Ex Parte Etzel et alDownload PDFPatent Trial and Appeal BoardMay 25, 201612562573 (P.T.A.B. May. 25, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/562,573 09/18/2009 32692 7590 05/27/2016 3M INNOVATIVE PROPERTIES COMPANY PO BOX 33427 ST. PAUL, MN 55133-3427 FIRST NAMED INVENTOR 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. 64729US006 4507 EXAMINER ADKINS, CHINESSA T ART UNIT PAPER NUMBER 1788 NOTIFICATION DATE DELIVERY MODE 05/27/2016 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): LegalUSDocketing@mmm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARK R. ETZEL, KANNAN SESHADRI, JERALD K. RASMUSSEN, CLINTON P. WALLER JR., DOUGLAS E. WEISS, and YI HE Appeal2015-001542 Application 12/562,573 Technology Center 1700 Before CHUNG K. PAK, JEFFREY T. SMITH, and WESLEY B. DERRICK, Administrative Patent Judges. PAK, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's decision finally rejecting claims 1, 3 through 14, and 21through23. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM-IN-PART. The subject matter on appeal is directed to an article in which polyethyleneimine ligand groups are grafted to, and extend from, the surface of a substrate, and to such an article further including quaternary ammonium 1 Appellants identify the Real Parties in Interest as 3M Innovative Properties Company and Wisconsin Alumni Research Foundation (Appeal Brief filed July 10, 2014 ("App. Br.") at 3.) Appeal2015-001542 Application 12/562,573 groups grafted to the surface of the substrate. (Spec. 3, 11. 1-17; 14, 11. 28- 30; 18, 11. 1-3.) Details of the appealed subject matter are recited in representative claims 1 and 3, which are reproduced below from the Claims Appendix to the Appeal Brief: 1. An article comprising a substrate and extending from the surfaces thereof grafted polyethyleneimine ligand groups forming a ligand-functionalized substrate; wherein the polyethyleneimine ligand groups are one or more of the formula: IX, or X, or l H)N-(CH,,CH)N)v (CH,,CH,,N)"- H - , - _I,,. , - - ~J CH2CH2NH2 XI, or XII, wherein: "~"is a divalent linking group grafted to the surface of the substrate and the polyethyleneimine ligand group, x may be zero and y is at least 1, and x + y is 2 to 50; 2 Appeal2015-001542 Application 12/562,573 wherein the ligand-functionalized substrate has enhanced binding selectivity for negatively charged biological species relative to positively charged species; wherein the negatively charged biological species comprise host cell proteins; and wherein the article yields a log-reduction value (LRV) of at least 5.0 for neutral viruses disposed in a solution comprising from 0 to about 150 mM salt. 3. An article comprising a substrate and extending from the surfaces thereof: grafted polyethyleneimine ligand groups forming a ligand-functionalized substrate; wherein the polyethyleneimine ligand groups are one or more of the formula: IX, or X, or XI, or XII, wherein: "~"is a divalent linking group grafted to the surface of the substrate and the polyethyleneimine ligand group, x may be zero and y is at least 1, and x + y is 2 to 50; and grafted quaternary ammonium groups on the surface of the substrate. 3 Appeal2015-001542 Application 12/562,573 Appellants seek review of the following grounds of rejection maintained by the Examiner in the Answer entered on September 11, 2014 ("Ans."): Claims 1, 4--10, 12-14, 21, and 22 under 35 U.S.C. § 103(a) as unpatentable over the disclosure of U.S. Patent 5,547 ,576 issued in the name of Onishi et al., on August 20, 1996 (hereinafter referred to as "Onishi"). Claims 3, 11, and 23 under 35 U.S.C. § 103(a) as unpatentable over the disclosure of Onishi in view of U.S. Patent 3,352,424 issued in the name of Guebert et al., on November 14, 1967 (hereinafter referred to as "Guebert"). DISCUSSION Upon consideration of the evidence on this appeal record and each of Appellants' contentions, we determine that Appellants have identified reversible error only in the Examiner's rejection of claims 3, 11, and 23 under 35 U.S.C. § 103(a) as unpatentable over Onishi and Guebert. Accordingly, we affirm the Examiner's§ 103(a) rejection of claims 1, 4--10, 12-14, 21, and 22 as unpatentable over Onishi for the reasons set forth in the Final Action entered February 12, 2014 ("Final Act.") and the Answer, but we reverse the Examiner's§ 103(a) rejection of claims 3, 11, and 23 for the reasons set forth in the Appeal Brief. We add the discussion below primarily for emphasis and completeness. 4 Appeal2015-001542 Application 12/562,573 ~· ,• £',..,, ... -1 A-1A-1,....-1A"-1 .. ,.....,..... .. ,..,.,_TTr"l,..,,l\-1A,..,./>.') Ke1ecuon or ciam1s l, 4---lU, lL-14, Ll, ana LL unaer j) u.~.L. s lUj\ar The critical issue on appeal for this rejection is: Have Appellants identified reversible error in the Examiner's determination that one of ordinary skill in the art at the time of the invention would have reasonably expected that the polyethyleneimine-functionalized substrate disclosed in Onishi would exhibit enhanced binding selectivity for negatively charged biological species, including negatively charged host cell proteins, relative to positively charged species, while also exhibiting a log reduction value of at least 5.0 for neutral viruses. On this record, we answer this question in the negative. Onishi discloses a polyethyleneimine ligand-functionalized substrate used to selectively remove viruses from solutions. (Onishi col. 3, 11. 29-32, 43--49; col. 5, 11. 36-39; col. 7, 11. 48-57.) The Examiner acknowledges that Onishi does not explicitly disclose that the polyethyleneimine ligand- functionalized substrate has enhanced binding selectivity for negatively charged biological species, including host cell proteins, relative to positively 2 We limit our discussion to those claims separately argued, and claims not separately argued stand or fall with the argued claims. 37 C.F.R. § 41.37(c)(l)(iv) ("[w]hen multiple claims subject to the same ground of rejection are argued as a group or subgroup by appellant, the Board may select a single claim from the group or subgroup and may decide the appeal as to the ground of rejection with respect to the group or subgroup on the basis of the selected claim alone.") Appellants argue claims 1, 4--10, 12-14, 21, and 22 as a group on the basis of limitations common to independent claims 1 and 8. (See generally App. Br. 11-14.) Therefore, for the purposes of this appeal, we select claim 1 as representative and decide the propriety of this rejection based on claim 1 alone. 5 Appeal2015-001542 Application 12/562,573 charged species. (Ans. 4.) However, the Examiner determines that one of ordinary skill in the art would have understood this to be the case in view of Onishi' s disclosure that polyamine compounds, which include polyethyleneimines, were known to act on negatively charged biological polymers, including cell membranes, and further disclosure that the basicity and molecular structure of polyamine compounds causes them to selectively capture cells and viruses. (Ans. 3--4; Onishi col. 4, 11. 53-57; col. 5, 11. IO- 15.) The Examiner further finds that Onishi discloses that a polyamine- functionalized substrate exhibited a virus removal rate of 99. 9% or more in a solution comprising 0 mM salt, corresponding to the log-reduction value recited in claim 1, which Appellants do not dispute. (Compare Ans. 4 with App. Br. 11-14; Onishi col. 13, 11. 23-42, 41-45 and 59-63; col.14, 11. 21-25 and 30-43.) Appellants do not contend that the polyethyleneimine ligand- functionalized substrate recited in claim 1 is structurally different from the polyethyleneimine ligand-functionalized substrate disclosed in Onishi. (App. Br. 11-14.) Instead, Appellants argue that the Examiner does not establish that it would have been obvious to one of ordinary skill in the art to produce a polyethyleneimine-functionalized substrate having enhanced binding selectivity for negatively charged biological species, including host cell proteins, relative to positively charged species, while also having a log reduction value of at least 5.0 for neutral viruses. (Id.) However, as discussed above, Onishi discloses that polyamine 6 Appeal2015-001542 Application 12/562,573 compounds, which include polyethyleneimines, were known to act on negatively charged biological polymers, including cell membranes. (Onishi col. 4, 11. 53-57.) Onishi also discloses that polyvalent cations were known to electrostatically bind negatively charged viruses, and negatively-charged glycoproteins found on the surfaces of many cells (Onishi col. 5, 11. 3-5, 25- 28), and further discloses that polyamines were known to selectively capture cells and viruses. (Onishi col. 5, 11. 10-15.) We agree with the Examiner that these disclosures would have reasonably suggested to one of ordinary skill in the art at the time of the invention that Onishi's polyethyleneimine- functionalized substrate would have enhanced binding selectivity for negatively charged biological species, including negatively charged host cell proteins, relative to positively charged species, as recited in claim 1. In addition, Onishi's disclosure that polyethyleneimine selectively absorbs viruses (Onishi col. 5, 11. 36-43), and that a polyamine- functionalized substrate exhibits a virus removal rate of 99.9% or more in a solution comprising 0 mM salt (Onishi col. 13, 11. 23--42) would have suggested to one of ordinary skill in the art at the time of the invention that Onishi's polyethyleneimine-functionalized substrate would have a log reduction value of at least 5. 0 for neutral viruses3, as recited in claim 1. Therefore, we are not persuaded of reversible error in the Examiner's determination that Onish reasonably would have suggested a 3 Appellants indicate that a log-reduction value of 5.0 corresponds to a 99.999 % virus removal rate. (App. Br. 13.) 7 Appeal2015-001542 Application 12/562,573 polyethyleneimine-functionalized substrate exhibiting enhanced binding selectivity for negatively charged biological species, including negatively charged host cell proteins, relative to positively charged species, while also exhibiting a log reduction value of at least 5.0 for neutral viruses, as recited in claim 1. Moreover, it is well-settled that language in an article claim directed to a function, operation, intent-of-use, and materials upon which the components of the article work, which does not structurally limit the claimed article, or patentably differentiate the claimed article from an otherwise identical prior art article, will not support patentability. See, e.g., In re Schreiber, 128 F.3d at 1477-79 ("Schreiber's contention that his structure will be used to dispense popcorn does not have patentable weight if the structure is already known" and "the Board [correctly] found that the Harz dispenser [for dispensing lubricating oil] would be capable of dispensing popcorn in the manner set forth in claim 1 of Schreiber's application."); see also In re Rishoi, 197 F.2d 342, 344--45 (CCPA 1952); In re Otto, 312 F.2d 937, 940 (CCPA 1963); In re Ludtke, 441F.2d660, 663---64 (CCPA 1971); In re Yanush, 477 F.2d 958, 959 (CCPA 1973). Appellants do not identify any structural differences between Onishi' s article and the article recited in claim 1. (App. Br. 11-14.) Nor do Appellants argue, much less demonstrate, that the functional limitations recited in claim 14 would have 4 The functional limitations recited in claim 1 are "wherein the ligand- functionalized substrate has enhanced binding selectivity for 8 Appeal2015-001542 Application 12/562,573 rendered the structure of the claimed article patentably distinguishable over the article disclosed in Onishi. (Id.) Accordingly, on this record, Appellants do not identify reversible error in the Examiner's determination that one of ordinary skill in the art, armed with the disclosures of Onishi, would have been led to the subject matter of claims 1, 4--10, 12-14, 21, and 22 within the meaning 35 U.S.C. § 103(a). We accordingly sustain the Examiner's§ 103(a) rejection of these claims as unpatentable over Onishi. Rejection of Claims 3, 11, and 23 under 35 U.S.C. § 103(a)5 Claims 3, 11, and 23 each require quaternary ammonium groups to be grafted to the surface of the polyethyleneimin-functionalized substrate. The Examiner concedes that Onishi does not disclose a polyethyleneimin-functionalized substrate having quaternary ammonium groups grafted to its surface, and relies on Guebert to remedy this deficiency in Onishi. (Ans. 9-10.) Guebert discloses a particulate anionic filter aid coated with a cationic organic polyelectrolyte used to attract and hold negatively charged biological species relative to positively charged species; wherein the negatively charged biological species comprise host cell proteins; and wherein the article yields a log-reduction value (LRV) of at least 5.0 for neutral viruses disposed in a solution comprising from 0 to about 150 mM salt." 5 Appellants argue claims 3, 11, and 23 as a group. (See generally App. Br. 14--20.) Therefore, for the purposes of this appeal, we select claim 3 as representative and decide the propriety of this rejection based on claim 3 alone. 9 Appeal2015-001542 Application 12/562,573 particles having a negative surface charge. (Guebert col. 1, 11. 12-17; col. 2, 11. 3---6.) Guebert discloses that suitable cationic organic polyelectrolytes include a polyvinylbenzyl quaternary ammonium salt, which have quaternary ammonium groups. (Guebert col. 1, 11. 24--30.) Guebert discloses that, in comparison with untreated filter aids, filter aids coated with such cationic organic polyelectrolytes permit larger volumes of liquids to be filtered per unit time, and allow for longer periods of operation between cleaning and/ or replacement of the filter. (Guebert col. 1, 11. 68-71.) The Examiner determines that it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate quaternary ammonium groups as disclosed in Guebert onto Onishi' s substrate to provide the benefits disclosed in Guebert. (Ans. 9-10.) However, we agree with Appellants that the Examiner does not demonstrate that there would have been an apparent reason or suggestion to modify Onishi' s article in such a way as to arrive at the article recited in claim 3. (App. Br. 18-19.) Onishi discloses that compounds having a quaternary ammonium group strongly interact with proteins, and as a result, in environments in which proteins are present, such as blood and liquid culture medium, such compounds non-specifically adsorb protein, diminishing their ability to selectively adsorb cells and viruses. (Onishi col. 4, 1. 63---col. 5, 1. 3.) The Examiner does not adequately explain, or provide any evidence to show, why one of ordinary skill in the art would have reasonably expected that incorporating a cationic polyvinylbenzyl 10 Appeal2015-001542 Application 12/562,573 quaternary ammonium salt as disclosed in Guebert onto the surface of Onishi's substrate would be useful, particularly when Onishi discloses that doing so would have a detrimental effect on the substrate's selective adsorption of viruses. Moreover, the Examiner does not adequately explain, or provide any evidence to show, why one of ordinary skill in the art reasonably would have grafted a quaternary ammonium group onto the surface of Onishi' s substrate, rather than coating the surface with compounds containing such groups, as disclosed in Guebert. (Guebert col. 2, 11. 20-23.) Accordingly, on this record, we concur with Appellants that the Examiner's evidence and explanation are not sufficient to establish a prima facie case of obviousness of the subject matter recited in claims 3, 11, and 23 in view of the disclosures of Onishi and Guebert within the meaning of 35 U.S.C. § 103(a). We therefore do not sustain this rejection of these claims. CONCLUSION In view of the reasons set forth above, we affirm the decision rejecting claims 1, 4--10, 12-14, 21, and 22 under§ 103(a), but reverse the Examiner's decision rejecting claims 3, 11, and 23 under§ 103(a). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED-IN-PART 11 Copy with citationCopy as parenthetical citation