Ex Parte Morris et alDownload PDFPatent Trial and Appeal BoardMar 20, 201311754759 (P.T.A.B. Mar. 20, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARY M. MORRIS, TIMOTHY G. LASKE, KENNETH T. HERUTH, MICHAEL R. UJHELYI, JESUS W. CASAS, and DAVID S. OLSON __________ Appeal 2011-004932 Application 11/754,759 Technology Center 3700 __________ Before DONALD E. ADAMS, ERIC GRIMES, and ULRIKE W. JENKS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to catheters. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification discloses that “[c]onventional catheters include at least one pressure responsive valve, such as a sleeve valve … [which] is formed by covering an exit port of the catheter with a sleeve” (Spec. 1, Appeal 2011-004932 Application 11/754,759 2 ¶ 07). The Specification discloses that “when the pressure differential exceeds a threshold, the fluid in the lumen of the catheter expands the sleeve and flows out of the catheter” (id.). Figure 1 of the Specification is shown below: Figure 1 shows “a schematic diagram illustrating a sleeve valve catheter 10 … inserted into … a vessel 12 of the patient” (id. at 3, ¶ 26). The figure shows sleeve 24 of sleeve valve 22 covering exit port 26 near distal end 18 of the catheter (id. at 4, ¶¶ 28-29). The Specification also discloses that “a material is applied at the interface between sleeve 24 and body 14 in order to prevent blocking between the[m]…. The term „blocking‟ refers to the cross-linking between the silicone material of sleeve 30 with the silicone material of catheter tube 14.” (Id. at 6, ¶ 34.) Claims 1, 2 and 4-12 are on appeal. Claim 1 is representative: 1. A medical device comprising: a catheter body including an interior surface defining a lumen and an exterior surface; an exit port formed within the catheter body to allow material to exit the lumen of the catheter body; a pressure responsive sleeve fitting around the exterior surface and covering the exit port, expandable from a closed position to an open position Appeal 2011-004932 Application 11/754,759 3 and having a thickness in the closed position varying from a greater thickness to a lesser thickness proximate the exit port; and an anti-blocking interface between the sleeve and the catheter body, proximate the exit port. Issue The Examiner has rejected claims 1, 2, 4-7, 11, and 12 under 35 U.S.C. § 102(e) as anticipated by Fischell, 1 and has rejected claims 8-10 under 35 U.S.C. § 103(a) as obvious in view of Fischell and either Moorehead 2 or Hurt. 3 We will consider these rejections together since Appellants have waived any argument based on Moorehead or Hurt (Appeal Br. 7). The Examiner finds that Fischell discloses a device meeting the limitations of claim 1, including “a thickness varying from a greater to lesser thickness (Figure 5, where the angled edges of the sleeve provide for a sleeve having a varying thickness)” (Answer 3). Appellants contend that Fischell does not disclose a pressure responsive sleeve that has “a thickness in the closed position varying from a greater thickness to a lesser thickness proximate the exit port,” as recited in claim 1, because in Fischell, the sleeve portion proximate the exit ports “is the thickest portion of the sleeve” (Appeal Br. 5). The issue presented is: Does the broadest reasonable interpretation of a pressure responsive sleeve “having a thickness in the closed position varying from a greater thickness to a lesser thickness proximate the exit 1 Fischell, US 2004/0049169 A1, published Mar. 11, 2004. 2 Moorehead, US 5,147,332, issued Sept. 15, 1992. 3 Hurt, US 2003/0216710 A1, issued Nov. 20, 2003. Appeal 2011-004932 Application 11/754,759 4 port,” as recited in claim 1, encompass the configuration of Fischell‟s device? Findings of Fact 1. Fischell discloses “a check valve for placement near the distal end of a catheter” (Fischell, abstract). 2. Fischell discloses that the “check valve is … formed from a low durometer, highly elastic, elastomer cylindrical tube” (id.). 3. Fischell discloses that “[w]hen pressurized fluid is injected through the catheter, the cylinder that is placed over one or more holes in the … catheter is forced to expand radially outward which allows the fluid to be injected into the blood vessel” (id.). 4. Figure 5 of Fischell is shown below: Figure 5 shows a longitudinal cross section of one embodiment of Fischell‟s check valve, which has an angled joint at the proximal and distal ends of check valve 22 (id. at 2, ¶¶ 0016, 0027). 5. Fischell discloses that “holes 24 are placed through the wall of the catheter 21 within the generally cylindrical groove 29” (id. at 2, ¶ 0026). 6. Fischell discloses that an “angled junction 25, when used with a tube 22 that is shrunk into the groove 29, assures that there will be no crack Appeal 2011-004932 Application 11/754,759 5 formed at the junction 25 into which a blood clot could form” (id. at 2, ¶ 0027). 7. The Specification states that Figure 1 shows “[s]leeve valve 22 compris[ing] a sleeve 24 that surrounds a portion of catheter body 14 proximate an exit port 26 and covers exit port 26” (id. at 4, ¶ 29). 8. Figure 7 of the Specification is shown below: Figure 7 shows “a cross-sectional end view of a sleeve valve catheter [ ] with a non-uniform thickness about the circumference of catheter body 14” (Spec. 11, ¶ 52). The Specification discloses that the “reduced thickness of sleeve 51 [sic, 30] proximate exit port 26 … decreases the pressure differential needed to separate sleeve 51 [sic] from catheter body[ ]14” (id.). Principles of Law [A]s an initial matter, the PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be Appeal 2011-004932 Application 11/754,759 6 afforded by the written description contained in the applicant's specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow. … The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed. … Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process. In re Zletz, 893 F.2d 319, 321-322 (Fed. Cir. 1989). Analysis Claim 1 is directed to a medical device comprising a catheter body with a pressure responsive sleeve fitting around its exterior surface and covering an exit port, where the pressure responsive sleeve has “a thickness in the closed position varying from a greater thickness to a lesser thickness proximate the exit port.” 4 Appellants argue that the claim language requires that the sleeve “must display a decrease in thickness proximate to the exit port as compared to its thickness less proximate to the exit port.… Fischell displays exactly the opposite structure.” (Appeal Br. 5.) The Examiner responds that the language of claim 1 does not require that the “lesser thickness portion of the sleeve must be the portion of the sleeve „nearest to‟ the exit port” (Answer 5). The Examiner reasons that “the term „proximate‟ can properly be defined as either „very close‟ or as 4 Appellants do not dispute that Fischell‟s device inherently includes the anti-blocking interface recited in claim 1. See Appeal Br. 6-7. Appeal 2011-004932 Application 11/754,759 7 „nearest‟” (id.); that the claim language does not require applying the definition of “proximate” as “nearest” (id.); and that the broadest reasonable interpretation of the claim language encompasses Fischell‟s device (id.). We agree with the Examiner‟s claim interpretation. The Specification does not expressly define “proximate” and therefore we give the term its ordinary definition. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (“[T]he words of a claim „are generally given their ordinary and customary meaning.‟”); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002) (A “claim term will not receive its ordinary meaning if the patentee acted as his own lexicographer and clearly set forth a definition of the disputed claim term in either the specification or prosecution history.”). Appellants do not dispute the Examiner‟s position that the ordinary meaning of “proximate” can be either “very close” or “nearest.” In accord with In re Morris, claim terms in prosecution are given the broadest reasonable interpretation that is consistent with the specification. The Specification characterizes the portion of catheter body 14 that surrounded by sleeve 24 in Figure 1 as “proximate an exit port 26” (FF 7). The Specification also characterizes Figure 7 as showing a sleeve having reduced thickness “proximate exit port 26” (FF 8), where the area of reduced thickness extends around the circumference of the sleeve well beyond the exit port itself. Thus, interpreting “proximate” to mean “very close” is consistent with the use of the term in the Specification. Since the Examiner‟s interpretation of “proximate” applies the broadest reasonable interpretation that is consistent with the Specification, Appeal 2011-004932 Application 11/754,759 8 that interpretation is the correct one to apply during the examination process. We agree with the Examiner that Fischell discloses a pressure responsive sleeve “having a thickness in the closed position varying from a greater thickness to a lesser thickness proximate the exit port” under this interpretation because Fischell‟s check valve (or pressure responsive sleeve) has to a lesser thickness at its proximal and distal ends, which are very close to the exit port(s). Thus, we affirm the rejection of claim 1 as anticipated by Fischell. Claims 2, 4-7, 11, and 12 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). We also affirm the rejections of claims 8 and 9 as obvious in view of Fischell and Moorehead, and of claim 10 as obvious in view of Fischell and Hurt, since Appellants have waived any arguments based on Moorehead or Hurt (Appeal Br. 7). Conclusion The broadest reasonable interpretation of a pressure responsive sleeve “having a thickness in the closed position varying from a greater thickness to a lesser thickness proximate the exit port,” as recited in claim 1, encompasses the configuration of Fischell‟s device. SUMMARY We affirm the rejection of claims 1, 2, 4-7, 11, and 12 under 35 U.S.C. § 102(e). We also affirm the rejection of claims 8-10 under 35 U.S.C. § 103(a). Appeal 2011-004932 Application 11/754,759 9 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation