Ex Parte HaleyDownload PDFPatent Trial and Appeal BoardMar 14, 201712325194 (P.T.A.B. Mar. 14, 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. 12/325,194 12/01/2008 Jeffrey T. Haley 15001.203 1019 39124 7590 03/16/2017 CAROL NOTTENBURG 264 SENECA PLACE NW RENTON, WA 98057 EXAMINER AHMED, HASAN SYED ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 03/16/2017 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): c arol. nottenburg @ cougarlaw. com chris.pratt@cougarlaw.com cnot@comcast.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEFFREY T. HALEY Appeal 2016-000053 Application 12/325,1941 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and ELIZABETH A. LaVIER, Administrative Patent Judges. LaVIER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant seeks review of the Examiner’s rejection of claims 42-46 and 50—53. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM. BACKGROUND The Specification relates to topical applications of cobalamin (vitamin B12) to epithelial tissues subject to mucositis. Spec. 1 8. Claim 42 is illustrative: 1 Appellant states the real party in interest is OraHealth Corp. Appeal Br. 4. Appeal 2016-000053 Application 12/325,194 42. A method for treating or preventing oral mucositis in a patient’s mouth, comprising: providing an effectively adhering, slowly dissolving troche adapted for adhering in the mouth and for slowly releasing bioactive cobalamin selected from the group consisting of one or more of methylcobalamin, adenosylcobalamin and hydroxocobalamin topically delivered to mucosal epithelial tissues in an area where mucositis occurs to reduce or prevent mucositis in the mouth. Appeal Br. 26 (Claims Appendix). APPEALED REJECTION2 Claims 42-46 and 50-53 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Sarill,3 Ben-Sasson,4 Haley ’178,5 Wick,6 Haley ’930,7 andEngstad.8 Final Action 4. DISCUSSION We agree with, and adopt, the Examiner’s reasoning and conclusions that the claims are obvious over the cited prior art references cited by the Examiner. We address Appellant’s arguments below. 2 In the Answer, the Examiner refers to rejections under 35 U.S.C. § 112, first and second paragraphs, which were part of the Final Rejection. See Ans. 2. As Appellant points out, however (see Reply Br. 2), the § 112 rejections were subsequently overcome. See Advisory Action, Sept. 18,2014. Accordingly, we review only the § 103 rejection. 3 Sarill et al., US 2002/0119947 Al, published Aug. 29, 2002. 4 Ben-Sasson, US 2005/0232981 Al, published Oct. 20, 2005. 5 Haley, US 2003/0124178 Al, published July 3, 2003. 6 Wick et al., 6,010,715, issued Jan. 4, 2000. 7 Haley, US 2004/0156930 Al, published Aug. 12, 2004. 8 Engstad, US 2006/0079481 Al, published Apr. 13, 2006. 2 Appeal 2016-000053 Application 12/325,194 As to illustrative claim 42, the Examiner finds that Sarill discloses cobalamin compositions that can promote the healing of aphthous ulcers (which occur in oral mucosa). Final Action 4 (citing Sarill || 26, 65). Administration may be topical. Id. at 4—5 (citing Sarill || 65, 67). Sarill states “[a]s defined herein, the term cobalamin refers to vitamin B12 in any of its biologically active forms, including cyanocobalamin, hydroxocobalamin, methylcobalamin, and adenosylcobalamin” (id. at 5 (quoting Sarill 132)), and can be formulated as a dissolving troche or tablet {id. (citing Sarill 174)). Sarill does not teach an “effectively adhering” troche, however, as recited in claim 42, or the adhesion thereof in the mouth near the site of mucositis. See Final Action 5—6. For these limitations, the Examiner relies on Haley ’178, which teaches adhesion of a patch on the site of canker sores. See id. at 6 (citing Haley ’178 17)). The Examiner also relies on Ben- Sasson, which describes tablets or suppositories to deliver vitamin B12, with adhesive polymers to assist adherence of the formulation to mucosal surfaces. See id. (citing Ben-Sasson ]f]f 18, 66, 85).9 The Examiner finds that claim 42 “contains the same components in the same configuration of the prior art,” and thus would have the same release properties. Final Action 6. Further, the Examiner finds that combining the references as claimed would have been obvious, because doing so would have been “useful in the delivery of active agents such as 9 The Examiner cites the other references (i.e., Wick, Haley ’930, and Engstad) in regard to certain dependent claims. See Final Action 6. We discuss the separately-argued dependent claims below. 3 Appeal 2016-000053 Application 12/325,194 vitamin B12 (i.e. cobalamin) across mucosal epithelia, as explained by BEN- SASSON.” Id. at 7. Appellant first argues that certain limitations of claim 42 are missing from the prior art. See Appeal Br. 10—17. Specifically, Appellant maintains that Sarill does not teach topical administration in the mouth, but rather oral administration for delivery of cobalamin into the bloodstream. Id. at 10—12 (discussing Sarill || 39, 65, 67); see Reply Br. 3. In other words, according to Appellant, Sarill teaches separate oral and topical modes of administration. Appeal Br. 12. As such, Appellant alleges, the Examiner’s findings amount to “cherry-pick[ing]” from Sarill, and are not based on Sarill’s actual teachings, Appellant maintains. Id. at 13. This is not persuasive. First, Appellant’s argument relies on an overly-strained reading of Sarill. Sarill discloses wide applications for its cobalamin compositions, including for treatment of ulcers and other skin conditions, and that topical application is “especially useful” for cellular uptake. Sarill | 65. Thus, this is not a case of too much “picking and choosing,” so much as one of modest, obvious modification of the prior art. Cf. KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) (“[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.”). Second, claim 42 recites that the cobalamin is “topically delivered to mucosal epithelial tissues.” Thus, claim 42 does not limit what happens to the cobalamin after delivery. In other words, claim 42 does not exclude a mechanism of action involving uptake into the bloodstream. 4 Appeal 2016-000053 Application 12/325,194 Next, Appellant argues10 that Sarill does not teach or suggest the claimed “bioactive cobalamin,” because Sarill includes cyanocobalamin (which requires conversion in the human body before it can be effective) among a list of what Sarill calls “biologically active forms” of cobalamin suitable for its compositions. Appeal Br. 14 (discussing Sarill 132); Reply Br. 4. However, as the Examiner points out, Sarill also includes forms of cobalamin (hydroxocobalamin, methylcobalamin, and adenosylcobalamin) specifically listed as “bioactive” in Appellant’s specification and recited as such in claim 42. Ans. 5 (citing Sarill 132; Spec. 1 8); see also Final Action 5 (citing Sarill 132). We thus agree with the Examiner that Sarill’s failure to differentiate cyanocobalamin from other, directly biologically active forms does not undermine Sarill’s express teaching of claimed forms of cobalamin—or, as the Examiner puts it, “such differentiation is not required 10 Appellant also attempts to distinguish the claimed bioactive cobalamin from Sarill by pointing to a declaration (and accompanying article) allegedly demonstrating surprising results. See Appeal Br. 15, 22. However, this declaration was never entered into the record. See Ans. 11; see also Advisory Action, Sept. 18, 2014. Appellant argues the Examiner’s failure to do so was erroneous (see Reply Br. 6), but an Examiner’s refusal to enter evidence is a petitionable matter, not an appealable one (see MPEP § 1204.04). Even assuming, arguendo, that the declaration should have been entered, we do not find it persuasive in overcoming the Examiner’s prima facie case of obviousness because the allegedly surprising results relate to the use of a known compound (methylcobalamin) for a known use (topical treatment of apthous ulcers), as taught in Sarill, over cyanocobalamin. Appellant’s reliance on the differences in mechanisms of activity between methylcobalamin and cyanocobalamin is no more persuasive in the context of rebutting the prima facie case any more than it is in attacking it, as discussed above. 5 Appeal 2016-000053 Application 12/325,194 to reject the limitation when there is an explicit teaching of bioactive cobalamin.” Ans. 6. Ben-Sasson, according to Appellant, does not teach or suggest “an effectively adhering, slowly dissolving troche” for the mouth. Appeal Br. 15. According to Appellant, Ben-Sasson focuses on delivery of vitamin B12 “across mucosal epithelia of the gastrointestinal tract,” and that “[i]ts reference to mucosal or vascular epithelia as including, but not limited to GI or respiratory epithelia, is only an explanation of locations where biological barriers are found,” not “sites of administration.” Id. at 16 (discussing Ben- Sasson 117). These arguments are not persuasive because Ben-Sasson was not cited for these purposes. See In re Keller, 642 F.2d 413, 426 (CCPA 1981) (“But one cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.”). As the Examiner points out, the rejection relies on Sarill, not Ben-Sasson, for a troche formulation. Ans. 6 (citing Final Action 5). And Haley ’178 was cited for troche adhesion to canker sores, i.e., in the mouth. See Final Action 6 (citing Haley ’178 1 7)). Likewise, as discussed above with respect to Sarill, Appellant’s distinction between topical delivery and delivery across a biological barrier (see Appeal Br. 17) is not borne out by the language of claim 42. Appellant also argues that the Examiner’s rationale for combining the references is conclusory. See Appeal Br. 20-21; see also Reply Br. 5—6. In particular, Appellant alleges that the Examiner provides no facts or analysis “to explain use of bioactive cobalamin to treat mucositis by topical application in an area where mucositis occurs, as recited in the claims.” Appeal Br. 20. Relatedly, Appellant also argues that the Examiner’s 6 Appeal 2016-000053 Application 12/325,194 combination is the product of impermissible hindsight. See id. at 22—23. We are not persuaded. As discussed above, Sarill itself teaches much of claim 42, i.e., using cobalamin in a troche to treat mucositis. See also Ans. 10. The other references, which the Examiner finds are in the same field of endeavor (of formulations for mucosal administration (see id. at 9)), thus each “logically would have commended itself to an inventor’s attention in considering [the] problem,” Innovention Toys, LLC v. MGA Entertainment, Inc., 637 F.3d 1314, 1321—22 (Fed. Cir. 2011) (quoting In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992)), i.e., to improving the usefulness of Sarill (see Final Action 7). Having considered each of Appellant’s arguments in light of the evidence of record, we are unpersuaded that the Examiner erred in rejecting claim 42. We are also unpersuaded that the Examiner erred in rejecting claims 43 46 and 50—53. Appellant’s arguments for claim 43 and 44 regarding Sarill’s alleged failure to teach “bioactive” cobalamin (see Appeal Br. 17— 18) recapitulate those made in regard to claim 42 and are unpersuasive for the same reasons. Appellant’s argument regarding claim 50, that the references fail to teach an adhesive “having at least 79.2% acacia gum” (see Appeal Br. 18) is not persuasive in view of the Examiner’s position that claim 20 of Wick encompasses an adhesive layer “exclusively comprised of acacia gum” (Ans. 9). Appellant’s alternative argument that claims 43 46 and 50-53 are patentable for the same reasons as claim 42 (see Appeal Br. 18) is unpersuasive in light of our affirmance of the Examiner’s rejection of claim 42. 7 Appeal 2016-000053 Application 12/325,194 CONCLUSION The rejection of claims 42^46 and 50-53 under 35 U.S.C. § 103(a) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 8 Copy with citationCopy as parenthetical citation