Ex Parte Golijanin et alDownload PDFPatent Trial and Appeal BoardFeb 4, 201511775037 (P.T.A.B. Feb. 4, 2015) 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. 11/775,037 07/09/2007 Dragan Golijanin URMC288 1512 4327 52360 7590 02/04/2015 ROBERT D. GUNDERMAN, JR. PATENT TECHNOLOGIES, LLC 150 LUCIUS GORDON DRIVE, SUITE 205 WEST HENRIETTA, NY 14586 EXAMINER GUPTA, VANI ART UNIT PAPER NUMBER 3777 MAIL DATE DELIVERY MODE 02/04/2015 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 DRAGAN GOLIJANIN, EDWARD M. MESSING, JAY E. REEDER, RONALD WOOD, and AIMEE JOHNSON __________ Appeal 2012-011590 Application 11/775,037 Technology Center 3700 __________ Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and AMANDA F. WIEKER, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method of identifying a lymph node draining the bladder of a patient with bladder cancer. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Parties in Interest as University of Rochester (see App. Br. 3). Appeal 2012-011590 Application 11/775,037 2 Statement of the Case Background Bladder cancer patients “diagnosed with superficial bladder tumors . . . can usually be successfully treated by transurethral resection of the bladder, with follow up by cystoscopy” (Spec. 1, ll. 20–23). “[D]etermining the extent to which tumor cells have spread to lymph nodes is important in determining the patient’s prognosis. . . . Lymph nodes which receive drainage from a cancerous organ are known as sentinel lymph nodes” (Spec. 2, ll. 3–6). “Sentinel lymph node . . . biopsies therefore can permit sparing other lymph nodes which may be present in the pelvic area, reducing trauma to the patient while maintaining or improving prognosis. . . .Thus, methods of accurately identifying sentinel lymph nodes are of great interest” (Spec. 2, ll. 9–14). The Claims Claims 1–10 are on appeal. Claim 1 is representative and reads as follows: 1. A method of identifying a lymph node draining the bladder of a patient with bladder cancer, comprising: (a) instilling into a lumen of the patient’s bladder a dye, dissolved in solution, which fluoresces at an emission wavelength when said dye is contacted with an excitation wavelength; (b) allowing the dye to be taken into the bladder and drain to said lymph node; (c) exposing the lymph node to a source of illumination comprising said excitation wavelength under conditions such that fluorescent dye in the lymph node fluoresces; and (d) detecting the presence of fluorescence of said dye in said lymph node, wherein the presence of fluorescence indicates that the lymph node is draining said bladder. Appeal 2012-011590 Application 11/775,037 3 The issue The Examiner rejected claims 1–10 under 35 U.S.C. § 103(a) as obvious over Grissom2 and Engler3 (Ans. 4–6). The Examiner finds that Grissom teaches administering a dye to the bladder consistent with the steps of claim 1, acknowledging that “Grissom does not teach administering into the lumen of the patient’s bladder by way of instillation” (Ans. 4–5). The Examiner finds that Engler “teaches instillation or ‘intravesical administration’ methods for administering dye into a patient’s bladder” (Ans. 5). The Examiner finds it obvious to [M]odify the identification of lymph node draining the bladder of a patient with bladder cancer teachings of Grissom with administering into the lumen of the patient’s bladder by way of instillation teachings of Engler because “increased penetration of dyes [to target areas] can be achieved by intravesical administration of different solvents,” as explained by Engler (Ans. 5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Grissom and Engler render the claims obvious? 2 Grissom et al., US 6,905,884 B2, issued June 14, 2005 (hereinafter “Grissom”). 3 Engler et al., US 2002/0111502 A1, published Aug. 15, 2002 (hereinafter “Engler”). Appeal 2012-011590 Application 11/775,037 4 Findings of Fact 1. Grissom teaches that “fluorescent cobalamins can be used as a diagnostic and prognostic marker (a) to distinguish cancer cells and tissues from healthy cells and tissues, including identifying lymph nodes containing cancer cells” (Grissom, col. 2, ll. 19–22). 2. Grissom teaches that the “fluorescent cobalamins will facilitate the identification and retrieval of positive lymph nodes. Thus . . . the fluorescent cobalamins can be used with the following cancers or cancers of: . . . urinary organs . . . bladder” (Grissom, col. 7, ll. 48–56). 3. Grissom teaches In the sentinel lymph node biopsy approach, a blue dye and/or radioactive tracer are injected into the breast near the tumor. A small incision is made under the arm to look for traces of the dye or radioactivity to identify the lymph node(s) that drain the area of the breast and, as a consequence, are most likely to contain metastatic cancer cells. In accordance with the present invention, a fluorescent cobalamin replaces the blue dye and radioisotope tracer currently used in sentinel lymph node biopsies. (Grissom, col. 7, ll. 32–40.) 4. Grissom teaches that the “fluorescent cobalamins can be administered intravenously, intrathecally, intratumorally, intramuscularly, intralymphatically, or orally” (Grissom, col. 6, ll. 63–65). 5. Engler teaches that: Initial experiments have shown that several factors including virus concentration, time of administration, and volume of dosing can influence gene transfer to the bladder epithelium after intravesical administration to rats. Because increased penetration of dyes can be achieved by Appeal 2012-011590 Application 11/775,037 5 intravesical administration of different solvents, modification of the adenovirus formulation was also investigated as an alternative strategy to increase adenovirus transgene expression in the bladder . . . . The instant experiments focused on the use of ethanol to increase adenovirus transgene expression in the bladder. (Engler 9 ¶ 116.) 6. Engler teaches that “rAd-gal was . . . instilled [into the bladder] . . . . The administered material was retained in the bladder for 45 minutes. The bladder[s] were then flushed with PBS . . . bladders were harvested . . . . Hydrolysis of Xgal by -galactosidase results in a blue color that localized to the superficial luminal bladder epithelium” (Engler 9 ¶ 117). Principles of Law “An examiner bears the initial burden of presenting a prima facie case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). Analysis Appellants contend that “Grissom does not disclose administering into the lumen of the bladder” (App. Br. 10). Appellants contend that “Engler clearly shows that agents instilled into the bladder are ‘localized to the superficial luminal bladder epithelium’” (App. Br. 11). Appellants contend that the “present inventors have discovered that a dye solution, when instilled into the lumen of the bladder, is transported to lymph nodes that drain the bladder. That is particularly unpredictable considering that the bladder is designed to hold liquid, and that urine is not known to drain through the lymphatic channels serving the bladder” (App. Br. 13). Appeal 2012-011590 Application 11/775,037 6 The Examiner responds that Grissom discusses clearly introducing the dye into the mouth (i.e., “orally”). The mouth, as one of ordinary skill in the art would understand it, could be considered as a part of a lumen of the bladder, since any liquid inserted into the mouth (i.e. oral cavity) is attached to various biological tubes or lumens that are biologically attached to the bladder, from which the liquid may be drained. (Ans. 7.) The Examiner finds that the ordinary artisan “would not be limited to using or instilling the dye used by Engler. Grissom already teaches administration of a dye into a lumen of the bladder; a dye that naturally drains to the lymph node. It is [Engler] that teaches the alternative manner by which the dye may be administered into the lumen - namely, instillation” (Ans. 8). We find that Appellants have the better position. We agree with Appellants that Grissom does not teach administration into the lumen of the bladder (FF 1–4). We also agree that Engler’s instillation into the bladder does not suggest or demonstrate any transfer of dye from the bladder into the lymphatic system or into sentinel lymph nodes (FF 5–6). We find the Examiner’s argument that oral administration is equivalent to instillation into the bladder unpersuasive because the bladder is a component of the renal system, not the digestive system. Orally administered dyes would need, in part, to pass through the stomach to the intestinal tract, be absorbed by the intestinal wall and carried into the bloodstream, filtered from the blood by the kidneys, pass through the ureter, enter the bladder and then enter the lymphatic system to finally, after this long journey, reach the sentinel lymph node of the bladder. On the record Appeal 2012-011590 Application 11/775,037 7 before us, we find no evidence that an orally administered dye would necessarily reach a sentinel lymph node of the bladder. See MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (“Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”) We are also not persuaded by the Examiner’s argument that Engler provides any reason to place Grissom’s dye into the lumen of the bladder for staining a sentinel lymph node, especially in light of Engler’s teaching that instilled dyes localize to the superficial luminal bladder epithelium. We recognize that “[o]bviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re O‘Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). In this case, however, there is no reasonable expectation that instillation of Grissom’s dye into the lumen of the bladder would enter the lymphatic system and stain cancerous cells in the sentinel lymph node based on the teachings of Grissom and Engler (FF 1–6). The Examiner also finds that “instillation of indocyanine green dye into the lumen of a bladder will naturally result in its draining to the lymph nodes in cancer patients, essentially due to the inherent nature of the indocyanine green dye” (Ans. 8). While the Examiner may be correct, the Examiner has failed to specifically identify where Grissom teaches the use of indocyanine green dye. More importantly, the Examiner fails to establish any reason to instill indocyanine green dye into the lumen of a bladder. Without such a reason, Appeal 2012-011590 Application 11/775,037 8 the mere fact that the dye might inherently travel to the sentinel lymph node of the bladder is irrelevant. “‘[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Grissom and Engler render the claims obvious. SUMMARY In summary, we reverse the rejection of claim 1–10 under 35 U.S.C. § 103(a) as obvious over Grissom and Engler. REVERSED cdc Copy with citationCopy as parenthetical citation