15316614 - (D) (P.T.A.B. Oct. 23, 2020)

Avantor Performance Materials, LLC

Patent Trials and Appeals BoardOct 23, 2020

15316614 - (D) (P.T.A.B. Oct. 23, 2020)

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. 15/316,614 12/06/2016 Bhaktavachalam THIYAGARAJAN 2198-154 PCT/US 9752 23869 7590 10/23/2020 Hoffmann & Baron LLP 6900 Jericho Turnpike Syosset, NY 11791 EXAMINER COHEN, STEFANIE J ART UNIT PAPER NUMBER 1732 MAIL DATE DELIVERY MODE 10/23/2020 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 BHAKTAVACHALAM THIYAGARAJAN, MARTINA COX, and NANDU DEORKAR Appeal 2020-000309 Application 15/316,614 Technology Center 1700 Before JEFFREY T. SMITH, N. WHITNEY WILSON, and DEBRA L. DENNETT, Administrative Patent Judges. WILSON, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s June 20, 2018 decision to finally reject claims 1, 3–7, and 10–20 (“Final Act.”). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Avantor Performance Materials, LLC (Appeal Br. 3). Appeal 2020-000309 Application 15/316,614 2 CLAIMED SUBJECT MATTER Appellant’s disclosure is directed to high purity carbohydrate composition and a method of making such a composition (Abstract). The method includes passing an aqueous carbohydrate solution through an anion exchange column including a polyethyleneimine (PEI) chromatographic media to obtain a purified solution and isolating the highly pure carbohydrate composition from the purified solution (id.). Claim 1, which is reproduced below, is illustrative of the claimed subject matter: 1. A method of making a highly pure carbohydrate composition comprising: i) passing an aqueous carbohydrate solution through an anion exchange chromatography column to obtain a purified solution; and ii) isolating a highly pure carbohydrate composition from said purified solution, wherein said anion exchange resins is made of polyethyleneimine (PEI), said highly pure carbohydrate composition is selected from the group of sucrose, galactose, or trehalose, and said carbohydrate composition has an endotoxin level of less than 1 endotoxin unit per gram. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Deorkar et al. US 2008/0203029 A1 August 28, 2008 Heikkilä et al. US 7,722,721 B2 May 25, 2010 MFK Series - https://web.archive.org/web/20120904100600/http://www.kochmembrane .com/Membrane-Products/Spiral/Microfiltration/MFK-Series.aspx REJECTIONS 1. Claims 1, 3–6, and 10–20 are rejected under 35 U.S.C. § 103 as unpatentable over Heikkilä in view of Deorkar. Appeal 2020-000309 Application 15/316,614 3 2. Claim 7 is rejected under 35 U.S.C. § 103 as unpatentable over Heikkilä in view of Deorkar, and further in view of MFK Series. OPINION Appellant does not argue either rejection or any claim separately. Accordingly, we focus our discussion on the rejection of claim 1 over Heikkilä in view of Deorkar. The remaining claims will stand or fall with claim 1. The Examiner finds that Heikkilä teaches a process for recovering galactose from a solution by subjecting the solution to one or more chromatographic fractionations using a strongly basic anion exchange resin, recovering at least one fraction enriched in galactose, and recrystallizing a crystalline galactose product from that fraction (Final Act. 2–3). The Examiner also finds that Heikkilä does not teach the use of anion exchange resins is made of PEI, but that Deorkar teaches the use of chromatographic media useful for bioseparations including PEI (Final Act. 4). The Examiner determines that it would have been obvious to use PEI as taught by Deorkar in Heikkilä’s process because Deorkar teaches that PEI provides a media offering enhanced separation capability, high capacity, and high stability (Final Act. 5). Appellant argues that Heikkilä’s process is complex, not simple and efficient like the claimed process (Appeal Br. 7). Appellant contends that Heikkilä’s process requires at least two chromatographic fractionation steps (id.; Appeal Br. 10, citing claim 1), and that a person of skill in the art would not look to Heikkilä for a simple, one step process (Appeal Br. 11). Appellant further argues that Heikkilä is directed to recovering galactose only, not other carbohydrates (Appeal Br. 10). Appeal 2020-000309 Application 15/316,614 4 Appellant also argues that a person of skill in the art would not have looked to Deorkar because Deorkar relates to the separation of proteins, not carbohydrates (Appeal Br. 11). Appellant’s arguments are not persuasive of reversible error. With regard to Appellant’s contention that Heikkilä requires at least two chromatographic fractionation steps, we note that Heikkilä states: The invention relates to a process of recovering galactose from a solution, which is derived from plant-based biomass. The process of the invention comprises subjecting said solution derived from plant-based biomass to one or more chromatographic fractionations, recovering at least one fraction enriched in galactose, subjecting said at least one fraction enriched in galactose to crystallization, and recovering a plant-based crystalline galactose product. In one embodiment of the invention, said one or more chromatographic fractionations comprise one or more chromatographic fractionation steps using a column packing material selected from strongly basic anion exchange resins. (Heikkilä, 6:42–55, emphasis added). Thus, Heikkilä plainly states that only a single fractionation step is required. The term “one or more” means that a single fractionation step is taught by the reference. That the claims require at least two fractionation steps does not change that the disclosure expressly indicates that only one fractionation step is required. A prior art reference is analyzed from the vantage point of all that it teaches one of ordinary skill in the art. See In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”). A reference is not limited to its preferred embodiment, but must be evaluated for all of its Appeal 2020-000309 Application 15/316,614 5 teachings, including its teachings of non-preferred embodiments. See In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979). In this instance Heikkilä teaches that only a single fractionation step is required, even if at least two are preferred, as reflected in the claims, the examples, and the prosecution history. A person of skill in the art reviewing Heikkilä would understand that a Heikkilä’s process could involve the use of a single chromatographic fractionation step. Moreover, the method of claim 1 is not limited to single fractionation step, as the claim states that the method “comprises” the recited steps, allowing for the inclusion of additional steps. With regard to Appellant’s argument that “[o]ne of ordinary skill in the art would not look to combine Deorkar and [Heikkilä] since the separations of proteins and carbohydrates are very different” (Appeal Br. 11), Appellant has not pointed to any evidence to support its position. Accordingly, this argument is entitled to little, if any, weight. In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Moreover, Appellant has not addressed the Examiner’s findings that (1) Deorkar discloses chromatographic media which are especially useful for bioseparators, and (2) Heikkilä’s method is a bioseparation method because the galactose is recovered from plant-based biomass and, therefore, is biologically based (Ans. 13). Nor has Appellant meaningfully challenged the Examiner’s explanation of why a person of skill in the art would have modified Heikkilä’s method to use Deorkar’s PEI chromatographic medium. Accordingly, we determine that Appellant has not demonstrated reversible error in the rejections. Appeal 2020-000309 Application 15/316,614 6 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–6, 10–20 103 Heikkilä, Deorkar 1, 3–6, 10–20 7 103 Heikkilä, Deorkar, MFK Series 7 Overall Outcome 1, 3–7, 10–20 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED