Ex Parte KabraDownload PDFPatent Trial and Appeal BoardJan 25, 201712630399 (P.T.A.B. Jan. 25, 2017) Copy Citation 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. 12/630,399 12/03/2009 Bhagwati P. Kabra PAT903481-US-NP 9660 1095 7590 01/27/2017 NOVARTIS PHARMACEUTICAL CORPORATION INTELLECTUAL PROPERTY DEPARTMENT ONE HEALTH PLAZA 433/2 EAST HANOVER, NJ 07936-1080 EXAMINER FAY, ZOHREH A ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 01/27/2017 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): phip.patents@novartis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BHAGWATI P. KABRA1 Appeal 2016-000616 Application 12/630,399 Technology Center 1600 Before JOHN G. NEW, SHERIDAN K. SNEDDEN, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a pharmaceutical suspension. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellant, the real party in interest is Novartis AG. (Appeal Br. 2.) Appeal 2016-000616 Application 12/630,399 STATEMENT OF THE CASE Claims on Appeal Claims 1—26 are on appeal. (Claims Appendix, Appeal Br. 17—20.) Independent claim 1 is illustrative and reads as follows: Claim 1: A pharmaceutical suspension, comprising: an aqueous solution that includes high molecular weight polyethylene glycol, polyethylene oxide or both as a suspending agent, the high molecular weight polyethylene glycol, when included, having a molecular weight that is at least 2000; and a therapeutic agent that is suspended by the high molecular weight polyethylene glycol, polyethylene oxide or both within the solution wherein: i. the polyethylene oxide, when included in the suspension, is in the suspension at a concentration that is at least 0.5 w/v% but less that 10 w/v% and has a molecular weight of 100,000 to 8,000,000; and ii. the polyethylene glycol, when included in the suspension, is in the suspension at a concentration that is at least 15 w/v% but less that 50 w/v%. Examiner’s Rejection Claims 1—26 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Takeuchi,2 Naka,3 and Castillo.4 (Ans. 3—5.) FINDINGS OF FACT FF 1. Takeuchi states that The concentration of PEG is within the range of 0.5 to 13 (W/v)%. This is because if the concentration of PEG is less than 0.5 (W/V)%, the resulting composition becomes hard to form gel at a local region and hence loses practical value, while if the concentration is more than 13 (w/v)%, the composition shows high viscosity in the sol state. (Takeuchi col. 3,11. 13—18.) 2 Takeuchi et al., US 5,756,552, issued May 26, 1998 (“Takeuchi”). 3 Naka et al., US 6,624,193 Bl, issued Sept. 23, 2003 (“Naka”). 4 Castillo et al., US 6,743,439 Bl, issued June 1, 2004 (“Castillo”). 2 Appeal 2016-000616 Application 12/630,399 FF 2. Takeuchi states that The weight-average molecular weight of PEG used in the present invention is preferably 1000 to 50,000. This is because if the weight-average molecular weight is less than 1000, the resulting composition tends to be hard to form gel at a local region, while if it is more than 50,000, the viscosity thereof in the liquid state is too high. {Id. at col. 2,11. 58—63.) FF 3. The Examiner finds that “polyethylene glycol and polyethylene oxide are synonyms, and PEG’S at the molecular weight of less than 100,000 are called polyethylene glycol and at the higher molecular weights are called polyethylene oxide.” (Ans. 6.) DISCUSSION Issue Whether a preponderance of evidence of record supports the Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a). Analysis The Examiner states that “[t]he prior art clearly teaches a suspension of a drug and the high molecular weight polyethylene glycol, polyethylene oxide. Such composition is expected to have all the characteristics of the claimed composition, considering that all the components are the same.” (Final Act. dated July 18, 2014, at 3.) The Examiner also states that Takeuchi “teaches the concentration of 0.5-13% for polyethylene glycol, which is close to the claimed lower limit concentration.” {Id. at 4; FF 1.) In the Answer, the Examiner states that Takeuchi “might teach away from using the concentration of polyethylene glycol above 13%, but it still reads on the concentration and molecular weight of polyethylene oxide as claimed herein.” (Ans. 6.) 3 Appeal 2016-000616 Application 12/630,399 Appellant argues that Takeuchi “specifically teach[es] away from moving outside of the range of PEG of 0.5 to 13%.” (Appeal Br. 9.) Appellant argues further that “the lower molecular weight limit for polyethylene glycol [sic oxide] is 100,000. Takeuchi [] teach[es] toward using a weight-average molecular weight of half of 100,000.” (Reply Br. 5; see FF 2.) We find that the Appellant has the better position. Takeuchi teaches polyethylene glycol (PEG) with a concentration within the range of 0.5 to 13 (w/v)% and a molecular weight of 1,000 to 50,000. (FF 1, 2.) Moreover, Takeuchi discourages the use of polyethylene glycol having a concentration or molecular weight outside those ranges. (Id.) Even if we assume that the polyethylene glycol taught by Takeuchi includes polyethylene oxide (see FF 3),5 Takeuchi teaches the concentration of the claimed polyethylene oxide (but not the molecular weight) and the molecular weight of the claimed polyethylene glycol (but not the concentration). (FF 1, 2.) Stated another way, Takeuchi does not teach or suggest (1) polyethylene glycol with a molecular weight of at least 2000 and a concentration of at least 15 w/v% but less than 50 w/v%, or (2) polyethylene oxide with a molecular weight of 100,000 to 8,000,000 and a concentration of at least 0.5 w/v% but less than 10 w/v%.6 5 The Examiner’s apparent assumption that Takeuchi also teaches polyethylene oxide, due to its reference to a few commercially available PEGs that may have molecular weights greater than 100,000 (Ans. 6), does not appear to be sound in light of its clear teaching of molecular weight less than 100,000 (FF 2). (See Appeal Br. 8, n.l (“[Appellant] finds no suggestion of polyethylene oxide in Takeuchi.”)). 6 Claim 21, the only other independent claim on appeal, includes limitations similar to claim 1. (Appeal Br. 19.) 4 Appeal 2016-000616 Application 12/630,399 The Examiner bears the initial burden of establishing a prima facie case of obviousness and has not done so. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Here, the Examiner fails to explain why a person skilled in the art would modify either the concentration or molecular weight of Takeuchi to meet the limitations of the claimed polyethylene oxide or polyethylene glycol, particularly in the face of clear discouragement against doing so. (FF 1, 2.) See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (Examiner has burden of showing “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”); see also In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (a reference may teach away by discouraging the claimed invention). Accordingly, we reverse. Conclusion of Law A preponderance of evidence of record fails to support the Examiner’s conclusion that claims 1—26 are obvious under 35 U.S.C. § 103(a). SUMMARY We reverse the rejection of all claims on appeal. REVERSED 5 Copy with citationCopy as parenthetical citation