Ex Parte Harks et alDownload PDFPatent Trials and Appeals BoardJun 26, 201914114214 - (D) (P.T.A.B. Jun. 26, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/114,214 10/27/2013 Godefridus Antonius Harks 24737 7590 06/28/2019 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus A venue Suite 340 Valhalla, NY 10595 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. 2011P00288WOUS 2476 EXAMINER LOUIS, RICHARD G ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 06/28/2019 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): patti. demichele@Philips.com marianne.fox@philips.com katelyn.mulroy@philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GODEFRIDUS ANTONIUS HARKS, GERT WIM 'T HOOFT, and RAYMOND CHAN Appeal2018-006897 Application 14/114,214 Technology Center 3700 Before JENNIFER D. BAHR, MICHELLE R. OSINSKI, and BRANDON J. WARNER, Administrative Patent Judges. WARNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Godefridus Antonius Harks et al. ("Appellants") 1 appeal under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1-3, 5-11, and 13-20. 2 See Appeal Br. 5. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM. According to Appellants, the real party in interest is Koninklijke Philips N.V. Appeal Br. 3. 2 We note that claims 4 and 12 stand objected to by the Examiner as being dependent upon a rejected base claim, but are indicated as being otherwise allowable. See Final Act. 2. Appeal2018-006897 Application 14/114,214 CLAIMED SUBJECT MATTER Appellants' disclosed invention "relates to the delivery of a prosthetic valve during a heart valve replacement procedure guided by localization during device deployment." Spec., p. 1, 11. 3--4. Claims 1, 9, and 16 are independent. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. An image-guided prosthetic valve deployment system, compnsmg: a prosthetic valve; a catheter having an elongated body with a proximal tip and a distal tip, the elongated body including a delivery section adjacent the distal tip for deploying the prosthetic valve relative to a heart valve within an anatomical region; wherein the delivery section includes a delivery segment operable for sensing a shape and an orientation of the delivery section within the anatomical region relative to a reference element located at a position along the delivery section; a delivery tracking system in communication with the delivery segment to track a position and an orientation of the prosthetic valve relative to the heart valve as a function of a sensed shape and a sensed orientation of the delivery section within the anatomical region relative to the reference element as sensed by the delivery segment; and an image guiding system in communication with the delivery tracking system to display an orientation of the prosthetic valve relative to a valve annulus plane of the heart valve derived from at least one of the sensed shape and the sensed orientation of the delivery section within the anatomical region relative to the reference element, wherein the valve annulus plane is extracted from within a volume image of the anatomical region excluding the prosthetic valve. 2 Appeal2018-006897 Application 14/114,214 EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: Anduiza US 2004/0049266 Al Mar. 11, 2004 Mire US 2004/0171924 Al Sept. 2, 2004 Boese US 2005/0228274 Al Oct. 13, 2005 Sugimoto US 2007/0106115 Al May 10, 2007 Salgo US 2008/0097210 Al Apr. 24, 2008 Younge US 2008/0285909 Al Nov. 20, 2008 Noettling US 2011/0046725 Al Feb.24,2011 REJECTIONS The following rejections are before us for review: I. Claims 1, 5, 6, 9, and 16 stand rejected under 35 U.S.C. § I03(a) as being unpatentable over Anduiza, Boese, and Noettling. Final Act. 3-5. II. Claims 2 and 10 stand rejected under 35 U.S.C. § I03(a) as being unpatentable over Anduiza, Boese, Noettling, and Younge. Id. at 5---6. III. Claims 3 and 11 stand rejected under 35 U.S.C. § I03(a) as being unpatentable over Anduiza, Boese, Noettling, and Sugimoto. Id. at 6-7. IV. Claims 7, 8, 15, 18, and 19 stand rejected under 35 U.S.C. § I03(a) as being unpatentable over Anduiza, Boese, Noettling, and Mire. Id. at 7-8. 3 Appeal2018-006897 Application 14/114,214 V. Claims 13, 14, 17, and 20 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, Noettling, and Salgo. Id. at 8. ANALYSIS Rejection I- Claims 1, 5, 6, 9, and 16 as unpatentable over Anduiza, Boese, and Noettling Appellants argue the rejection of independent claims 1, 9, and 16 together (see Appeal Br. 12-14), and rely on the same arguments for dependent claims 5 and 6 (see id. at 15). We select independent claim 1 as representative of the issues that Appellants present in the appeal of this rejection, and claims 5, 6, 9, and 16 stand or fall with claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv). The Examiner found that Anduiza discloses a system and method for deploying a prosthetic heart valve including, in relevant part, a catheter ( delivery apparatus 21, see paragraph [0051] and claim 24) having an elongated body with a proximal tip and a distal tip, the elongated body including a delivery section ( area covering prosthesis 10) adjacent the distal tip capable deploying the prosthetic valve ( 11) relative to a heart valve within an anatomical region; see paragraphs [0057], [0058]. Final Act. 3. The Examiner acknowledged that Anduiza "fails to disclose a delivery segment, at least partially circumscribe[ing] the valve, operable for sensing a shape and an orientation of the delivery section within the anatomical region relative to a reference element located at a position along the delivery section." Id. at 3--4. However, the Examiner found that Boese discloses 4 Appeal2018-006897 Application 14/114,214 a similar catheter as shown in Figure 4, used for the same purpose of navigating through the vasculature of the body; see paragraph [0003]; wherein the catheter includes a delivery segment (bending sensor 15a-15f, see paragraph [0027]), at least partially circumscribing a space where valve could be, operable for sensing a shape and an orientation of the delivery section within the anatomical region relative to a reference element (distal most bending element 12) located at a position along the delivery section; See paragraph [0031 ]; a delivery tracking system ( control device 5, see paragraph [0027]) in communication with the delivery segment to track a position and orientation as a function of a sensed shape and sensed orientation of the delivery section, for the purpose of precisely controlling the catheter to avoid perforation of the vasculature. See paragraphs [0012], [0013]. Id. at 4. The Examiner determined that it would have been obvious to modify Anduiza's system "to include the delivery segment and reference element disclosed by Boese ... in order to precisely control[] the catheter to avoid perforation of the vasculature." Id. Appellants argue that "Boese fails to describe, teach[,] or suggest a reference element located at a position along a delivery section adjacent a distal tip of catheter 2." Appeal Br. 14. In particular, Appellants assert: At paragraph [0031 ], Boese teaches a longitudinal location of each pairing of bending element 12 and a bending sensor 15 within the delivery segment of catheter 2 is known by a control device 5. A proper interpretation of paragraph [0031] of Boese reveals Boese in fact limits a reference element for tracking a shape of catheter 2 via bending sensors 15 as either the control device itself or a proximal control of catheter 2. This is evidenced by the facts that ( 1) any portion of catheter 2 serving as a reference element would have to be localized by control device 5 within a global coordinate system prior to control device 5 determining a shape of catheter 2 via bending sensors 5 relative to the localized portion of catheter 2, and (2) a failure of Boese to describe, teach[,] or suggest a localization by control 5 Appeal2018-006897 Application 14/114,214 device 5 of any portion of catheter 2 within a global reference coordinate prior to control device 5 determining a shape of catheter 2 via bending sensors 5 relative to the localized portion of catheter 2. Id. at 13-14. We are not persuaded by Appellants' argument. Boese discloses that, "[ v ]ia the control device 5 [,] the signals of all bending sensors 15 assigned to the individual bending elements 12 and thereby also of bending sensors 15g-15k assigned to bending elements 12g- 12k are recorded." Boese ,r 31 (boldface omitted). Boese discloses that control device 5 uses individual sensor signals to record the bend of each bending sensor, and the longitudinal position and the position in the catheter cross section of each bending sensor is known to control device 5. See id. Boese also discloses that the sensor signals can be assigned to one point or section on catheter 2 such that, based on the sensor signals, control device 5 can determine catheter shape. See id. However, Appellants do not identify, nor do we discern, any disclosure in paragraph 31 of Boese that would limit the reference element to "either the control device itself or a proximal control of catheter 2." Appeal Br. 13-14. Appellants offer no factual evidence or persuasive technical reasoning to support the speculative assertion that "any portion of catheter 2 serving as a reference element would have to be localized by control device 5 within a global coordinate system prior to control device 5 determining a shape of catheter 2 via bending sensors 5 relative to the localized portion of catheter 2." Id. at 14. Appellants' assertions amount to no more than attorney argument unsupported by objective evidence and, thus, are entitled to little, if any, weight. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); see also In re 6 Appeal2018-006897 Application 14/114,214 Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (attorney arguments in a brief cannot take the place of evidence). Additionally, the Examiner explains in the Answer that "the plain meaning of the term 'reference element' is a structure which can be referred to with respect to something else." Ans. 2. The Examiner takes the position that the distal-most bending element 12 of Boese meets the disputed limitation because it "is located along what one [ ofJ ordinary skill in the art would understand to be a delivery section and is capable of being used as a reference with respect to something else." Id. at 3 ( citing Boese ,r 28). In this regard, Appellants do not submit a Reply Brief to contest the Examiner's position. On the record before us, Appellants do not identify a deficiency in the Examiner's finding as to the disclosure of Boese, particularly as explained in the Answer. After careful consideration of the evidence of record, Appellants' arguments do not apprise us of error in the Examiner's determination that the subject matter of claim 1 would have been obvious. Accordingly, we sustain the rejection of claim 1, and of claims 5, 6, 9, and 16 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over Anduiza, Boese, and Noettling. Rejection II- Claims 2 and 10 as unpatentable over Anduiza, Boese, Noettling, and Younge Appellants argue the rejection of dependent claims 2 and 10 together as a group. See Appeal Br. 16-18. We select claim 2 as representative of the issues that Appellants present in the appeal of this rejection, and claim 10 stands or falls with claim 2. 7 Appeal2018-006897 Application 14/114,214 The Examiner found that Younge discloses a similar catheter as shown in Figures 15, 16A-C with a delivery segment in the form of an optical fiber ( optical fibers 12) including a deformation sensor optic array ( detector 15) operable for sensing the shape and the orientation of the delivery section within the anatomical region relative to the reference element and wherein the deformation sensor array defines the reference element, for the purpose of monitoring the bending of the catheter. [S]ee paragraph [0095]. Final Act. 5. The Examiner determined that it would have been obvious to modify the Anduiza, Boese, and Nettling combination to have "an optical fiber including a deformation sensor optic array operable for sensing the shape and the orientation of the delivery section because it would only require the substitution of one known alternative means for another to produce nothing but predictable results." Id. at 6 (citing KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). Appellants argue that Younge discloses "an optical fiber for sensing a shape and orientation of a catheter relative to references (See, Younge at paragraphs [0082]-[0087] and [0120]), but not relative to a reference located in a distal delivery section of the catheter that is defined by the optical fiber." Appeal Br. 17 (underlining omitted). However, the Examiner explains in the Answer that "the plain meaning of the term 'reference element' is a structure which can be referred to with respect to something else." Ans. 3. The Examiner takes the position that "[ t ]he distal end of the catheter disclosed by Younge is clearly a structure which can be referred to with respect to something else." Id. In this regard, Appellants do not contest the Examiner's position. On the record before us, Appellants do not identify a deficiency in the Examiner's finding as to the disclosure of Younge, particularly as explained in the Answer. 8 Appeal2018-006897 Application 14/114,214 For the above reasons, Appellants' arguments do not apprise us of error in the Examiner's findings or reasoning in support of the conclusion of obviousness with respect to claim 2. Accordingly, we sustain the rejection of claim 2, and of claim 10 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over Anduiza, Boese, Noettling, and Younge. Rejection III - Claims 3 and 11 as unpatentable over Anduiza, Boese, Noettling, and Sugimoto Appellants argue the rejection of dependent claims 3 and 11 together. See Appeal Br. 18-20. We select claim 3 as representative of the issues that Appellants present in the appeal of this rejection, and claim 11 stands or falls with claim 3 . The Examiner found that Sugimoto discloses a similar delivery segment ( coils S 1-S5, see paragraph[ s] [003 6], [0037]), which performs the same function of tracking the shape of the catheter in substantially the same manner to produce substantially the same result as the delivery segment disclosed by Anduiza ... , wherein the delivery segment is an electromagnetic sensor including a[ n] electromagnetic coil array operable for sensing the shape and the orientation of the delivery section within the anatomical region relative to the reference element; and wherein the electromagnetic coil array defines the reference element. See paragraph [044]. Final Act. 6. The Examiner determined that it would have been obvious to modify the Anduiza, Boese, and Nettling combination such that the delivery segment is an electromagnetic sensor including a[ n] electromagnetic coil array operable for sensing the shape and the orientation of the delivery section within the anatomical region relative to the reference element; and wherein the electromagnetic coil array defines the reference element, 9 Appeal2018-006897 Application 14/114,214 because it would only require the substitution of one known equivalent for another to produce nothing but predictable results. Id. at 6-7 (citing KSR, 550 U.S. at 398). Appellants argue that Sugimoto discloses "coils for sensing a shape and orientation of an endoscope relative to a magnetic field generator external to the endoscope (See, Sugimoto at paragraphs [0024]-[0029]), but not relative to a reference located in a distal delivery section of the endoscope." Appeal Br. 20 (underlining omitted). In response to Appellants' argument, the Examiner explains that "the plain meaning of the term 'reference element' is a structure which can be referred to with respect to something else." Ans. 3. The Examiner takes the position that "[t]he distal end of the catheter disclosed by Sugimoto is clearly a structure which can be referred to with respect to something else. The coils disclosed by Sugimoto define the shape of the catheter overall and thus necessarily define the shape and position of the distal end." Id. In this regard, Appellants do not contest the Examiner's position. On the record before us, Appellants do not identify a deficiency in the Examiner's finding as to the disclosure of Sugimoto, particularly as explained in the Answer. For the above reasons, Appellants' arguments do not apprise us of error in the Examiner's findings or reasoning in support of the conclusion of obviousness with respect to claim 3. Accordingly, we sustain the rejection of claim 3, and of claim 11 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over Anduiza, Boese, Noettling, and Sugimoto. 10 Appeal2018-006897 Application 14/114,214 Rejection IV - Claims 7, 8, 15, 18, and 19 as unpatentable over Anduiza, Boese, Noettling, and Mire Appellants argue the rejection of dependent claims 7, 8, 15, 18, and 19 together. See Appeal Br. 21-24. We select claim 7 as representative of the issues that Appellants present in the appeal of this rejection, and claims 8, 15, 18, and 19 stand or fall with claim 7. The Examiner found that Mire discloses a display of an orientation axis perpendicular to the plane; and a display of an angular orientation of a prosthetic vector relative to the orientation axis, the prosthetic vector being representative of the position and the orientation of the prosthetic relative to its deployment location, wherein a display of the orientation of the prosthetic relative to the plane ... includes: a display of an angular differential valve between the orientation axis and the prosthetic vector, a display of an orientation axis perpendicular to the plane, and a display of an angular orientation of a vector relative to the orientation axis, the vector being representative of the position and the orientation of the therapeutic device relative to the anatomical object for the purpose of more precise navigation of a surgical instrument or implant with six degrees of freedom accuracy. [S]ee paragraph [0078]. Final Act. 7. The Examiner determined that it would have been obvious to modify the Anduiza, Boese, and Nettling combination to the display features of Mire "in order to more precisely navigat[ e] ... a surgical instrument or implant with six degrees of freedom accuracy." Id. at 8. Appellants argue that Mire discloses "a computation of force vectors on an anatomical object (See, Mire at paragraph [O 115]), but fails to teach a display of a vector representative of a position and an orientation of a prosthetic valve/therapeutic device relative to the heart valve/anatomical object." Appeal Br. 23 (underlining omitted). However, Appellants' arguments with respect to paragraph 31 of Mire (see Appeal Br. 23) are not 11 Appeal2018-006897 Application 14/114,214 responsive to the Examiner's findings as to the disclosure of Mire presented in the rejection (see Final Act. 7 (citing Mire ,r 78)). The Examiner explains that Mire shows in [F]igure 5 and describes in paragraph [0078] a display of an orientation of therapeutic device relative to plane of its surroundings which includes a display of an orientation axis capable of being perpendicular to the valve annulus plane and a display of an angular orientation of a prosthetic vector relative to the orientation axis, the vector capable of being representative of the position and orientation of the prosthetic valve relative to the heart valve. The [Appellants'] remarks do not address paragraph [0078] or what is shown in Figure 5. Ans. 3--4. In this regard, Appellants do not specifically address the Examiner's findings as to the disclosure of Mire as presented in rejection of record. For the above reasons, Appellants' arguments do not apprise us of error in the Examiner's findings or reasoning in support of the conclusion of obviousness with respect to claim 7. Accordingly, we sustain the rejection of claim 7, and of claims 8, 15, 18, and 19 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over Anduiza, Boese, Noettling, and Mire. Rejection V - Claims 13, 14, 17, and 20 as unpatentable over Anduiza, Boese, Noettling, and Salgo Claims 13. 14. and 17 With respect to the rejection of dependent claims 13, 14, and 17, Appellants rely on arguments presented for patentability of independent claims 9 and 16. See Appeal Br. 15-16. For the same reasons that Appellants' arguments do not apprise us of error in the rejection of claims 9 and 16, these arguments likewise do not apprise us of error in the rejection 12 Appeal2018-006897 Application 14/114,214 of claims 13, 14, and 17. Accordingly, we sustain the rejection of claims 13, 14, and 17 under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, Noettling, and Salgo. Claim 20 In rejecting dependent claim 20, which depends from independent claim 16, the Examiner found that Salgo discloses a similar image-guided system as shown in Figures 1-9 which includes an image guiding system ... capable of extracting a valve annulus plane of the heart valve from within a volume image of the anatomical region and for displaying an overlay ( distinctive line or color stripe) of the valve annulus plane on an X-ray image of the anatomical region, or displaying an orientation of the prosthetic valve relative to the valve annulus plane of the heart valve, for the purpose of monitoring movement of the heart valve. [S]ee paragraphs [0002], [0022], [0024], [0046]. Final Act. 8. The Examiner concluded that, given the teachings of the prior art, it would have been obvious to modify the Anduiza, Boese, and Nettling combination to include the features of Salgo "in order to monitor[] movement of the heart valve and ensure correct placement of the valve." Id. Appellants argue that "Sal go teaches the use of markers for delineating landmarks in an image (See, Salgo at paragraph [0039]), but fails to teach the use of marker[ s] representative of a sensed physiological parameter of the anatomical region." Appeal Br. 25 (underlining omitted). The Examiner explains that "the plain meaning of the term 'physiological parameter' is value which determines the characteristic of something relating to physiology. Salgo discloses the location of the valves are sensed and displayed." Ans. 4 ( citing Salgo ,r 24 ). The Examiner takes the position that 13 Appeal2018-006897 Application 14/114,214 "sensing the location of the valve constitutes a physiological parameter because the location of a valve is a characteristic of something relating to physiology." Id. In this regard, Appellants do not contest the Examiner's position. On the record before us, Appellants do not identify a deficiency in the Examiner's finding as to the disclosure of Salgo, particularly as explained in the Answer. For the above reasons, Appellants' arguments do not apprise us of error in the Examiner's findings or reasoning in support of the conclusion of obviousness with respect to claim 20. Accordingly, we sustain the rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable over Anduiza, Boese, Noettling, and Salgo. DECISION We AFFIRM the Examiner's decision rejecting claims 1, 5, 6, 9, and 16 under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, and Noettling. We AFFIRM the Examiner's decision rejecting claims 2 and 10 under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, Noettling, and Younge. We AFFIRM the Examiner's decision rejecting claims 3 and 11 under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, Noettling, and Sugimoto. We AFFIRM the Examiner's decision rejecting claims 7, 8, 15, 18, and 19 under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, Noettling, and Mire. 14 Appeal2018-006897 Application 14/114,214 We AFFIRM the Examiner's decision rejecting claims 13, 14, 17, and 20 under 35 U.S.C. § 103(a) as being unpatentable over Anduiza, Boese, Noettling, and Salgo. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 15 Copy with citationCopy as parenthetical citation