Ex Parte DeMartino et alDownload PDFPatent Trial and Appeal BoardJun 28, 201813660508 (P.T.A.B. Jun. 28, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/660,508 10/25/2012 22928 7590 07/02/2018 CORNING INCORPORATED SP-TI-3-1 CORNING, NY 14831 FIRST NAMED INVENTOR Steven Edward DeMartino 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. SP12-277 1626 EXAMINER YAGER, JAMES C ART UNIT PAPER NUMBER 1782 NOTIFICATION DATE DELIVERY MODE 07/02/2018 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): usdocket@corning.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WENDELL P. WEEKS, ROBERT ANTHONY SCHADT, STEVEN EDWARD DEMARTINO, and JOHN STEPHEN PEANASKY Appeal2017-000881 Application 13/660,508 Technology Center 1700 Before ADRIENE LEPIANE HANLON, DONNA M. PRAISS, and N. WHITNEY WILSON, Administrative Patent Judges. PRAISS, Administrative Patent Judge. DECISION ON APPEAL 1 1 In explaining our Decision, we refer to the Specification filed Oct. 25, 2012 ("Spec."), the Final Office Action dated Aug. 12, 2015 ("Final Act."), the Appeal Brief filed Apr. 8, 2016 ("App. Br."), the Examiner's Answer dated Aug. 11, 2016 ("Ans."), and the Reply Brief filed Oct. 11, 2016 ("Reply Br."). Appeal2017-000881 Application 13/660,508 STATEMENT OF THE CASE2 Appellant3 appeals under 35 U.S.C. § 134(a) from the Examiner's decision to reject claims 50, 51, 55-73, and 75-83 as obvious under 35 U.S.C. § 103(a) over Baak. 4 , 5 App. Br. 6-16; Final Act. 7. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. The subject matter on appeal relates to a chemically and mechanically durable pharmaceutical container that is delamination resistant and formed, in part, of a glass composition. Spec. ,r 2. According to the Specification, delamination is the tendency of the interior surface of a pharmaceutical package to shed glass particulates following exposure to pharmaceutical solutions, which often destabilizes the active pharmaceutical ingredient present in the solution, thereby rendering it ineffective or unsuitable for therapeutic use. Id. ,r 9. Independent claims 55, 66, and 75 are illustrative ( emphasis added to highlight disputed limitations): 55. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored in the container, comprising an active pharmaceutical ingredient]] 2 This Appeal is related to Appeals 2017-000592 and 2017-000671 (Applications 13/660,704 and 13/660,708, respectively). App. Br. 3 (Appellant's statement concerning related appeals contains a typo graphical error interposing Application 13/660,508, the subject of this appeal, with that of Application 13/660,704). 3 Applicant, Coming Incorporated, is the Appellant and is also identified in the Appeal Brief as the real party in interest. App. Br. 3. 4 Baak et al., US 4,065,317, issued Dec. 27, 1977 ("Baak"). 5 The rejections of the claims on the grounds of obviousness-type double patenting stand withdrawn by the Examiner in view of the approved Terminal Disclaimer dated March 4, 2016 and the abandonment of Application No. 13/660,683. Ans. 4. 2 Appeal2017-000881 Application 13/660,508 [sic], wherein the pharmaceutical container comprises a glass composition comprising: Si02 in a concentration greater than about 7 4 mol. %; alkaline earth oxide comprising MgO and CaO, wherein CaO is present in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1. 0 mol. % relative to the glass composition, and a ratio (CaO (mol.%)/(CaO (mol.%)+Mg0 (mol.%))) is less than or equal to 0.5; and Y mol. % alkali oxide, wherein the alkali oxide comprises Na20 in an amount greater than about 8 mol.%, wherein the glass composition is free of boron and compounds of boron, wherein the pharmaceutical composition comprises Adalimumab. App. Br. 21-22 (Claims App'x). 66. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: from about 7 4 mol. % to about 78 mol. % Si02; from about 4 mol. % to about 8 mol. % alkaline earth oxide, wherein the alkaline earth oxide comprises both MgO and CaO and a ratio (CaO (mol.%)/(CaO (mol.%)+Mg0 (mol.%))) is less than or equal to 0.5; X mol. % Ab03, wherein X is greater than or equal to about 2 mol.% and less than or equal to about 10 mol.%; and Y mol. % alkali oxide, wherein the alkali oxide comprises Na20 in an amount greater than or equal to about 9 mol.% and less than or equal to about 15 mol. %, a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, wherein the pharmaceutical composition comprises Adalimumab. App. Br. 23 (Claims App 'x). 7 5. A de lamination resistant pharmaceutical container comprising a pharmaceutical composition stored in the 3 Appeal2017-000881 Application 13/660,508 container, wherein the pharmaceutical container comprises a glass composition comprising: from about 7 4 mol. % to about 78 mol. % Si02; alkaline earth oxide comprising both CaO and MgO, wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol.% and less than or equal to about 1. 0 mol. % relative to the glass composition, and a ratio (CaO (mol.% )/(CaO (mol.%)+Mg0 (mol.%))) is less than or equal to 0.5; X mol. % Ah03, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. % ; and Y mol. % alkali oxide, wherein the alkali oxide comprises from about 0.01 mol.% to about 1.0 mol.%K20 and a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, wherein the pharmaceutical composition comprises Adalimumab. App. Br. 24 (Claims App 'x). OPINION The Examiner concludes that claims 50, 51, 55-73, and 75-83 would have been obvious to one of ordinary skill in the art at the time of the invention for the reasons stated on page 7 of the Final Action. Appellant does not separately argue the patentability of the dependent claims. App. Br. 6-16. In accordance with 37 C.F.R. § 4I.37(c)(l)(iv), each dependent claim will stand or fall together with the independent claim from which it depends. Claim 55 Appellant argues that the rejection is inconsistent with the examination of six other applications in which the claimed glass compositions were allowable over the teachings of Baak. App. Br. 7-8. 4 Appeal2017-000881 Application 13/660,508 Appellant contends that the Examiner erred in rejecting claim 55 over Baak because "Baak teaches innumerable possible glass compositions based on vast ranges of recited elements, without any identification that their presence in certain amounts or ratios is critical." App. Br. 9. Appellant asserts that the exemplary claimed composition taught by Baak, listed below, includes broader ranges for components than the pending claims and also teaches that some of the claimed components may or may not be present since the ranges extend down to "O." Id. Baak Appellant's Claim 55 Si02: 70-82 mol. % Si02: greater than about 74 mol.% Zr02: 2-8 mol. % Ab03: 0-5 mol.% Na20: 0-10 mol.% Na20: greater than about 8 mol.% K20: 0-10 mol. % CaO: 0-15 mol.% CaO: 0.1-1.0 mol.% SrO: 0-15 mol.% BaO: 0-15 mol.% MgO: 0-15 mol.% (Na20 + K20): 3-10 mol.% (CaO+SrO+BaO+Mg0):2-15 mol. % Regarding evidence of criticality of the claimed ranges, Appellant identifies Example 1 in the Specification as showing compositions having a Si02 content of 74--78 mol.%, which is within the claimed range, as well as compositions with less than 74 mol.% Si02. Id. at 11. According to Appellant, this demonstrates "criticality and improved properties resulting from the claimed range of SiOi'' because the high Si02 content "resulted in improved hydrolytic resistance" compared to the lower Si02 content. Id. Appellant also argues that Example 3 of the Specification demonstrates that the MgO and CaO content, specifically the ratio of CaO/(CaO+MgO) of less than or equal to 0.5, is critical in achieving suitable 5 Appeal2017-000881 Application 13/660,508 diffusivity because the data in Table 10 and Figures 4 and 5 show glasses with higher diffusivities can be produced by minimizing the ratio of CaO/(CaO+MgO). Id. at 12. Appellant further contends that the data in Table 10 shows decreasing the ratio to less than 0.5 decreases the ion exchange process times needed to achieve a given compressive stress and depth of layer and that decreasing the ratio by increasing the MgO concentration generally improves the resistance of the glass to hydrolytic degradation. Id. at 12-13 (citing Spec. ,r,r 184--86). Appellant additionally argues that Baak fails to acknowledge or appreciate the existence of delamination and asserts that delamination and Appellant's method of testing for de lamination differ from leaching and Baak' s method of determining chemical resistance or susceptibility to leaching. Id. at 13-16. The Examiner responds that each application is reviewed individually and that the cited art discloses overlapping ranges with the constituents of the pending claims. 6 Ans. 4. Regarding claim 55, the Examiner finds that it broadly recites ranges for Si02, alkaline earth oxide comprising MgO and CaO as well as the ratio of CaO to CaO and MgO, and Na02, however, the data presented is neither commensurate in scope with the claim nor a proper side by side comparison. Id. at 5-6. The Examiner explains that it is not clear from compositions A-Fin Example 1 whether the amount of Si02 or the amounts of the multiple other components in the composition that vary between compositions A-Fare causing the change in results. Id. at 6. The 6 Cf Fessenden v. Coe, 99 F.2d 426, 432 (D.C. Cir. 1938) (upholding rejection of claims which were identical with claims allowed over same prior art in patent to another inventor, stating in doing so that "[t]wo wrongs cannot make a right"). 6 Appeal2017-000881 Application 13/660,508 Examiner also finds that the ranges of components in Example 3 are not commensurate with the scope of the claim. Id. at 7-8. Regarding Baak teaching leaching but not delamination, the Examiner responds that there is no evidence in the record that the container of Baak is not delamination resistant. Id. at 9. In the Reply Brief, Appellant reiterates that six other examiners determined the claimed containers were nonobvious over the teachings of Baak and that Baak does not address the issue of delamination or provide guidance on how to solve the problem. Reply Br. 2--4. Appellant also argues that the ranges disclosed by Baak are so broad that they do not provide a starting point nor is it a matter of optimization to develop the claimed composition, but, rather, the situation is analogous to the nonobviousness of a species over the prior art disclosure of a broad genus and Baak fails to disclose a recognizable class of species with common properties. Id. at 4--7 (citing In re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994); In re Jones, 958 F.2d 347, 350 (Fed. Cir. 1992); Stratojlex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1537 (Fed. Cir. 1983); In re Ruschig, 343 F.2d 965, 974 (CCPA 1965)). Appellant further contends that of the 61 example glass compositions disclosed in Baak's Tables I-IV, none contain between 0.1 mol.% and 1.0 mol.% CaO, more than half do not include any MgO and/or CaO, half of those that do contain CaO and MgO do not include a ratio less than or equal to 0.5, and none include at least 8 mol.% ofNa20, but, rather, 5 mol.% or less ofNa20. Id. at 8. Appellant also asserts that the data presented are commensurate in scope with the claims and that the Examples are evidence 7 Appeal2017-000881 Application 13/660,508 of the criticality of the claimed ranges, including a CaO/(CaO+MgO) ratio of less than 0.5 to achieve suitable diffusivity. Id. at 10-12. We review the appealed rejections for error based upon the issues identified by Appellant and in light of the arguments and evidence produced thereon. Cf Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) ("it has long been the Board's practice to require an applicant to identify the alleged error in the examiner's rejections")). Essentially for the reasons stated in the Final Action and the Answer, we are not persuaded by Appellant that the Examiner reversibly erred in rejecting claim 55 over Baak. We add the following primarily for emphasis. Appellant does not dispute that Baak discloses a glass container for pharmaceuticals composed of various ingredients within specific ranges as itemized on page 10 of the Appeal Brief. Nor does Appellant dispute that the claimed ranges of components are encompassed by the ranges disclosed for Baak's exemplary glass container. Regarding the claimed ratio, Appellant concedes that some of the examples in Baak include a ratio of CaO/(CaO+MgO) that is less than or equal to 0.5 as required by claim 55. Reply Br. 8 ("Additionally, of those compositions in Baak that do comprise MgO and/or CaO, at least half do not include a ratio (CaO (mol. %)/(CaO (mol. %)+Mg0 (mol. %))) less than or equal to 0.5, as required by pending claim 55.). In addition, Appellant also does not argue that the pharmaceutical composition recited in claim 55 distinguishes over Baak. Appellant's arguments focus on distinguishing Baak' s glass container composition on the basis that ( 1) Baak does not disclose the narrower ranges recited in Appellant's claim 55 or the delamination problem that Appellant's 8 Appeal2017-000881 Application 13/660,508 composition allegedly solved and that (2) Appellant's claimed ranges are critical to achieving improved properties. App. Br. 9-16. We are not persuaded by Appellant's arguments because Appellant's evidence does not adequately demonstrate criticality of the claimed ranges for the components and ratios of components that are encompassed by Baak's disclosure. Therefore, the preponderance of the evidence supports the Examiner's underlying findings and determination that the claims would have been obvious over the teachings of Baak. Appellant does not dispute the Examiner's finding that Baak discloses a glass container composition comprising Si02, CaO, Na20, and MgO in ranges that overlap the claimed ranges that is suitable for holding pharmaceutical compositions (Final Act. 7). Therefore, having identified the pertinent disclosures of Baak and determining that it would have been obvious to use the containers of Baak to hold a known pharmaceutical composition is nothing more than using a known article for its intended use in a known environment to accomplish an entirely expected result, the Examiner has established a prima facie case of obviousness of claim 55 over Baak. In re Petersen, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("A prima facie case of obviousness typically exists where the ranges of a claimed composition overlap the ranges disclosed in the prior art."); In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) ("[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a primafacie case ofunpatentability."). Once a prima facie case of unpatentability has been established, the burden then shifts to Appellant to overcome the prima facie case with argument and/ or evidence. Obviousness 9 Appeal2017-000881 Application 13/660,508 is then determined on the basis of the evidence as a whole and the relative persuasiveness of the arguments. Oetiker, 977 F.2d at 1445. We are not persuaded by Appellant's argument that Baak provides no direction for a glass composition for containing a pharmaceutical having Si 02, CaO, MgO, and Na20 in the claimed ranges (App. Br. 1 O; Reply Br. 7). The Examiner's finding that Baak discloses glass compositions having ranges for the components Si02, CaO, MgO, and Na20 that encompass the claimed ranges and are suitable for holding pharmaceutical compositions due to their properties of high chemical resistance and low thermal coefficient of expansion is supported by the record and suggests optimization within the ranges disclosed by Baak. Final Act. 7 ( citing Baak 1: 14--30); see also Baak 5:47-6:3 (providing examples of glass compositions that "exhibit excellent chemical durability and good working characteristics" for use in pharmaceutical packaging.). "Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range." Peterson, 315 F.3d at 1329-30 (holding claim to a superalloy composition prima facie obvious over prior art reference having overlapping ranges even through narrower ranges recited for two of the components claimed). Accordingly, we are not persuaded that the Examiner erred in rejecting the claims on the basis that the claimed ranges are narrower than those taught by Baak. Appellant's argument that none of the 61 examples of glass container compositions disclosed in Baak contain the specific ranges of CaO and Na20 required by claim 55 (Reply Br. 8), also is not persuasive of error. A reference may be relied upon for all that it would have reasonably suggested 10 Appeal2017-000881 Application 13/660,508 to one having ordinary skill in the art. Merck & Co. v. Biocraft Labs., 874 F.2d 804, 807 (Fed. Cir. 1989). Moreover, Baak's broader teachings to include Si02, CaO, and Na20 in a glass container composition are not limited to the specific compositions of the 61 examples shown in Baak's Tables I-VI because "a reference is not limited to the disclosure of specific working examples." In re Mills, 470 F.2d 649,651 (CCPA 1972) (citation omitted). Whether an invention has produced unexpected results is a question of fact. In re Mayne, 104 F.3d 1339, 1343 (Fed. Cir. 1997). "[T]here is no hard-and-fast rule for determining whether evidence of unexpected results is sufficient to rebut a primafacie case of obviousness." Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006); see also In re Dillon, 919 F.2d 688, 692-93 (Fed. Cir. 1990) ("[e]ach situation must be considered on its own facts."). However, a party asserting unexpected results as evidence of nonobviousness has the burden of proving that the results are unexpected. In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997). "[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." In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Moreover, "when an inventor tries to distinguish his claims from the prior art by introducing evidence of unexpected 'synergistic' properties, the evidence should at least demonstrate 'an effect greater than the sum of the several effects taken separately."' Merck & Co., 874 F.2d at 808; see also In re Kollman, 595 F.2d 48, 55 n. 6 (CCPA 1979) ("Synergism, in and of itself, is not conclusive of unobviousness in that synergism might be expected."). 11 Appeal2017-000881 Application 13/660,508 We are not persuaded that Appellant has demonstrated unexpected results with data (Example 1 of the Specification) that shows a trend between lower Si02 content and improved hydrolytic resistance and data (Example 3 of the Specification) that shows a trend between a lower ratio of CaO/(CaO+MgO) and higher diffusivities. App. Br. 11-13. That Appellant has identified trends in the properties of glass compositions that were not appreciated by the prior art does not render the claimed compositions unexpected and nonobvious. See Peterson, 315 F.3d at 1330 ("In general, an applicant may overcome a prima facie case of obviousness by establishing 'that the [ claimed] range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.' That same standard applies when, as here, the applicant seeks to optimize certain variables by selecting narrow ranges from broader ranges disclosed in the prior art. Moreover, the applicant's showing of unexpected results must be commensurate in scope with the claimed range."). Moreover, Appellant does not persuasively rebut the Examiner's finding that the evidence presented is not commensurate in scope with the claims (Ans. 6-7). While Appellant's evidence may be relevant to the benefits associated with the ranges claimed for specific components, they do not establish criticality across the range claimed nor do they show that those benefits were unexpected. At most, Appellant's evidence shows "improved hydrolytic resistance" (App. Br. 11) at Si02 content ranging from 74.8 mol% to 77.4 mol% compared to compositions with 70.8 mol% and 72.8 mol%. Similarly, Appellant's assertion that Example 3 demonstrates criticality of the MgO and CaO content at most shows that compositions meeting the claimed range of CaO/(CaO+MgO) ratio result in "suitable diffusivity" 12 Appeal2017-000881 Application 13/660,508 (App. Br. 13) which does not evidence criticality over the claimed range compared to the prior art. In addition, Appellant does not adequately rebut the Examiner's finding (Ans. 6) that the evidence presented does not properly compare compositions such that criticality of a single component, for example Si 02, can be determined because multiple other components vary in the compositions that are compared. See In re Dunn, 349 F.2d 433, 439 (CCPA 1965) ( cause and effect sought to be proven is lost in the welter of unfixed variables). Moreover, the Specification itself reflects that the data is not conclusive when it states that "[b ]ased on these test results, it is believed that the acid resistance of the glass samples improves with increased Si02 content." Spec. ,r 173. Argument alone asserting criticality of the claimed ranges (Reply Br. 10-11) is insufficient to rebut the Examiner's findings. It is well settled that arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139--40 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Appellant's assertion that delamination is distinguishable from leaching or chemical degradation disclosed by Baak (App. Br. 15-16) is not persuasive of error. Appellant does not assert that delamination resistance is an unexpected result of the claimed composition nor does Appellant assert that Baak's glass composition lacks this property. Instead, Appellant asserts that "one skilled in the art would not look to the teachings of Baak, directed to compositions designed to minimize or prevent leaching of tramp particles, in an effort to design glass compositions which minimize or prevent delamination of substantial glass flakes." (App. Br. 16; Reply Br. 13). The problem with Appellant's argument is that both Baak and Appellant's 13 Appeal2017-000881 Application 13/660,508 Specification concern pharmaceutical containers and thus would have been expected to have similar properties. Baak 1: 14--30; Spec. ,r 2. On balance, the evidence of record weighs in favor of the Examiner's conclusion that the glass container composition recited in claim 55 would have been obvious to one of ordinary skill in the art to use to hold a known pharmaceutical composition in view of the teachings of Baak. Claims 66 and 7 5 In addition to the arguments discussed above in connection with claim 55, Appellant argues that Example 2 demonstrates the criticality of a Y:X ratio of at least 1.0 where X is Ab03 and Y is alkali oxide as required by claims 66 (specifying that the alkali oxide comprises 9-15 mol% Na20) and 75 (specifying that the alkali oxide comprises 0.01-1.0 mol% K20). App. Br. 11-12. According to Appellant, the data in Table 9 evidences the influence of the alkali to alumina ratio on melting behavior, hydrolytic resistance, and compressive stress obtainable through ion exchange strengthening, and that the ratio of Y :X should be greater than or equal to 0.9 or 1 to obtain a glass that is readily meltable and formable. Id. at 11. The Examiner responds that the data presented is not commensurate with the scope of the claims and that no comparative data is provided as the compositions in Table 9 all have a Y:X ratio over 0.90. Ans. 6-7. In the Reply Brief, Appellant contends that of the 61 example glass compositions disclosed in Baak's Tables I-IV, none contain between 0.1 mol.% and 1.0 mol.% CaO and more than half do not include any MgO and/or CaO, none include Na20 in the range of 9-15 mol% required by claim 66, but, rather, 5 mol.% or less ofNa20, none include 0.01-1.0 mol% 14 Appeal2017-000881 Application 13/660,508 K20 as required by claim 75, but, rather, greater than 1.0 mol% K20, and nearly a third do not include any Ab03 as required by claims 66 and 75. Reply Br. 9-10. Appellant also asserts that the data presented are commensurate in scope with the claims and that the Examples are evidence of the criticality of the claimed ranges, including CaO/(CaO+MgO) ratio of less than 0.5 to achieve suitable diffusivity and an Y:X ratio of at least 1.0 to achieve "good melt behavior, superior ion exchange performance, and superior hydrolytic resistance." Id. at 11. For the reasons stated in the Final Action and the Answer, we are not persuaded of reversible error in any of the Examiner's findings as to Baak and the Examiner's determination that claims 66 and 7 5 would have been obvious to one of ordinary skill in the art over the cited prior art. We add the following primarily for emphasis. We note that Appellant does not dispute that Baak discloses ranges that encompass both the components and ratios recited in claims 66 and 75. Appellant's arguments distinguishing claims 66 and 75 over the individual 61 examples disclosed in Baak are not persuasive of reversible error because "a reference is not limited to the disclosure of specific working examples." In re Mills, 4 7 0 F .2d at 651. Regarding Appellant's evidence of unexpected results due to the Y:X ratio required by claims 66 and 75, Appellant does not rebut the Examiner's finding (Ans. 7) that the data in Table 9 lacks comparative data from which criticality can be assessed because all have an Y:X ratio over 0.90. Arguments of counsel asserting criticality based on insufficient data cannot take the place of factually supported objective evidence sufficient to establish the alleged criticality of the claimed ranges. 15 Appeal2017-000881 Application 13/660,508 See, e.g., In re Huang, 100 F.3d at 139--40; In re De Blauwe, 736 F.2d at 705. On balance, the evidence of record weighs in favor of the Examiner's conclusion that claims 66 and 75 are unpatentable over Baak. CONCLUSION We affirm the Examiner's rejection of claims 50, 51, 55-73, and 75- 83 as obvious under 35 U.S.C. § 103(a). DECISION The Examiner's decision 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). AFFIRMED 16 Copy with citationCopy as parenthetical citation