Ex Parte Khan et alDownload PDFBoard of Patent Appeals and InterferencesAug 23, 201010812380 (B.P.A.I. Aug. 23, 2010) 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. 10/812,380 03/29/2004 Iftikhar Khan 1800-000001 2606 7590 08/24/2010 Nazir A Khan MD 150 Glenmora Drive Burr Ridge, IL 60527 EXAMINER DEAK, LESLIE R ART UNIT PAPER NUMBER 3761 MAIL DATE DELIVERY MODE 08/24/2010 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Ex parte IFTIKHAR KHAN and NAZIR KHAN ____________________ Appeal 2010-003194 Application 10/812,380 Technology Center 3700 ____________________ Before WILLIAM F. PATE III, STEVEN D.A. McCARTHY and MICHAEL W. O’NEILL, Administrative Patent Judges. McCARTHY, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-003194 Application 10/812,380 The Appellants appeal under 35 U.S.C. § 134 from the Examiner’s 1 decision finally rejecting claims 1-5, 7-10, 12-14, 17 and 18 under 35 U.S.C. 2 § 103(a) as being unpatentable over Squitieri (US 6,102,884, issued Aug. 15, 3 2000) and Parks (US 5,399,173, issued Mar. 21, 1995); finally rejecting 4 claims 6, 11, 15, 16, 19 and 20 under § 103(a) as being unpatentable over 5 Squitieri, Parks and Trerotola (US 5,591,226, issued Jan. 7, 1997); finally 6 rejecting claim 10 under § 103(a) as being unpatentable over Squitieri and 7 Trerotola; and finally rejecting claim 17 under § 103(a) as being 8 unpatentable over Squitieri, Parks and Twardowski (US 5,509,897, issued 9 Apr. 23, 1996).2 An oral hearing was held on July 22, 2010. We have 10 jurisdiction under 35 U.S.C. § 6(b). 11 We sustain the rejection of claim 17, which is illustrative of the 12 claimed subject matter: 13 17. A method for performing hemodialysis on a 14 patient comprising: 15 a. surgically inserting an arteriovernous shunt 16 into a patient, wherein said arteriovenous 17 shunt comprises: 18 19 i. an arterial graft comprising a body, a lead 20 end and a terminal end, said lead end being 21 configured for subcutaneous connection to 22 an artery by anastomosis, wherein said 23 arterial graft has a first diameter; and 24 2 The Examiner also has entered an objection to the drawing. Final Office Action mailed June 16, 2008 at 2. An objection to the drawings is subject to review by petition and is not appealable to the Board of Patent Appeals and Interferences. See Ex Parte Frye, 94 U.S.P.Q.2d 1072, 1077- 78 (BPAI 2010). Appeal 2010-003194 Application 10/812,380 3 ii. a single lumen venous outflow catheter 1 comprising an intake end and a depositing 2 end, said depositing end being configured 3 for insertion through a vein into the right 4 atrium of the heart, wherein said venous 5 outflow catheter has a second diameter 6 different from said first diameter; and 7 iii. a cylindrical cuff operable to direct passage 8 of blood from said arterial graft to said 9 venous outflow catheter, said cuff 10 comprising an inlet in blood communication 11 with an outlet: 12 1. said inlet being disposed about and 13 connected to said terminal end of said 14 arterial graft; and 15 ii. said outlet being disposed about and 16 connected to said intake end of said venous 17 outflow catheter; wherein said cuff provides 18 a secure fit for said arterial graft first 19 diameter and said venous outflow catheter 20 second diameter. 21 b. connecting said arterial graft to a 22 hemodialysis apparatus; 23 c. collecting blood from the patient through 24 said arterial graft; 25 d. passing said blood through the hemodialysis 26 apparatus; 27 e. collecting purified blood from hemodialysis 28 apparatus; and 29 f. transmitting said purified blood through said 30 cuff into said venous outflow catheter which 31 is located in the right atrium and the blood is 32 directly deposited into the right atrium. 33 Appeal 2010-003194 Application 10/812,380 4 OPINION 1 2 Rejection of Claim 17 3 ISSUES 4 The Appellants argue the rejection of claim 17 separately from the 5 rejections of the remaining claims. In view of the Examiner’s findings and 6 conclusions, and the Appellants’ contentions, the following issues are raised 7 in with regard to the rejection of claim 17: 8 • First, is Park analogous art? (Compare Br. 18 and 24 with Ans. 9 10). 10 • Second, would one of ordinary skill in the art familiar with the 11 combined teachings of Squitieri, Park and Twardowski have had 12 reason to modify the hemodialysis and vascular system taught by 13 Squitieri to include a single lumen venous outflow catheter 14 comprising a depositing end configured for insertion through a 15 vein into the right atrium of the heart? (Compare Br. 15 and 24 16 with Ans. 7-8). 17 • Third, would one of ordinary skill in the art familiar with the 18 combined teachings of Squitieri, Park and Twardowski have had 19 reason to modify the method of using Squitieri’s system to include 20 a step of depositing blood directly into the right atrium of the 21 heart? (Id.) 22 • Fourth, would the subject matter of claim 17 have been prima facie 23 obvious even assuming for purposes of this appeal only that the 24 combined teachings of Squitieri, Park and Twardowski would have 25 provided one of ordinary skill in the art no reason to modify 26 Appeal 2010-003194 Application 10/812,380 5 Squitieri’s system to include certain features of the Appellants’ 1 preferred embodiment related to the recited cylindrical cuff which 2 were pointed out in the Appeal Brief but not recited in claim 17? 3 (Compare Br. 15-16, 18-19 and 24 with Ans. 9). 4 • Fifth, does the probative value of the evidence supporting the 5 Examiner’s conclusion that the subject matter of claim 17 would 6 have been obvious outweigh the probative value of the Appellants’ 7 objective evidence of nonobviousness? (Compare Br. 25-27 with 8 Ans. 12). 9 10 FINDINGS OF FACT 11 The record supports the following additional findings of fact (“FF”) 12 by a preponderance of the evidence. 13 1. We adopt the Examiner’s finding that: 14 Squitieri discloses an arteriovenous shunt system 15 comprising an arterial graft 53 with a lead end 62 16 anastomosed to an artery and [a] terminal end 17 connected to needle access site 80, which acts as a 18 connector that corresponds to applicant’s cuff. . . . 19 The access site 80, corresponding to applicant’s 20 cuff, directs passage of blood from the arterial 21 catheter to the venous catheter, and is in 22 communication with the terminal end of the 23 arterial graft and the inlet end of the venous 24 catheter (see FIGS 6-9, column 5, lines 19-60). 25 (Ans. 4). 26 2. Squitieri discloses that a preferred size for a graft serving the 27 purpose of graft 53 would be approximately 7 mm in diameter and 28 Appeal 2010-003194 Application 10/812,380 6 transitioning downward to an open end portion of approximately 4 mm in 1 diameter. (See Squitieri, col. 3, l. 67 – col. 4, l. 2). 2 3. We adopt the Examiner’s finding that Squitieri’s arteriovenous 3 shunt system “further comprises a venous outflow catheter 65 with an 4 outflow end that is capable of being inserted through a vein.” (Ans. 4). 5 4. Squitieri describes tube 65 as including a plurality of 6 perforations 66 at the outflow end of the tube and that the outlet end is 7 positioned in the venous system 67. (Squitieri, col. 5, ll. 45-48). Figure 7 of 8 Squitieri depicts the outflow end of the tube 65 positioned upstream of the 9 heart near the position of the right atrium. 10 5. Squitieri teaches that positioning the outflow end of the tube 65 11 in the venous system 67 avoids problems associated with anastomosing the 12 outflow end to vein. (Squitieri, col. 2, ll. 27-32). Squitieri does not 13 mention, much less criticize or disparage, placement of the outflow end in 14 the right atrium of the heart. 15 6. Squitieri recognizes that excessive turbulence and shear forces 16 in the vascular system are undesirable. (See Squitieri, col. 3, ll. 5-8). 17 7. We adopt the Examiner’s finding that “Twardowski discloses 18 an apparatus and method for hemodialysis in which a venous catheter 19 comprises a distal end 138a disposed within the right atrium, delivering 20 treated blood to the right atrium in order to provide a long-term indwelling 21 catheter.” (Ans. 7, citing Twardowski, col. 6, ll. 15-48; col. 11, ll. 15-35; 22 and fig. 9). 23 8. Twardowski’s indwelling catheter is a double-lumen catheter. 24 (Twardowski, col. 6, ll. 15-16). 25 Appeal 2010-003194 Application 10/812,380 7 9. Twardowski teaches that “such catheters are preferably 1 proportioned to be implanted in a major vein of the patient, with the distal 2 tip of the catheter being positioned in the right atrium of the heart. This 3 provides a high and turbulent blood flow to the catheter distal tip, as well as 4 a bigger chamber, which minimizes the chances for the catheter distal tip to 5 press against the wall thereof.” (Twardowski, col. 3, ll. 45-51). 6 Twardowski also recognizes that reducing pressure and abrasion against 7 blood vessel walls has the advantage of reduction in clotting and tissue 8 irritation, thereby providing a catheter which is capable of long-term 9 indwelling in the arteriovenous system of a patient. (Twardowski, col. 3, ll. 10 17-21). 11 10. Twardowski teaches that the dimensions of the catheter may be 12 chosen to match the vein in which the catheter is to be implanted. 13 (Twardowski, col. 4, ll. 47-49). 14 11. Parks discloses an enteral feeding device including a ferrule. 15 (Parks, col. 3, ll. 67-68). 16 12. Figure 13 of Parks discloses a cuff or ferrule 212 in which the 17 transition 220 between a larger inner diameter at one end and a narrower 18 inner diameter at the other end is longer and at a shallower angle than other 19 examples depicted in Parks. The upper end of the ferrule 212 as depicted in 20 Figure 13 includes conical walls 218, 220 which would enable a tubular 21 conduit to be inserted (see Parks, col. 7, ll. 50-54) in such a manner as to 22 provide a degree of continuity between the inner diameter of the tubular 23 conduit and the diameter of the wall 220 near the inserted end of the conduit. 24 13. The Appellants in their Specification do not disclose any detail 25 of the interior configuration of the preferred cuff 13 which connects their 26 Appeal 2010-003194 Application 10/812,380 8 preferred arteriovenous graft 11 to their preferred venous outflow catheter 1 12. (See, e.g., Spec. 9, para. 0026 and fig. 1). 2 14. The Appellants present an unexecuted declaration to which the 3 results of two studies are attached. Each involved “HeRO” vascular access 4 devices, which the Appellants’ unexecuted declaration identifies as 5 hemodialysis arteriovenous shunts “identical to the applicants claimed 6 invention.” 7 15. One study, reported by a Dr. H. Katzman, reached the 8 conclusion that the bacteremia rate associated with the “HeRO” device 9 surpassed bacteremia rates from IJ tunneled dialysis (TDC) and graft 10 literature. The study also concluded that the patency rate associated with the 11 “HeRO” device surpassed the patency rate from the TDC literature and was 12 comparable to the patency rate from graft literature. (Exhibit 1 to 13 declaration). The other study, reported by a Dr. Chris Stout and others, 14 reported successful placement of the “HeRO” device in fifty of fifty-two 15 patients to undergo placement attempts. (Exhibit 2 to declaration). 16 16. Neither study compares the subject matter of claim 17 to a 17 system of the type described by Squitieri. 18 17. The only arguable evidence which the Appellants appear to 19 provide to show that the results reported in the two studies were unexpected 20 is a bare statement to that effect in the unexecuted declaration and arguments 21 in the Appeal Brief. 22 18. Trerotola discloses a body implantable device in the form of a 23 stent-graft extending between a brachial artery and an auxiliary vein. 24 (Trerotola, col. 3, ll. 57-60 and col. 6, ll. 21-22). Trerotola also teaches the 25 Appeal 2010-003194 Application 10/812,380 9 use of polyurethane as a biostable flexible material. (Trerotola, col. 2, ll. 29-1 33). 2 3 PRINCIPLES OF LAW 4 In determining whether the subject matter of a claim would have been 5 obvious, an examiner must undertake the factual inquiries listed in Graham 6 v. John Deere Co., 383 U.S. 1, 17-18 (1966). In order to justify rejecting a 7 claim as unpatentable, the examiner must articulate some “reasoning with 8 some rational underpinning to support the legal conclusion of obviousness.” 9 In re Kahn, 441 F.3d 977, 988 (Fed. Cir 2006). This reasoning must show 10 that “there was an apparent reason to combine the known elements in the 11 fashion claimed.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). 12 The apparent reason need not appear in, or be suggested by, one or more of 13 the references on which the examiner relies. Instead, the examiner may 14 employ common sense not inconsistent with the ordinary level of knowledge 15 and skill in the art when analyzing the evidence. Perfect Web Techs. v. 16 InfoUSA, Inc., 587 F.3d 1324, 1328-29 (Fed. Cir. 2009). 17 In order to reject a claim under section 103(a), an examiner must 18 establish at least a “prima facie” case that the claimed subject matter would 19 have been obvious. Once the examiner produces prima facie evidence that 20 the claimed subject matter would have been obvious, the applicant may 21 present additional evidence tending to rebut the examiner’s conclusion that 22 the claimed subject matter would have been obvious. If the applicant 23 presents additional evidence to rebut the examiner’s conclusion, the 24 examiner must consider all of the evidence anew. If the evidence presented 25 by the examiner and any evidence presented by the applicant, considered 26 Appeal 2010-003194 Application 10/812,380 10 anew, demonstrate that the claimed subject matter would have been obvious 1 to one of ordinary skill in the art, the claim is properly rejected under 2 § 103(a). In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984). 3 4 ANALYSIS 5 Parks is analogous art. The established precedent of our reviewing 6 court sets up a two-fold test for determining whether art is analogous: 7 “First, we decide if the reference is within the field of the inventor’s 8 endeavor. If it is not, we proceed to determine whether the reference is 9 reasonably pertinent to the particular problem with which the inventor was 10 involved.” In re Deminski, 796 F.2d 436, 442 (Fed. Cir. 1986). Claim 17 11 expressly recites that the diameters of arterial graft and the venous outflow 12 catheter differ. Therefore, one problem with which the Appellants were 13 involved was the problem of connecting two tubes of different diameter. 14 Parks is within the medical field, broadly speaking, and addresses this 15 problem by means of Parks’ ferrule or connector 70. Since Parks is 16 reasonably pertinent to a particular problem with which the inventor was 17 involved, Parks is analogous art. 18 One of ordinary skill in the art would have had reason to modify the 19 hemodialysis and vascular system taught by Squitieri to include a single 20 lumen venous outflow catheter comprising a depositing end configured for 21 insertion through a vein into the right atrium of the heart. Twardowski 22 teaches providing a long-term indwelling catheter by disposing a distal end 23 138a of the catheter within the right atrium and delivering treated blood to 24 the right atrium. (FF 7). As the Examiner correctly concludes, it would 25 have been obvious “to advance the catheter disclosed by the cited prior art 26 Appeal 2010-003194 Application 10/812,380 11 deeper into the patient’s vasculature to the right atrium, as disclosed by 1 Twardowski, in order to provide a long-term indwelling catheter without 2 major drawbacks.” (Ans. 7-8). More specifically, Squitieri recognizes that 3 excessive turbulence and shear forces in the vascular system is undesirable. 4 (FF 6). Twardowski teaches that extending a catheter conducting a 5 hemodialysis outflow to the right atrium of the heart provides a bigger 6 chamber in which to deposit turbulent, high shear outflow, “which 7 minimizes the chances for the catheter distal tip to press against the wall 8 thereof.” (FF 9). One of ordinary skill in the art would have recognized that 9 placing the outflow of Squitieri’s single-lumen catheter in the right atrium 10 would reduce the pressure and abrasion on the wall tissue near the outflow, 11 thereby providing a long-term indwelling catheter. (See id.) 12 As the previous paragraph indicates, the teachings of Squitieri are not 13 inconsistent with those of Twardowski. Squitieri teaches that positioning the 14 outflow end of the venous outflow catheter 65 in the venous system 67 15 avoids problems associated with anastomosing the outflow end to the vein. 16 (FF 5). This advantage would not be undermined by extending the venous 17 outflow catheter into the heart as taught by Twardowski. Although 18 Twardowski describes a double-lumen catheter (FF 8) and Squitieri’s tube 19 65 appears to have only one lumen, this structural difference would not have 20 dissuaded one of ordinary skill in the art from applying Twardowski’s 21 teachings concerning the advantages of depositing the outflow into the right 22 atrium of the heart rather than into a vein. As the Examiner points out, the 23 claimed subject matter may have been obvious from the teachings of the 24 prior art even if the preferred embodiments described in the prior art cannot 25 be physically combined. In re Keller, 642 F.2d 413, 425 (CCPA 1981). 26 Appeal 2010-003194 Application 10/812,380 12 Claim 17 does not recite a cuff made of biocompatible material, a cuff 1 which covers the venous outflow catheter only or a cuff which connects the 2 outflow catheter to the arterial graft by surgical anastomosis. Assuming for 3 purposes of this appeal only that the combined teachings of Squitieri, Park 4 and Twardowski would have provided one of ordinary skill in the art no 5 reason to modify Squitieri’s system to include a cuff having these features, 6 this assumption would not foreclose a conclusion that the subject matter of 7 claim 17 would have been obvious. 8 The Appellants appear to contend that the combined teachings of 9 Squitieri, Parks and Twardowski would have provided one of ordinary skill 10 in the art no reason to connect an arterial graft and a venous outflow catheter 11 of the types described by Squitieri (and as expanded in view of the teachings 12 of Twardowski) by means of a cuff disposed about ends of the graft and 13 catheter which “provides a secure fit for said arterial graft first diameter and 14 said venous outflow catheter second diameter.” Even assuming, as the 15 Appellants argue, that particular embodiments of Parks’ cuff or ferrule have 16 ridged inner surfaces and would act as foreign bodies within the lumen of 17 the arterial graft and the venous outflow catheter, leading to obstruction of 18 the flow of blood and thrombosis (see Br. 18-19), these concerns would not 19 have discouraged one of ordinary skill in the art from the combination 20 proposed by the Examiner. 21 For example, Figure 13 of Parks discloses cuff or ferrule 212 in which 22 the transition 220 between a larger inner diameter at one end and a narrower 23 inner diameter at the other end is longer and at a shallower angle than other 24 examples depicted in Parks. The upper end of the ferrule 212 as depicted in 25 Figure 13 includes conical walls 218, 220 which would enable a tubular 26 Appeal 2010-003194 Application 10/812,380 13 conduit to be inserted in such a manner as to provide a degree of continuity 1 between the inner diameter of the tubular conduit and the diameter of the 2 wall 220 near the inserted end of the conduit. (FF 12). Assuming, as the 3 Appellants appear to assert, that one of ordinary skill in the art would 4 recognize that a ridged inner surface would disrupt laminar blood flow, 5 Figure 13 of Parks would have provided guidance to one of ordinary skill in 6 the art as to how to reduce the disruption of laminar blood flow through the 7 cuff or ferrule. The Appellants’ assertion that the ridged inner surfaces of 8 some embodiments of Parks’ ferrules would have discouraged those of 9 ordinary skill in the art from combining elements from Squitieri, Parks and 10 Twardowski in the fashion claimed in claim 17 is not persuasive. 11 The Appellant’s assertion is particularly unpersuasive in view of their 12 failure to disclose in their Specification any details of the interior of their 13 preferred cuff 13. (See FF 13). The absence of such disclosure implies that 14 the Appellants believed as of their filing date that one of ordinary skill in the 15 art seeking to practice the subject matter of claim 17 had sufficient skill to 16 design or procure a cuff capable of connecting an arteriovenous graft to a 17 venous outflow catheter of different diameter without disrupting laminar 18 blood between the two. Since it was within the level of ordinary skill to 19 design or procure such as cuff, a need to do so would not have discouraged 20 one of ordinary skill in the art from modifying Squitieri’s system in the 21 fashion claimed in claim 17. 22 For these reasons, we conclude that the subject matter of claim 17 23 would have been prima facie obvious from the combined teachings of 24 Squitieri, Parks and Twardowski. Since the Appellants have submitted 25 evidence in rebuttal of obviousness, we now turn to consider this evidence. 26 Appeal 2010-003194 Application 10/812,380 14 When such evidence is presented it is our duty to consider the evidence 1 anew. See, e.g., In re Eli Lilly & Co., 902 F.2d 943, 945 (Fed. Cir. 1990). 2 We also are mindful that objective evidence of nonobviousness in any given 3 case may be entitled to more or less weight depending on its nature and its 4 relationship with the merits of the invention. Stratoflex Inc. v. Aeroquip 5 Corp., 713 F.2d 1530, 1539 (Fed. Cir. 1983). 6 The probative value of the Appellants’ objective evidence is low. As 7 the Examiner points out, the Appellants provide no evidence of an actual 8 long felt need in the art and rely on nothing more than unsupported argument 9 as evidence of commercial success. (See Ans. 12; see also Br. 26 and 27). 10 The Appellants’ evidence of unexpected result is less insubstantial. (See FF 11 15). 12 Nevertheless, two factors to be considered in determining the weight 13 to be given evidence of unexpected results is the degree to which the 14 evidence compares results of the claimed subject matter against those of the 15 closest prior art and the degree to which the evidence shows that the results 16 are unexpected. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1370-71 17 (Fed. Cir. 2007). The Appellants’ evidence fails to compare the claimed 18 subject matter against the closest prior art, Squitieri. Neither do the 19 Appellants provide evidence or reasoning to support their assertion that the 20 bacteremial and patency results identified in the evidence would have been 21 unexpected. (FF 16 and 17). Having considered the evidence presented by 22 the Appellants and weighed all of the evidence anew, the weight of the 23 evidence supports the Examiner’s legal conclusion that the subject matter of 24 claim 17 would have been obvious. 25 26 Appeal 2010-003194 Application 10/812,380 15 CONCLUSIONS 1 Park is analogous art. 2 One of ordinary skill in the art familiar with the combined teachings 3 of Squitieri, Park and Twardowski would have had reason to modify the 4 hemodialysis and vascular system taught by Squitieri to include a single 5 lumen venous outflow catheter comprising a depositing end configured for 6 insertion through a vein into the right atrium of the heart. 7 One of ordinary skill in the art familiar with the combined teachings 8 of Squitieri, Park and Twardowski would have had reason to modify the 9 method of using Squitieri’s system to include a step of depositing blood 10 directly into the right atrium of the heart. 11 The subject matter of claim 17 would have been prima facie obvious 12 even assuming for purposes of this appeal only that the combined teachings 13 of Squitieri, Park and Twardowski would have provided one of ordinary 14 skill in the art no reason to modify Squitieri’s system to include certain 15 features of the Appellants’ preferred embodiment related to the recited 16 cylindrical cuff which were pointed out in the Appeal Brief but not recited in 17 claim 17. 18 The probative value of the evidence supporting the Examiner’s 19 conclusion that the subject matter of claim 17 would have been obvious 20 outweighs the probative value of the Appellants’ objective evidence of 21 nonobviousness. 22 We sustain the rejection of claim 17 under § 103(a) as being 23 unpatentable over Squitieri, Parks and Twardowski. 24 Appeal 2010-003194 Application 10/812,380 16 Remaining Claim Rejections 1 Claims 1 and 13 are independent. Claim 1 recites an arteriovenous 2 shunt including a single lumen venous outflow catheter. Claim 13 recites a 3 system including an arteriovenous shunt with a single lumen venous outflow 4 catheter. In both claim 1 and claim 13, the single lumen venous outflow 5 catheter comprises an intake end and a depositing end. The depositing end 6 is configured for insertion through a vein into the right atrium of the heart. 7 Without the teachings of Twardowski, the Examiner has identified 8 nothing in the combined teachings of Squitieri and Parks which might have 9 suggested to one of ordinary skill in the art to extend an outlet end of an 10 outlet tube such as Squitieri’s tube 65 to reach into the right atrium of the 11 heart. (See, e.g., Ans. 5 and 8-9). Neither has the Examiner articulated any 12 reason why one of ordinary skill in the art familiar with the teachings of 13 Squitieri and Parks might have modified Squitieri’s system so that an outlet 14 end of an outlet tube extended into the right atrium. The Examiner’s finding 15 that Squitieri teaches the outlet tube 65 might be of various sizes does not 16 imply in and of itself a reason why one of ordinary skill in the art might have 17 extended the tube to reach into the right atrium. We do not sustain the 18 Examiner’s rejection of claims 1-5, 7-10, 12-14, 17 and 18 under § 103(a) as 19 being unpatentable over Squitieri and Parks. 20 Neither does the Examiner articulate reasoning adequate to explain 21 how the teachings of Trerotola remedies the deficiencies in the teachings of 22 Squitieri for purposes of the rejection of claim 10 or the deficiencies in the 23 combined teachings of Squitieri and Parks for purposes of the rejections of 24 claims 6, 11, 15, 16, 19 and 20. We do not sustain the rejections of claims 6, 25 11, 15, 16, 19 and 20 under § 103(a) as being unpatentable over Squitieri, 26 Appeal 2010-003194 Application 10/812,380 17 Parks and Trerotola or the rejection of claim 10 under § 103(a) as being 1 unpatentable over Squitieri and Trerotola. 2 3 DECISION 4 We AFFIRM the Examiner’s decision rejecting claim 17. 5 We REVERSE the Examiner’s decision rejecting claims 1-16 and 18-6 20. 7 No time period for taking any subsequent action in connection with 8 this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 9 § 1.136(a)(1)(iv) (2007). 10 11 AFFIRMED-IN-PART 12 13 14 Klh 15 16 17 18 NAZIR A. KHAN, MD 19 150 GLENMORA DRIVE 20 BURR RIDGE, IL 60527 21 Copy with citationCopy as parenthetical citation