Ex Parte BuscemiDownload PDFPatent Trial and Appeal BoardFeb 26, 201311426133 (P.T.A.B. Feb. 26, 2013) 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. 11/426,133 06/23/2006 Paul J. Buscemi 13033.23US01 1411 23552 7590 02/26/2013 MERCHANT & GOULD PC P.O. BOX 2903 MINNEAPOLIS, MN 55402-0903 EXAMINER PATEL, TARLA R ART UNIT PAPER NUMBER 3772 MAIL DATE DELIVERY MODE 02/26/2013 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 PAUL J. BUSCEMI ____________ Appeal 2011-003429 Application 11/426,133 Technology Center 3700 ____________ Before DONALD E. ADAMS, ERIC GRIMES, and ERICA A. FRANKLIN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claim 1 (App. Br. 11; Ans. 2; Reply Br. 2). We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE Claim 1 is directed to a method for treating obstructive sleep apnea and is reproduced in the Claims Appendix of Appellant’s Brief. Claim 1 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Conrad. 1 We reverse. 1 Conrad et al., US 2005/0092334 A1, published May 5, 2005. Appeal 2011-003429 Application 11/426,133 2 ISSUE Does the preponderance of evidence on this record support a conclusion that Conrad suggests an implant comprising a fibrosis-inducing agent and an anchor, wherein the fibrosis-inducing agent is anchored to the hyoid bone by the anchor, as required by Appellant’s claimed invention? FACTUAL FINDINGS (FF) FF 1. Appellant’s Figures 1 and 4 are reproduced below: Fig. 1 is a schematic representation of an upper airway of a patient. Fig. 1 shows the tongue T with a tongue base TB opposing a pharyngeal wall PW. The hard palate HP and soft palate SP reside over the top of tongue T with the soft palate SP extending rearward to a trailing end TE between the tongue base TB and the pharyngeal wall PW. A hyoid bone HB resides near the bottom of the tongue near an epiglottis E. A mandible or jaw bone JB is at the front of the tongue T. (Spec. 4: 25-30.) “Fig. 4 is the view of Fig. 1 showing a region of the tongue to be stiffened according to … [Appellant’s] invention” (id. at 3: 22-23). Specifically, Appellant’s [I]nvention stiffens the tongue base in a manner to create a stiffened area which is anchored to the hyoid bone HB. This is schematically illustrated in Fig. 4 where an area to be stiffened is indicated by X. The area X extends substantially from the Appeal 2011-003429 Application 11/426,133 3 hyoid bone rearward towards a back surface of the tongue and upwardly along a back wall of the tongue toward a free end of the soft palate. This region extends laterally superior to the hyoid bone and preferably includes an area including the genioglosus muscle in the region of the hyoid bone. (Spec. 5: 11-17.) FF 2. Conrad suggests “a method for treating obstructive sleep apnea comprising: identifying a patient with sleep apnea … attributable at least in part to movement of a base of a tongue of said patient toward a pharyngeal wall of said patient[ and] placing an implant … within said tongue” (Ans. 4). FF 3. Conrad’s Figures 1, 11, and 21 are reproduced below: “FIG. 1 is a side elevation, schematic view of a patient illustrating structure defining an upper airway of the patient and showing[, inter alia,] an implant [10] according to an embodiment of … [Conrad’s] invention positioned … in the tongue and secured to the bony structure of the jaw” (Conrad 1: ¶ [0013]; 2: ¶ [0039]). [I]mplant 10 includes an elongated member 12 having a tissue in-growth end 14 and a static end 16. The tissue in-growth end 14 may be any tissue growth inducing material (e.g., felt or PET) to induce growth of tissue into the end 14 to secure the Appeal 2011-003429 Application 11/426,133 4 end 14 to surrounding tissue following implantation. The elongated member 12 may be suture material one end secured to the felt 14 and with the static end 16 being a free end of the suture material 12. An anchor 18 (shown in the form of a treaded [sic] eye- bolt although other fastening mechanisms could be used) is secured to the jawbone JB…. The end 16 is secured to the anchor 18. The end 14 is placed in the tongue near the tongue base TB. A surgeon adjusts a tension of the suture 12. This causes the tongue base TB to be urged toward the jawbone JB thereby placing the tissue of the tongue in compression. (Conrad 2: ¶¶ [0040]-[0042].) “FIG. 11 is a view similar to that of FIG[]. 1 … showing an alternative embodiment” (id. at 2: ¶ [0023]). Elements in common with those of FIG[]. 1 … are numbered identically. The tissue in-growth end 14 is embedded in the tongue T near the tongue base TB. In stead [sic] of an anchor 18 in the jaw bone JB as described with reference to FIG. 1, the embodiment of FIG. 11 employs an[] additional tissue in- growth material 118 embedded in the tongue T near the jaw bone JB. (id. at 3: ¶ [0054]; Ans. 4 (Conrad suggests that “in lieu of a jawbone anchor …, a tissue embedded anchor[] (such as anchor 118) could be used”).) FIG. 21 is a view of FIG. 11 showing an alternative embodiment of Conrad’s invention, wherein a lever, illustrated as a cable secured to an epiglottis cartilage, is positioned to advance a hyoid bone of a patient (id. at ¶¶ [0023]; [0031]; [0033]; and [0034]). “The cable 190’ may pass through (as shown) or over the hyoid bone HB. The cable 190’ further passes Appeal 2011-003429 Application 11/426,133 5 through the geniohyoid muscle GM and terminates at a second end 194’ at the jawbone JB where it is secured to an anchor 170” (id. at 4: ¶ [0063]). FF 4. “Conrad fails to explicitly disclose where said implant is located entirely within a region laterally superior of the hyoid bone” (Ans. 4). ANALYSIS The method of Appellant’s claim 1 comprises, inter alia, the placement of an implant in a region of the tongue of a patient (Appellant’s Claim 1). Appellant’s claim 1: (a) defines the region as extending laterally superior to a hyoid bone, substantially from the hyoid bone rearward toward a back surface of the tongue; and (b) requires that the implant is located entirely within the foregoing region of the tongue (id.; Reply Br. 4). In addition, Appellant’s claim 1 requires the implant to include a fibrosis- inducing agent and an anchor, wherein the fibrosis-inducing agent is anchored to the hyoid bone by the anchor (id.). Based on Conrad, Examiner concludes that, at the time of Appellant’s claimed invention, it would have prima facie obvious to a person of ordinary skill in this art to combine the portion of the anchor that passes over the hyoid with the fibrosis inducing agent such as anchor 14 since Conrad provides motivation for the combination … to achieve an implant located entirely within a region laterally superior of the hyoid bone in order to enhance manipulation of the hyoid bone for airway patency. (Ans. 4-5; id. at 6). In support of this conclusion, Examiner characterizes Conrad’s cable 190’ as an anchor and reasons that since Conrad suggests fibrosis inducing agents as anchors, “[t]he primary fibrosis inducing agent 14 could … be relied on as the fibrosis agent that is attached to the portion Appeal 2011-003429 Application 11/426,133 6 of the anchor (190’) that passes over the hyoid bone” (Id. at 4; see also id. at 5). Notwithstanding Examiner’s assertion to the contrary, Conrad’s element 190’ is a cable not an anchor (FF 3; see Reply Br. 5 (Examiner’s rejection relies on an unsupported modification of “the material of [Conrad’s] cable 190’ so as to provide anchoring characteristics”); App. Br. 9 (Conrad’s “cable 190’ is not anchored to the hyoid bone”); Cf. Ans. 4-6). Accordingly, Examiner failed to establish an evidentiary basis on this record to support a conclusion that Conrad suggests an implant comprising a fibrosis-inducing agent and an anchor, wherein the fibrosis-inducing agent is anchored to the hyoid bone by the anchor, as required by Appellant’s claimed invention. CONCLUSION OF LAW The preponderance of evidence on this record fails to support a conclusion that Conrad suggests an implant comprising a fibrosis-inducing agent and an anchor, wherein the fibrosis-inducing agent is anchored to the hyoid bone by the anchor, as required by Appellant’s claimed invention. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Conrad is reversed. REVERSED cdc Copy with citationCopy as parenthetical citation