Appellants do not separately identify any specific arguments with respect to these claims. We therefore affirm for the reasons given by the Examiner. A statement which merely points out what a claim recites will not be considered an argument for separate patentability of the claim. 37 C.F.R. § 4I.37(c)(l)(iv). 13 Appeal2017-005188 Application 12/613,739 Conclusion of Law The evidence of record supports the Examiner's conclusion that the prior art renders the method of the claims obvious. B. 35 U.S.C. § 103(a) over Belson '912, Belson '007, Webster, and Moll Claim 6 Appellants contend: "As described by Belson, the follow-the-leader approach does not require a kinematic model ... The trailing segments of Belson are controlled without such a model. Thus, the motivation for the combination of the three references is inappropriate and a prim a facie obviousness rejection has not been made." (App. Br. 16-17). 14 Appeal2017-005188 Application 12/613,739 We find this argument unpersuasive for the reasons discussed above. Because we find Belson '912 teaches an approach other than follow-the- leader for some segments, as "[ s Jome of the segments are steerable or controllable by a user," the Examiner's motivation for using Moll's kinematic model (see, e.g., Moll ,r,r 238-245) for those user controlled segments in combination with safe path processes of Belson '007 (FF 5) and Webster (FF 12), reasonably renders claim 6 obvious. Claim 7 Appellants contend: The Examiner admitted that Webster failed to suggest anything about a kinematic model, ("However, Webster et al. fails to teach using a kinematic model." FOA at pg. 5.) and so Webster cannot suggest anything about a cost function for such a model. It appears that the express claim limitations have been reduced to a gist of any minimization technique that generates orientations and something that might include a position. (App. Br. 17). We find this argument unpersuasive. Appellants do not dispute that Moll teaches "minimizing a cost function" as recited in claim 7, but rather contend that Webster does not teach this limitation. However, the Examiner relies upon all of the teachings in the prior art, not Webster alone, to render the claim obvious. The Examiner reasonably finds "accurate mathematical models of the forward and inverse kinematics are essential for the control of a robotically controlled medical device" (Final Act. 5) and we agree that the use of improved mathmatical approaches such as the cost function analysis used by Moll for movement of cannulas would reasonably be applied to other systems that control cannulas such as the system of Belson '912, 15 Appeal2017-005188 Application 12/613,739 Belson '007, and Webster to maximize the accuracy and performance of the movements. SUMMARY In summary, we affirm the rejection of claims 1, 3, and 4 under 35 U.S.C. § 103(a) as obvious over Belson '912, Belson '007, and Webster. Claims 5, 14, and 15 fall with claim 1. We affirm the rejection of claims 6 and 7 under 35 U.S.C. § 103(a) as obvious over Belson '912, Belson '007, Webster, and Moll. 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 16 Copy with citationCopy as parenthetical citation