Colgate-Palmolive CompanyDownload PDFPatent Trials and Appeals BoardNov 26, 20212021000135 (P.T.A.B. Nov. 26, 2021) 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. 15/630,465 06/22/2017 Paul Thomson 11173-00-US-01-OC 4627 23909 7590 11/26/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER WEBB, WALTER E ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 11/26/2021 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): Patent_Mail@colpal.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PAUL THOMSON, NIHAL DOGU, DIVINO RAJAH, CARLO DAEP, REHANA BEGUM-GAFUR, and MICHAEL PRENCIPE ____________ Appeal 2021-000135 Application 15/630,465 Technology Center 1600 ____________ Before JOHN E. SCHNEIDER, DEBRA L. DENNETT, and RACHEL H. TOWNSEND, Administrative Patent Judges. DENNETT, Administrative Patent Judge. DECISION ON APPEAL1 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the Examiner’s decision to reject claims 1, 10–12, 15, 17–20, and 22 of 1 In our Decision, we refer to the Specification (“Spec.”) of Application No. 15/630,465 filed June 22, 2017; the Final Office Action dated Jan. 3, 2020 (“Final Act.”); the Appeal Brief filed June 3, 2020 (“Appeal Br.”); the Examiner’s Answer dated Aug. 5, 2020 (“Ans.”); and the Reply Brief filed Oct. 5, 2020 (“Reply Br.”). 2 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Colgate-Palmolive Company as the real party in interest. Appeal Br. 2. Appeal 2021-000135 Application 15/630,465 2 Application 15/630,465, which constitute all the claims pending in this application. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM. The subject matter of the invention relates to oral care compositions comprising zinc oxide and either zinc citrate or zinc lactate, and a stannous source. Spec. ¶ 1. Claim 1, reproduced below from the Claims Appendix of the Appeal Brief, represents the claimed subject matter: 1. An oral care composition comprising: a. a first source of zinc comprising zinc oxide; b. a second source of zinc comprising zinc citrate; c. stannous fluoride, wherein the amount of stannous fluoride is about 0.454%, by total weight of the composition, and d. sodium tripolyphosphate, wherein the amount of tripolyphosphate is about 3.0% by total weight of the composition, wherein the zinc citrate is in an amount of about 0.5 wt.% and zinc oxide is present in an amount of about 1 wt.% based on the total weight of the composition. Appeal 2021-000135 Application 15/630,465 3 REFERENCES The Examiner relies on the following prior art in rejecting the claims as obvious under 35 U.S.C. § 103: Name Reference Date Maloney et al. (“Maloney”) US 2013/0287709 A1 Oct. 31, 2013 Fruge et al. (“Fruge”) WO 2011/053291 A1 May 5, 2011 Strand et al. (“Ross”)3 EP 2 057 978 B1 Oct. 12, 2011 REJECTIONS The Examiner maintains the rejection of claims under 35 U.S.C. § 103 as follows: (1) claims 1, 10–12, 15, 17–20, and 22 over Maloney in view of Ross; and (2) claims 1, 10–12, 15, 17–20, and 22 over Fruge in view of Maloney. Final Act. 3, 5. The Examiner provisionally rejects claims 1, 10– 12, 15, 17–20, and 22 on the ground of nonstatutory double patenting over claims 1–3, 5, 7, 9–11, 13, 15–18, 20, 21, 32, 33, 36, 38, and 39 of Application No. 15/525,381 (now issued as U.S. Pat. No. 10,251, 823). Id. at 7–8. DISCUSSION We review the appealed rejections for error based upon the issues identified by Appellant and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential), 3 The first inventor on EP 2 057 978 B1 is Ross Stand. Although we typically refer to prior art patents and published applications by the first inventor’s surname, here we follow the Examiner’s mistaken use of the given name for ease of reference to the record. Appeal 2021-000135 Application 15/630,465 4 (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the [E]xaminer’s rejections.”). After considering the evidence presented in this Appeal and each of Appellant’s arguments, we are not persuaded that Appellant identifies reversible error. Thus, we affirm the Examiner’s rejections for the reasons expressed in the Final Office Action and the Answer. We add the following primarily for emphasis. Obviousness Rejections The Examiner rejects claims 1, 10–12, 15, 17–20, and 22 as obvious over (1) Maloney in view of Ross, and (2) Fruge in view of Maloney. Final Act. 3–7. Appellant does not provide separate arguments for the different rejections. See Appeal Br. 5–10. We select claim 1 as representative of the rejected claims. 37 C.F.R. § 41.37(c)(1)(iv). Claims 10–12, 15, 17–20, and 22 stand or fall with claim 1 for each rejection. Of relevance to this appeal, in the first rejection the Examiner finds that Maloney teaches oral care compositions comprising combinations of metal ions wherein the source of metal ions includes mixtures of zinc and stannous compounds, such as zinc citrate, zinc oxide, and stannous fluoride. Final Act. 3. Maloney teaches “the second metal salt is present in an amount effective to provide a synergistic increase in the uptake of the metal ion of the first or second metal salt.” Id. (quoting Maloney ¶ 11). Maloney teaches an example comprising 0.1 to 5 %wt zinc citrate and 0.05 to 2 %wt zinc oxide; these ranges overlap the claimed amounts of “about 0.5 wt.%” zinc citrate and “about 1 wt.%” zinc oxide. Id. at 3–4 (compare Maloney ¶ 48, with Appeal Br. 12 (Claims App.)). Appeal 2021-000135 Application 15/630,465 5 The Examiner finds that Ross teaches combining 0.2% to 3% divalent metal ions comprising from 0.1 % to 1.5% zinc ions, from 0.1 to 2% tin (II) ions (stannous ions) with a source of fluoride ions in oral care compositions, and teaches an embodiment comprising 0.454% stannous fluoride. Id. at 4 (citing Ross ¶¶ 9, 47). The Examiner finds that Ross teaches the composition gives improved microbial activity from the zinc/stannous combination. Id. (quoting Ross ¶ 10). The Examiner determines that it would have been obvious to one of ordinary skill in the art at the time of filing to add a source of stannous ions, e.g. stannous fluoride, to the example in Maloney for the benefit of improved antimicrobial activity from the zinc/stannous combination as taught by Ross. Id. In the second rejection, the Examiner finds that Fruge teaches, inter alia, a dentifrice comprising combinations of zinc and stannous ions, and “a need in the art to provide dentifrice compositions that [] effectively combine sources of stannous, fluoride, and zinc ions in combination with a polyphosphate.” Id. at 4 (citing Fruge, ¶ 10). The source of fluoride ions and stannous ions is preferably stannous fluoride. Id. The source of zinc ions is preferably zinc citrate, and may include zinc oxide. Id. (citing Fruge ¶ 36). Fruge teaches an embodiment comprising 2.0% zinc citrate, 0.454% stannous fluoride, and 3.0 % sodium tripolyphosphate. Id. (citing Fruge ¶ 93). Fruge teaches that the amount of zinc citrate may be adjusted to about 0.5% and the metal ions may be present in a concentration of about 0.25% to about 11%. Id. at 6 (citing Fruge ¶ 69). The Examiner relies on the disclosures in Maloney reviewed above. Id. at 6–7. The Examiner determines that it would have been obvious to one Appeal 2021-000135 Application 15/630,465 6 of ordinary skill at the time of filing to combine zinc citrate with zin oxide in the compositions of Fruge because Maloney teaches the addition of an insoluble zinc oxide to a composition comprising a soluble zinc citrate synergistically increases delivery of the metal (zinc) to hydroxyapatite. Id. at 7 (quoting Maloney ¶ 49). Appellant contends that “[t]he invention here required a recognition that the inclusion of zinc oxide and zinc citrate were variables that could be modified to obtain increased stannous availability in the composition, an insight not provided by the cited references.” Appeal Br. 6. Therein lies the rub for Appellant. Recognition that inclusion of both zinc oxide and zinc citrate in an oral care composition increases stannous availability may or may not be novel and nonobvious, but “the name of the game is the claim.” See In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998) (quoting Giles Sutherland Rich, Extent of Protection and Interpretation of Claims— American Perspectives, 21 Int’l Rev. Indus. Prop. & Copyright L. 497, 499 (1990). Appellant’s motivation and purpose do not control an obviousness determination: In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103. KSR Inter’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007) (emphasis added). In the appeal before us, none of the claims are drawn to the alleged point of novelty repeatedly identified by Appellant. See, e.g., Appeal Br. 7 (“[T]he Examiner has not demonstrated that one of skill in the art would have had a reasonable expectation that zinc salts could increase the availability of stannous.”); id. at 5 (“None of Maloney, Ross, or Fruge teach Appeal 2021-000135 Application 15/630,465 7 or suggest that zinc oxide could be specifically combined with zinc citrate and stannous fluoride, much less that this combination could specifically increase the metal deposition of either stannous and/or zinc.”). The Examiner’s burden to establish a prima facie case does not require a showing that the prior art discloses features, functionality, or advantages not recited in the claims. See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (rejecting appellant’s nonobviousness argument as based on limitation not expressly recited in claim, stating “limitations are not to be read into the claims from the specification”); Application of Golen, 352 F.2d 385, 389 (CCPA 1965) (affirming obviousness rejection and dismissing argument distinguishing prior art based on feature that “is not supported by any limitation in his claims”); In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“Many of appellant's arguments fail from the outset because, . . . they are not based on limitations appearing in the claims.”). Having selected claim 1 as representative of the claims above, we note that it is drawn to an oral care composition comprising a first source of zinc comprising zinc oxide in an amount of about 1 wt.%, a second source of zinc comprising zinc citrate in an amount of about 0.5 wt.%, stannous fluoride in an amount of about 0.454% by total weight of the composition, and sodium tripolyphosphate in an amount of about 3.0% by total weight of the composition. Appeal Br. 12 (Claims App.). If the references cited by the Examiner teach these limitations, a skilled artisan would have been motivated to combine the teachings of the references, and would have had a reasonable expectation of success in doing so, the claim is obviousness unless Appellant successfully rebuts the determination. See Intelligent Bio- Appeal 2021-000135 Application 15/630,465 8 Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–68 (Fed. Cir. 2016). An Appellant may rebut a prima facie case of obviousness by showing the prior art combination is deficient, that no motivation exists to modify the prior art as suggested by the Examiner, the presence of unexpected results achieved by the claimed subject matter relative to the prior art, or other objective evidence of nonobviousness. In re Mayne, 104 F.3d 1339, 1342 (Fed. Cir. 1997); In re Geisler, 116 F.3d 1465, 1469–70 (Fed. Cir. 1997); In re Dillon, 919 F.2d 688, 692–93 (Fed. Cir. 1990) (en banc). Appellant disputes that one of ordinary skill in the art would have been motivated to combine the disclosures of Maloney and Ross, or of Fruge and Maloney. Appeal Br. 5–6. We disagree. Maloney teaches inclusion of two sources of zinc ions, Maloney ¶ 12 (teaching the first and second metal salts are salts of the same metal), where the first zinc salt is zinc citrate and the second zinc salt is zinc oxide, id. ¶¶ 13–14. and where the second zinc salt is present in an amount to provide a synergistic increase in the delivery of the metal ion of the first zinc salt, id. ¶¶ 12, 49. We agree with the Examiner’s conclusion that it would have been obvious to combine Ross’s disclosure of 0.454 wt% stannous fluoride and 0.1–1.5 wt% zinc ions, e.g., 0.533 wt% zinc citrate, with Maloney’s disclosure of compositions comprising 0.1–5 wt% zinc citrate and 0.05–2 wt% zinc oxide because Ross teaches that combining zinc ions with stannous ions can give a broader spectrum of anti-microbial activity.4 Final Act. 4. An improvement such as 4 Appellant argues that “Ross provides no evidence to support” the statement contained therein that “[c]ombining zinc ions with stannous ions can give a Appeal 2021-000135 Application 15/630,465 9 a broader spectrum of antimicrobial activity qualifies as “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness” in support of the rejection over Maloney in view of Ross. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). We also agree with the Examiner’s conclusion that it would have been obvious to combine Fruge’s disclosures with those of Maloney. Final Act. 5–7. Fruge teaches “a need in the art to provide dentifrice composition can [sic] effectively combine sources of stannous, fluoride, and zinc ions in combination with a polyphosphate,” and a composition comprising 2.0 % zinc citrate and 0.454% stannous fluoride. Fruge ¶¶ 10, 94. Maloney teaches oral care compositions comprising combinations of metal ions wherein the source of metal ions includes mixtures of zinc and stannous compounds, including zinc citrate, zinc oxide, and stannous fluoride. Maloney ¶¶ 3, 13, 18. Maloney teaches that the addition of zinc oxide to a composition comprising zinc citrate synergistically increases the delivery of the metal (zinc) to hydroxyapatite. Id. ¶ 49. Our reviewing court has repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the broader spectrum of anti-microbial activity.” Ans. 5. However, for purposes of § 103, a reference is prior art for all that it discloses, and here Ross contains the explicit statement that “[c]ombining zinc ions with stannous ions can give a broader spectrum of anti-microbial activity.” Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991); see also In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (explaining that “[i]t is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art”). Appellant’s argument is, thus, unpersuasive. Appeal 2021-000135 Application 15/630,465 10 combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal – and even common-sensical – we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references. Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006). Here, a skilled artisan would be capable of combining the references to synergistically increase the delivery of zinc, making the product more desirable—and obvious. To render an invention obvious, the prior art does not have to address the same problem addressed by a patent applicant. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007); see also, In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (“As long as some motivation or suggestion to combine the references is provided by the prior art taken as a whole, the law does not require that the references be combined for the reasons contemplated by the inventor.”). Appellant argues that “both Ross and Fruge highlight difficulties in formulating stannous ions, zinc ions, polyphosphates, and combinations thereof, thereby teaching away from modifying the formulations disclosed.” Appeal Br. 6. Appellant’s argument is not persuasive. Teaching away requires that a reference “criticize, discredit, or otherwise discourage the solution claimed” by Appellant. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Ross and Fruge indicate that challenges exist, but go on to provide solutions to such challenges by their inventions. Appeal 2021-000135 Application 15/630,465 11 Under these circumstances, Ross and Fruge do not criticize, discredit, or otherwise discourage the solution in claim 1. Appellant argues that one of ordinary skill in the art would not have had a reasonable expectation of success, more specifically, “a reasonable expectation that zinc salts could increase the availability of stannous.” Appeal Br. 7. The reasonable expectation of success requirement for a prima facie case of obviousness refers to the likelihood of success in combining references to meet the limitations of the claimed invention. See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (“[F]ailure to consider the appropriate scope of the . . . claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error.” (emphasis added)). In other words, the correct inquiry is whether a skilled artisan has a motivation to combine accompanied by a reasonable expectation of achieving what is claimed. See Proctor & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (An invention is obvious if “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” (internal citation omitted)). “[O]nly a reasonable expectation of success, not a guarantee, is needed.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007); In re Longi, 759 F.2d 887, 897 (“[A] reasonable expectation of success, not absolute predictability” supports a conclusion of obviousness). Appellant’s argument fails to address whether there would have been a reasonable expectation of success in achieving the composition of claim 1. See Appeal Br. 7–10. Although the cited references suggest some Appeal 2021-000135 Application 15/630,465 12 challenges had been present, the references also provide solutions to those challenges. Appellant’s discussion of In re Stepan, 868 F.3d 1342 (Fed. Cir. 2017) is inapposite. In Stepan, the claim required a concentrate having a cloud point above at least 70°C, and “[t]he Board failed to explain why it would have been ‘routine optimization’ to select and adjust the claimed surfactants and achieve a cloud point above at least 70°C.” Id. at 1344–46. Here, claim 1 does not require that zinc salts increase the availability of stannous ions. See Appeal Br. 12–13 (Claims App.). Moreover, in contrast to Appellant’s position, In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), is applicable here as it concerns the presumption of the existence of a prima facie case of obviousness when the ranges of a claimed position overlap the ranges disclosed in the prior art. See id. at 1329. As discussed above, the cited references disclose ranges of zinc citrate, zinc oxide, stannous fluoride, and sodium tripolyphosphate that overlap the amounts of these components in claim 1. The presumption of obviousness may be rebutted if Appellant shows that (1) the prior art taught away from the claimed invention, In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997); or (2) there are new and unexpected results relative to the prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1321 (Fed. Cir. 2004). As discussed above, Appellant fails to show that the cited references teach away from the claimed invention. We next address whether unexpected results overcome the presumption of obviousness. The burden of showing unexpected results rests on the one who asserts them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). A showing Appeal 2021-000135 Application 15/630,465 13 of unexpected results may be probative of nonobviousness if Appellant establishes at least: (1) that there actually is a difference between the results obtained through the claimed invention and those of the prior art, In re Klosak, 455 F.2d 1077, [1080] (CCPA 1972); and (2) that the difference actually obtained would not have been expected by one skilled in the art at the time of invention, Id.; In re D’Ancicco, 439 F.2d 1244, [581247–48] (CCPA 1971). In re Freeman, 474 F.2d 1318, 1324 (CCPA 1973). In this case, Appellant establishes neither prong. First, Appellant must demonstrate a difference between the claimed invention and the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”). Appellant directs us to Table 2, Example 3, and Example 4 of the Specification in support of the assertion of unexpected results. Appeal Br. 10. This evidence shows that, in comparison to a composition comprising stannous fluoride and zinc lactate (Control Formulation), stannous uptake increased with an unclaimed formulation (Example 2, comprising 0.8% rather than 0.5% zinc citrate), but decreased (Example 3) or was unchanged (Example 4) for a composition comprising the claimed amounts of stannous fluoride, zinc citrate, zinc oxide, and sodium tripolyphosphate (Test Formulation). This data provides no evidence of differences in increased stannous uptake between the claimed composition and the Control Formulation. Second, Appellant fails to show that any difference actually obtained in uptake of zinc would have been unexpected by one skilled in the art at the time of invention. See Freeman, 474 F.2d at 439 F.2d at 1324. Only in the Appeal 2021-000135 Application 15/630,465 14 briefing does Appellant assert any unexpected difference, and then the comparison is not between the claimed composition and the closest prior art. See Appeal Br. 7–10, Reply Br. 3–4. In its entirety, regarding something “unexpected,” the Specification states It is an unexpected benefit that that current formulation use comparable amounts of stannous and zinc than previous formulations, but still maintain or improve the availability of stannous and zinc in the oral cavity of a user. Spec. ¶ 5 (emphasis added). At best, the quoted language provides no evidence of what formulations provide an allegedly unexpected benefit. “It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)); see also In re Wood, 582 F.2d 638, 642 (CCPA 1978) (“Mere lawyer’s arguments and conclusory statements in the specification, unsupported by objective evidence, are insufficient to establish unexpected results.”); In re Lindner, 457 F.2d 506, 508 (CCPA 1972) (“Mere conclusory statements in the specification . . . are entitled to little weight when the Patent Office questions the efficacy of those statements.”). Furthermore, unexpected results must be “commensurate in scope with the degree of protection sought by the claims on appeal.” In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005); see also In re Graselli, 713 F.2d 731, 743 (Fed. Cir. 1983) (“It is well settled ‘that objective evidence of non- obviousness must be commensurate in scope with the claims which the evidence is offered to support.’” (internal citation omitted)). The degree of protection Appellant seeks with claim 1 is a composition comprising about 1 wt% zinc oxide, about 0.5 wt% zinc citrate, about 0.454% stannous fluoride Appeal 2021-000135 Application 15/630,465 15 by total weight of the composition, and about 3.0% by total weight of the composition. Appeal Br. 12 (Claims App.). The Specification provides inadequate evidence to conclude that the Test Formulation exhibits unexpected results (compare Example 1 with Example 3), much less to expand the test results to formulations of any breadth greater than the single Test Formulation described. “Commensurate in scope” means that the evidence provides a reasonable basis for concluding that the untested embodiments encompassed by the claims would behave in the same manner as the tested embodiment(s). See In re Lindner, 457 F.2d 506, 508 (CCPA 1972). The preponderance of the evidence fails to support the existence of unexpected results to rebut the prima facie case of obviousness. For the reasons above, we sustain the Examiner’s rejection of claim 1 as obvious over Maloney in view of Ross and over Fruge in view of Maloney. We sustain the rejection of claims 10–12, 15, 17–20, and 22 over the same references for the same reasons. Provisional Nonstatutory Double Patenting Rejection Claims 1, 10–12, 15, 17–20, and 22 are provisionally rejected as unpatentable over claims 1–3, 5, 7, 9–11, 13, 15–18, 20, 21, 32, 33, 36, 38, and 39 of Application No. 15/525,381 (now issued as U.S. Pat. No. 10,251, 823). Final Act. 7–8. In the Appeal Brief, Appellant requests the provisional rejection be held in abeyance until claims are allowed. Appeal Br. 11. The Reply Brief contains new argument which could have been but was not presented in the Appeal Brief. Compare Reply Br. 7, with Appeal Br. 11. Under regulations governing appeals to the Board, a new argument not timely presented in the Appeal 2021-000135 Application 15/630,465 16 Appeal Brief will not be considered when filed in a Reply Brief, absent a showing of good cause explaining why the argument could not have been presented in the Appeal Brief. See Ex parte Borden, 93 USPQ2d 1473, 1477 (BPAI 2010) (informative) ) (“the reply brief [is not] an opportunity to make arguments that could have been made in the principal brief on appeal to rebut the Examiner’s rejections, but were not.”); compare also Optivus Tech., Inc. v. Ion Beam Applications S.A., 469 F.3d 978, 989 (Fed. Cir. 2006) (argument raised for the first time in the Reply Brief is considered waived); see also 37 C.F.R. § 41.37 and § 41.41. Because the record contains no such showing, we will not consider the new argument in the Reply Brief. We affirm the provisional nonstatutory double patenting rejection. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 10–12, 15, 17–20, 22 103 Maloney, Ross 1, 10–12, 15, 17–20, 22 1, 10–12, 15, 17–20, 22 103 Fruge, Maloney 1, 10–12, 15, 17–20, 22 1, 10–12, 15, 17–20, 22 Provisional Nonstatutory Double Patenting 15/525,381 1, 10–12, 15, 17–20, 22 Overall Outcome 1, 10–12, 15, 17–20, 22 Appeal 2021-000135 Application 15/630,465 17 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 Copy with citationCopy as parenthetical citation