Ex Parte Gronau et alDownload PDFPatent Trial and Appeal BoardJan 3, 201712766424 (P.T.A.B. Jan. 3, 2017) 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. 12/766,424 04/23/2010 Soeren GRONAU 2565/224 1402 26216 7590 01/05/2017 FISH & RICHARDSON P.C. (FRESENIUS) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER TOWNSEND, GUY K ART UNIT PAPER NUMBER 3761 NOTIFICATION DATE DELIVERY MODE 01/05/2017 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): PATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SOEREN GRONAU, GOETZ GUENTHER, JUERGEN HAECKER, MARTIN LAUER, JOACHIM MANKE, DEJAN NIKOLIC, and MANFRED WEIS Appeal 2015-003199 Application 12/766,424 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134 involving claims 1—15, 17—30, 32, 35—54, and 64 (App. Br. 1). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants identify “[t]he real party in interest [as] FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH” (App. Br. 1). Appeal 2015-003199 Application 12/766,424 STATEMENT OF THE CASE Appellants’ “invention relates to an external functional means. It further relates to a blood treatment apparatus, as well as methods” (Spec. 1:10—11). More particularly, “[t]he external functional means comprises at least one housing body, at least one chamber integrated into the housing body for receiving medical fluids, at least one passage integrated into the housing body for receiving and/or conducting a medical fluid, and at least one valve means” {id. at 1:30-2:1). Independent claim 1 is representative and reproduced in the Claims Appendix of Appellants’ Appeal Brief. Claims 1—15, 17, 18, 22—25, 27, 30, 32-41, 48—52, and 64 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Beden.2 Claims 19-21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beden and Delnevo.3 Claims 42-47 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beden and Stanus.4 Claims 26, 53, and 54 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beden and Plahey.5 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 2 Beden et al., US 2005/0230292 Al, published Oct. 20, 2005. 3 Delnevo et al., US 2006/0289360 Al, published Dec. 28, 2006 4 Stanus et al., US 2005/0283132 Al, published Dec. 22, 2005. 5 Plahey et al., US 7,935,074 B2, issued May 3, 2011. 2 Appeal 2015-003199 Application 12/766,424 FACTUAL FINDINGS (FF) FF 1. Beden suggests “an apparatus for the treatment of a medical liquid comprising a liquid treatment machine and a cassette insertable therein substantially made of a rigid base body of the cassette with fitted chambers and passages and a foil covering them” (Beden Abstract; see also Ans. 3—5). FF 2. Figure 1 of Beden is reproduced below: Figure 1 shows “a cassette 10” (Spec. 126) having “[pjassages 28,” “valves 30” (id. at 127), “a venous port [48]” (id. at 130), “pump chambers 50” (id. at 131), “a venting chamber 56,” (id. at 132), an “arterial injection septum 16,” and a “venous injection septum 20” (id. at 136; see also Ans. 3—5). 3 Appeal 2015-003199 Application 12/766,424 ANALYSIS Bedew. Appellants’ independent claim 1 requires, inter alia, the single-needle chamber is disposed on a venous blood side of the medical device and above the venous blood chamber relative to an orientation of the medical device during its use, the single needle chamber being in fluid communication with the at least one passage integrated into the housing body for at least one of receiving and conducting a medical fluid only via the venous blood chamber. (Appellants’ claim 1). Examiner finds that Beden suggests “a medical device Fig. 1, comprising: ... at least one venous blood chamber (50B) Fig.l; [0031] Fig. 12” and a “single needle port (48) being in fluid communication with the at least one passage (28B) [0030JF11—13 integrated into the housing body (10) Fig. 1 for at least one of receiving and conducting a medical fluid only via the venous blood port (48) [0030JF11—13” (Ans. 5 (emphasis omitted)). Examiner acknowledges that “Beden does not teach that a single needle chamber is disposed on the venous side of the device and in fluid communication with the passage for receiving or conducting a medical fluid, but Beden instead teaches the use of a port (48) Fig. 1” {id. at 6 (emphasis omitted). Examiner concludes that it would have been obvious to provide the claimed access chamber as a substitute element of access port of Beden,... in order to provide addition of medical fluids through a port attached to passage (28) [0038JF25—27 and to not interrupt blood flow [0030]F 1 ,[]6—8; as taught by Beden, and to provide a fluid treatment apparatus comprising an insertable cassette for a large flexibility of different applications while maintaining fast and simple exchangeability [0006JF2—5; as taught by Beden; and since it has been held that an express 4 Appeal 2015-003199 Application 12/766,424 suggestion to substitute one equivalent component or process for another is not necessary to render such a substitution obvious. (Ans. 6 (emphasis omitted).) We are not persuaded. Beden suggests “a venous port [48]” connected to “pump chambers 50” (FF 2). Fluid communication between the venous port and the pump chambers is via “[pjassages 28,” “valves 30,”, “a venting chamber 56,” an “arterial injection septum 16,” and a “venous injection septum 20,” among other things (FF 2). Examiner has not provided sufficient “articulated reasoning with some rational underpinning” — based on Beden — why the skilled artisan would make the changes necessary to arrive at a medical device with the claimed features. KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441F.3d 977, 988 (Fed. Cir. 2006). Examiner identified Beden’s “pump chambers 50” as being equivalent to the claimed venous blood chamber (see Ans. 5). We observe that Examiner also referred to Beden’s chamber 56 but did not clearly identify chamber 56 as equating to the claimed venous blood chamber (see Ans. 4—6, 16). We also note Examiner’s reference to Beden’s port 48 as a single needle port 48, but then identified passage 28B for receiving and conducting fluid only via the venous port 48 (see id. at 16). Even if the venous port is substituted with a chamber as Examiner asserted, Beden does not suggest “the single-needle chamber being in fluid communication with the at least one passage integrated into the housing body for at least one of receiving and conducting a medical fluid only via the venous blood chamber” as required by claim 1 (emphasis added; see also App. Br. 4, Reply Br. 3). Examiner does not explain clearly where Beden suggests this limitation, or why Beden’s passages, valves, venting chamber, 5 Appeal 2015-003199 Application 12/766,424 or septums would be eliminated “to not interrupt blood flow” (see Ans. 6). “[Rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). The preponderance of evidence on this record fails to support Examiner’s conclusion that it would have been obvious to modify the medical device of Beden such that “the single-needle chamber [is] in fluid communication with the at least one passage integrated into the housing body for at least one of receiving and conducting a medical fluid only via the venous blood chamber” as claimed. The combination of Beden and Delnevo: Based on the combination of Beden and Delnevo, Examiner concludes that it would have been obvious to “provide a the dialysis cassette pump of Delnevo with the cassette of Beden, using the teaching of Delnevo and one of skill would have been motivated to do so, in order to collect and return blood to the patient, as taught by Delnevo [0023]L3^4” (Ans. 13 (emphasis omitted)). Examiner, however, failed to establish that Delnevo makes up for the deficiency of Beden as discussed above. The combination of Beden and Stanus: Based on the combination of Beden and Stanus, Examiner concludes that it would have been obvious to provide tamper or reuse protection via touch protection element, as a the dialysis container access port/safety tab of Stanus, with the cassette of Beden, using the teachings of Stanus, and one of 6 Appeal 2015-003199 Application 12/766,424 skill would have been motivated to do so, in order to provide protection for touch (contamination) or tampering (for safety) for dialysis additive connections [0047JL3—1; [0053]L3—5, as taught by Stanus. {Id. at 14 (emphasis omitted).) Examiner, however, failed to establish that Stanus makes up for the deficiency of Beden as discussed above. The combination of Beden and Plahey: Based on the combination of Beden and Plahey, Examiner concludes that it would have been obvious to provide the 11—15 or 8 degree inclination angle based on the teaching of Plahey, and one would have been motivated to do so, in order to provide a dialysis cassette apparatus provide openings and a door that can be closed in parallel to connect and enclose the cassette within the apparatus [0013JL1—17, as taught by Plahey, and since such inclinations are known in the art; and since optimizing such angles depending on their intended use is within the skill of those skilled in the art. {Id. at 14—15 (emphasis omitted).) Examiner, however, failed to establish that Plahey makes up for the deficiency of Beden as discussed above. CONCLUSION OF LAW The preponderance of the evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1—15, 17, 18, 22—25, 27, 30, 32—41, 48—52, and 64 under 35 U.S.C. § 103(a) as unpatentable over Beden is reversed. The rejection of claims 19-21 under 35 U.S.C. § 103(a) as unpatentable over the combination of Beden and Delnevo is reversed. The rejection of claims 42-47 under 35 U.S.C. § 103(a) as unpatentable over the combination of Beden and Stanus is reversed. 7 Appeal 2015-003199 Application 12/766,424 The rejection of claims 26, 53, and 54 under 35 U.S.C. § 103(a) as unpatentable over the combination of Beden and Plahey is reversed. REVERSED 8 Copy with citationCopy as parenthetical citation