Ex Parte EtzelDownload PDFPatent Trial and Appeal BoardDec 18, 201511776774 (P.T.A.B. Dec. 18, 2015) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111776,774 07/12/2007 60961 7590 12/22/2015 Intellectual Property Dept/Dewitt Ross & Stevens Wisconsin Alumni Research Foundation 2 East Mifflin Street, Suite #600 Madison, WI 53703-2865 Mark R. Etzel 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 09820.399 7378 EXAMINER HORNING, MICHELLE S ART UNIT PAPER NUMBER 1648 NOTIFICATION DATE DELIVERY MODE 12/22/2015 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): docket-ip@dewittross.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARK R. ETZEL 1 Appeal2013-006081 Application 11/776,774 Technology Center 1600 Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a disposable virus-trapping membrane. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellant, the real party in interest is Wisconsin Research Alumni Foundation (App. Br. 2.) Appeal2013-006081 Application 11/776,774 STATEivIENT OF THE CASE Claims on Appeal Claims 1, 3-5, 7-11, 13-15, and 23-25 are on appeal. 2 Claim 1 is illustrative and reads as follows: 1. A disposable, virus-trapping membrane comprising: a disposable, micro-porous filter membrane; and a multi-modal anion-exchange ligand immobilized on the membrane, wherein the ligand is dimensioned and configured to: (a) bind neutral viruses; (b) have a pKa sufficiently high to repel basic proteins via electrostatic charge repulsion; and ( c) yield a log-reduction value (LRV) of at least 1.0 for the neutral viruses disposed in a solution comprising 50 mM salt. Examiner's Rejections Claims 1, 3-5, 7-11, 13-15, and 23-25 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Phillips3 and Johansson, 4 as further evidenced by paragraph 71 of the Specification. 5 (Final Act. 2.)6 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 2 Claims 2, 6, and 12 are cancelled and claims 16-22 are withdrawn. 3 Michael Phillips et al., Performance of a membrane adsorber for trace impurity removal in biotechnology manufacturing, J. CHROMATOGRAPHY, A, 1078, pp. 74--82 (2005). 4 Bo-Lennart Johansson et al., Preparation and characterization of prototypes for multi-modal separation media aimed for capture of negatively charged biomolecules at high salt conditions, J. CHROMATOGRAPHY, A, 1016, pp. 21-33 (2003). 5 The Specification is cited for the pKa inherency of tyrosinol and tris(2- aminoethyl)amine (TAEA), and that TAEA has a positive charge at pH 7. Examiner refers to paragraphs 69 and 71 on pages 20-22 of the Specification. 6 Office Action dated Mar. 19, 2012. 2 Appeal2013-006081 Application 11/776,774 FINDil~GS OF FACT 1. Phillips teaches a disposable, microporous membrane adsorber that utilizes a quaternary amine ligand for removal of trace impurities, such as viruses. (Phillips, Abstract; pp. 74--75, 78-79.) 2. Johansson teaches a library of about 60 multi-modal anion-exchange ligands. (Johansson, Abstract; pp. 21-22.) ANALYSIS Examiner states that it would have been obvious "to substitute a ligand with any known ligand," and that the log-reduction value (LRV) "is an inherent feature of ligands disclosed by the prior art." (Final Act. 3--4.) Examiner concludes that "[t]he combined teachings of Phillips and Johansson meet the structural limitations of the claims and thus, must also meet the inseparable, functional properties of the claimed membrane." (Ans. 15.) Appellant argues that LRV is not an inherent property of the ligands of Johansson as a class, pointing to test data in the Specification (Table 2) regarding phenylalaninol (compound 53 in Johansson) and the LRV for the neutral virus cpX-174. (App. Br. 10; Spec., p. 25, 1. 24--p. 31, 1. 21.) According to Appellant: Yet, as evidenced by the specification, compound 53 is incapable of binding cpXl 74 at any capacity at a NaCl concentration of 150 mM and yields only an LRV of 0.1 at 50 mM NaCL See Table 2 of the specification. Ifa practitioner in the art were to choose phenylalaninol rather than tris(2- aminoethyl)amine to place on the membrane of Phillips et al., the membrane so modified would not inherently fulfill any of the recited LRV s. (Reply Br. 6.) 3 Appeal2013-006081 Application 11/776,774 We agree with Appellant. It is well settled that "[i]nherency ... may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." MEHL/Biophile Int'!. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)); see also Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194--96 (Fed. Cir. 2014) (discussing inherency in the obviousness context). Here, Appellant's test data shows that the LRV for phenylalaninol is 0.1 at 50 mM NaCl and 0.0 at 150 mM NaCL (Spec., p. 28.) The independent claims recite a LRV of "at least 1.0" in a solution comprising 50 mM salt (claims 1 and 11) and a solution comprising 150 mM salt (claim 23). Appellant's data thus shows that the structure formed by the combined teachings of Phillips and Johansson may not necessarily "meet the inseparable, functional properties of the claimed membrane." (See Ans. 15.) Appellant's data shows that the claimed LR V is not an inherent feature of all the compounds disclosed by Johansson. Accordingly, we reverse. CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1, 3-5, 7-11, 13-15, and 23-25 under 35 U.S.C. § 103(a) is reversed. REVERSED lp 4 Copy with citationCopy as parenthetical citation