Ex Parte Deorkar et alDownload PDFPatent Trial and Appeal BoardAug 29, 201311813434 (P.T.A.B. Aug. 29, 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. 11/813,434 07/06/2007 Nandu Deorkar 2198-18 PCT/US/RCE II 2411 23869 7590 08/29/2013 Hoffmann & Baron LLP 6900 Jericho Turnpike Syosset, NY 11791 EXAMINER ZALASKY, KATHERINE M ART UNIT PAPER NUMBER 1777 MAIL DATE DELIVERY MODE 08/29/2013 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 NANDU DEORKAR, ROBERT C. BUSS, JOSEPH M. MLADOSICH, and PAUL A. BOUIS ____________ Appeal 2012-006357 Application 11/813,434 Technology Center 1700 ____________ Before CHUNG K. PAK, MICHAEL P. COLAIANNI, and GEORGE C. BEST, Administrative Patent Judges. PAK, Administrative Patent Judge DECISION ON APPEAL The named inventors (hereinafter “Appellants”)1 appeal under 35 U.S.C. § 134 from the Examiner’s final rejection of claims 6 through 8, 10 through 12, 15, 16, 19, and 20, all of the claims pending in the above- identified application.2 We have jurisdiction pursuant to 35 U.S.C. § 6(b). 1 Appellants identify the real party in interest as Avantor Performance Materials, Inc. owned by Avantor Performance Materials Holdings S.A., a Luxembourg Company. (See Appeal Brief filed September 20, 2011 (“App. Br.”) at 2.) 2 (See id.; Final Office action mailed April 18, 2011(“FR”) at 1.) Appeal 2012-006357 Application 11/813,434 2 STATEMENT OF THE CASE The subject matter on appeal is directed to “chromatographic media, preferably mixed anion exchangers, mixed anion-cation exchangers and hydrophobic exchangers.” (Spec. 1, ll. 8-10.) The chromatographic media is “prepared using polymeric particles derivatized3 with polyethyleneimine, and preferably such polyethyleneimine derivatized polymeric particles further functionalized with appropriate reactants.” (Id. at 5, ll. 14-17.) This polymeric particle-based chromatographic media is said to minimize or avoid the stability problem associated with conventional silica particle-based chromatographic media at high pH. (Id. at 3, ll. 5-14.) The polymeric particle-based chromatographic media, like the conventional silica particle- based chromatographic media, is used for separating proteins (id. at 1-2.) Details of the appealed subject matter are recited in representative claim 64 reproduced below: 6. Chromatographic media comprising epoxidized polymeric resin particles derivatized by reaction with polyethyleneimine on the surface of the polymer and wherein the epoxidized polymeric particles are epoxidized polyacrylates or polymethacrylates, wherein the polymeric resin particles derivatized with polyethyleneimine on the surface of the polymer are functionalized by reaction of a functionalization reagent with terminal amino groups of the polyethyleneimine on the surface of the polymeric resin, and wherein the functionalization reagent is selected from the group consisting 3 The term “derivatized” recited in the claims on appeal includes polyethyleneimine reacted or bound to the surface of epoxidized polyacrylate or polymethacrylate particles, but excludes polyethyleneimine cross-linked to epoxidized polyacrylate or polymethacrylate particles. (Spec. 3, ll. 17-18.) 4 For purposes of this appeal, we limit our discussion to argued claim 6 consistent with 37 C.F.R. § 41.37(c)(1)(vii). Appeal 2012-006357 Application 11/813,434 3 of: acid anhydrides, sulfonation agents, alkyl chlorides, and alkyl chlorides containing quaternary ammonium functionality, and mixtures thereof. (App. Br. 13 (Claims App’x)). Appellants seek review of the Examiner’s rejection of claims 6 through 8, 10 through 12, 15, 16, 19, and 20 under 35 U.S.C. § 103(a) as unpatentable over either Muranaka ‘7295 or ‘8206 in view of Ramsden7 maintained in the Examiner’s Answer mailed December 8, 2011 (“Ans.”). (See App. Br. 5.) DISCUSSION Appellants do not dispute the Examiner’s finding that either Muranaka ‘729 or ‘820 discloses chromatographic media comprising epoxidized polymeric particles, such as epoxidized polyacrylate or polymethacrylate particles, derivatized with polyethyleneimine. (Compare Ans. 4-5 and 6 with App. Br. 6-12.) Nor do Appellants dispute the Examiner’s finding that either Muranaka ‘729 or ‘820 teaches employing such derivatized polymeric particles in chromatography for separating proteins.8 (Compare Ans. 4-5 and 6 with App. Br. 6-12.) 5 U.S. Patent Application Publication No. 2002/0134729 A1 published in the name of Muranaka et al. on September 26, 2002 (“Muranaka ‘729”). 6 U.S. Patent No. 6,689,820 B2 issued to Muranaka et al. on February 10, 2004 (“Muranaka ‘820”). 7 U.S. Patent No. 4,551,245 issued to Ramsden et al. on November 5, 1985 (“Ramsden”). 8 Indeed, Muranaka ‘729 or ‘820 teaches that polyethyleneimine introduced onto the fine particles surface exhibits an enhanced ion exchanging capacity and an enhanced adsorption capacity for protein. (Muranaka ‘729, 4, ¶¶ [0039] and [0061]; Muranaka ‘820, col. 8, ll. 4-18.) Appeal 2012-006357 Application 11/813,434 4 Rather, Appellants contend that one of ordinary skill in the art, armed with the knowledge reflected in the collective teachings of either Muranaka ‘729 or ‘820, and Ramsden, would not have been led to functionalize polyethyleneimine reacted or bound to the surface of epoxidized polyacrylate or polymethacrylate particles, with a reasonable expectation of successfully using them in chromatography for separating proteins. (App. Br. 7-8.) In support of this contention, Appellants assert that Ramsden does not teach functionalizing polyethyleneimine on the surface of epoxidized polyacrylate or polymethacrylate particles for the purpose of solving the stability problem associated with using silica particles at high pH. (Id. at 7.) According to Appellants, Ramsden is directed to functionalizing polyethyleneimine bound to the surface of silica particles, rather than to functionalizing polyethyleneimine bound to the surface of the epoxidized polymeric particles. (Id.) Appellants also contend that the claimed subject matter imparts unexpected results relative to the closest prior art, thereby overcoming any inference of obviousness reflected in the collective teachings of either Muranaka ‘729 or ‘820, and Ramsden. (Id. at 8-12.) In support of this contention, Appellants refer to Examples 33, 34, and 37 and Figures 1, 2, and 3 in the instant application and to a declaration executed by one of the inventors, Nandu Deorkar, on August 4, 2010 (“Deorkar Declaration”). (Id.) Thus, the dispositive questions raised are: (1) Did the Examiner err in finding that one of ordinary skill in the art, armed with the knowledge reflected in the collective teachings of either Muranaka ‘729 or ‘820, and Ramsden, would have been led to functionalize polyethyleneimine reacted or bound to the surface of epoxidized Appeal 2012-006357 Application 11/813,434 5 polyacrylate or polymethacrylate particles, with a reasonable expectation of successfully using them in chromatography for separating proteins? (2) Did the Examiner err in determining that Appellants have not demonstrated that the showing in the Declaration and the Specification is sufficient to outweigh the evidence of obviousness reflected in the collective teachings of either Muranaka ‘729 or ‘820, and Ramsden? On this record, we answer these questions in the negative substantially for the reasons set forth by the Examiner in the Answer. We add the following for emphasis and completeness. As found by the Examiner at page 7 of the Answer, Ramsden teaches that polyethyleneimine (PEI) bound to the surface of silica particles, like the polyethyleneimine bound to the surface of epoxidized polyacrylate or polymethacrylate particles taught by Muranaka ‘729 or ‘820, are useful as packing materials in chromatography columns for separating proteins. (See Ramsden, col. 1, l. 45 to col. 2, l. 31; see also Appellants’ admission at page 2 of the Specification regarding “‘Polyethyleneimine Bound Chromatographic Packing,’” such as PEI derivatized or covalently bound silica particles.) Ramsden also teaches that functionalized polyethyleneimine, like non-functionalized polyethyleneimine, can be bound to the surface of silica particles for use in chromatography for separating proteins. (See Ans. 4-7 and Ramsden, col. 1, ll. 5-24 and col. 4, ll. 31-51.) In particular, Ramsden teaches that functionalizing polyethyleneimine bound to silica particles with an acylating agent, such as acetic anhydride or butyryl chloride, provides “marked advantages in separating proteins” with a good hydrolytic stability. (See Ans. 4-8 and Ramsden, col. 4, ll. 45-56, col. 5, l. 48 to col. 6, l. 7.) In other words, the collective teachings of Muranaka ‘729 Appeal 2012-006357 Application 11/813,434 6 or ‘820 and Ramsden indicate that silica particles and polymeric particles, such as epoxidized polyacrylate or polymethacrylate particles, can be interchangeably used with polyethyleneimine (PEI) or functionalized polyethyleneimine (PEI) in chromatography for the protein separation purposes, with the use of the functionalized polyethyleneimine imparting a superior protein separation result relative to the use of the non- functionalized polyethyleneimine. Given the above teachings, we find no reversible error in the Examiner’s determination that one of ordinary skill in the art would have had an apparent reason to employ a functionalized PEI (PEI functionalized with an acylating agent, such as acetic anhydride or butyryl chloride) bound to the surface of either silica particles or polymeric particles, such as epoxidized polyacrylate or polymethacrylate particles, with a reasonable expectation of successfully using them as packing materials in chromatography for separating proteins. In reaching this determination, we have noted the reason or motivation provided by the collective teachings of either Muranaka ‘729 or ‘820 and Ramsden to arrive at the epoxidized polymeric particles having the bound functionalized PEI recited in the claims on appeal is not identical to the problem solving or reason stated by Appellants in the Specification. However, such reason or motivation need not be identical to that contemplated by Appellants so long as it would have led one of ordinary skill in the art to the claimed subject matter.9 In re Kemps, 97 F.3d 1427, 9 It is understandable that Muranaka ‘729 or ‘820 is not concerned with the problem solving contemplated by Appellants. Muranaka ‘729 and ‘820 are directed to PEI bound to the surface of epoxidized polymeric particles, such as epoxidized polyacrylate or polymethacrylate particles, which, according Appeal 2012-006357 Application 11/813,434 7 1430 (Fed. Cir. 1996) (“Although the motivation to combine here differs from that of the applicant, the motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness.”) Appellants rely on Examples 33, 34, and 37 and Figures 1, 2, and 3 in the instant application and on the Deorkar Declaration to demonstrate that the claimed subject matter as a whole shows unexpected results relative to the closest prior art. The examples and figures in the instant application relied upon by Appellants show protein separation comparisons between chromatographic columns packed with silica media sold as “J T Baker product no. 7285” or “PEI silica media” sold as J T Baker “Product Number 7264, lot N 16084” and chromatographic columns packed with 70 grams or 60 grams PEI functionalized polymer particles prepared according to Example 1 which are further reacted with 56. 3 grams of butyric anhydride and 36 grams of triethylamine or 49 grams of 3(dimethylamino) propyl chloride at specific reaction conditions for specific reaction periods. According to Example 1, the polymer particles having bound PEI are prepared as follows: 12 g epoxy bearing methacrylate polymer with average particle size of 35 micron diameter and 200 ml dioxane are placed in a 1L round bottom flask equipped with a funnel, agitator, reflux condenser and positive nitrogen pressure inlet and stirred for 30 min to allow the resin to swell. 20 g polyethyleneimine (PEI, average molecular weight 600 Daltons) is added and the funnel rinsed with an additional 150 ml dioxane. The stirred mixture is refluxed overnight. After allowing the mixture to cool, the mixture is transferred to a to Appellants, does not suffer from any instability problem at high pH, unlike PEI bound to silica particles. Appeal 2012-006357 Application 11/813,434 8 filter flask, drained, washed once with dioxane, three times with methanol and dried under vacuum at 60oC. (Spec. 8-9.) The Specification indicates the criticality of employing a particular solvent to eliminate the presence of water. (Id. at 10, ll. 11-15.) Appellants do not refer to any part of the Specification to provide the details of silica media sold as “J T Baker product no. 7285” or “PEI silica media” sold as J T Baker “Product Number 7264, lot N 16084.” The Deorkar Declaration relied upon by Appellants also states that “epoxidized resin particles derivatized with PEI, but without the functionalization groups as disclosed in Muranaka” were compared with “such epoxidized resin particles derivatized with PEI, but functionalized with the functionalization groups (succinic anhydride) to provide both weak anion and weak cation exchange in accordance with our claimed invention.” According to page 2 of the Deorkar Declaration, “[t]he non-functionalized PEI derivatized epoxidized resin particles media of Muranaka could not separate the mixture of proteins whereas the functionalized PEI derivatized epoxidized resin particles media of this invention clearly separated such proteins. . . .” However, the Deorkar Declaration does not indicate what epoxidized resin particles and PEI were used and what reaction conditions and solvents were used to derivatize such unknown epoxidized resin particles with an unknown amount of a PEI having an unknown number average molecular weight in its test. The Deorkar Declaration’s stated results contradict Appellants’ own statement in the Specification that the chromatographic media “prepared using polymeric particles derivatized with polyethyleneimine” is useful for separating proteins as discussed supra. Appeal 2012-006357 Application 11/813,434 9 As correctly found by the Examiner at page 9 of the Answer, Muranaka ‘729 and ‘820 are the closest prior art inasmuch as they are directed to PEI bound to the surface of epoxidized polyacrylate or polymethacrylate particles useful as chromatography packing materials in separating proteins. Notwithstanding the statements based on certain ambiguous experiments in the Deorkar Declaration to the contrary, Muranaka ‘729 actually showed “a large adsorption capacity for protein and a high separation performance” when anion exchangers prepared from 50 grams of epoxidized porous hydrophilic acrylate polymer particles having an average particle diameter of 10 µm reacted with 15 grams of polyethyleneimine having a number average molecular weight of 70,000 were used as chromatography packing materials in separating proteins. (See, e.g., Muranaka ‘729, 4, ¶¶ [0039] and [0061], Example 1.) Nowhere do Examples 33, 34 and 37 and Figures 1, 2, and 3 in the instant application indicate that the closest prior art, namely Example 1 of Muranaka ‘729, was compared with the claimed subject matter. Nor can it be ascertained from the ambiguous showing in the Deorkar Declaration whether the claimed subject matter was compared with the closest prior art, Example 1 of Muranaka ‘729. On this record, Appellants have not demonstrated that the showing relied upon is based on a comparison between the claimed subject matter and the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); In re Chapman, 357 F.2d 418, 422 (CCPA 1966). Moreover, as correctly found by the Examiner at page 10 of the Answer, Appellants have not demonstrated that the showing in the Specification and the Deorkar Declaration is reasonably commensurate in scope with the degree of protection sought by the claims on appeal. While Appeal 2012-006357 Application 11/813,434 10 the showing is limited to employing cation or anion exchangers prepared from 12 g epoxy bearing methacrylate polymer particles having an average particle size of 35 micron diameter with 20 g, 60 g, or 70 g polyethyleneimine having an average molecular weight of 600 Daltons in a specific solvent and two or three specific functionalizing agents for functionalizing polyethyleneimine bound to the epoxy bearing methacrylate polymer particles, the claims on appeal are not so limited. On this record, Appellants have not shown that the unexpected results allegedly achieved with a very few specific anion and cation exchanges are also applicable to all of the chromatographic media covered by the claims on appeal. See, e.g., In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (“Even assuming that the results were unexpected, Harris needed to show results covering the scope of the claimed range. Alternatively Harris needed to narrow the claims.”); In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978)(“Establishing that one (or a small number of) species gives unexpected results is inadequate proof, for ‘it is the view of this court that objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.’” (quoting In re Tiffin, 448 F.2d 791, 792 (CCPA 1971)). Accordingly, based on the totality of evidence of record, including due consideration of Appellants’ arguments and evidence anew in light of the evidence proffered by the Examiner, we determine that the preponderance of evidence weighs most heavily in favor of obviousness within the meaning of 35 U.S.C. § 103(a). Appeal 2012-006357 Application 11/813,434 11 ORDER Upon consideration of the record, and for the reasons given above and in the Answer, it is ORDERED that the Examiner’s decision rejecting the claims on appeal under 35 U.S.C. § 103(a) is AFFIRMED; and FURTHER ORDERED that no time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a) (2010). AFFIRMED bar Copy with citationCopy as parenthetical citation