Ex Parte Bene et alDownload PDFPatent Trial and Appeal BoardFeb 28, 201310503766 (P.T.A.B. Feb. 28, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 10/503,766 08/06/2004 Bernard Bene PN0057 US-WO 01 (405.0046 3807 26813 7590 02/28/2013 MUETING, RAASCH & GEBHARDT, P.A. P.O. BOX 581336 MINNEAPOLIS, MN 55458-1336 EXAMINER MENON, KRISHNAN S ART UNIT PAPER NUMBER 1777 MAIL DATE DELIVERY MODE 02/28/2013 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 PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BERNARD BENE, NICHOLAS GOUX, PER HAQNSSON, THOMAS HERTZ, OLOF JANSSON, ROLAND PERSSON, JAN STERNBY, and PERRY ASBRINK ____________ Appeal 2011-009910 Application 10/503,766 Technology Center 1700 ____________ Before TERRY J. OWENS, MICHAEL P. COLAIANNI, and GEORGE C. BEST, Administrative Patent Judges. BEST, Administrative Patent Judge. DECISION ON APPEAL On July 26, 2010, the Examiner finally rejected claims 148-178, 180, 183, 184, 186, and 187 of Application 10/503,766 under 35 U.S.C. § 102(e) as anticipated, under 35 U.S.C. § 103(a) as obvious, and under the judicially- created doctrine of obviousness-type double patenting, and also rejected claim 187 under 35 U.S.C. § 112, ¶ 2 as indefinite. Appellants seek reversal of these rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM. Appeal 2011-009910 Application 10/503,766 2 BACKGROUND The ’766 application describes a method for determining the fluid flow rate in a blood access structure, often called a fistula, used for extra- corporeal treatment of blood, e.g., dialysis (Spec. 1). As described in the ’766 application, the fluid flow rate may be calculated based upon conductivity measurements of the dialysis fluid and the blood treatment unit effluent (id.). Maintenance of a high fluid flow rate in the fistula is important so that the amount of blood that is recirculated through the dialysis machine is minimized and treatment can be completed in an efficient and effective manner (id. at 1-2). Claim 184 is representative of the ’766 application’s claims and is reproduced below: 184. A method for determining a fluid flow rate (Qa) in a blood access having an upstream position and a downstream position using a blood treatment apparatus, the blood treatment apparatus including: a blood treatment unit having a semi permeable membrane delimiting a first chamber through which blood removed from said blood access passes and a second chamber through which dialysis liquid passes, an arterial line connected to an inlet of the first chamber, and a venous line connected to an outlet of the first chamber, said arterial and venous lines being able to be configured according to at least a normal configuration, in which said arterial line carries blood from said upstream position of said blood access, and said venous line carries blood towards said downstream position of said blood access, and to at least a reversed configuration, in which said arterial line carries blood from said downstream position of said blood Appeal 2011-009910 Application 10/503,766 3 access, and said venous line carries blood towards said upstream portion of said blood access, said method comprising the steps of: passing a dialysis liquid through the second chamber of said treatment unit, at least for a time interval (T) said dialysis liquid upstream the treatment unit having a concentration (Ci) of at least one substance being different from the concentration of the same substance in blood, wherein the step of passing a dialysis liquid through the second chamber comprises the following sub-steps: passing a first dialysis liquid through the second chamber of said treatment unit, said first dialysis liquid presenting a first concentration for said substance, then increasing or decreasing, at a time Ti, the concentration of the substance in the first dialysis liquid for passing through the second chamber a second dialysis liquid which, during the time interval T after the increasing or decreasing sub-step, has a concentration of at least said substance different from the concentration of the same substance in blood and different from the concentration of the same substance in first dialysis liquid; keeping substantially constant, during the time interval T after the increasing or decreasing sub-step, the concentration of said at least one substance in the second dialysis liquid upstream of the treatment unit, switching the venous and arterial lines, during said time interval (T) after the increasing or decreasing sub-step, between one of said normal and reversed configurations to the other of said normal and reversed configuration; obtaining, downstream of the treatment unit, a first post- treatment unit conductivity of the second dialysis liquid or a first post treatment unit concentration of said Appeal 2011-009910 Application 10/503,766 4 substance in the second dialysis liquid, said first post treatment conductivity or concentration referring to the dialysis liquid before switching of the venous and arterial lines during said time interval (T); obtaining, downstream of the treatment unit, a second post treatment unit conductivity of the second dialysis liquid or post treatment unit concentration of said substance in the dialysis liquid, said second post treatment conductivity or concentration referring to the dialysis liquid after switching of the venous and arterial lines during said time interval (T); calculating the fluid flow rate (Qa) in said blood access, as a function of: said first post treatment unit concentration or conductivity; and of said second post treatment unit concentration or conductivity. (App. Br. 35-37 (Claims App’x)). REJECTIONS 1. The Examiner finally rejected claim 187 under 35 U.S.C. § 112, ¶ 2 as indefinite (Final Rejection (“FR”) 4-5 (July 26, 2010); Ans. 4-5). 2. The Examiner finally rejected claims 148-178, 183, 184, 186, and 1871 on the ground of obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 6,726,647 B1 (“Sternby ’647,” issued April 27, 2004) in view of U.S. Patent No. 6,648,845 B1 (“Gotch,” issued Nov. 18, 2003) (FR 5-7; Ans. 6-8). 1 The Examiner also finally rejected claim 180 on this ground. Claim 180, however, had been cancelled by Appellants before entry of the Final Rejection (see Amendment (“Amdt.”) 22 (July 16, 2010)). Appeal 2011-009910 Application 10/503,766 5 3. The Examiner finally rejected claims 148-178, 183, 184, 186, and 1872 under 35 U.S.C. § 103(a) as obvious over WO 00/244403 (“Sternby ’440,” published May 4, 2000) in view of Gotch (FR 7- 10; Ans. 8-11). 4. The Examiner finally rejected claims 148-178, 183, 184, 186, and 1874 under 35 U.S.C. § 102(e) as being anticipated by or in the alternative under 35 U.S.C. § 103(a) as being obvious over Gotch (FR 10-11; Ans. 12-15). DISCUSSION Rejection 1. The Examiner finally rejected claim 187 as indefinite. The relevant portion of claim 187 is set forth below: 187. A method for determining a fluid flow rate (Qa) in a blood access having an upstream position and a downstream position . . . said method comprising the steps of: passing a first dialysis liquid through the second chamber of said treatment unit, said first dialysis liquid presenting a first conductivity; generating a gradient between the conductivity of the first dialysis liquid and a second dialysis liquid; 2 The Examiner also finally rejected claims 180 and 185 on this ground. As discussed in n.1, supra, Appellants cancelled claim 180 prior to entry of the Final Rejection. The same is true of claim 185 (see Amdt. 22). 3 We follow the Examiner, who, without objection, cited Sternby ’647 as the U.S. equivalent to Sternby ’440. 4 See n.2, supra. Appeal 2011-009910 Application 10/503,766 6 passing the second dialysis liquid through the second chamber of said treatment unit, said second dialysis liquid presenting a second conductivity, a conductivity difference between the blood and the second dialysis liquid being about from 1 to 2 mS/cm, . . . . (App. Br. 40-42 (Claims App’x) (emphasis added)). The Examiner argues that the phrase “generating a gradient between the conductivity of the first dialysis liquid and a second dialysis liquid” is indefinite because a person of ordinary skill in the art would be confused by the use of the term gradient in claim 187 (Ans. 5). The Examiner asserts that, as presently worded, the claim “gives the impression that the first and the second dialysis liquids are applied simultaneously or together, which is confusing. The term ‘gradient’ means gradually changing, whereas the change in concentration from the first to the second dialysis liquid is disclosed as abrupt” (id.). Appellants, on the other hand, argue that a person of ordinary skill in the art would understand from the Specification that the term “generating a gradient” means increasing or decreasing the conductivity of the dialysis liquid (App. Br. 16-17). We are not persuaded by either argument. As the Examiner correctly concluded (Ans. 5), a person of ordinary skill in the art would normally understand the term “generating a gradient” to require a gradual change in the conductivity of the dialysis fluid. See also WEBSTER’S NINTH NEW COLLEGIATE DICTIONARY 530 (1985) (“a rate of regular or graded ascent or descent;” “a part sloping upward or downward”). Appellants, on the other hand, argue that a person of ordinary skill in the art would understand that the term “generating a gradient” means increasing or decreasing the conductivity in any manner whatsoever, based upon the disclosure provided in the Specification (App. Br. 17). Appellants Appeal 2011-009910 Application 10/503,766 7 are attempting to redefine the phrase “generating a gradient” so that it is broader than its ordinary meaning to a person of ordinary skill in the art. While Appellants are free to redefine terms in their Specification, any such novel definitions must be clearly indicated. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Appellants’ Specification does not clearly indicate that the term gradient is being used in a manner other than its ordinary and customary meaning. Accordingly, a person of ordinary skill in the art would give the phrase “generating a gradient” its ordinary and customary meaning. A person of ordinary skill in the art would have understood from Appellants’ Specification that the conductivity measurements must be performed when the conductivity of the dialysis fluid at the inlet is stable so that an equilibrium value for the effluent conductivity can be measured (see Figs. 5 & 6). Therefore, such a person would have understood that it is immaterial to the claimed method whether the transition from the first dialysis liquid to the second dialysis liquid is accomplished in a gradual or abrupt manner. Accordingly, one of ordinary skill in the art, giving Appellants’ claim term “generating a gradient” its broadest reasonable interpretation consistent with the Specification, would have considered that term to encompass an abrupt change. Because the term “generating a gradient” is not insolubly ambiguous, we reverse the Examiner’s rejection of claim 187 as indefinite. Rejections 2 and 3. Appellants argue for reversal of these rejections together on the basis of the limitations set forth in claim 184 (App. Br. 18- 22). Accordingly, all of the claims in the ’766 application stand or fall with claim 184. Appeal 2011-009910 Application 10/503,766 8 Appellants argue that the rejections of claim 184 as obvious over the combination of either Sternby ’440 or Sternby ’647 (collectively, Sternby) with Gotch should be reversed because Sternby and Gotch, either alone or in combination, fail to describe or suggest several features recited in claim 184 (App. Br. 18). First, Appellants argue that Sternby fails to teach changing the concentration of a substance in the dialysis fluid upstream of the dialyzer unit because Sternby is concerned with the measurement of urea in the dialysis fluid downstream of the dialyzer unit (id.). The Examiner agrees that Sternby does not describe these limitations and points to Gotch as providing the necessary disclosure (Ans. 10, 16). Appellants argue that Gotch fails to remedy the deficiencies in Sternby’s disclosure because Gotch describes methods for determining access flow rate by determining dialysance values rather than concentrations or conductivities (App. Br. 20-21). However, as the Examiner explains (Ans. 16-18), while Gotch describes the calculation of the fluid flow rate in the fistula from dialysance values (Gotch Eq. (17)), Gotch further describes the determination of dialysance values by measurement of concentration or conductivity values (id. at 2:64-3:20). Indeed, Gotch expressly states that “it is possible to determine dialysance or clearance from conductivity measurements alone” (id. at 12:66-67) and describes a preferred embodiment which determines dialysance values via a series of conductivity measurements of the dialysis fluid upstream and downstream of the dialysis unit when dialysis fluids having differing initial sodium ion concentrations are used (id. at 13:12-35). Second, Appellants argue that using Gotch’s process to determine the fluid flow rate in the fistula cannot be accomplished while meeting claim Appeal 2011-009910 Application 10/503,766 9 184’s requirement that the concentration of the substance being measured be kept constant at the dialysis unit inlet while the concentration of the substance in the dialysis unit effluent is measured in the normal and reversed flow conditions (App. Br. 21-22). The Examiner, however, demonstrates that this argument is incorrect (Ans. 18-19). Furthermore, as the Examiner points out (id. at 19), Appellants’ method for determining the fluid flow rate in the fistula requires determination of the transport rate (Tr) of substances over the semipermeable membrane in the dialyzer unit and the ultrafiltration flow rate (Quf) in addition to the concentrations of the substance in the dialyzer unit effluent (Spec. 4). Appellants’ Specification states that the effective ionic dialysance can be used to determine the transport rate Tr (id.). In view of the foregoing, we determine that the Examiner did not err in concluding that the claims of the ’766 application would have been obvious to a person of ordinary skill in the art in view of the combination of Sternby and Gotch. Rejection 4. Appellants’ arguments against the Examiner’s rejection of the ’766 application’s claims as either anticipated by or obvious over Gotch alone are the same as those asserted against the combination of Sternby and Gotch (App. Br. 20-22). Therefore, we also affirm this rejection. CONCLUSION As discussed above, we reverse the Examiner’s rejection of claim 187 as indefinite, but we affirm the rejections of all of the claims in the ’766 application as obvious over Gotch, whether alone or in combination with either Sternby ’440 or Sternby ’647. Because we have affirmed rejections of Appeal 2011-009910 Application 10/503,766 10 all of the claims in the ’766 application, we affirm the Examiner’s decision not to allow any of the appealed claims. 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 bar Copy with citationCopy as parenthetical citation