Markus Storr et al.

Patent Trials and Appeals Board

Mar 31, 2022

2020005959 (P.T.A.B. Mar. 31, 2022)

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. 13/578,161 08/09/2012 Markus Storr 52759-222213 6393 23643 7590 03/31/2022 Barnes & Thornburg LLP (IN) 11 S. Meridian Street Indianapolis, IN 46204 EXAMINER GORDON II, BRADLEY R ART UNIT PAPER NUMBER 1773 NOTIFICATION DATE DELIVERY MODE 03/31/2022 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): INDocket@btlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARKUS STORR, BERND KRAUSE, HERMANN GOEHL, THOMAS ERTL, and ALEXANDER GEKELER Appeal 2020-005959 Application 13/578,161 Technology Center 1700 Before BEVERLY A. FRANKLIN, RAE LYNN P. GUEST, and BRIAN D. RANGE, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 9-11, 21, 22, 24-26, 28, 30-32, 34, 35, 37-39, 41-44, and 50-56. Ans. 3. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Gambro Lundia AB. Appeal Br. 3. Appeal 2020-005959 Application 13/578,161 2 CLAIMED SUBJECT MATTER Claim 9 is illustrative of Appellant’s subject matter on appeal and is set forth below (with text in bold for emphasis): 9. A method for treatment of liver failure, the method comprising: passing blood of a patient with liver failure into a dialysis device comprising a dialysis membrane that allows the passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of about 0.1 to about 1.0 in the presence of whole blood, wherein the dialysis membrane has a sieving coefficient in plasma for albumin of from about 0.1 to about 0.2, and wherein the dialysis membrane has a sieving coefficient in plasma for myoglobin of from about 0.85 to about 1.0, wherein the dialysis device comprises a dialysis side and a dialysate side, and wherein dialysate on the dialysis side of the dialysis device is an albumin solution comprising human serum albumin at a concentration of from about 5% to about 12% by weight; recycling the albumin solution by passing it through a low-flux dialyzer opposite of an aqueous buffered solution for the removal of water-soluble substances from the albumin solution; passing the recycled albumin solution into the dialysate side of the dialysis device; and returning the blood from the dialysis device to the patient. Appeal Br. 21 (Claims App.). Appeal 2020-005959 Application 13/578,161 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Stange et al. (“Stange”) US 5,744,042 Apr. 28, 1998 Buck US 2006/0144782 A1 July 6, 2006 Stadlbauer et al., Removal of Bile Acids by Two Different Extracorporeal Liver Support Systems in Acute-on-Chronic Liver Failure, 53 ASAIO J., 187-193 (2007) REJECTION Claims 9-11, 21, 22, 24-26, 28, 30-32, 34, 35, 37-39, 41-44, and 50-56 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Stadlbauer in view of Buck and Stange. OPINION We review the appealed rejections for error based upon the issues Appellant identifies, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”). Upon review of the evidence and each of the respective positions set forth in the record, we find that the preponderance of evidence supports Appellant’s position in the record. Accordingly, we reverse the Examiner’s rejection on appeal essentially for the reasons set forth in the record by Appellant, and add the following for emphasis. We refer to the Examiner’s stated rejection set forth on pages 4-11 of the Non-final Office Action mailed June 28, 2019. Therein, the Examiner Appeal 2020-005959 Application 13/578,161 4 makes findings with regard to Stadlbauer. Non-final Act. 4. The Examiner notes that Stadlbauer does not teach certain claim elements (as listed on page 4 of the Non-final Office Action), including a dialysis membrane having a sieving coefficient in plasma for albumin of from about 0.1 to about 0.2 as claimed. The Examiner states that Buck’s membrane has similarities with Appellant’s disclosed membrane for the reasons presented on page 5 of the Non-final Office Action. It is the Examiner’s position that both Appellant’s membrane and Buck’s membrane are presumed to have the same properties, including having a sieving coefficient in plasma for albumin of from about 0.1 to about 0.2. Non-final Act. 5. Appellant argues that the properties of the claimed dialysis membrane are distinguishable from the membrane of Buck, and thus a person of ordinary skill in the art would not arrive at the claimed invention based on the combination of references proposed by the Examiner. Appeal Br. 10. More specifically, Appellant refers to Figure 3b of Buck which displays the sieving coefficient of the high cut-off membrane according to Buck. Appeal Br. 10-11. Appellant argues that as can be seen from Figure 3b of Buck (reproduced on page 11 of the Appeal Brief), the sieving coefficient of albumin for Buck’s membrane is not within the claimed range of about 0.1 to about 0.2. Instead, as shown by Figure 3b of Buck, the sieving coefficient for albumin is below 0.05. Accordingly, Appellant submits that Buck does not teach or suggest the dialysis membrane of the claimed invention. Appeal Br. 11. In response, the Examiner states that Figure 3 of Buck shows sieving coefficients in whole blood and in water, whereas the claim recitation is Appeal 2020-005959 Application 13/578,161 5 “sieving coefficient in plasma”. Ans. 3. It is thus the Examiner’s belief that there is a difference between plasma versus whole blood with regard to coefficients, and therefore is unpersuaded by Appellant’s arguments related to Buck’s Figure 3b. In reply, Appellant argues that one skilled in the art would understand that the difference in sieving coefficients between whole blood and plasma is not significant. In other words, it is well known in the art that similar sieving coefficients are observed in whole blood and in plasma and, thus, a sieving coefficient in whole blood is predictive of a sieving coefficient in plasma. Reply Br. 2-3. In support of this position, Appellant refers to an article by Urbani et al. and an ISO8637 publication, and these publications are discussed by Appellant on pages 3-4 of the Reply Brief, which we refer to herein. As such, we find that Appellant’s stated position is supported by a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). In view of the above, we reverse the rejection. CONCLUSION We reverse the Examiner’s decision. Appeal 2020-005959 Application 13/578,161 6 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 9-11, 21, 22, 24-26, 28, 30-32, 34, 35, 37- 39, 41-44, 50-56 103(a) Stadlbauer, Buck Stange 9-11, 21, 22, 24-26, 28, 30-32, 34, 35, 37- 39, 41-44, 50-56 REVERSED