Ex Parte Ori et alDownload PDFPatent Trials and Appeals BoardMay 23, 201913503577 - (D) (P.T.A.B. May. 23, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/503,577 04/23/2012 127226 7590 05/28/2019 BIRCH, STEW ART, KOLASCH & BIRCH, LLP 8110 Gatehouse Road Suite 100 East Falls Church, VA 22042-1248 Tatsuya Ori 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 7088-0lOlPUS 1 6432 EXAMINER FALKOWITZ, ANNA R ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 05/28/2019 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): mailroom@bskb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TATSUYA ORI, HARUKA NISHITANI, SA YURI IWASAKI, YUY A YAMAMOTO, and CHIDZURU NISHIMOTO Appeal2018-003346 Application 13/503,577 1 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a dental curable composition that bonds to teeth, which have been rejected as obvious and/or as failing to comply with the written description requirement. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Curable polymer compositions are known for use in the dental field for repair of missing parts of a tooth, for repair of dental caries, for 1 Appellants identify the real party in interest as Sun Medical Co., Ltd. (Br. 1.) Appeal2018-003346 Application 13/503,577 temporary sealing in prosthetic repair, and sealer in root canal. (Spec. 1-3.) Appellants' invention is directed to a curable composition for such uses. (Id. at 3.) Claims 32-35, 37--41, 43-59, and 61---63 are on appeal. 2 Claim 32 is representative, with paragraphing added, and reads as follows: 32. A dental curable composition that bonds to teeth, compnsmg: (A) a polymerizable monomer; and (B) an organic amine-based polymerization initiator, wherein the component (A) contains (A') a long-chain polymerizable monomer having a chain length of 19 or more atoms, which contains a polyalkylene glycol di(meth)acrylate having at least 4 oxyalkylene recurring units (-(-(-CH2-)rO-)n-) ( wherein p is an integer of 2 or more, and n is an integer of 4 or more) in the molecule, and the composition contains water alone or a mixed solvent of water and an organic solvent miscible with water, which is (G) a solvent miscible with the long-chain polymerizable monomer, and (C) a soft resin material being not substantially dissolved by the component (A) and having median particle diameter of 0.01 to 500 µmis contained in the composition, and when the amount (parts by weight) based on 100 parts by weight of the component (A) of the component (A') is [a'] and the amounts (parts by weight) based on 100 parts by weight of the total of the components (A) and (B) of the components (A), (B) and (C) are (a), (b) and (c), respectively, 70 <(a)< 99.99, 0.01 < (b) < 30, 1 < [a']/5 + (c)/1, 0 < [a']< 95, and O < (c) < 250, 2 Claim 60 is also pending, but stands withdrawn from consideration. (Non- Final Action 1.) 2 Appeal2018-003346 Application 13/503,577 wherein the soft resin material ( C) is at least one selected from the group consisting of polyethylene, polypropylene, ethylene propylene copolymer, ethylene propylene terpolymer, silicone polymer, polyisoprene, ethylene vinyl acetate copolymer and acrylic acid ester copolymer. (Br. Claims Appendix at 1.) The following grounds of rejection by the Examiner are before us on review: Claim 63 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Claims 32-35, 37--41, 43-54, 58, 59, 61, and 63 under 35 U.S.C. § 103 as unpatentable over Ori, 3 Fischer, 4 and Yamamoto. 5 Claims 55-57 under 35 U.S.C. § 103 as unpatentable over Ori, Fischer, Yamamoto, and Ige. 6 Claim 62 under 35 U.S.C. § 103 as unpatentable over Ori, Fischer, Yamamoto, and Andersen. 7 3 Ori et al., WO 2007/018220 Al, published Feb. 15, 2007. Ori W0'220 is a Japanese language document. The Examiner relied on its translation as found in the US patent publication US 2009/0137697 Al, published May 28, 2009. We also rely on the English translation of W0'220 that the Examiner relied upon. 4 Fischer et al., US 2006/00788484 Al, published Apr. 13, 2006. 5 Yamamoto et al., WO 98/16187 Al, published Apr. 23, 1998. The Examiner relied on a translated version of this publication, as do we. 6 Ige et al., US 5,296,513, issued Mar. 22, 1994. 7 Andersen et al., US 2009/0087812 Al, published Apr. 2, 2009. 3 Appeal2018-003346 Application 13/503,577 DISCUSSION Written Description: New Matter The Examiner finds that the range of 30<( c) :S 250 is not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention at the time the application was filed. (Ans. 6-7; Non-Final Action 3.) The Examiner finds that the Specification provides that ( c) can be present in the following ranges: O<(c) :S 250, O<(c) :S 200, O<(c) :S 150. (Non-Final Action 3.) Appellants' only argument for support is that the Specification at page 38 "fully and explicitly" supports claim 63 because it states "'the lower limit of the amount of the component (C) is preferably 30 parts by weight."' (Br. 10.) The Examiner finds that while the Specification does identify that the lower limit of ( c) can "preferably [be] 30 parts by weight" (Spec. 38, ,r 3), that is only if (C) is present without (A'). (Ans. 7.) The Examiner explains that claim 63, as an open ended claim using the transition word "comprising" does not exclude the presence of A'. (Id.) Appellants do not respond to the Examiner's finding. Arguments not made are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2017). "In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue." Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. See id. We, agree with the Examiner's factual finding that the portion of the Specification relied on by Appellants to 4 Appeal2018-003346 Application 13/503,577 establish support for the lower limit of the claimed range for C is limited to the situation where (A') is not also present. Claim 63, however, does not specify that situation. Consequently, we do not find the Specification to convey with reasonable clarity to those skilled in the art that the inventor was in possession of the range recited in claim 63; accordingly, we affirm the Examiner's rejection of claim 63 under 35 U.S.C. § 112, first paragraph. II Obviousness Appellants do not dispute the Examiner's factual findings regarding the teachings of the prior art. Arguments not made are waived. See 37 C.F.R. § 4I.37(c)(l)(iv). Appellants argue that the Examiner's rationale for combining the references "cannot be based on mere conclusory statements and must be clearly articulated," and that the Examiner's rejection fails in this regard. (Br. 14.) We disagree. The Examiner points to express teachings of using an A' polymer as defined in claim 32 (namely, nona propylene glycol di(meth)acrylate) and a soft material in combination to provide a dental implant that is removable in Yamamoto. (Non-Final Action 15 ( citing Yamamoto 16, ,r 2).) The Examiner explains that Yamamoto teaches that the inclusion of polymers like nona propylene glycol di(meth)acrylate allow for the customization of the cure rate and improves mechanical strength of the cured material. (Id.) The Examiner also finds that Ori teaches a dental curable composition that includes a di(meth)acrylate polymerizable monomer and that one of ordinary skill in the art would have been motivated to include the nona propylene glycol di(meth)acrylate polymer taught by Yamamoto to 5 Appeal2018-003346 Application 13/503,577 customize the cure rate of the dental curable composition of Ori. We agree. (See Yamamoto 15-16.) The Examiner also indicated that inclusion of the soft resin material (C) as claimed would have been obvious in light of the teachings of Yamamoto and Fischer. The Examiner pointed out that Fischer teaches soft thermoplastic resins that provide flexibility to material that fit around teeth in the mouth and which material will hold its shape and that it would have been obvious to one of ordinary skill in the art to substitute the gutta-percha soft material with the soft resin of Fischer with a reasonable expectation of success and predictable results. (Non-Final Action 8, 15-16.) We agree. Ori teaches that its composition can be used as a root canal filling material. ( Ori ,r 1.) Yamamoto teaches root canal materials need to maintain their sealability when physical force is applied but also need to be removable. (Yamamoto 3, 21-22.) Yamamoto explains that gutta-percha is a relatively soft material used for the purpose of allowing a curable composition used in root canals to be removed. (Yamamoto 22.) Fischer teaches a composition that can be injection molded that is flexible but retains its shape and is safe for use in the mouth and that can be polyethylene or polypropylene. (Fischer ,r,r 11, 31-32.) In light of these teachings, we find the Examiner has provided sufficient evidence to establish a prima facie case for the obviousness of substituting Fischer's soft thermoplastic material for the gutta-percha of Yamamoto with a reasonable expectation of success and to use that along with the nona propylene glycol di(meth)acrylate polymer in Ori with the predictable result of being able to remove the root canal material. 6 Appeal2018-003346 Application 13/503,577 Appellants contend that they have provided evidence of unexpected and unpredictable results, and thus, a conclusion of obviousness cannot be maintained. (Br. 11-13 (discussing results), 13-14 (noting that the cited references do not provide a "proper reason or rationale that would allow one of ordinary skill in the art to arrive at the claimed invention" because "unexpected and unpredictable results over the closest prior art" have been shown).) Appellants rely on three separate Declarations of inventor, Mr. Tatsuya Ori. 8 We disagree that Appellants' evidence establishes the non- obviousness of the claimed invention. The comparative testing was as follows. Ori Declaration 1 tests the composition of Example 7 of Ori, albeit with almost double the amount of each component described in that Example, for its ability to be removed. (Compare Ori Declaration 1 at 19 with Ori Example 7 .) Example 7 of Ori does not include an A' polymer of a component (C) as claimed. (Ori Declaration 1 at Table A.) The rating of the composition for removability was "unsatisfactory," meaning that none of five dental mechanic judges determined that the material was easily removed, whereas "satisfactory", meaning that five out of five dental mechanic judges determined that the material was easily removed. (Id. at 2.). The comparative Examples include 23G as polymer A' at 4.9 parts by weight and PE at 40.7 parts by weight and 8 The first Declaration of Mr. Ori was submitted with the response filed January 20, 2016 ("Ori Declaration 1"). The second Declaration of Mr. Ori was submitted with the response filed September 8, 2016 ("Ori Declaration 2"). The third Declaration of Mr. Ori was submitted with the response filed May 23, 2017 ("Ori Declaration 3"). (Br. 11-12.) 9 We note that there are no page numbers on Ori Declaration 1. We assign consecutive numbers to that Declaration. 7 Appeal2018-003346 Application 13/503,577 the removability for the compositions were judged satisfactory. (Id. at 2, and Table A.) Ori Declaration 2 determines bond strength of Example 7 of Ori, Example 7 of Fischer, and the same two comparative examples tested in Ori Declaration 1. ( Ori Declaration 2 at 1.) The data demonstrated that the Ori Example 7 had the strongest bond, whereas the 2 comparative Examples had a lower bond strength and Example 7 of Fischer had no bond strength. (Id. at Table B.) "To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention." Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Mr. Ori avers in his third Declaration that he considers "the combination of bond strength and removability" to be unexpected. (Ori Declaration 3 at 1.) He considers the unexpectedness to be that the data demonstrates that the Fischer example that included a soft resin did not bond to teeth at all and the Ori example that did not include a soft resin bonded to teeth but could not be removed. (Id. at 2.) The removability of the comparative compositions that include C, as compared to Ori's example 7, however, is not unexpected in light of Yamamoto and Fischer's teachings. Yamamoto explains that "the combinational use with a relatively soft material, such as gutta-percha is convenient particularly in the case where the curable composition according to the present invention is removed from the dental root canal." (Yamamoto at 22.) Yamamoto further indicates that the soft material can be used in 8 Appeal2018-003346 Application 13/503,577 combination with (Yamamoto 22-23) a curable composition that includes a monomer within the scope of the claimed A' for the purpose of adjusting the curing rate of the curable composition (Yamamoto 15-16) and a monofunctional polymerizable monomer (Yamamoto 3, 6-10 (providing a list of monomers for use in addition to the polyfunctional monomer used for adjusting the curing rate)), which composition has the necessary adhesive properties needed for a curable root canal composition to adhere to the wall of the dental root canal (Yamamoto 5 (noting an object of the curable composition is to provide sealability for filing in a dental root canal)). Appellants' evidence does not include a comparison to this prior art. The decreasing of bond strength, with the addition of C to the composition is also not unexpected in light of Yamamoto and Fischer's teachings that inclusion of a soft material will assist removability. Decreased bond strength would have been expected to provide for the removability aspect provided by the soft resin. The fact that the Fischer composition had no ability to bond is also not unexpected, in light of the fact that Fischer's composition is taught to be a dental tray that is removable from the teeth. (Fischer ,r 59.) It is the addition of a sticky treatment composition that provides for the tray to adhere to the teeth so as to "be worn while performing normal daily activities, such as talking." (Id. ,r 60.) That the Fischer Example 7 composition, which did not include the dental curable components of Yamamoto and gutta-percha, does not demonstrate unexpected bonding strength and removability compared to a composition of the closest prior art. Mr. Ori also states that in light of the known mechanisms for obtaining bonding to the dentine of the root canal, which involves diffusion 9 Appeal2018-003346 Application 13/503,577 of monomers, one of ordinary skill in the art would not have expected "bonding strength" to be obtained "with the component (A') alone" because it has "a high molecular weight" and the necessary diffusion "becomes unsatisfactory." (Ori Declaration 3 at 2-3.) While it may be the case that A' does not satisfactorily diffuse completely, such is not relevant to establishing non-obviousness because the Examiner's rejection was not based on substituting A' for the other monomers taught by Ori, but to add such a monomer to control the cure rate in light of Yamamoto' s teachings. Because of the diffusion requirements for bonding strength, Mr. Ori also states that one of ordinary skill in the art would not have expected to obtain bonding strength by addition of a polymer of Fischer as component C. (Id. at 3.) However, this too is not relevant to establishing non-obviousness because the rejection was based on Yamamoto' s teaching that gutta-percha, a soft thermoplastic material, provides for removability of a curable dental composition that has sealability. Fischer was relied upon simply for teaching a known substitute thermoplastic material for gutta-percha, not that it would provide "bonding strength." Appellants' data does not establish a reason that one of ordinary skill in the art would have found Fischer's thermoplastic material to be unexpected in achieving the removability function that gutta-percha was known to achieve in a curable dental resin known to have bonding strength to the wall of the dental root canal. Finally, in the third Declaration Mr. Ori notes that the inventors determined that a composition that includes component A' is easily removed. (Ori Declaration 3 at 3 (referring to Spec. 66, Table 2).) We agree that the Specification provides an example of a composition that has satisfactory removability that includes monomers that are within the scope 10 Appeal2018-003346 Application 13/503,577 of A' and does not include any other monomers (see Spec. 63, Table 1 (Comparative Example 2)), such does not demonstrate unexpected results of the claimed invention, which provides for A' with other polymerizable monomers. To rebut a prima facie case of obviousness, the unexpected results must be a showing with respect to the claimed invention. In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). For the foregoing reasons, we do not find the Declaration evidence persuasively establishes unexpected results or unpredictability. Moreover, even if we did find the testing data established an unexpected difference to the closest prior art, the showing is not commensurate in scope with the claimed invention, as the Examiner noted. (Ans. 8.) Appellants do not respond to the Examiner's position. As noted above, arguments not made are waived. See 37 C.F.R. § 4I.37(c)(l)(iv). "It is well established that the objective evidence of nonobviousness must be commensurate in scope with the claims." In re Lindner, 457 F.2d 506, 508 (CCP A 1972). The inventive composition that was used in the comparison testing employed 23G as polymer A' at 4.9 parts by weight and PE as Cat 40.7 parts by weight. (Ori Declaration 1 at 2 ("Run 2 and Run 3"), and Table A (Runs 2 and 3), Ori Declaration 2 at 1 ("The compositions of Runs 1 to 3 correspond to the compositions of Runs 1 to 3 in my former declaration filed on January 20, 2016.")) The composition recited in claim 32 includes a broad description of compounds within the scope of A' and C and provides for a parts by weight range for each. One data point is insufficient to "to ascertain a trend in the exemplified data which would allow [one having ordinary skill in the art] ... to reasonably extend the probative value thereof." In re Kollman, 595 F.2d 48, 56 (CCPA 1979). 11 Appeal2018-003346 Application 13/503,577 After considering all the evidence anew before us, we conclude that Appellants have not provided sufficient evidence to show the non- obviousness of the claimed subject matter (In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984); In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976)), and have not demonstrated an error in the Examiner's rejection of claim 32. Claims 33-35, 37--41, 43-54, 58, 59, 61, and 63 have not been argued separately and, therefore, fall with claim 32. 37 C.F.R. § 4I.37(c)(l)(iv). In arguing for the reversal of the two additional obviousness rejections made by the Examiner, Appellants rely on the same argument set forth above. We affirm these additional rejections for the reasons discussed above. SUMMARY We affirm the rejection of claim 63 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. We affirm the rejection of claims 32-35, 37--41, 43-54, 58, 59, 61, and 63 under 35 U.S.C. § 103 as unpatentable over Ori, Fischer, and Yamamoto. We affirm the rejection of claims 55-57 under 35 U.S.C. § 103 as unpatentable over Ori, Fischer, Yamamoto, and Ige. We affirm the rejection claim 62 under 35 U.S.C. § 103 as unpatentable over Ori, Fischer, Yamamoto, and Andersen. 12 Appeal2018-003346 Application 13/503,577 TIME PERIOD FOR RESPONSE 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 13 Copy with citationCopy as parenthetical citation