Capsugel Belgium NV

Patent Trials and Appeals BoardAug 3, 2021

2020006190 (P.T.A.B. Aug. 3, 2021)

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. 15/313,512 11/22/2016 Aur¿lien Sivert 9156-93204-03 5113 120501 7590 08/03/2021 Klarquist Sparkman, LLP (Capsugel) 121 SW Salmon Street, Suite 1600 Portland, OR 97204 EXAMINER PHAN, DOAN THI-THUC ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 08/03/2021 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): docketing@klarquist.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AURÉLIEN SIVERT, CYRILLE ANDRÉS, and HASSAN BENAMEUR 1 Appeal 2020-006190 Application 15/313,512 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and ULRIKE W. JENKS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a pharmaceutical composition, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellant identifies the real party in interest as Capsugel Belgium NV. Appeal Br. 4. We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2020-006190 Application 15/313,512 2 STATEMENT OF THE CASE Appellant’s invention relates to an orally disintegrating tablet comprising solid lipid particles comprising various active ingredients . . . , wherein the solid lipid particles minimize or eliminate any unpleasant taste of the substances in the oral cavity and aid in stability of the active ingredient. The active ingredients are taste-masked without the requirement for sugars and/or sweeteners. Spec. ¶ 3. Claims 1–5, 7–12, 14, 15, 17–20, and 22–27 are on appeal. Claim 1, reproduced below, is illustrative (formatting added): 1. A pharmaceutical composition, comprising: an orally disintegrating tablet comprising a disintegrant, a binder, and a plurality of solid lipid particles, wherein a solid lipid particle of the plurality of solid lipid particles comprises a plurality of active agent particles in a lipid matrix, wherein said disintegrant is present in an amount of from 0.5 weight percent to 10 weight percent of the total weight of the tablet, said binder is present in an amount of from 10 weight percent to 60 weight percent of the total weight of the tablet, wherein said solid lipid particles have an average particle size of 500 micrometers or less and are present in an amount of from 5 weight percent to 50 weight percent of the total tablet weight, and wherein said lipid matrix is present in an amount greater than 50 weight percent of the total weight of said solid lipid particles. Claims 20 and 26 are also independent, and more narrowly define pharmaceutical compositions like that of claim 1. Both claim 20 and claim 26 include the limitations that the solid lipid particles are present in an Appeal 2020-006190 Application 15/313,512 3 amount of from 5 weight percent to 50 weight percent of the total tablet weight and the lipid matrix is present in an amount greater than 50 weight percent of the total weight of said solid lipid particles. The claims stand rejected as follows: Claims 1–5, 7–10, 12, 14, 15, 20, and 22–26 under 35 U.S.C. § 103 as obvious based on Prasad,2 Geyer,3 and Ioualalen4 (Ans. 4); Claims 17, 18, and 27 under 35 U.S.C. § 103 as obvious based on Prasad, Geyer, Ioualalen, and Platteeuw5 (Ans. 10); and Claims 11 and 19 under 35 U.S.C. § 103 as obvious based on Prasad, Geyer, Ioualalen, and Shen6 (Ans. 11). OPINION Obviousness: Prasad, Geyer, and Ioualalen Claims 1–5, 7–10, 12, 14, 15, 20, and 22–26 stand rejected as obvious based on Prasad, Geyer, and Ioualalen. The Examiner finds that “Prasad teaches an oral disintegrating tablet comprising lipid solid dispersion comprising active agent(s) particles dispersed in a lipid matrix, wherein the lipid solid dispersion is dried into free flowing powders (solid particles).” Ans. 4. The Examiner finds that “Prasad teaches the concentration of the lipids (lipid matrix) in the lipid solid dispersion is in the range of about 20 to 80% of the total weight of the dispersion.” Id. The Examiner finds that 2 Prasad et al., WO 2010/143199 A1, pub. Dec. 16, 2010. 3 Geyer et al., US 5,380,535, pat. Jan. 10, 1995. 4 Ioualalen et al., US 2010/0221298 A1, Sept. 2, 2010. 5 Platteeuw et al., US 2004/0265375 A1, Dec. 30, 2004. 6 Shen et al., US 2011/0306539 A1, pub. Dec. 15, 2011. Appeal 2020-006190 Application 15/313,512 4 Prasad also teaches that “the oral disintegrating tablet contains disintegrants and binders,” but “does not teach the amount of disintegrant, the amount of binder, the amount of solid particles in the tablet and the particle size of the solid lipid particles.” Id. at 4–5. The Examiner finds that “Geyer teaches a chewable tablet composition which disintegrates rapidly in the mouth comprising drug particles dispersed in a lipid matrix and the drug-lipid mixture is dried to a powder (particles).” Id. at 5. The Examiner finds that Geyer teaches that its tablet contains disintegrants, binder, and drug/lipid in amounts that overlap the ranges recited in Appellant’s claims. Id. at 5–6. The Examiner also finds that Geyer teaches that the drug/lipid particles in its tablet “have average particle sizes from about 10–150 microns.” Id. at 5. The Examiner concludes that it would have been obvious to determine the optimal particle sizes of the solid lipid particles and amount of lipid matrix in the solid lipid particles and amounts of disintegrant, binder and solid lipid particles in the oral disintegrating tablet of Prasad, via routine optimization, per guidance from Geyer and Prasad, and produce the claimed invention. Id. at 6. The Examiner also notes that “where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ . . . , a prima facie case of obviousness exists.” Id. The Examiner cites Ioualalen as providing a reason “to optimize the amount of lipid” in Prasad’s solid lipid particles to be “closer to 80% by weight” (i.e., toward the upper end of Prasad’s 10–80% range), because Ioualalen teaches that “solid lipid particles containing lipid matrix content as high as 75% by weight have been known to be suitable for use in tablet Appeal 2020-006190 Application 15/313,512 5 formulation.” Id. at 7. “Thus, Ioualalen provides the guidance and motivation to optimize the amount of lipid matrix in the solid lipid particles of Prasad to an amount of 75% by weight.” Id. We agree with the Examiner that the cited references support a prima facie case of obviousness. Prasad discloses “solid dispersions for the improved delivery of poorly water-soluble compounds.” Prasad 1:5–6. More specifically, Prasad discloses “a pharmaceutical composition in the form of a solid dispersion wherein a poorly soluble drug is dissolved in a lipid carrier medium. . . . The drug dispersed in the lipid dispersion is dried into free flowing powders by spray drying.” Id. at 5:3–7. Prasad states that “[t]he concentration of the lipids in the lipid solid dispersion . . . is in the range of about 20 to 80% of the total weight of the dispersion, preferably in the range of about 40% to about 60% of the total weight of the dispersion.” Id. at 8:17–19. Prasad discloses that its “lipid solid dispersion formulation . . . may further comprise one or more pharmaceutical excipients such as one or more fillers, diluents, disintegrants, binders,” etc. Id. at 9:12–14. Prasad provides examples of suitable fillers (diluents), disintegrants, and binders. Id. at 9:16– 29. Prasad discloses that its lipid solid dispersion can be processed to prepare various dosage forms, including an orally disintegrating tablet. Id. at 10:9–12. As the Examiner noted, Prasad does not disclose that the solid lipid/drug particles in its dispersion have an average size of 500 μm or less, as recited in Appellant’s claim 1, nor does Prasad disclose the weight percent of disintegrant, binder, and particles in its suggested orally disintegrating tablet. Appeal 2020-006190 Application 15/313,512 6 However, Geyer discloses “a non-aqueous, chewable composition which disintegrates rapidly in the mouth for the delivery of unpalatable pharmaceutically-active compounds.” Geyer 2:25–28. Geyer’s composition comprises one or more unpalatable pharmaceuticals intimately dispersed or dissolved in a pharmaceutically-acceptable lipid in which each component is solid at ambient temperatures, and a matrix for said drug and lipid comprising (a) one or more solid granulating agents, and, optionally, (b) minor amounts of additives such as buffering agents, sweeteners, flavoring agents, rapid dispersal agents, or the like. Id. at 2:29–36. Geyer discloses that “granulating agents . . . include such compounds as sorbitol, mannitol, dextrose, sucrose, lactose, or like sugars, starches, or mixtures thereof.” Id. at 6:2–6. Prasad suggests including these same sugars in its solid lipid dispersion formulation as fillers or diluents. Prasad 9:16–19. Appellant’s Specification defines “binders,” as recited in claim 1, to include these same sugars. Spec. ¶ 24. Geyer states that the matrix of its composition can also include dispersing agents. Geyer 5:65 to 6:1. Geyer states that preferred rapid dispersal agents include sodium starch glycolate, crospovidone, and croscarmellose sodium. Id. at 6:51–58. These components are “disintegrants,” as defined by Appellant’s Specification. Spec. ¶ 22. Geyer states that its composition includes 0.1–5 wt%, preferably 0.25–2.5 wt% of preferred rapid dispersal agent (i.e., disintegrant). Geyer 6:60–63. Geyer describes a composition comprising ibuprofen as the active agent. Id. at 8:1–20. Geyer states that, in addition to ibuprofen and lipid, the composition contains a granulating agent in an amount of “25–75% wt., Appeal 2020-006190 Application 15/313,512 7 preferably 30–70% wt., most preferably 40–60% wt. The granulating agent is preferably mannitol.” Id. at 8:8–10. The composition also comprises “dispersal agents in an amount of from 1–30% wt., preferably from 2–20% wt., most preferably from 7–15% wt.” Id. at 8:11–13. “Preferably, the dispersal agents include a mixture such as 4–7% wt. hydroxyethyl cellulose, 2–5% wt. corn starch, and 1.5–4.5% wt. croscarmellose sodium.” Id. at 8:16–19. Geyer also states that “the drug may range in weight from about 0.1% to 75%, more preferably 0.5% to 40%, and the lipid 5% to 50%, more preferably 10% to 40%, based on the total weight of the composition.” Id. at 7:34–38. Finally, Geyer discloses that its chewable drug composition can be produced using a spray congealing process or using a fluidized bed apparatus, both of which result in average particle sizes of less than 500 micrometers. See id. at 4:23 to 5:13. In sum, Prasad suggests that its lipid solid dispersion formulation can comprise fillers (diluents) and binders, in addition to powdered lipid/active agent particles, and can be made into an orally disintegrating tablet. Prasad also suggests that its lipid/active agent particles can contain 20–80%, preferably 40–60%, lipid.7 7 The Examiner cites Ioualalen as further evidence that solid lipid particles with a lipid content greater than 50 wt% would have been obvious. Ans. 7. However, as the Examiner noted, “where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ . . . a prima facie case of obviousness exists.” Id. at 6. Prasad discloses solid lipid particles with 20– 80% lipid, so Ioualalen’s disclosure is not necessary to support a prima facie case of obviousness. Appeal 2020-006190 Application 15/313,512 8 Geyer discloses a tablet that rapidly disintegrates in the mouth, and comprises a pharmaceutical dispersed in a lipid, as well as granulating agents (which are the same as Prasad’s fillers and claim 1’s binder) and disintegrants. Geyer suggests amounts of lipid/active agent particles, granulating agents, and disintegrants that overlap the range of amounts of those components recited in claim 1. Geyer also discloses methods of making lipid/active agent particles that average less than 500 micrometers in size. We agree with the Examiner that it would have been obvious to a person of ordinary skill in the art to use the amounts of lipid/active agent particles, granulating agent (a.k.a. filler or binder), and disintegrant taught by Geyer in Prasad’s formulation, and to make Prasad’s lipid/active agent particles as taught by Geyer (and therefore less than 500 micrometers in average size). Geyer provides the skilled artisan with a reason to use its teachings in making Prasad’s orally disintegrating tablet, because Geyer teaches that following its suggestions results in a “composition which disintegrates rapidly in the mouth.” Geyer 2:26. Appellant argues “it was generally known in the art that lipids in tablet formulations results in slowing of, and can even prevent, tablet disintegration” but, “[c]ontrary to conventional wisdom . . . , the inventors of the present application determined that high amounts of the lipid matrix could be used in orally disintegrating tablets (‘ODTs’)” and “provid[e] ODT embodiments that exhibited decreased breakage/friability issues, prevented premature release of active ingredients having objectionable tastes, and also improv[e] active ingredient stability.” Appeal Br. 7. Appeal 2020-006190 Application 15/313,512 9 Appellant cites the Sivert Declaration8 as evidence that “it was conventional wisdom . . . that lipid components were suitable for use in preparing oral solid dosage forms with controlled or sustained release profiles, but lipid components were not conventionally used in orally disintegrating tablets (ODTs), particularly at high amounts.” Id. at 7–8. Appellant argues that the Declaration shows that those skilled in the art “recognized that high amounts of lipids would not be compatible with ODTs because lipids are insoluble in water and thus would slow disintegration of the tablet upon exposure to the very medium that is intended to cause the tablet to disintegrate.” Id. at 8. Appellant argues that the Examiner did not give the Declaration, and the evidence cited therein, the weight that it deserves. Id. at 12. Appellant also argues that Prasad and Ioualalen do not provide a reasonable expectation of success in using “their disclosed lipid compositions . . . in an ODT, and certainly not at the amounts recited by Appellant’s claims.” Appeal Br. 8–9. Appellant argues that “none of the examples in Prasad or in Ioualalen is directed to ODTs. . . . It therefore follows that there are no examples or embodiments disclosed by Ioualalen or Prasad wherein their respective drug/lipid formulations comprise greater than 50 weight percent of a lipid matrix and wherein the lipid matrix is provided in an ODT.” Id. at 9. Appellant argues that “Geyer . . . also advocates for amounts of its lipid component that are less than 50 weight percent.” Id. 8 Declaration under 37 C.F.R. § 1.132 of Aurélien Sivert, filed June 25, 2018. Appeal 2020-006190 Application 15/313,512 10 We have considered Appellant’s arguments in light of the Sivert Declaration (and its supporting evidence), but do not find them persuasive.9 The Sivert Declaration states that lipid excipients are conventionally used in controlled-release or sustained-release dosage forms, but “they are not conventionally used for ODTs.” Sivert Decl. ¶ 8A. Dr. Sivert states that “it was recognized by individuals having ordinary skill in the art that lipids, and particularly high amounts of lipids, are not compatible with ODTs because lipids are insoluble in water and thus would slow disintegration of the tablet upon exposure to the very medium that is intended to cause the tablet to disintegrate.” Id. The Declaration includes three exhibits that are said to corroborate the conventional understanding. Id. However, Appellant’s argument and the Sivert Declaration (and its supporting evidence) are not persuasive because they are not directed to the limitations of the claims as they currently stand. Claim 1 is directed to a pharmaceutical composition comprising (among other things), “solid lipid particles compris[ing] a plurality of active agent particles in a lipid matrix, . . . wherein said solid lipid particles . . . are present in an amount of from 5 weight percent to 50 weight percent of the total tablet weight” and “said lipid matrix is present in an amount greater than 50 weight percent of the total weight of said solid lipid particles.” Thus, claim 1 requires the lipid/active agent particles to comprise more than 50 wt% lipid, but it only requires those particles to be 5 wt%, and 9 The declaration specifically addresses a rejection that is different from the one on appeal (see ¶ 6), but we have considered it to the extent that it is relevant to Appellant’s arguments. Appeal 2020-006190 Application 15/313,512 11 no more than 50 wt%, of the total tablet. Thus, the claimed orally disintegrating tablet includes only 2.5 wt% to 25 wt% of lipid overall (50% of 5% equals 2.5%, 50% of 50% equals 25%). Appellant’s argument that “high amounts of lipids would not be compatible with ODTs,” (Appeal Br. 8), and the declaratory evidence to the same effect, therefore are not directed to the limitations of the claimed composition. Consistent with the limitations of claim 1, Prasad discloses that “[t]he concentration of the lipids in the lipid solid dispersion of [its] invention is in the range of about 20 to 80% . . . , preferably in the range of about 40% to about 60% of the total weight of the dispersion.” Prasad 8:17–19 (emphasis added). Prasad states that its formulation “may further comprise one or more pharmaceutical excipients such as one or more fillers, diluents, disintegrants, binders, lubricants etc[.] or mixture thereof.” Id. at 9:12–14. Thus, Prasad suggests an amount of lipid in its lipid solid dispersion (or “solid lipid particles,” in the claim language) that is encompassed by Appellant’s claims, and Appellant has not shown that such an amount would have been thought by those skilled in the art to be incompatible with an orally disintegrating tablet. Appellant presents separate arguments for independent claims 20 and 26. Appeal Br. 13–19. In both cases, however, the arguments are the same as were presented for claim 1. The arguments for claims 20 and 26 therefore are unpersuasive for the reasons discussed above with regard to claim 1. In summary, we affirm the rejection of claims 1, 20, and 26 under 35 U.S.C. § 103 based on Prasad, Geyer, and Ioualalen. Claims 2–5, 7–10, 12, Appeal 2020-006190 Application 15/313,512 12 14, 15, and 22–25 were not argued separately and fall with claims 1, 20, and 26. 37 C.F.R. § 41.37(c)(1)(iv). Obviousness: Prasad, Geyer, Ioualalen, and Platteeuw Claims 17, 18, and 27 stand rejected as obvious based on Prasad, Geyer, Ioualalen, and Platteeuw. Claims 17 and 18 depend from claim 1 and add the limitation that the composition has a physical robustness of 15N to 100N, or 20N to 50N, respectively; claim 27 depends from claim 1 and adds the limitation that “the orally disintegrating tablet is formulated to disintegrate in the oral cavity in 10 to 60 seconds.” Appeal Br. 24, 26. The Examiner finds that Prasad, Geyer, and Ioualalen do not teach the additional limitations of claims 17, 18, and 27. The Examiner finds that “Platteeuw teaches an oral disintegrating tablet generally hav[ing] a hardness from 10 to 50 N, and preferably 30 N, . . . [which] can be optimize[d] based on the tablet composition and the desired level of oral disintegration speed.” Ans. 10. The Examiner also finds that “Platteeuw teaches the tablet exhibits oral disintegratability in not more than 60 seconds.” Id. Based on these teachings, the Examiner concludes that it would have been obvious to determine the optimum hardness of the oral disintegrating tablet so as to achieve the desired level of oral disintegration speed per guidance from Platteeuw . . . because as discussed above, Platteeuw provided the guidance for producing an oral disintegrating tablet having a hardness from 10 to 50 N, which is a hardness that is generally suitable for oral disintegrating tablet, and can be optimize based on the tablet composition and the desired level of oral disintegration speed such that the tablet disintegrates in 60 seconds or less. Id. at 10–11. Appeal 2020-006190 Application 15/313,512 13 Appellant argues that, as explained in the Sivert Declaration, Platteeuw uses low amounts of a lipid to coat the active ingredients used in its ODT, specifically only 9 wt% Compritol®. . . . While Platteeuw discloses that its ODT can exhibit hardness values 20N to 50N, it does not teach or suggest using amounts of a lipid matrix in the ODT above its disclosed 9 wt% and certainly does not teach or suggest that such embodiments would exhibit (or would be expected to exhibit) the same hardness values. Appeal Br. 19–20. Appellant argues that the Examiner has not “established that a person of ordinary skill in the art would have a reasonable expectation that using Appellant’s amount of lipid matrix (‘greater than 50 weight percent,’ as recited by claim 1) would successfully result in a ODT with a robustness in the ranges recited by claims 17 and 18.” Id. at 20. Similarly, with respect to claim 27, Appellant argues that, “[w]hile Platteeuw discloses that its ODT can exhibit a disintegration profile of not more than 60 seconds, it does not teach or suggest using amounts of a lipid matrix in the ODT above its disclosed 9 wt% and certainly does not teach or suggest that such embodiments would exhibit (or would be expected to exhibit) the same disintegration time profile.” Id. Again, however, Appellant’s arguments are premised upon a requirement for a level of lipid in the claimed composition that is not recited in the claims. As discussed above, claim 1 (from which claims 17, 18, and 27 depend) requires that the solid lipid particles in the claimed composition include more than 50 weight percent lipid, but the claim only requires 5–50 weight percent of the orally disintegrating tablet to be solid lipid particles. Thus, the required lipid content of the overall tablet is 50% of 5–50%, or Appeal 2020-006190 Application 15/313,512 14 2.5–25%, by weight of the overall tablet. Appellant’s arguments are therefore unpersuasive. Obviousness: Prasad, Geyer, Ioualalen, and Shen Claims 11 and 19 stand rejected as obvious based on Prasad, Geyer, Ioualalen, and Shen. Claim 11 depends from claim 1 and adds the limitation that the active agent particles have an average diameter of 0.1–10 μm. Claim 19 depends from claim 1 and adds the limitation that “the active agent particles comprise at least one of fexofenadine and loratadine.” With regard to claim 11, Geyer teaches methods of making its active agent/lipid powder that produce particles with an average size of 10–150 microns. Geyer 4:43–45, 5:9–11. Thus, we agree with the Examiner that the cited references support a prima facie case of obviousness. See, e.g., In re Brandt, 886 F.3d 1171, 1177 (Fed. Cir. 2018) (“[T]he claimed range of ‘less than 6 pounds per cubic feet’ and the prior art range of ‘between 6lbs/ft3 and 25lbs/ft3’ are so mathematically close that the examiner properly rejected the claims as prima facie obvious.”). With regard to claim 19, the Examiner found that “Shen teaches a tablet [that] contain[s] solid microparticles containing drug particles dispersed in a matrix of excipient,” where suitable drugs include “antihistamines including fexofenadine and loratadine.” Ans. 12. The Examiner concluded that it would have been obvious “to include antihistamines such as fexofenadine and loratadine as the drug in the solid lipid particles of Prasad” because “Shen provided the guidance for using antihistamines such as fexofenadine and loratadine as the suitable drugs in Appeal 2020-006190 Application 15/313,512 15 the solid lipid particles, and Prasad indicated that the suitable drugs for use in the solid lipid particles include histamine receptor antagonists.” Id. at 13. We agree with the Examiner’s findings and conclusion. Appellant argues that “Shen’s disclosed list of drugs spans three columns of the published application (page 4–5). Fexofenadine and loratadine are two options out of myriad different drugs in the laundry list that Shen provides.” Appeal Br. 21. Appellant argues that “Shen provides no teaching or suggestion to pick fexofenadine or loratadine and certainly provides not motivation to include such drugs in an ODT. . . . Similar to Shen, Prasad also includes a laundry list of therapeutic agents that purportedly could be used in its lipid solid dispersion but does not disclose fexofenadine or loratadine.” Id. at 22. These arguments are unpersuasive. Prasad discloses that its pharmaceutical composition is “useful for the oral delivery of poorly water soluble therapeutic agents” (Prasad 7:2–5), including “histamine receptor antagonists” (i.e., antihistamines). Prasad 7:22 to 8:1. Shen discloses “a process for making particles for delivery of drug nanoparticles” where “[t]he drug may be a poorly-soluble drug.” Shen ¶¶ 45, 47. Shen states that such drugs include “antihistamines” (id. ¶ 47), including “fexofenadine” and “loratidine” (id. ¶ 59). Thus, the cited references would have suggested using fexofenadine or loratadine as the active agent in the orally disintegrating tablets made obvious by the cited prior art. Appeal 2020-006190 Application 15/313,512 16 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–5, 7–10, 12, 14, 15, 20, 22–26 103 Prasad, Geyer, Ioualalen 1–5, 7–10, 12, 14, 15, 20, 22–26 17, 18, 27 103 Prasad, Geyer, Ioualalen, Platteeuw 17, 18, 27 11, 19 103 Prasad, Geyer, Ioualalen, Shen 11, 19 Overall Outcome 1–5, 7–12, 14, 15, 17– 20, 22–27 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED