Novartis AG

Patent Trials and Appeals BoardOct 20, 2020

14833378 - (D) (P.T.A.B. Oct. 20, 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. 14/833,378 08/24/2015 Steve Yun Zhang PAT056351-US-NP 9602 31781 7590 10/20/2020 ALCON RESEARCH, LLC PATENT DEPARTMENT 11460 JOHNS CREEK PARKWAY JOHNS CREEK, GA 30097-1556 EXAMINER ROLLAND, ALEX A ART UNIT PAPER NUMBER 1796 NOTIFICATION DATE DELIVERY MODE 10/20/2020 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): alcon_PAIR@firsttofile.com patent.docketing@alcon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte STEVE YUN ZHANG ____________ Appeal 2020-000251 Application 14/833,378 Technology Center 1700 ____________ Before KAREN M. HASTINGS, GEORGE C. BEST, and N. WHITNEY WILSON, Administrative Patent Judges. BEST, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–20 of Application 14/833,378. Final Act. (January 22, 2019). We have jurisdiction under 35 U.S.C. § 6. For the reasons set forth below, we reverse. I. BACKGROUND The ’378 Application describes methods for producing a soft silicone hydrogel contact lens that has been surface-modified to increase the 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Alcon Inc. as the real party in interest. Appeal Br. 1. Appeal 2020-000251 Application 14/833,378 2 hydrophilicity of the surface. Spec. 1–3. In particular, the Specification describes methods for forming a stable base coating on a silicone hydrogel contact lens by contacting the contact lens with an aqueous solution of a homo- or copolymer of acrylic acid or an acrylic acid derivative. Id. at 2–3. Claim 1 is representative of the ’378 Application’s claims and is reproduced below from the Appeal Brief’s Claims Appendix. 1. A method for producing coated silicone hydrogel contact lenses each having a crosslinked hydrophilic coating thereon, comprising the steps of: (a) obtaining a silicone hydrogel contact lens from a polymerizable composition comprising (i) at least one silicone-containing vinylic monomer or macromer, (ii) from about 35% to about 56% by weight of N- vinylpyrrolidone relative to the total amount of polymerizable components, and (iii) one or more hydrophilic vinylic monomers selected from the group consisting of N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, 2-acrylamidoglycolic acid, 3-acryloylamino-1-propanol, N-hydroxyethyl acrylamide, N-[tris(hydroxymethyl)methyl]-acrylamide, N-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3- methylene-2-pyrrolidone, 1-methyl-5-methylene-2- pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5- methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene- 2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1- n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3- methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2- pyrrolidone, 1-n-butyl-3-methylene-2-pyrrolidone, 1-tert- butyl-3-methylene-2-pyrrolidone, 2-hydroxyethyl- methacrylate, 2-hydroxyethyl acrylate, hydroxypropyl acrylate, hydroxypropyl methacrylate, trimethyl- ammonium 2-hydroxypropylmethacrylate hydrochloride, aminopropyl methacrylate hydrochloride, dimethyl- Appeal 2020-000251 Application 14/833,378 3 aminoethyl methacrylate, glycerol methacrylate, a C1-C4- alkoxy polyethylene glycol (meth)acrylate having a weight average molecular weight of up to 1500, methacrylic acid, N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, N-vinyl-N-methyl acetamide, allyl alcohol, and mixtures thereof, wherein the silicone hydrogel contact lens has a polymer matrix containing polyvinylpyrrolidone segments; and (b) contacting the silicone hydrogel contact lens with an aqueous solution of a homo- or copolymer of acrylic acid or C1- C3 alkylacrylic acid to form a base coating on the silicone hydrogel contact lens, wherein the aqueous solution of the homo- or copolymer of acrylic acid or C1-C3 alkylacrylic acid has a pH of from about 2.5 to about 5.5, wherein the homo- or copolymer of acrylic acid or C1-C3 alkylacrylic acid has a weight average molecular weight Mw of at least about 50,000 Daltons and is polyacrylic acid, polymethacrylic acid, polyethylacrylic acid, polypropylacrlic acid, poly(acrylic acid-co-methacrylic acid), poly[(meth)acrylic acid-co-ethylacrylic acid], poly[(meth)acrylic acid-co- propylacrylic acid], poly[(meth)acrylic acid-co-acrylamide], poly[(meth)acrylic acid-co-vinylpyrrolidone], poly[ethylacrylic acid-co-acrylamide], poly[ethylacrylic acid-co- vinylpyrrolidone], poly[propylacrylic acid-co-acrylamide], poly[propylacrylic acid-co-vinylpyrrolidone], hydrolyzed poly[(meth)acrylic acid-covinylacetate], hydrolyzed poly[ethylacrylic acid-co-vinylacetate], hydrolyzed poly[propylacrylic acid-co-vinylacetate], or combinations thereof, wherein the polyvinylpyrrolidone segments of the polymer matrix form, with the homo- or copolymer of acrylic acid or C1- C3 alkylacrylic acid, strong interpolymer complexes which are stable as characterized by having a water-break-up-time (WBUT) of about 20 seconds or more after the silicone hydrogel contact lens with the base coating thereon has been Appeal 2020-000251 Application 14/833,378 4 autoclaved at 115°C to 125°C in a phosphate buffered saline having a pH from about 6.5 to about 7.5 for about 30 minutes. Appeal Br. 8 (some paragraphing and indentation added). II. REJECTION On appeal, the Examiner maintains2 the following rejection: 1. Claims 1–20 are rejected under 35 U.S.C. § 103 as unpatentable over the combination of Valint,3 Rankin,4 Ferreiro,5 and Qiu.6 Final Act. 4. III. DISCUSSION Appellant argues for the reversal of the rejection of claims 1–20 as a group. See Appeal Br. 4–7. For reasons that shall become apparent, we limit our discussion to claim 1, the only independent claim. Appellant argues that the Examiner has failed to establish a prima facie case of obviousness because the combination of asserted references does not describe or suggest any of three limitations recited in claim 1. Because we determine that the Examiner erred by finding that Valint describes or suggests a polymerizable composition including both about 35 to about 56 weight percent NVP and a second hydrophilic vinylic monomer 2 The Examiner has withdrawn the rejection of claim 1 as indefinite. Ans. 3. 3 US 6,440,571 B1, issued August 27, 2002. 4 US 3,171,752, issued March 2, 1965. 5 US 2008/0226922 A1, published September 18, 2008. 6 US 2002/0086160 A1, published July 4, 2002. Appeal 2020-000251 Application 14/833,378 5 selected from the Markush group in claim 1, we need only address that limitation. Valint describes a composition comprising 10–50 wt. % NVP. Valint 7:3–20. This overlaps with the claimed range, rendering prima facie obvious. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of the claimed composition overlap the ranges disclosed in the prior art.”); In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974) (concluding that a claimed invention was rendered prima facie obvious by a prior art reference whose disclosed range (0.020- 0.035% carbon) overlapped the claimed range (0.030-0.070% carbon)). The Examiner found that it would have been obvious to include 2- hydroxyethyl methacrylate (HEMA)—one of the hydrophilic vinylic monomers in claim 1’s Markush group—in the polymerizable composition in addition to NVP because Valint’s Example 1 describes a representative silicone hydrogel contact lens material comprising 30% NVP and 1% N- vinyloxycarbonyl alanine (VINAL7). Final Act. 4 (citing Valint 17: 15–42). According to the Examiner, VINAL is a hydrophilic vinylic monomer. Id. (citing Koch8 ¶ 15 as evidence). According to the Examiner, because Valint’s Example 1 uses a mixture of NVP and an additional hydrophilic vinylic monomer in its polymerizable composition, it would have been obvious to use a combination of NVP and the other hydrophilic monomers described in Valint—i.e., HEMA—in a polymerizable composition. Id. 7 Both the Examiner and Appellant refer to VINAL as VINDAL. 8 US 2009/0146328 A1, published June 11, 2009. Appeal 2020-000251 Application 14/833,378 6 Appellant argues that the Examiner’s finding is incorrect because it is based on impermissible hindsight gleaned from the invention. Appeal Br. 5. According to Appellant, VINAL is included in Valint’s polymerizable composition to provide carboxylic acid functionalities that are essential to Valint’s surface treatment of the contact lens. Id. (citing Valint Examples 13, 16, 17). We agree with Appellant. A person of ordinary skill in the art reading Valint would have understood that VINAL’s inclusion in the polymerizable composition is for the purpose of providing carboxylic acid functionalities to serve as attachment points for later surface modification of the contact lens. Thus, the evidence does not support a finding that Valint would have suggested adding HEMA to the polymerizable composition comprising 10 to 50 weight percent NVP because HEMA is an ester and would not provide the needed carboxylic acid functionality. Moreover, Valint teaches the use of either NVP or HEMA in the polymerizable composition. See Valint 7:3–20. Valint does not mention using a mixture of the two monomers.9 For this reason, a person of ordinary skill in the art would not have been motivated to create a polymerizable composition comprising both NVP and HEMA based upon Valint’s teachings. Thus, we reverse the rejection of claim 1. Because we have reversed the rejection of claim 1, we also reverse the rejection of claims 2–20, which depend from claim 1. 9 Valint does not include the commonly used phrase “or mixtures thereof” to conclude its list of hydrophilic monomers. Valint 7:19. Rather, Valint states that its polymerizable composition comprises “10 to 50 percent, preferably 20 to 40 percent, by weight of a hydrophilic monomer” selected from a list that includes both NVP and HEMA as possible alternatives. Id., 7:9–10 (emphasis added). Appeal 2020-000251 Application 14/833,378 7 IV. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–20 103 Valint, Rankin, Ferreiro, Qiu 1–20 REVERSED