10461839 (B.P.A.I. Jun. 25, 2009)

Ex Parte Kerwin et al

Board of Patent Appeals and InterferencesJun 25, 2009

10461839 (B.P.A.I. Jun. 25, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte BRUCE KERWIN, BYEONG CHANG, and LEI SHI __________ Appeal 2008-004371 Application 10/461,839 Technology Center 1600 __________ Decided1:June 25, 2009 __________ Before DONALD E. ADAMS, ERIC GRIMES, and MELANIE L. McCOLLUM, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants have requested rehearing of the decision entered March 9, 2009 (“Decision”). The Decision affirmed the rejection of claims 1-3, 6, and 10-16 as obvious in view of the combination of Fisher and Edwards. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date shown on this page of the decision. The time period does not run from the Mail Date (paper delivery) or Notification Date (electronic delivery). Appeal 2008-004371 Application 10/461,839 ISSUE Did our analysis of the rejection of claims 1-3, 6, and 10-16 as obvious in view of the combination of Fisher and Edwards result in a new ground of rejection? If so, did our analysis misapprehend or overlook a material fact on this record? FINDINGS OF FACT FF 1. Appellants contend that the Board relied on “two new factual assertions to support its decision” (Req. Reh’g. 2). Specifically, Appellants contend that the Board’s findings that: 1. “a concentration of at least 45 mg/ml PEGsTNF-R1 would have been obvious to a person of ordinary skill in the art in view of the combination of Fisher and Edwards”; and 2. “a person of ordinary skill in the art would have reasonably expected that a formulation comprising 45 mg/ml of PEGsTNF-R1 as taught by the combination of Fisher and Edwards would have a viscosity of less than 400 cP or 200 cP” represent new factual findings that necessitate a new ground of rejection which would provide Appellants with an opportunity to provide the Examiner with “evidence concerning the new factual findings made in the Decision” (Req. Rhg. 2 and 7). FF 2. Appellants’ Specification discloses that in “preliminary studies with PEGsTNF-R1 it was found that as the PEGsTNF-R1 is concentrated, the viscosity of the solution increases exponentially” (Spec. 5: 9-12). 2 Appeal 2008-004371 Application 10/461,839 PRINCIPLES OF LAW A new ground of rejection occurs when the Examiner and the Board rejected a claim for different reasons. In re Kumar, 418 F.3d 1361, 1368 (Fed. Cir. 2005), citing In re Waymouth, 486 F.2d 1058, 1060-61 (CCPA 1973). “[T]he ultimate criterion of whether a rejection is considered ‘new’ in a decision by the board is whether appellants have had fair opportunity to react to the thrust of the rejection”. In re Kronig, 539 F.2d 1300, 1302 (CCPA 1976). Other principles of law are set forth in the Decision. ANALYSIS For the following reasons, we agree with Appellants that the Decision raises new issues and therefore our affirmance of the Examiner’s rejection under 35 U.S.C. § 103, should have been a new ground of rejection on this record. We previously found that the Examiner’s reliance on Lukas fails to support the Examiner’s finding that a person of ordinary skill in this art would recognize that 5 ml is an appropriate volume to administer as a single subcutaneous dose to monkeys (Decision 12). This is a significant finding that cuts against the rationale that led the Examiner to conclude that Appellants’ concentration of at least 45 mg/ml would have been obvious to a person of ordinary skill in this art at the time the invention was made (Decision 8; Ans. 4). Nevertheless, we found that since the prior art taught that an effective subcutaneous dosage of PEGsTNF-R1 was 250 mg, it would have been 3 Appeal 2008-004371 Application 10/461,839 within the level of ordinary skill in this art to identify/optimize a working formulation that would provide a 250 mg dose of PEGsTNF-R1 in a reasonable volume (Decision 12). In this regard, we found that a reasonable working formulation having “a concentration of at least 45 mg/ml PEGsTNF-R1 would have been obvious to a person of ordinary skill in the art in view of the combination of Fisher and Edwards” (Decision 12-13). We then agreed with the Examiner that a composition comprising 45 mg/ml PEGsTNF-R1 would “have a viscosity of less than 400 cP and/or 200 cP” (Decision 13). While we did not rely on the “viscosity reference sheet” relied upon by the Examiner (Ans. 10), we did rely on Fisher’s teaching of “suitable pharmaceutical excipients that contribute to the stability and viscosity of the PEGsTNF-R1 formulation” (Decision 13-14; Req. Rhg. 3). However, neither Fisher nor Edwards suggest that a PEGsTNF-R1 composition should have a viscosity of less than 400 cP and/or 200 cP. At best, Fisher suggests that the composition may contain excipients that modify or maintain the viscosity of a composition (Decision 6). Edwards is silent with respect to the viscosity of the composition. Thus, while, at best there is a suggestion in the art of excipients that modify or maintain the viscosity of a composition, we have no teaching in the art of a particular viscosity for subcutaneous administration of a composition and certainly no teaching of a viscosity of 200 or less than 400 cP. Instead, we have a disclosure in Appellants’ Specification teaching that in “preliminary studies with PEGsTNF-R1 it was found that as the PEGsTNF-R1 is concentrated, the viscosity of the solution increases exponentially” (FF 2). 4 Appeal 2008-004371 Application 10/461,839 On reconsideration, we agree with Appellants that our conclusion regarding the viscosity element of the claimed invention was based on hindsight (Req. Rhg. 3-5). Nothing in Edwards or Fisher alone or in combination would direct a person of ordinary skill in the art to a viscosity of less than 400 cP and/or 200 cP. CONCLUSION OF LAW Our analysis of the rejection of claims 1-3, 6, and 10-16 as obviousness in view of the combination of Fisher and Edwards resulted in a new ground of rejection. In addition, on reflection, we find that our analysis misapprehended or overlooked material facts on this record. Accordingly, we grant Appellants’ request for rehearing and modify our prior Decision to reverse all grounds of rejection on appeal. REHEARING GRANTED; REVERSED Ssc: AMGEN INC. LAW DEPARTMENT 1201 AMGEN COURT WEST SEATTLE, WA 98119 5