Ex Parte CohenDownload PDFPatent Trial and Appeal BoardMar 24, 201712748894 (P.T.A.B. Mar. 24, 2017) 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. 12/748,894 03/29/2010 Amit COHEN 0K-042100US 6106 (065513-0230) 67337 7590 03/28/2017 DYKEMA GOSSETT PLLC (STJ) 4000 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402 EXAMINER GUPTA, VANI ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 03/28/2017 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): MN_IPMail @ dykema. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AMIT COHEN Appeal 2015-007312 Application 12/748,894 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method for tracking a tool relative to a wall of a region of interest of a patient. The Examiner rejected the claims on the ground of obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. which is a1 Appellant identifies the Real Party in Interest as Mediguide Ltd., subsidiary of St. Jude Medical, Inc. (see App. Br. 1). Appeal 2015-007312 Application 12/748,894 Statement of the Case Background Appellant’s “invention relates generally to a method and related system for detecting contact with a wall of a region of interest” (Spec. 11). The Claims Claims 1—20 are on appeal. Independent claim 1 is representative and reads as follows (emphasis added): 1. A method for tracking a tool relative to a wall of a region of interest of a patient, the method comprising: tracking the motion of the tool, wherein the tool includes a positioning sensor at a distal end thereof configured to (i) sense one or more characteristics of a magnetic field produced by a medical positioning system and (ii) generate a signal indicative of a sensor position of the positioning sensor, and creating a tool motion profile including generating, using the medical positioning system in response to said signal, the tool position; calculating a correlation value representative of the correlation between the tool motion profile and a wall motion profile indicative of the motion of the wall; and determining when the correlation value exceeds a threshold, the correlation value exceeding the threshold being indicative of contact of the tool with the wall of the region of interest. The Issue The Examiner rejected claims 1—20 under 35 U.S.C. § 103(a) as obvious over Kesten2 and Kaiser3 (Ans. 2—13). 2 Kesten et al., US 6,493,575 Bl, issued Dec. 10, 2002. 3 Kaiser et al., US 2009/0198298 Al, published Aug. 6, 2009. 2 Appeal 2015-007312 Application 12/748,894 The Examiner finds that Kesten teaches a method for tracking a tool relative to a wall of a region of interest of a patient, the method comprising the steps of: tracking the motion of the tool and creating a tool motion profile (col. 16,11. 31 — 64; col. 17,11.24—39). Kesten teaches also using a medical positioning system, (Abstract: “A catheter tracking system for visualization of fluoroscopic images . . .”) in response to a signal generated by the tool (or component of the tool: “radiopaque markers”) to generate a position of the tool (col. 3,11. 47 — 51; col. 14, line 56 —col. 15, line 8 and col. 16,11. 31 — 38; this includes details of the catheter tracking with use of this catheter tracking system and radiopaque markers). Kesten also suggests determining a wall motion profile indicative of the motion of the wall and (col. 16 line 49-60, wall motion profile is ECG signal which is indicative of the motion of the wall) calculating a correlation value representative of the correlation between the tool motion profile and a wall motion profile indicative of the motion of the wall (col. 16,11. 54-64; col. 17,11.2A-39;^s. 10A, 10B, 10C) and determining when the correlation value exceeds a threshold, the correlation value exceeding the threshold being indicative of contact of the tool with the wall of the region of interest (col. 16, line 40 — 64). (Ans. 2-3.) The Examiner acknowledges that Kesten does not [teach] the method as claimed, wherein the tool includes a positioning sensor at a distal end thereof configured to (i) sense one or more characteristics of a magnetic field produced by a medical positioning system and (ii) generate a signal indicative of a sensor position of the positioning sensor. {Id. at 3.) 3 Appeal 2015-007312 Application 12/748,894 The Examiner finds that Kaiser teaches using a medical position system and tool wherein the tool includes a position sensor associated with the region of interest or heart wall that (i) senses one or more characteristics of a magnetic field produced by the nearby medical position system ([0029]: “the electromagnetic tracking system 44 can determine the position of the catheter 52 by measuring the field strength at the sensor 58 location;” see also paragraphs [0030 — 0032]) and (ii) generate a signal indicative of a sensor position of positioning sensor ([0032]: “voltage signals”). Kaiser’s magnetic-based medical position system works in conjunction with Kaiser’s fluoroscopic imaging (imaging device described in [0017]). Kaiser teaches also providing wall motion data from the position indicating signals ([0032]: “electromagnetic sensor coil 258R, 25 8L, respectively, which has been positioned to monitor cardiac wall motion ... as a result of tracking the sensor coil within the patient during a cardiac cycle as the heart wall moves . . .”). {Id. at 3 4.) The Examiner concludes that it would have been obvious to modify the medical positioning system and the position sensor of Kesten with the magnetic field generating and sensor position sensing capabilities of the medical positioning system and the position sensor that senses one or more characteristics of a magnetic field produced by the nearby medical position system of Kaiser to provide Kesten with additional means for tracking the distal end of catheter in approximation with the heart wall, along with the existing image-guidance means already taught by Kesten. {Id. at 4.) The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Kesten and Kaiser render the claims obvious? 4 Appeal 2015-007312 Application 12/748,894 Findings of Fact 1. The Specification teaches that “[t]he predetermined data may be collected prior to the procedure, based on standard parameters known within the medical field, actual and/or real-time measurements collected from the patient, or a combination of standard and actual measurements” (Spec. 141). 2. Kesten teaches A catheter tracking system for visualization of fluoroscopic images, the system comprising a fluoroscope for generating fluoroscopic image data, a fluoroscopic image visualization monitor, a catheter having an elongated shaft, particularly an intraventricular catheter, distal tip and a radio opaque portion adjacent the distal tip. A circumferential radio opaque band may be used to determine the relative position, orientation and motion of the catheter. An image analysis system capable of analyzing the image of the catheter and the radio opaque band, for receiving fluoroscopic image data from the fluoroscope determining physical parameters related to the left ventricle, and the relative position, orientation and motion of the catheter therein, and for determining the location and other parameters of treatment on intraventricular surfaces. (Kesten Abstract; see also Ans. 2—3.) 3. Kesten teaches that it is known that the size and shape of the ventricle changes with the cardiac cycle. Adding an input to the image computer which correlates to the cardiac cycle such as the ECG signal would allow the image computer to capture, store and register several images of the ventricle shape all corresponding to different, but known periods during the cardiac cycle. This also allows a monitor to be updated with the generated image one time per cardiac cycle, which allows the user to see changes (such as motion of the catheter) which do not have the additional motion of the cardiac cycle superimposed. 5 Appeal 2015-007312 Application 12/748,894 It is also known that during the respiratory cycle the heart moves relative to a fixed reference outside of the body such as the fluoroscope. The motion due to respiration can be tracked by monitoring the respiratory cycle. (Kesten 15:60-16:8; see also Ans. 6.) 4. Kaiser teaches A method and system for use in selecting a cardiac pacing site includes sensors for tracking wall motion (e.g., sensors coupled to the right and left ventricular heart wall). The wall motion of one or more non-paced cardiac cycles is compared to the wall motion of one or more paced cardiac cycles to determine the effectiveness of one or more pacing sites. For example, image data may be generated to notify the user as to the effectiveness of the one or more pacing sites. (Kaiser Abstract; see also Ans. 3 4.) 5. Kaiser teaches a “system . . . which generally includes an imaging device . . ., an electromagnetic navigation or tracking system . . .” (Kaiser 115; see also Ans. 3^4). 6. Kaiser teaches that while a fluoroscopic C-arm imaging device ... is shown . . ., any other alternative imaging modality may also be used. For example, isocentric fluoroscopy, bi-plane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high frequency ultrasound (HIFU), optical coherence tomography (OCT), intra-vascular ultrasound (IVUS), 2D, 3D or 4D ultrasound, or intraoperative CT or MRI may also be used to acquire pre-operative or real-time images or image data of the patient . . . [ijmage datasets from hybrid modalities, such as positron emission tomography (PET) combined with CT, or single photon emission computer tomography (SPECT) combined with CT, could also provide functional image data superimposed onto anatomical data to be used to confidently reach target sights within the heart or 6 Appeal 2015-007312 Application 12/748,894 other areas of interest. Further, for example, it is further noted by acquiring images in more than one plane, an icon representing the location of a catheter or other instrument, introduced and advanced in the patient . . ., may be superimposed in more than one view on display . . . allowing simulated bi-plane or even multi-plane views, including two and three-dimensional views (Kaiser | 17; see also Ans. 3—4.) Principles of Law The Supreme Court explains that “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int 7 v. Teleflex Inc., 550 U.S. 398, 418 (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. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Analysis Claims 1—5, 7—10, and 13—20: Appellant argues the patentability of these claims as a group. We thus select claim 1 as representative. We adopt the Examiner’s findings of fact and reasoning with respect to the rejection of claim 1, and agree with the Examiner that claim 1 would have been obvious over Kesten and Kaiser. We address below Appellant’s arguments. We recognize, but are not persuaded, by Appellant’s contention that to 7 Appeal 2015-007312 Application 12/748,894 modify the positioning system (i.e., image processing software) and the position sensor (i.e., radiopaque markers) of Kesten as contended by the Examiner, with the electromagnetic sensors of Kaiser, would change Kesten’s principle of operation from an image-based position and orientation determining process using a specially-constructed catheter to an electromagnetic field-based position determining process, as well as rendering the modified catheter of Kesten unsatisfactory for its intended purpose. (App. Br. 7—8.) Appellant also contends that “one of ordinary skill in the art would not have found it obvious to supplement Kesten with Kaiser, as stated by the Examiner,” and that merely providing “additional means for tracking the distal end” is simply a statement of the result of the combination and does not constitute a reason for making the combination in the first place. The Examiner’s reliance on the result of the combination as a reason for the combination constitutes improper logic. (Id. at 8; see also Reply Br. 2—3.) More particularly, Appellant argues that “contributing an additional (i.e., duplicative) positioning system of Kaiser into Kesten will not result in a combination that is any of stronger, cheaper, cleaner, faster, lighter, smaller, more durable or more efficient than Kesten alone” (App. Br. 9; see also Reply Br. 4—6). As the Examiner explains, the radiopaque markers along the length of the catheter are passive localizing devices that provide positional data by reflecting the fluoroscopic energy emitted by Kesten’s fluoroscopic device, but do not sense anything (e.g. data from an outside source) and therefore are different from the positional sensor at the distal end of the device (as taught by Kaiser). Kaiser teaches an active localizing sensor that transmits positional data to and receives positional data from the localizing system, data about the position of the distal end 8 Appeal 2015-007312 Application 12/748,894 of the device (as described in paragraphs [009 — 0032]). Additionally, Kaiser’s magnetic-based medical position system works in conjunction with fluoroscopic imaging technology (imaging device, as described in paragraph [0017] of Kaiser). Kaiser teaches also providing wall motion data from the position indicating signals ([0032]: “electromagnetic sensor coil 258R, 258L). ... As both Kesten and Kaiser are medical positioning systems and the Kaiser reference is open to MRI and fluoroscopy (as explained in the cited paragraphs of Kaiser), it would be reasonable to one of ordinary skill in the art to combine the two references such that the Kesten reference has an additional sensing means of the device position (as taught by Kaiser) in addition to fluoroscopy- radiopaque-marker (imaging) tracking means of the device position (as taught by Kesten). It would also be [a] reasonable motivation to one of ordinary skill in the art to combine these positional sensing technologies of Kesten and Kaiser as the combination would provide improved accuracy and precision of tracking of the entire length of the catheter device, which would help provide better results of treatment to the patient. This is not merely a statement of result of the combination, but also a valid reason for providing such a combination of technologies. (Ans. 13—14; FF 2—7.) See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[Attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness”). We recognize, but are not persuaded, by Appellant’s contention that such a combination would appear to be more costly (due to duplicate structure), heavier (duplicate structure), more complex (due to duplicate structures) and possibly less durable as a result, and potentially less efficient by virtue of having to coordinate duplicate positioning systems. Appellant, based on the current record, does not discern why one of ordinary skill would be incented or motivated to the make the combination of Kesten and Kaiser, and for at least this reason, further submit that the rejection is improper. 9 Appeal 2015-007312 Application 12/748,894 (App. Br. 9.) As the Examiner explains, [duplication of parts or structures does not necessarily lead to higher cost, heavier devices, and/or less durable devices because there are also other factors involved in making devices such as making devices that are more complex so that they are capable of accomplishing more tasks or needs. Furthermore, while trying to make devices more complex, artisans of ordinary skill will also look for ways to lower costs by finding cheaper material that is also more efficient, durable, lighter, biocompatible, etc. (Ans. 9.) See In re Geisler, 116 F.3d at 1470. See also Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“[OJbviousness must be determined in light of all the facts, and there is no rule that a single reference that teaches away will mandate a finding of nonobviousness. Fikewise, a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.”) A combination of references may be obvious even if the combination eliminates a benefit of one of the references. See In re Urbanski, 809 F.3d 1237, 1242 (Fed. Cir. 2016). Consequently, Appellant has provided no persuasive factual evidence to show that Kesten’s device, as modified by Examiner, would have been either more expensive, more difficult or in any way inoperable in relation to tracking a tool relative to a wall of a region of interest of a patient. Appellant contends that paragraph [0017] of Kaiser is directed to different imaging embodiments, not its tracking functionality. Thus, such purported advantage is inapplicable to the proposed modification since the Examiner cites Kaiser for its teaching of a reference positioning sensor and not its teaching of 10 Appeal 2015-007312 Application 12/748,894 imaging capabilities. Moreover, the statement “confidently reach target sites” is at most laudatory in nature, and the unmodified disclosure of Kesten can already be said to make similar disclosures (e.g., col. 3,11. 36-41: “. . . to allow faster and more accurate placement of channels.”). (App. Br. 9 see also Reply Br. 6.) This argument is unpersuasive. Concerning paragraph [0017] of Kaiser, as the Examiner explains, this is in reference to one of the many teachings of Kaiser that presents device tracking means in conjunction with compatible medical imaging technology, including the one taught by Kesten (i.e. fluoroscopy imaging). As indicated above, Kaiser also teaches device position tracking via position sensor located at distal end of the device (for example, see paragraphs [0029 — 0032] of Kaiser). (Ans. 15 (emphasis added).) In other words, the use of a magnetic field for tracking does not foreclose its use in imaging because one capability is not exclusive with respect to the other capability. We recognize, but are not persuaded, by Appellant’s contention that the Examiner has not explained how [the] combination [of Kaiser and Kester] would work, in light of the radio opaque marker bands interposed between a source of electromagnetic radiation and the positioning sensor. While the Examiner mentions that Kaiser teaches “that it is possible to use fluoroscopic imaging system with an electromagnetic tracking system” (p. 14), Kaiser does not address the situation presented above involving interposed radio opaque marker bands. (App. Br. 11.) More particularly, Appellant argues that “the electromagnetic positioning sensor of Kaiser—now at the distal end of the tool of Kesten— would be enclosed by the above-mentioned plurality of radio opaque marker bands” (id.; see also Reply Br. 8—9). Appellant also argues that 11 Appeal 2015-007312 Application 12/748,894 metal can interfere with the operation of an electromagnetic field sensor, as seen by reference to at least U.S. Pat. No. 6,233,476 (“metal object interference”). In this light, Appellant submits that one of ordinary skill in the art would understand the potential problems referred to by Appellant attendant the combination proposed by the Examiner. (Id.) We are not persuaded. The combination of Kaiser and Kesten does not require that the electromagnetic sensor be enclosed by the radio opaque marker bands. In other words, the claims do not exclude the positioning of an electromagnetic sensor next to or near a radio opaque marker, as opposed to one of them being enclosed relative to the other. “[Limitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[Ajppellanf s arguments fail from the outset because ... they are not based on limitations appearing in the claims.”). Moreover, Appellant does not provide any evidentiary basis to support the contention that metal interference would render the combination Kaiser and Kesten inoperable. See In re Geisler, 116 F.3d at 1470. Kaiser evidences that fluoroscopic imaging may be used with other modalities such as magnetic resonance imaging (FF 6; see also Ans. 15—16). We therefore agree with the Examiner that it would have been obvious include a position sensor using a magnetic field as taught by Kaiser with the medical positioning system of Kesten (see Ans. 4, 16). The combined teachings of Kesten and Kaiser regarding magnetic field sensing, would yield predictable results of more accurate tracking of medical devices (see Ans. 14). 12 Appeal 2015-007312 Application 12/748,894 We therefore affirm the rejection of independent claims 1, 14, and 18. Because Appellant does not argue the claims separately, claims 2—5, 7—10, 13, 15—17, 19, and 20 fall with these claims. Claim 6: Claim 6 recites “wherein creating the wall motion profile is further performed based on one of (i) predetermined motion pattern data for the region of interest and (ii) a combination of the predetermined motion pattern data and the measured region of interest motion data” (see Appellant’s claim 6). Appellant contends that “the ECG signal in Kesten does not constitute predetermined motion pattern data’ because the ECG signal is not predetermined but is rather disclosed as a real time signal” (App. Br. 13 see also Reply Br. 10-11). This argument is unpersuasive. The Specification teaches that “[t]he predetermined data may be collected prior to the procedure, based on standard parameters known within the medical field, actual and/or real-time measurements collected from the patient, or a combination of standard and actual measurements” (FF 1). Kesten teaches that “[ajdding an input to the image computer which correlates to the cardiac cycle such as the ECG signal would allow the image computer to capture, store and register several images of the ventricle shape all corresponding to different, but known periods during the cardiac cycle,” and that “[i]t is also known that during the respiratory cycle the heart moves relative to a fixed reference outside of the body such as the fluoroscope. The motion due to respiration can be tracked by monitoring the respiratory cycle” (FF 3). 13 Appeal 2015-007312 Application 12/748,894 We thus agree with the Examiner that interpretation of predetermined motion dat[a] in Kesten includes to [sic] what is considered a normal cardiac cycle or respiratory cycle, and cited passages Keston’s teachings of using “amplitude-correlation function” is used for determining actual cycle or actual position when it deviates from a threshold or normal cardiac motion data ) i.e. corresponding predetermined data or level). (Ans. 17.) Claims 11 and 12: Claim 11 recites “wherein the at least one component is the frequency-based component, and wherein said comparing includes: determining whether a predetermined frequency component present in the wall motion is present in the tool motion” (see Appellant’s claim 11). Claim 12 depends from claim 11. The Examiner asserts that the rejection of claims 11 and 12 were based on “passages of Kesten that rely on frequency-based components of ECG that record cardiac cycle of the heart (which implicitly includes heart wall motion data). . . col. 16 line 60-col. 17, line 12)” (Ans. 16). The Examiner’s explanation is unpersuasive. Instead, we agree with Appellant that “Kesten discloses that its wall contact detection ‘is implemented by creating a correlation function between an amplitude of the catheter movement with the ECG signal’ (emphasis added; col. 16, lines 60— 62)” (App. Br. 12; see also Reply Br. 10—11). Accordingly, the Examiner has not met the burden to show that claim 11 would have been obvious. We thus reverse the rejection of claim 11. Because of its dependency from claim 11, we reverse the rejection of claim 12 as well. 14 Appeal 2015-007312 Application 12/748,894 SUMMARY In summary, we affirm the rejection of claims 1, 14, and 18 under 35 U.S.C. § 103(a) as obvious over Kesten and Kaiser. Claims 2—5, 7—10 and 13 fall with claim 1, claims 15—17 fall with claim 14, and claims 19 and 20 fall with claim 18. We also separately affirm claim 6. We reverse the rejection of claims 11 and 12 under 35 U.S.C. § 103(a) as obvious over Kesten and Kaiser. AFFIRMED-IN-PART 15 Copy with citationCopy as parenthetical citation