Ex Parte Golijanin et alDownload PDFPatent Trial and Appeal BoardMar 28, 201711851312 (P.T.A.B. Mar. 28, 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. 11/851,312 09/06/2007 Dragan Golijanin 577672000900 9069 136579 7590 03/30/2017 Novadaq Technologies Inc. c/o Morrison & Foerster LLP 755 Page Mill Road Palo Alto, CA 94304-1018 EXAMINER JONES, DAMERON LEVEST ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 03/30/2017 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): EOfficePA @ mofo.com PatentDocket @ mofo. com pair_mofo @ firsttofile. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DRAGAN GOLIJANIN, LUKASZ BRZOZOWSKI, and RONALD WOOD1 Appeal 2015-005990 Application 11/851,312 Technology Center 1600 Before FRANCISCO C. PRATS, TAWEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a method of localizing a lymph node draining a penile tumor. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE The sole rejection before us for review is the Examiner’s rejection of claims 1—16 under 35 U.S.C. § 103(a) for obviousness over Woltering.2 Ans. 3^4; Non-Final Action 2—A? 1 Appellants identify Novadaq Technologies Inc. as the real party in interest. App. Br. 1. Appeal 2015-005990 Application 11/851,312 Claims 1, 9, and 12 are representative and read as follows (App. Br. A-l, A-2): 1. A method of localizing before or during a surgical operation a lymph node draining a penile tumor having edges and a base, in a subject, comprising: a) 10 minutes to 24 hours prior to said surgical operation, injecting the edges or the base of said tumor of said subject with a dye which fluoresces at an emission wavelength when said dye is contacted with an excitation wavelength; b) exposing said lymph node before or during said operation to illumination, the illumination comprises said excitation wavelength and causes said fluorescent dye to fluoresce; and, c) detecting the fluorescence of said dye at said lymph node. 9. A method of claim [1, wherein said dye is a tricarbocyanine dye, and] wherein the tricarbocyanine dye is indocyanine green. 12. A method of claim 1, wherein said dye is injected between 1 hour and 6 hours before said surgical operation. DISCUSSION The Examiner’s Prima Facie Case The Examiner’s position, essentially, is that Woltering teaches or suggests a process having all of the features of claims 1—16. After reviewing the relevant teachings in Woltering {see Ans. 2—3), the Examiner concludes that claims 1—16 would have been obvious to an ordinary artisan, because “both Appellant and Woltering disclose methods of localizing lymph node in a subject having a penile tumor/cancer using a fluorescent dye wherein the 2 U.S. Patent No. 7,381,400 B2 (issued June 3, 2008). 3 Non-Final Rejection entered January 22, 2014. 2 Appeal 2015-005990 Application 11/851,312 dye may be administered] in a time frame of 10 minutes to 24 hours prior to the surgical operation.” Id. at 3. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. As the Supreme Court pointed out in KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398 (2007), when determining whether the prior art supplied a reason for practicing the claimed subject matter, the analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418; see also id. at 421 (“A person of ordinary skill is ... a person of ordinary creativity, not an automaton.”). Ultimately, therefore, “[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Appellants do not persuade us that a preponderance of the evidence fails to support the Examiner’s prima facie case of obviousness as to either claim 1 or claim 9. In particular, Appellants do not persuade us that the 3 Appeal 2015-005990 Application 11/851,312 Examiner erred in finding that Woltering suggests the process recited in Appellants’ claims 1 and 9. As required by claim 1, Woltering discloses a process of localizing, before or during a surgical operation, a lymph node draining a penile tumor. See Woltering, abstract (describing a “procedure for sentinel lymph node identification and biopsy”); see also id. at 6:1—8 (procedure can be used to identify sentinel lymph node “of any solid tumor that is known to metastasize, including . . . penile cancer”). In Woltering’s process, a radiolabeled dye is mixed with an unlabeled dye, which may be identical to the radiolabeled dye except for the label, the unlabeled dye being present in a “sufficient amount to enhance visual location of the lymph node(s).” Id. at 4:5—6. As to claim 1 ’s first step of injecting the dye, as the Examiner found (Ans. 2), Woltering discloses that the dye mixture “is injected at the time of surgery, and rapidly migrates to reach the lymph nodes in less than 20 min, more preferably in less than 15 min, and most preferably in less than 10 min.” Woltering, 4:8—11. Although Woltering states that the dye mixture is injected “at the time of surgery” (see id.), because the dye takes up to 20 minutes to migrate to the lymph node (see id.), Appellants do not persuade us (see App. Br. 7—11; Reply Br. 2—6) that the Examiner erred in finding that Woltering suggests that the dye should be injected up to 20 minutes prior to the surgery that visualizes the lymph node. Because injecting the dye mixture up to 20 minutes prior to the surgery is encompassed by the range in Appellants’ claim 1 of injecting 10 minutes to 24 hours before surgery, we discern no 4 Appeal 2015-005990 Application 11/851,312 error in the Examiner’s finding that Woltering suggests injecting its dye at a time encompassed by claim 1. As required by claim 1, Woltering discloses that its dye may be any of a number of dyes, including a “fluorescent dye, an ultraviolet fluorescent dye, a visible fluorescent dye, and [an] infrared fluorescent dye . . . Woltering, 4:58—59. As to steps (b) and (c) of claim 1, exposing the lymph node to illumination at a wavelength that causes fluorescence and thereby detecting the lymph node, Woltering discloses that “the presence of the non- radiolabeled dye in a tissue may be observed optically due to the non- radiolabeled dye’s visible, ultraviolet, or infrared absorption, fluorescence, luminescence, or phosphorescence.” Id. at 8:53—57 (emphasis added). Given this teaching, Appellants do not persuade us (see App. Br. 9; Reply Br. 4—5) that the Examiner erred in finding that Woltering suggests exposing the lymph node to illumination at a wavelength that causes fluorescence and thereby detecting the lymph node. In sum, given the discussed teachings, we agree with the Examiner that Woltering would have suggested performing a process having all of the steps and features of Appellants’ claim 1. Accordingly, we find that a preponderance of the evidence supports the Examiner’s prima facie case of obviousness as to claim 1. Appellants’ arguments do not persuade us to the contrary. It might be true that the radioactive colloid discussed by Woltering in relation to the prior art (see Woltering, 1:49-2:52) does not correspond to a fluorescently visualized dye, as Appellants argue. See App. Br. 7—9; Reply Br. 3. That fact does not, however, undercut Woltering’s express teachings, discussed 5 Appeal 2015-005990 Application 11/851,312 above, of the desirability of using an optically visualized dye, which may be a fluorescent dye, which has up to a 20 minute migration period. As to Appellants’ contention that “Woltering neither contemplates nor enables the localization of lymph nodes by injecting a fluorescent dye prior to surgery” (Reply Br. 4), as noted above, Woltering expressly teaches visualizing a dye using the dye’s “visible, ultraviolet, or infrared absorption, fluorescence, luminescence, or phosphorescence.” Woltering, 8:55—57 (emphasis added). Appellants do not direct us to any specific persuasive evidence suggesting that an ordinary artisan, armed with the knowledge in the art, would have been unable to visualize a tumor, based on this teaching. In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner’s prima facie case of obviousness as to claim 1. Because Appellants do not identify any specific persuasive objective evidence of nonobviousness, we affirm the Examiner’s rejection of claim 1 for obviousness over Woltering. Because they were not argued separately, claims 2—8, 10, 11, and 13—16 fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). As to claim 9, as the Examiner found (Ans. 2), Woltering discloses that “iodocyanine green” is among useful dyes. Woltering, 5:4. Appellants do not dispute that Woltering’s iodocyanine green is the same dye as the indocyanine green (ICG) recited in claim 9. As to Appellants’ argument that iodocyanine green is part of a laundry list of useful dyes (Reply Br. 5), we note that iodocyanine green is one of only about eight dyes expressly listed in Woltering. See Woltering, 5:1—7. As to Appellants’ argument that Woltering only exemplifies dyes that are visible to the naked eye (App. Br. 13—14), as noted above Woltering expressly teaches visualizing fluorescent 6 Appeal 2015-005990 Application 11/851,312 dyes, including those that fluoresce under infrared or ultraviolet radiation (see Woltering, 8:53—57), and Appellants have not identified any specific persuasive evidence suggesting that an ordinary artisan, armed with the knowledge in the art, would have been unable to fluorescently visualize a tumor, based on that teaching. In sum, because Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner’s prima facie case of obviousness as to claim 9, and because Appellants do not advance specific persuasive objective evidence of nonobviousness as to claim 9, we affirm the Examiner’s rejection of claim 9 over Woltering. As Appellants argue, however, claim 12 requires the dye to be injected between 1 and 6 hours before the surgical operation. See App. Br. 11—12, see also id. at A-2 (claim 12). As noted above, Woltering teaches using dyes that migrate to the lymph node of interest in at most 20 minutes. See Woltering, 4:8—11. The Examiner does not specifically address claim 12, either in the presentation of the prima facie case or responding to Appellants’ arguments. Nor does the Examiner explain specifically why Woltering’s teaching of using a dye with a migration period of at most 20 minutes would suggest injecting the dye at the time period in relation to surgery required by claim 12. We note, as the Examiner argues (Ans. 10—11), that Woltering describes an experiment establishing the migration time of methylene blue. See Woltering 6:10-7:7. The Examiner does not explain adequately, however, why that experiment would have suggested that, when performing a surgical operation to localize a lymph node, an ordinary artisan would have failed to follow Woltering’s express teaching of using a dye that migrates in 20 7 Appeal 2015-005990 Application 11/851,312 minutes or less. Accordingly, because we agree with Appellants that the Examiner did not explain sufficiently why an ordinary artisan would have performed a process meeting all of the requirements of claim 12, we reverse the Examiner’s rejection of that claim over Woltering. SUMMARY For the reasons discussed, we affirm the Examiner’s rejection of claims 1—11 and 13—16 under 35 U.S.C. § 103(a) for obviousness over Woltering. For the reasons discussed, however, we reverse the Examiner’s rejection of claim 12 under 35 U.S.C. § 103(a) for obviousness over Woltering. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART 8 Copy with citationCopy as parenthetical citation