Ex Parte Takanashi et alDownload PDFPatent Trial and Appeal BoardDec 29, 201613262732 (P.T.A.B. Dec. 29, 2016) 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. 13/262,732 10/03/2011 Kurato Takanashi TOYA196.001APC 5507 20995 7590 01/03/2017 KNOBBE MARTENS OLSON & BEAR LLP 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 EXAMINER PARAD, DENNIS J ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 01/03/2017 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): jayna.cartee@knobbe.com efiling @ knobbe. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KURATO TAKANASHI, YOICHIRO GOTO, TERUO MARUTA, and MASATAKE DAIRAKU1 Appeal 2016-000661 Application 13/262,732 Technology Center 1600 Before JOHN G. NEW, RICHARD J. SMITH, and DAVID COTTA, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL appellants state the real party-in-interest is Nichi-Iko Pharmaceutical Co, Ltd. App. Br. 2. Appeal 2016-000661 Application 13/262,732 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1, 2, 4, and 6.2 Specifically, claims 1, 2, and 4 stand rejected as unpatentable under U.S.C. § 103(a) as being obvious over the combination of Shudo, et al. (US 2007/0026075 Al, February 1, 2007) (“Shudo”) and Harada (WO 2008/088039 Al, July 24, 2008) (“Harada”) as evidenced by English translation (US 2010/0016362 Al, January 21, 2010). Claim 6 stands rejected as unpatentable under U.S.C. § 103(a) as being obvious over the combination of Shudo, Harada, and Toshio et al. (JP 2000256181, September 19, 2000) (“Toshio”). Claims 1, 2, 4, and 6 also stand provisionally rejected as unpatentable under the nonstatutory doctrine of obviousness-type double patenting as being unpatentable over the combination of claims 1-6 of copending US Application Ser. No. 13/262,800 and Shudo.3 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CFAIMED INVENTION Appellants’ invention is directed to a method for imparting an appropriate rupture strength and high drug-release properties to a jelly formulation comprising pectin. The jelly formulation of the present invention comprises a drug, pectin, and divalent metal ion, and further 2 Claims 3 and 5 are canceled. App. Br. 11. 3 This application has since issued as US Patent No. 9,125,809. 2 Appeal 2016-000661 Application 13/262,732 comprises a component selected from sucrose, maltitol and C3-C4 alditols, and a component selected from C5-C6 alditols in combination. Abstr. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A jelly formulation comprising a drug, pectin, and divalent metal ion, wherein the jelly formulation further comprises polyoxyethylene polyoxypropylene glycol, sodium chloride, xylitol, and a component selected from sucrose, maltitol and C3- C4 alditols, wherein a gelling agent other than pectin is present at 0-0.1 % times the mass of pectin content, and wherein the drug is donepezil hydrochloride. App. Br. 11. ISSUES AND ANALYSES We agree with, and adopt, the Examiner’s findings and conclusion that the appealed claims are obvious over the combined cited prior art references. We address the arguments raised on appeal by Appellants below. Issue 1 Appellants argue that the Examiner erred in finding the combined cited prior art references teach or suggest all of the limitations of the claims. App. Br. 5. Analysis Appellants argue the Examiner improperly relies upon Shudo as teaching a jelly formulation with pectin as the only gelling agent. App. Br. 5 (citing Shudo 127, Exs. 1-6). According to Appellants, only Shudo 3 Appeal 2016-000661 Application 13/262,732 Examples 1-4, 1-5, and 1-6 include pectin (0.2% concentration) and all of these Examples include additional gelling agents besides pectin, notably 1 - carrageenan at 0.5% concentration. Id. Therefore, Appellants contend, a second gelling agent is present in these Examples at 2.5 times the concentration of pectin. Id. at 5—6. Consequently, Appellants assert, Shudo neither teaches nor suggests the limitation of claim 1 reciting, “wherein a gelling agent other than pectin is present at 0-0.1 % times the mass of pectin content.” Id. at 6 (emphasis omitted). Appellants dispute the Examiner’s reliance on paragraph [0027] of Shudo as teaching pectin as the sole gelling agent. App. Br. 6. Appellants point to Shudo’s teaching that: “[i]n representative embodiments, e.g., where locust bean gum is employed as a thickening agent (as reviewed in greater detail below), the gelling agent is a carrageenan or pectin.” Id. (quoting Shudo 127). Therefore, Appellants argue, Shudo teaches that when pectin is used, locust bean gum is also present. Id. Although the Examiner characterizes locust bean gum as a “thickening agent,” Appellants argue Shudo also explicitly teaches that locust bean gum is an exemplary gelling agent in the preceding paragraph. Id. (citing Shudo 126). Therefore, Appellants contend, when taken in context, paragraph [0027] does not disclose pectin as the sole gelling agent, but rather teaches pectin in combination with a second gelling agent, which is locust bean gum. Id. Appellants argue that although Shudo teaches: “that the composition may include a gelling agent (i.e., a single gelling agent)” the exemplary compositions of Shudo all contain more than one component that may be a gelling agent. App. Br. 6 (quoting Final Act. 8). By way of example, Appellants point to Table 1, which lists I-carrageenan, K-carrageenan, locust bean gum, and pectin. Id. Appellants note that none of the exemplary 4 Appeal 2016-000661 Application 13/262,732 embodiments taught by Shudo contain only a single gelling agent or a second gelling agent in addition to pectin in which gelling agent other than pectin is present at 0-0.1 % times the mass of pectin content. Id. Appellants therefore assert that the language “a gelling agent,” as used in Shudo, is not intended to mean a single chemical species. Id. The Examiner responds that the disclosed examples and preferred embodiments of Shudo do not constitute a teaching away from its broader teachings or nonpreferred embodiments. Ans. 11 (citing In re Susi, 440 F.2d 442 (C.C.P.A. 1971)). The Examiner finds Shudo teaches that the compositions of the invention may include “a gelling agent” (i.e., an embodiment of a single gelling agent) and that the amount can be altered to various desired concentration ranges. Id. (citing Shudo 126). The Examiner finds the teachings of Shudo do not require two or more gelling agents to achieve the gelling properties of the formulation. Id. Therefore, the Examiner finds, although certain exemplary embodiments include more than one gelling agent at a particular concentration, Shudo does not teach away from its broader disclosure, which includes an embodiment of a single gelling agent at a wide range of concentrations. Id. We are not persuaded by Appellants’ arguments. Shudo is directed to: “[gjelled Donepezil compositions and methods for making and using the same” and explicitly states that: “it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary.” Shudo 8—9. Shudo teaches: Compositions of the invention may also include a gelling agent. Representative gelling agents of interest include, but are not limited to: carrageenan, pectin, agar, alginic acid, sodium alginate, gelatin, mannan, konjak, konjak mannan, glucosic mannan, chitosan, acacia gum, xanthan gum, locust bean gum, 5 Appeal 2016-000661 Application 13/262,732 .... In representative embodiments, the amount of gelling agent present in the composition ranges from about 0.01 to about 10 wt % (e.g., from about 0.01 to about 5.0 wt %); where ranges interest include from about 0.5 to about 10 wt %, such as from about 1 to about 7 wt %, and including from about 2 to about 5 wt %. Shudo 126 (emphasis added). Shudo further teaches: “[i]n representative embodiments, e.g., where locust bean gum is employed as a thickening agent (as reviewed in greater detail below), the gelling agent is a carrageenan or pectin.” Id. 127. Shudo also teaches that for embodiments containing thickening agents, including locust bean gum: [T]he amount of thickening agent present in the composition ranges from about 0.01 to about 10 wt% (e.g., from about 0.01 to about 5.0 wt%); where ranges interest include from about 0.5 to about 10 wt %, such as from about 1 to about 7 wt %, and including from about 2 to about 5 wt %. Shudo 129. We find that Shudo thus teaches that locust bean gum can act as both a stiffening and a gelling agent within the same range of concentrations. However, claim 1 does not require that pectin be the sole gelling agent of the composition, as Appellants argue. Claim 1 recites “wherein a gelling agent other than pectin is present at 0-0.1 % times the mass of pectin content.” Shudo teaches that locust bean gum, which Appellants argue is a gelling agent, can be present in ranges of concentrations relative to the ranges of pectin that fall within the prescribed 0-0.1% required by claim 1. Moreover, we do not read these teachings of Shudo as requiring more than one gelling agent. Shudo explicitly teaches that its compositions may include “a gelling agent” and that a representative gelling agent is pectin. 6 Appeal 2016-000661 Application 13/262,732 Shudo 126. We interpret the use of the indefinite article “a” in this passage as meaning a single gelling agent, as opposed to “gelling agents.” Although it also teaches multiple gelling/stiffening agents, we agree with the Examiner’s finding that a person of ordinary skill in the art would understand Shudo, in the cited passage, as teaching that a single gelling agent, pectin, may be used in the compositions taught. Nor are we persuaded by Appellants’ argument that, because all of the Examples teach the use of more than one potential gelling agent, the use of a single gelling agent is excluded by Shudo. When conducting an obviousness analysis “all disclosures of the prior art, including unpreferred embodiments, must be considered.” Merck & Co., Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). In the appeal before us, we have explained why we find Shudo teaches a single gelling agent may be used in a composition. We consequently affirm the Examiner’s rejection of the claims over the combined cited prior art. Issue 2 Appellants argue that their unexpected results overcome the Examiner’s prima facie conclusion of obviousness. App. Br. 7. Analysis Appellants point to the Declaration of Kurato Takanashi (the “Takanashi Declaration”), one of the inventors in the instant appeal, in support of their argument that their claimed invention exhibits unexpected results. App. Br. 7. Appellants argue that the data presented in the Takanashi Declaration demonstrates that the use of pectin as a primary gelling agent, with any second gelling agent at a concentration which is 7 Appeal 2016-000661 Application 13/262,732 0.1 % or less of the mass of the pectin content, is critical to achieve optimal rupture strength. Id. According to Appellants, the Takanashi Declaration discloses that Formulations 4—6, which contain a second gelling agent other than pectin at more than 0 .1 % of the mass of the pectin, did not have acceptable rupture strengths. Id. (citing Takanashi Deck Tables 1, 2). Furthermore, Appellants argue, the addition of xylitol unexpectedly improves drug release rate and improves rupture strength. Id. (citing Takanashi Deck Tables 1—3). Appellants argue further that the unexpected combination of desired rupture strength and drug release rate, as exemplified by Formulation 7, in the Takanashi Declaration, and in Appellants’ Specification at paragraphs [0026]—[0027] and Figures 3-4, is unexpected in view of the references. App. Br. 7. According to Appellants, neither Shudo nor Harada disclose anything regarding drug release rate and, Appellants argue, the effect of xylitol on both rupture strength and drug release rate was unexpected. Id. at 7-8. Appellants admit that Shudo teaches xylitol, but argue that it is merely taught as an option among a number of sweetening agents; Appellants assert there is no motivation provided to choose xylitol from the list, nor was it predictable that xylitol, a sweetening agent, could influence the drug release rate, as shown in Figure 4 of Appellants’ Specification and the Declaration. App. Br. 8. Finally, Appellants argue that although Shudo teaches polyoxyethylene polyoxypropylene glycol as one possible surfactant, Shudo does not include polyoxyethylene polyoxypropylene glycol in any of the examples. App. Br. 8 (citing Shudo 125). Appellant argue there would have been no reason to choose that particular surfactant. Id. However, 8 Appeal 2016-000661 Application 13/262,732 Appellants argue, their Specification discloses that the inclusion of polyoxyethylene polyoxypropylene glycol in the formulation improves slidability, as exemplified by Pluronic F68 in Table 2. Id. (citing Spec. 29-32; Tables 2, 3). Consequently, Appellants argue, the advantage of including polyoxyethylene polyoxypropylene glycol in the claimed formulations would not have been predicted from the teachings of Shudo. We are not persuaded by Appellants’ arguments. “[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991). Appellants do not adduce any evidence from the prior art that shows that the results described in the Specification and the Takanashi Declaration would have been unexpected when compared to the closest prior art. The fact that Shudo and Harada are silent with respect to the rupture strength or drug delivery of their compositions is not sufficient to show that the results are unexpected—Appellants must show that the results are unexpected when compared to results presented in the prior art. See In re Klosak, 455 F.2d 1077, 1080 (C.C.P.A. 1972) (“[I]t is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference”); see also Ex parte The NutraSweet Co., 19 USPQ2d 1586 (BPAI 1991). Neither do we find that the data presented in the Takanashi Declaration are persuasive of unexpected results. As an initial matter, claim 1 recites no particularized range of the concentration of pectin in the composition, only a relative ratio between pectin and a second gelling agent (0-0.1%). Consequently, we are not persuaded that the results disclosed by the Takanashi Declaration, which use a single concentration of pectin (1.4g), 9 Appeal 2016-000661 Application 13/262,732 are commensurate with scope of the claims. The data are further not commensurate with the scope of the claims because formulation 3 — which is encompassed by the claims — has a rupture strength of 35.6 which is below the 40-120g rupture strength that Appellants allege is desirable. See Takahashi Decl. 14. Furthermore, we are not persuaded by the data presented in the Takanashi Declaration that there is a significant difference between the Formulations containing no second gelling agent and those with more or less than 0.1% of the pectin concentration. Formulations 2 and 3 contain a “second gelling agent” at concentrations that are less than 0.1% of the concentration of pectin, whereas Formulations 4—6 possess concentrations of the second gelling agent that are greater than 0.1%. Takanashi Decl. Table 1. The rupture strengths of Formulations 2 and 3 are 77.6 and 35.6, respectively, whereas the rupture strengths of Formulations 4—6 are “unmeasurable,” 39.2, and 31.2, respectively. Id. Table 2. The rupture strength of Formulation 7, which contains no second gelling agent, but which alone contains xylitol, has a rupture strength of 76.2, which is comparable to that of Formulation 1 (which also contains no second gelling agent), which has a rupture strength of 60.7. Id. Tables, 1 & 2. To the extent this data reflects a difference between formulations, the data and Appellants’ arguments do not persuade us that it is a difference probative of unexpected results. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (Unexpected results that are probative of nonobviousness are those that are “different in kind and not merely in degree from the results of the prior art”) (citation omitted). Consequently, we affirm the Examiner’s rejection of claims 1,2, and 4. Furthermore, although Appellants argue claim 6 separately, they rely on 10 Appeal 2016-000661 Application 13/262,732 the same arguments presented with respect to claims 1, 2, and 4. App. Br. 9—10. For the reasons presented above, we similarly affirm the Examiner rejection of claim 6. Issue 3 Appellants request that the double patenting rejection be held in abeyance until allowable subject matter is indicated. App. Br. 10. We have affirmed the Examiner’s rejection of the claims over the Examiner’s combined cited prior art. Because Appellants have waived argument on this ground on the merits, we also affirm the Examiner’s rejection of claims 1, 2, 4, and 6 on this ground. See 37 C.F.R. § 41.37(c)(iv). DECISION The Examiner’s rejection of claims 1, 2, 4, 6 as unpatentable 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)(1). AFFIRMED 11 Copy with citationCopy as parenthetical citation