Ex Parte GessweinDownload PDFBoard of Patent Appeals and InterferencesJun 2, 201010394630 (B.P.A.I. Jun. 2, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte DOUGLAS GESSWEIN ____________ Appeal 2009-006682 Application 10/394,630 Technology Center 3700 ____________ Decided: June 2, 2010 ____________ Before LINDA E. HORNER, STEFAN STAICOVICI and KEN B. BARRETT, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL Appeal 2009-006682 Application 10/394,630 2 STATEMENT OF THE CASE Douglas Gesswein (Appellant) appeals under 35 U.S.C. § 134 (2006) from the Examiner’s decision rejecting claims 1-20. We have jurisdiction over this appeal under 35 U.S.C. § 6 (2006). THE INVENTION Appellant’s invention relates to a guiding catheter 100 including an open lumen 204, an inner liner 202, one or more steering lumens 208, one or more inflation lumens 212, an intermediate sheath 210, and an outer sheath 206. Spec. 6, ll. 3-15 and fig. 2. By pressurizing and depressurizing fluid within steering lumens 208, via inflation lumens 212, the catheter 100 is steered within blood vessels. Spec. 6, ll. 16-24. Claim 1 is representative of the claimed invention and reads as follows: 1. A guiding catheter for accessing a patient's heart, comprising: a flexible shaft having an open lumen and a pre-shaped distal portion; one or more inflatable steering lumens disposed within a wall of the flexible shaft proximate the pre-shaped distal portion; and one or more inflation lumen portions of the steering lumens in fluid connection with the steering lumens, the inflation lumen portions accessible at a proximal end of the shaft, wherein changing a fluid pressure of the steering lumens alters a shape of the pre-shaped distal end of the flexible shaft. Appeal 2009-006682 Application 10/394,630 3 THE REJECTIONS The Examiner relies upon the following as evidence of unpatentability: Del Guercio US 3,665,928 May 30, 1972 Maloney US 4,906,230 Mar. 6, 1990 Loiterman US 4,983,165 Jan. 8, 1991 Sogawa US 5,308,323 May 3, 1994 The following rejections are before us for review: The Examiner rejected claims 1-20 under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The Examiner rejected claims 1, 2, 7, 9-12, 15, 18, and 19 under 35 U.S.C. § 102(b) as anticipated by Del Guercio. The Examiner rejected claims 1, 2, 9, 10, 12, and 15 under 35 U.S.C. § 102(b) as anticipated by Maloney. The Examiner rejected claims 12-14 under 35 U.S.C. § 102(b) as anticipated by Loiterman. The Examiner rejected claims 12-20 under 35 U.S.C. § 102(b) as anticipated by Sogawa. THE ISSUES 1. Do the limitations “inflatable steering lumens” in claims 1-11 and 15- 20 and “means for inflatably steering” in claims 12-14 render claims 1-20 indefinite under 35 U.S.C. § 112, second paragraph? 2. Does each of Del Guercio, Maloney, and Loiterman teach a catheter having “inflatable steering lumens”? Appeal 2009-006682 Application 10/394,630 4 3. Does Sogawa teach a catheter having “inflatable steering lumens” located within a wall of the catheter shaft? SUMMARY OF DECISION We REVERSE. OPINION Issue (1) The indefiniteness rejection Each of independent claims 1, 9, and 15 includes the limitation “one or more inflatable steering lumens.” With respect to independent claim 12, while it does not explicitly recite “one or more inflatable steering lumens,” it does recite “means for inflatably steering the distal end of the flexible shaft disposed within a wall of the flexible shaft.”1 According to the Examiner, a lumen cannot be inflatable. Final Rejection, mailed Mar. 21, 2006, at 3. Rather, the Examiner takes the position that the material surrounding the lumen is inflatable. Ans. 3-4. In response, Appellant argues that “the term ‘inflatable lumen’ is an acceptable way of describing a lumen that may expand or contract.” App. Br. 8. It is well established that the test for definiteness under 35 U.S.C. § 112, second paragraph, is whether "those skilled in the art would understand what is claimed when the claim is read in light of the specification." Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations omitted). In this case, although we agree with the Examiner that in an inflatable lumen it is the material surrounding the lumen that expands, nonetheless, when the material expands the lumen also 1 Appellant’s Specification describes such “means for inflatably steering” as being inflatable steering lumens 208. Spec. 6, ll. 16-18; App. Br. 6 Appeal 2009-006682 Application 10/394,630 5 expands. For example, as Appellant argues, when blowing air into a balloon the walls of the balloon expand as the interior space of the balloon also expands. See Reply Br. 8. As such, we agree with Appellant that the term “inflatable lumen” would be understood in the art to mean a lumen that expands or contracts. See App. Br. 8. Accordingly, we conclude that claims 1-20 are not indefinite under 35 U.S.C. § 112, second paragraph. Therefore, the rejection of claims 1-20 under 35 U.S.C. § 112, second paragraph, as being indefinite cannot be sustained. Issue (2) The anticipation rejection over Del Guercio Appellant argues that Del Guercio does not teach a catheter having one or more “inflatable steering lumens.” App. Br. 9. In response, the Examiner takes the position that because the collar 32 and the grips 30 of Del Guercio are made from rubber, the walls surrounding the channels 36, 38 and/or 44, 46 are also made of rubber, and as such are inflatable. Ans. 5. The Examiner appears to interpret the channels 36, 38 and/or 44, 46 of Del Guercio as the claimed “inflatable steering lumens.” We disagree with the Examiner’s position for the following reasons. First, we find that an ordinary and customary meaning of the term “inflate” is “to swell or distend with air or gas.” MERRIAM WEBSTER’S COLLEGIATE DICTIONARY (10th Ed. 1997). In other words, we find that an “inflatable steering lumen” is a steering lumen that can swell or distend, that is, can expand when pressurized with a gas. Second, we note that the Examiner appears to rely on a theory of inherency to show that Del Guercio teaches that the walls surrounding the channels 36, 38 and/or 44, 46 are made of rubber, and as such are inflatable. “Inherent anticipation requires that the Appeal 2009-006682 Application 10/394,630 6 missing descriptive material is ‘necessarily present,’ not merely probably or possibly present, in the prior art.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002) (quoting In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)). In this case, the question raised is whether the walls surrounding the channels 36, 38 and/or 44, 46 of Del Guercio are necessarily inflatable. It is our finding that when a fluid is forced through constriction 42 of Del Guercio’s catheter, a jet stream is formed which forces the fluid to attach to one of walls 70 and 72. For example, when the fluid attaches to wall 70 the fluid flows through channel 36 and impinges upon tip member 16 upon exiting at opening 56. The passage of the fluid through the opening 56 shifts the tip member to the right as shown in Figure 3 and increases the pressure at opening 50 of channel 44 to deflect the fluid to the opposite wall 72. Thus, the fluid is directed into channel 38 and impinges upon tip member 36 upon exiting at opening 62 to move the tip member 16 to the left in a direction opposite that shown in Figure 3 and to increase the pressure at opening 48 of channel 46. Continued passage of fluid through channels 36, 38 causes automatic oscillation of the tip member 16 until the member 16 reaches an impenetrable obstacle or until the forcing of fluid is discontinued. Del Guercio, col. 4, l. 44 though col. 5, l. 12 and fig. 3. Hence, it is our finding that the oscillation of tip member 16 is the result of fluid pressure balances at openings 48, 50, 52, and 56. If the walls surrounding the channels 36, 38 and/or 44, 46 were inflatable, as the Examiner opines, the expansion of the walls would modify the cross-section of the channels 36, 38 and/or 44, 46 and as such would modify the fluid pressure balances at openings 48, 50, 52, and 56. Hence, a change in the Appeal 2009-006682 Application 10/394,630 7 fluid pressure balances at openings 48, 50, 52, and 56 would affect the lateral oscillatory motion of tip member 16. Therefore, we conclude that the walls surrounding the channels 36, 38, and/or 44, 46 are not necessarily inflatable. The Examiner has not provided sufficient evidence to support the finding that channels 36, 38 and/or 44, 46 of Del Guercio constitute “inflatable steering lumens,” as called for by each of independent claims 1, 9, 12, and 15. Inasmuch as we found that Del Guercio does not teach “inflatable steering lumens,” Del Guercio does not teach all the elements of independent claims 1, 9, 12, and 15 or their respective, rejected dependent claims. Accordingly, the rejection of claims 1, 2, 7, 9-12, 15, 18, and 19 under 35 U.S.C. § 102(b) as anticipated by Del Guercio cannot be sustained. The anticipation rejection over Maloney Appellant argues that Maloney does not teach a catheter having one or more “inflatable steering lumens.” App. Br. 11. In response, the Examiner takes the position that “if the steering lumens [22, 24] within the walls were not inflatable, then the bellows [20] would not be able to expand.” Ans. 6. The Examiner appears to interpret the inflation lumen 24 and the fluid passage 22 of Maloney as the claimed “inflatable steering lumens.” Since the Examiner has not specifically pointed to any portion of Maloney to show that the inflation lumen 24 and the fluid passage 22 are inflatable, the Examiner appears to rely on a theory of inherency to make such a showing. It is our finding that the bellows folds 20 of Maloney are in fluid communication with the inflation lumen 24 through the fluid passage 22. Maloney, col. 4, ll. 13-17 and fig. 2. Furthermore, Maloney specifically Appeal 2009-006682 Application 10/394,630 8 teaches that the passage of pressurized gas from the inflation lumen 24 through the fluid passage 22 places the bellows folds 20 in longitudinal tension so as to cause distal portion 18 of catheter 12 to deflect in a controlled manner and hence allow catheter 12 to follow a tortuous path within a patient’s body. Maloney, col. 4, l. 57 through col. 5, l. 10 and figs. 1, 2, and 4. Hence, if the walls surrounding the inflation lumen 24 and the fluid passage 22 were inflatable, as the Examiner opines, the expansion of the walls would modify the pressure of the gas impinging on bellows 20 and hence would affect the amount of deflection of the distal portion 18 of Maloney’s catheter 12. In conclusion, the walls surrounding the inflation lumen 24 and the fluid passage 22 are not necessarily inflatable. Therefore, the Examiner has not provided sufficient evidence to support the finding that inflation lumen 24 and fluid passage 22 of Maloney constitute “inflatable steering lumens,” as called for by each of independent claims 1, 9, 12, and 15. Inasmuch as we found that Maloney does not teach “inflatable steering lumens,” Maloney does not teach all the elements of independent claims 1, 9, 12, and 15 or their respective, rejected dependent claims. Accordingly, the rejection of claims 1, 2, 9, 10, 12, and 15 under 35 U.S.C. § 102(b) as anticipated by Maloney likewise cannot be sustained. The anticipation rejection over Loiterman Appellant argues that Loiterman does not teach “means for inflatably steering the distal end of the flexible shaft.” App. Br. 13. In response, the Examiner takes the position that “element 7 would be capable of being Appeal 2009-006682 Application 10/394,630 9 inflated.” Ans. 7. The Examiner appears to interpret the ducts 7 of Loiterman as the claimed “means for inflatably steering the distal end of the flexible shaft.” Since the Examiner has not specifically pointed to any portion of Loiterman to show that ducts 7 are inflatable, it appears that the Examiner is once more relying on a theory of inherency to make such a showing. Loiterman teaches a catheter having a tubular member 1, a distal set of balloons 4, a proximal set of balloons 5, and ducts 7 connected to each balloon 4, 5 for providing a pressurized fluid to balloons 4, 5. Loiterman, col. 3, ll. 29-30 and 48-50; col. 4, ll. 7-18; and figs. 1 and 3. Loiterman further teaches that selective inflation of balloons 4, 5 causes catheter tip deflection. Loiterman, col. 4, ll. 24-31. As such, if the walls surrounding the ducts 7 were inflatable, as the Examiner opines, the expansion of the walls would modify the pressure of the gas inflating the balloons 4, 5 and hence would affect the amount of catheter tip deflection. Hence, the walls surrounding the ducts 7 are not necessarily inflatable. Therefore, the Examiner has not provided sufficient evidence to support the finding that the ducts 7 of Loiterman constitute “means for inflatably steering the distal end of the flexible shaft,” as called for independent claim 12. Inasmuch as we found that Loiterman does not teach, “means for inflatably steering the distal end of the flexible shaft,” Loiterman does not teach all the elements of independent claim 12. Accordingly, the rejection of claims 12-14 under 35 U.S.C. § 102(b) as anticipated by Loiterman cannot be sustained. Issue (3) Appeal 2009-006682 Application 10/394,630 10 The anticipation rejection over Sogawa Appellant argues that Sogawa fails to teach “means for inflatably steering the distal end of the flexible shaft disposed within a wall of the flexible shaft,” as per claim 12 and “one or more inflatable steering lumens disposed between the inner lining and the outer sheath at a distal portion of the flexible shaft,” as per claim 15. App. Br. 14. According to Appellant, the inflatable compartments 4 of Sogawa are located on the exterior surface of the catheter tube. Id. The Examiner responds that the inflatable steering lumen 4 of Sogawa (inflatable compartment 4) is located within the interior of outer wall 2, specifically between outer wall 2 and the inner lining 6. Ans. 7. It is our finding that Sogawa teaches a front tip of a catheter including a balloon 2 having a plurality of inflatable compartments 4 (inflatable steering lumens) separated by walls 3. Sogawa, col. 2, ll. 33-38 and figs. 1 and 2. Sogawa further teaches a channel 5 for supplying a pressurized gas to each inflatable compartment 4 via openings 9 in the wall of tube 6. Sogawa, col. 2, ll. 38-43 and fig. 2. Furthermore, Sogawa teaches a channel 7 located within inside tube 6 for supplying drugs. Sogawa, col. 2, ll. 47-49 and fig. 2. Since pressurized gas and drugs are supplied through channels 5 and 7, respectively, a person of ordinary skill in the art would have readily recognized that the tube 6 of Sogawa constitutes the shaft of catheter 1, whereas the inflatable compartments 4 are part of balloon 2. Accordingly, we agree with Appellant that inflatable compartments 4 of Sogawa are located on the exterior surface of the catheter tube, that is, on the exterior of the tube 6. See App. Br. 14. Hence, Sogawa fails to teach inflatable steering lumens located within a wall of the catheter shaft. Appeal 2009-006682 Application 10/394,630 11 Inasmuch as we found that Sogawa does not teach inflatable steering lumens located within a wall of the catheter shaft, Sogawa does not teach all the elements of independent claims 12 and 15 or their respective, rejected dependent claims. Accordingly, the rejection of claims 12-20 under 35 U.S.C. § 102(b) as anticipated by Sogawa cannot be sustained. CONCLUSIONS 1. The limitations “inflatable steering lumens” in claims 1-11 and 15-20 and “means for inflatably steering” in claims 12-14 do not render claims 1-20 indefinite under 35 U.S.C. § 112, second paragraph. 2. Neither of Del Guercio, Maloney, nor Loiterman teaches a catheter having “inflatable steering lumens.” 3. Sogawa fails to teach a catheter having “inflatable steering lumens” located within a wall of the catheter shaft. DECISION The Examiner’s decision to reject claims 1-20 is reversed. REVERSED mls HOLLINGSWORTH & FUNK 8500 NORMANDALE LAKE BLVD SUITE 320 MINNEAPOLIS, MN 55437 Copy with citationCopy as parenthetical citation