Ex Parte Kondrosky et alDownload PDFPatent Trial and Appeal BoardAug 29, 201613337987 (P.T.A.B. Aug. 29, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/337,987 12/27/2011 John D. Kondrosky 34284 7590 08/31/2016 Rutan & Tucker, LLP 611 ANTON BL VD SUITE 1400 COST A MESA, CA 92626 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. 101672.0068P2 4116 EXAMINER HOEKSTRA, JEFFREY GERBEN ART UNIT PAPER NUMBER 3736 NOTIFICATION DATE DELIVERY MODE 08/31/2016 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): patents@rutan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN D. KONDROSKY and ABTIHAL RAJI-KUBBA Appeal2014-009385 Application 13/337,987 Technology Center 3700 Before JAMES P. CAL VE, GEORGE R. HOSKINS, and AMANDA F. WIEKER, Administrative Patent Judges. CAL VE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from the final rejection of claim 1. Appeal Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal2014-009385 Application 13/337 ,987 CLAIMED SUBJECT MATTER Claim 1, the sole claim on appeal, is reproduced below. 1. A method for positioning a catheter tip in a vasculature of a patient, comprising: providing a detection system including a plurality of magnetic sensors and an ECG-based detector; providing a guidewire including a rare-earth magnet in a distal region of the guidewire and a plurality of depth markings along a length of the guidewire, each depth marking indicating a relative distance from a distal end of the guidewire; disposing a catheter over the guidewire until a distal end of the catheter is adjacent the distal end of the guidewire, and thereafter coupling the catheter to the guidewire to form a catheter/guidewire combination; inserting the catheter/guidewire combination into the vasculature, advancing the catheter/guidewire combination through the vasculature to a first location using the magnetic sensors in the detection system; decoupling the guidewire from the catheter and advancing the guidewire distal end through the catheter distal end to a second location in the vasculature using the magnetic sensors in the detection system, the depth markings on a proximal region of the guidewire indicating the distance between the guidewire distal end and the catheter distal end; moving the catheter over the guidewire until the catheter distal end is at the second location, and thereafter again coupling the catheter to the guidewire to re- form the catheter/ guidewire combination; advancing the catheter/guidewire combination from the second location to a third location using the ECG- based detector in the detection system; and removing the guidewire from the catheter. 2 Appeal2014-009385 Application 13/337 ,987 REJECTIONS Claim 1 is rejected under 35 U.S.C. § 112, first paragraph, for lack of written description. Claim 1 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Kondrosky (US 2008/0255475 Al, pub. Oct. 16, 2008), Arenas (US 4,676,249, iss. June 30, 1987), and Lemon (US 2010/0222664 Al, pub. Sept. 2, 2010). ANALYSIS Claim 1 for lack of written description The Examiner found that the current application claims priority from application 12/104,253 so the effective filing date of claim 1 is April 16, 2008. Final Act. 10. The Examiner found that application 12/104,253 does not disclose the following limitations of claim 1: ( 1) a detection system that includes a plurality of sensors and an ECG-based detector; (2) coupling the catheter to the guidewire after the catheter is moved to a second location to reform the catheter/guidewire combination; and (3) advancing the catheter and guidewire combination to a third location. Id. at 9--10. The Examiner found that application 12/104,253 discloses a detection system including a plurality of magnetic sensors in one embodiment and an ECG-based detector in other embodiments. Id. at 9 (citing Spec. i-f 29). The Examiner reasoned that this disclosure would be understood to disclose two different detectors for detecting the position of guidewire distal end. Ans. 8. One detection system uses magnetic sensors and another uses an ECG-based detector in another embodiment. Id. The Examiner found that application 12/104,253 did not disclose a detection system that included a plurality of magnetic sensors and an ECG-based detector, as claimed. Id.; Final Act. 9. 3 Appeal2014-009385 Application 13/337 ,987 The Examiner found that application 12/104,253 does not disclose the step of coupling the guidewire and catheter together again after moving the catheter distal end to a second location. Final Act. 9; Ans. 9. The Examiner found that the second location is disclosed as the desired location and thus is the final point to which the catheter and guidewire are moved so there is no recoup ling of the catheter and guidewire for further advancing. Final Act. 9; Ans. 9. As a result, the Examiner found that application 12/104,253 does not disclose advancing the catheter/guidewire from the second location to a third location, either. Final Act. 9-10 (citing Spec. i-f 40); Ans. 9-10. Appellants argue that provisional application 60/923,636 from which the current application claims priority discloses that the guidewire can have a permanent magnet or EKG lead thereon. Appeal Br. 9. Appellants argue that the provisional application also discloses that a magnetic field location device or EKG device is placed over a desired location of a patient and the magnetic field device or EKG device senses the magnetic field emanating from the permanent magnet located on the distal end of the guidewire. Id. Appellants further argue that because it is disclosed that a magnetic field location device or EKG device senses a magnetic field emanating from the permanent magnet, a skilled artisan understands that the permanent magnet is part of both embodiments. Id. at 9-11; Reply Br. 8. Appellants also argue that application 12/104,253 discloses that any type of detection system may be used to detect the dipole or other aspect of magnetic elements 48 to indicate the position and/or orientation of the distal end 36 of the guidewire 30 when in the vasculature of a patient and there is no express exclusion of using an ECG detector with magnetic sensors. See Reply 6-7; Appeal Br. 10. 4 Appeal2014-009385 Application 13/337 ,987 Appellants also argue that the specification discloses that once the guidewire reaches the desired position after being advanced temporarily beyond the distal end of the catheter to move around an obstacle, then, the catheter is positioned there. Appeal Br. 12-13. Appellants further argue that just because the guidewire is decoupled temporarily from the catheter and advanced individually upon encountering an obstruction does not alter the disclosure that the guidewire and catheter are advanced together to the final destination and thus may be returned to their combined assembly state and advanced together after the temporary time period is over. Reply Br. 10. To obtain the filing date of an earlier-filed application, a claim in a later-filed application must be supported by the disclosure in the earlier-filed application as provided by section 112, first paragraph. 35 U.S.C. §§ 119(e) (provisional application), 120 (continuation application), 121 (divisional application); see Bradford Co. v. Conteyor N. Am., Inc., 603 F.3d 1262, 1269 (Fed. Cir. 2010) (each application in a chain leading back to an earlier application must satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, to obtain the filing date of the earlier application); Dynamic Drinkware, LLC v. Nat 'l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (to claim priority from the filing date of a provisional application, the specification of the provisional must provide a written description of the invention claimed in the non-provisional application). The test to apply '"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 Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). 5 Appeal2014-009385 Application 13/337 ,987 \Ve find that the disclosures of provisional application 60/923,636 and non-provisional application 12/104,253, from which the current application 13/337,987 claims priority as a divisional, do not reasonably convey to a skilled artisan that Appellants possessed a method for positioning a catheter tip in a vasculature of a patient comprising "providing a detection system including a plurality of magnetic sensors and an ECG-based detector," "coupling the catheter to the guidewire to re-fmm the catheter/guidewire combination" at a second location, and "advancing the catheter/guidewire combination from the second location to a third location using the ECG- based detector in the detection system" as recited in claim 1. Claim 1 recites these features, but claim 1 is an original claim only to the present application, which was filed on December 27, 2011. Final Act 7; Reply Br. 4-5. Current claim 1 is some evidence of the disclosure that may be required for a skilled artisan to understand that Appellants were in possession of the claimed subject matter, but only as of December 27, 2011. \Ve find no disclosure of the claimed detection system or the steps of recoupling at a second location and advancing to a third location in the prior- filed applications. The prior applications do not have to provide a verbatim disclosure of the claimed subject matter but they must reasonably convey to a skilled artisan that Appellants possessed this claimed subject matter. Lockivoodv. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Provisional application 60/923,636 discloses an embodiment with a magnetic detector device including those in U.S. Patent Nos. 6,263,230, 6,216,028, 6,129,668, and 5,879,297. Appeal Br. 9. vVe have no evidence that any of those patents also disclose a detection system including magnetic sensors and an ECG-based detector, as presently claimed. See Ans. 1 8-19. 6 Appeal2014-009385 Application 13/337 ,987 Instead, Appellants point to a disclosure in the provisional application that a guidewire can have a permanent magnet or EKG leads thereon, and a magnetic field location device or EKG device is placed over a location of a patient. Appeal Br. 9. These disclosures indicate that Appellants possessed two detection systems: one with magnetic sensors to locate a magnetic field and one with an EKG-based device. The disclosure that "[t]he rnagnetic field location device or the EKG device senses the magnetic field emanating from the permanent magnet" is consistent with the other embodiments that a magnetic sensor detection device or an EKG-based detector can be used to detect the guidewire. There is no disclosure that both detectors are used ..._, together to locate the guidewire. Rather, the disclosure indicates that either type of detector (magnetic sensor or EKG-based), by itself: suffices to locate the guide wire. Appeal Br. 9. The incorporated patents use magnetic sensors to sense magnetic fields of plural magnets and a processor to estimate their position in a three-dimensional space. See US 6,263)30, 2:60----61, Abstract. The general disclosure that other types of detection systems may be used to detect the dipole or other aspects of magnetic elements 48 to locate the position and/or orientation of the distal 36 of guidewire 30 indicates that other detectors besides a magnetic sensor or an EKG--based detector may be used. It does not reasonably convey that a magnetic sensor and EKG-based detector may be combined into a single detection system, as claimed. The disclosure of an exemplary detection apparatus comprising plural magnetic sensors and "other embodiments'' that use an ECG-based detector reasonably conveys that magnetic sensor detectors and ECG-based detectors are alternative detection systems. The Specification discloses only magnetic sensors to detect the guidewire distal region 46. Spec.~ 40; Reply Br. 10. 7 Appeal2014-009385 Application 13/337 ,987 Additionally, we find no disclosure that reasonably conveys to a skilled artisan that catheter 12 is recoupled to guidewire 30 at a second location and then, the clamped catheter and guidewire are advanced to a third location, as claimed. The Specification discloses that guidewire 30 may be advanced temporarily by itself beyond the distal end of the catheter to "the desired location" if an obstruction is encountered. Spec. ,-i- 40. Then, catheter 12 can be advanced relative to guidewire 30 until its distal end "also is at the desired location." Id. As a result, "the distal ends of the catheter 12 and guidewire 30 are both at the desired location" and "[t]he guidewire 30 can then be removed." Id. \Ve can find no disclosure that catheter 12 and guidewire 30 are recoupled again or advanced further after reaching a second/desired location. Instead, guidewfre 30 is removed once the distal end of catheter 12 reaches a second, desired location. Id.; see Ans. 10. Thus, claim l is not supported by the disclosures of non-provisional application 12/104,253 or provisional application 60/923,636. 1 We sustain the rejection of claim 1 as lacking a written description in those earlier-filed applications to support a filing date earlier than December 27, 2011. 1 Appellants argue that the Examiner erred in focusing on the disclosures of these two applications, rather than the present application that is on appeal, in entering the written description rejection. Reply Br. 4--5. Appellants do not, however, cite any disclosure in the present application that differs from the two parent applications as providing written description suppmi, except to mention that claim 1 on appeal is an "original, not amended, claim" in the present application. Id. "Although many original claims will satisfy the written description requirement, certain claims may not" Ariad Pharms .. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010) (en bane). \Ve do not consider whether original claim l in the present application provides sufficient written description suppmi for claim l on appeal, because this argument was raised for the first time in the Reply Brief~ depriving the Examiner of an opportunity to respond to it See 3 7 C.F .R. § 41.41 (b )(2 ). 8 Appeal2014-009385 Application 13/337 ,987 Claim 1 as unpatentable over Kondrosky, Arenas, and Lemon Appellants argue that Kondrosky and Lemon are not prior art because their respective filing dates of April 16, 2008, and August 22, 2008, do not antedate the April 16, 2008 filing date of application 121104,253 or the April 16, 2007 filing date of provisional application 60/923,636. Appeal Br. 13- 14; Reply Br. 12-13. Because the earlier-filed applications do not provide a written description of the subject matter of claim 1, as discussed above, this argument is not persuasive. .As .Appellants provide no other arguments, we sustain the rejection of claim 1 under 35 U.S.C. § 103(a). Objections to Specification and Drawings The Examiner's objection to new paragraph [0040a] as adding new matter relates to the rejection of claim 1 because new paragraph [0040a] discloses that "detection system 68 may include a plurality of magnetic sensors 70 and an ECG-based detector 72" and the catheter is again coupled to the guidewire and advanced from the second location to a third location. Final Act. 16. Normally, objections are petitionable, rather than appealable, matters, but where, as here, the new matter relates to both an objection and a rejection, the issue is appealable. See MANUAL OF PATENT EXAMINING PROCEDURE§§ 608.04(c), 2163.06 II. (9th Ed. Rev. 7, Nov. 2015). Because the new matter objection involves the same issues as the rejection of claim 1 for lack of written description, our decision regarding that rejection resolves the objection to the Specification. New paragraph [0040a] adds new matter. Because the Examiner's objection to new Figures 12 and 13 involves the same issues as the written description rejection, our decision regarding that rejection also resolves those drawing objections. Figures 12 and 13 add new matter not supported by the earlier-filed applications. Final Act. 14--16. 9 Appeal2014-009385 Application 13/337 ,987 DECISION We AFFIRM the rejections of claim 1. No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation