10389773 (B.P.A.I. May. 4, 2010)

Ex Parte Kamm et al

Board of Patent Appeals and InterferencesMay 4, 2010

10389773 (B.P.A.I. May. 4, 2010)

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. 10/389,773 03/18/2003 Michael A. Kamm 3920-0113P 3228 23364 7590 05/05/2010 BACON & THOMAS, PLLC 625 SLATERS LANE FOURTH FLOOR ALEXANDRIA, VA 22314-1176 EXAMINER KIM, JENNIFER M ART UNIT PAPER NUMBER 1628 MAIL DATE DELIVERY MODE 05/05/2010 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte MICHAEL A. KAMM and ROBIN K. S. PHILLIPS __________ Appeal 2009-010818 Application 10/389,773 Technology Center 1600 __________ Decided: May 5, 2010 __________ Before ERIC GRIMES, DEMETRA J. MILLS, and RICHARD M. LEBOVITZ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants have requested rehearing of the decision entered February 16, 2010 (“Decision”), which affirmed the rejection of claims 12-22 under 35 U.S.C. § 103(a). Appellants argue that the evidence does not show that the concentration of phenylephrine in the topical products cited by the Examiner would be effective in raising anal sphincter pressure (Req. Rhg. 2-3). Appeal 2009-010818 Application 10/389,773 2 Appellants also argue that references cited by Speakman show that “the implication of IAS in fecal incontinence has been known since well before Yamato was published and for at least two decades before the priority date claimed for the present application,” providing support for their position that the claimed method would not have been obvious (id. at 4). These arguments were not made in the initial briefing of this appeal and new arguments are not allowed in a request for rehearing. See 37 C.F.R. § 41.37(c)(1)(vii) (“Any arguments or authorities not included in the brief or a reply brief pursuant to § 41.41 will be refused consideration by the Board, unless good cause is shown.”); 37 C.F.R. § 41.52(a)(1) (“Arguments not raised in the briefs before the Board . . . are not permitted in the request for rehearing except as permitted by paragraphs (a)(2) and (a)(3) of this section,” neither of which applies here). See also Cooper v. Goldfarb, 154 F.3d 1321, 1331 (Fed. Cir. 1998) (“A party cannot wait until after the Board has rendered an adverse decision and then present new arguments in a request for reconsideration.”). Appellants also argue that “[t]here is no disclosure in Yamato to indicate that phenylephrine would be effective in increasing IASP even in patients with normal IAS if applied other than by injection or topically in and around the anal canal” (Req. Rhg. 2). A “request for rehearing must state with particularity the points believed to have been misapprehended or overlooked by the Board.” 37 C.F.R. § 41.52(a)(1). Whether topical application of phenylephrine would have been expected to be effective was addressed on page 8 of the Decision. Therefore, it is not a point that we overlooked or misunderstood. Appeal 2009-010818 Application 10/389,773 3 Finally, Appellants argue that the Decision “appears to overlook the fact, albeit acknowledged as Finding of Fact 9, that Yamato discloses that phenylephrine produced no significant effect on the fall in IASP (internal anal sphincter pressure) caused by RBD [rectal balloon distension]” and therefore Yamato teaches that “phenylephrine would not increase IASP in healthy IAS relaxed by RBD or other stimulus” (Req. Rhg. 2). Appellants argue that it is irrelevant that RBD is intended to mimic rectoanal reflex because “[i]t did, in fact, cause IASP to fall” (id.). We are not persuaded by this argument that we misunderstood Yamato’s disclosure. Yamato is relevant to the issue of whether a skilled worker would have reasonably expected administration of phenylephrine to increase IASP in patients with fecal incontinence (Decision 6). Appellants argued in their Appeal Brief that it would not support such an expectation because “‘when Yamato et al. makes its subjects unhealthy by subjecting them to rectal balloon distension to cause IASP to fall,’ phenylephrine did not affect the fall in IASP” (Decision 7, quoting Appeal Br. 7). We pointed out that Yamato discloses that RBD is intended to mimic the rectoanal reflex, not to make a subject unhealthy (id.). The fact that phenylephrine does not affect fall of IASP induced by RBD does not provide a basis for doubting that it would increase IASP in patients with fecal incontinence. Yamato shows that RBD causes a fall in IASP in healthy subjects. See Yamato 426, Figure 2: at a dosage of 0 (no drug) RBD induces a roughly 75% drop in IASP. Thus, inducing the rectoanal reflex – as indicated by a fall in IASP – is the normal, healthy response to RBD. The fact that phenylephrine does not interfere with that Appeal 2009-010818 Application 10/389,773 4 normal response is not a basis for doubting that it would increase IASP under other conditions. Appellants have not shown that we misapprehended or overlooked any issues of fact or law in the Decision. The request for rehearing is denied. REHEARING DENIED lp BACON & THOMAS, PLLC 625 SLATERS LANE FOURTH FLOOR ALEXANDRIA VA 22314-1176