11327700 (B.P.A.I. Jul. 11, 2012)

Ex Parte Dave

Board of Patent Appeals and InterferencesJul 11, 2012

11327700 (B.P.A.I. Jul. 11, 2012)

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. 11/327,700 01/06/2006 Vipul Bhupendra Dave CRD-5298-USNP 1854 100369 7590 07/11/2012 Dergosits & Noah LLP Three Embarcadero Center, Suite 410 San Francisco, CA 94111 EXAMINER STRASZHEIM, REBECCA L ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 07/11/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte VIPUL BHUPENDRA DAVE __________ Appeal 2011-005067 Application 11/327,700 Technology Center 3700 __________ Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and STEPHEN WALSH, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an implantable drug delivery device. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-005067 Application 11/327,700 2 Statement of the Case Background The Specification teaches that “the invention relates to drug delivery devices comprised of bioabsorbable materials formed into desired geometries by different polymer processing methods” (Spec. 1, ll. 7-9). The Claims Claims 1, 2, 5-7, 10, 12, 13, and 21 are on appeal. Claim 1 is representative and reads as follows: 1. An implantable drug delivery device comprising: a tubular structure having a flat solvent cast film strip of bioabsorbable polymer wound into a helical pattern, the flat strip having a pair of opposed sides and a pair of opposed ends; and at least one drug or bio-active agent uniformly distributed throughout the bioabsorbable polymer to form a blended composition. The issues A. The Examiner rejected claims 1, 2, 12, 13, and 21 under 35 U.S.C. § 102(b) as anticipated by Phan 1 (Ans. 4). B. The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as obvious over Phan and Whitbourne 2 (Ans. 4-5). C. The Examiner rejected claims 1, 5-7, 12, 13, and 21 under 35 U.S.C. § 103(a) as obvious over Brown 3 and Michal 4 (Ans. 5-6). 1 Phan et al., US 5,954,744, issued Sep. 21, 1999. 2 Whitbourne et al, US 2004/0117007 A1, published Jun. 17, 2004. 3 Brown, B., US 2006/0079955 A1, issued Apr. 13, 2006. 4 Michal, G., US 6,824,559 B2, issued Nov. 30, 2004. Appeal 2011-005067 Application 11/327,700 3 D. The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as obvious over Brown, Michal, and Whitbourne (Ans. 6-7). A. 35 U.S.C. § 102(b) over Phan The Examiner finds that Phan “teaches a stent (90), as can be seen in figs. 3A-C, made from one elongate strip in the shape of a parallelogram (Examiner is considering the long sides of the parallelogram the opposed sides and the short sides of the parallelogram the opposed ends)” (Ans. 4). The Examiner finds that the “strip maybe made from biodegradable polymer and may incorporate therapeutic agent - for it[]s controlled release . . . as well as a radiopaque material” (Ans. 4). The Examiner finds that the “therapeutic agent maybe added to the polymer prior to it[]s polymerization and formation into a sheet, as such Examiner has to assume the therapeutic agent would distribute uniformly throughout the polymer” (Ans. 4). Appellant contends that “nothing in Phan discloses such uniform distribution. When making this statement, the Office relies upon certain unsupported assertions to conclude that claims 1-2, 12-13 and 21 are anticipated by Phan. Applicants note that the assertions appear to be Official Notice taken by the Examiner, yet the Examiner has failed to provide evidence in support of this Official Notice” (App. Br. 3). Appellant contends that “there is no reasonable basis to conclude that adding a therapeutic agent to a polymer before polymerization will result in a uniform distribution of agent in the polymer. It is well know[n] that a mixture does not necessarily uniformly distribute the added ingredient throughout the base material” (App. Br. 4). Appeal 2011-005067 Application 11/327,700 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s finding that the therapeutic agent of Phan is expressly or inherently “uniformly distributed throughout the bioabsorbable polymer” as required by claim 1? Findings of Fact 1. The Specification teaches that “[p]olymer formulations can be prepared using these solutions that may include radiopaque agents, drugs or combinations thereof. These formulations are tumbled and mixed to prepare uniform dispersions” (Spec. 59, ll. 4-7). 2. Phan teaches that the “stent of the present invention is designed to be carried on the balloon of a balloon catheter to a target site in a vessel. In particular, the stent is intended for use in a vessel to prevent post- angioplasty vessel reclosure, or restenosis. In general, the stent is suitable for use in a variety of body cavities” (Phan, col. 2, ll. 57-62). 3. Phan teaches that the “the strip segments are formed of a memory polymer, such as a methacrylate-containing polymer or an acrylate- containing polymer. The memory polymer may also be biodegradable or may contain a therapeutic agent for controlled release of the agent to the target site” (Phan, col. 1, ll. 53-57). 4. Phan teaches that the stent “includes a therapeutic agent for controlled release of the agent at the target site. The agent can be incorporated into the stent by passive diffusion after fabrication of the stent, or more preferably, by addition of the agent prior to extruding the polymer or prior to polymerization of the polymer sheet or tube” (Phan, col. 5, ll. 49- 55). Appeal 2011-005067 Application 11/327,700 5 5. Figures 3A-3C of Phan are reproduced below: “FIGS. 3A-3C shows a stent 90 formed of an elongate strip having one strip segment, where the segment has the shape of a parallelogram (FIGS. 3A- 3C). As seen in FIG. 3A, segment 92 in its memory condition is a flat strip having the shape of a parallelogram” (Phan, col. 7, ll. 10-14). 6. Phan teaches that the flat strip “segment is placed into its closed, high-curvature condition by activating the polymer transition and winding the segment around a balloon catheter” (Phan, col. 7, ll. 14-17). 7. Phan teaches that: An exemplary methacrylate-containing memory polymer is prepared by mixing the monomers methyl methacrylate, polyethyleneglycol methacrylate, butylmethacrylate in a 2:1.5:1 ratio. A crosslinker, such as hexanedioldimethacrylate, and a thermal or UV initiator, such as benzoin methyl ether or azobisisobutylnitrile (AIBN), are added and the formulation is stirred as polymerization proceeds. The monomers can be polymerized into a polymer for extrusion in a conventional Appeal 2011-005067 Application 11/327,700 6 extruder to provide a length of a tubular structure or a flat sheet, which are crosslinked by exposure to UV light, high energy electrons, gamma radiation or heat. (Phan, col. 5, ll. 1-12). Principles of Law “It is well settled that a prior art reference may anticipate when the claim limitations not expressly found in that reference are nonetheless inherent in it.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1349 (Fed. Cir. 2002). See, e.g., MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed.Cir.1999) (“Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.”) Once a prima facie case of anticipation has been established, the burden shifts to the Appellant to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). See also In re Spada, 911 F.2d 705, 708-09 (Fed. Cir. 1990). Analysis Phan teaches an implantable stent (FF 2) which “may contain a therapeutic agent for controlled release of the agent to the target site” (Phan, col. 1, ll. 53-57; FF 3). Phan teaches that the device has a flat strip (Figure 3A; FF 5) which may be wound into a helical pattern (Figure 3C; FF 5) Appeal 2011-005067 Application 11/327,700 7 where the flat strip “segment is placed into its closed, high-curvature condition by activating the polymer transition and winding the segment around a balloon catheter” (Phan, col. 7, ll. 14-17; FF 6). Phan teaches that the bioactive agent is more preferably incorporated into the polymer “prior to polymerization of the polymer sheet or tube” (Phan, col. 5, ll. 54-55; FF 4). Phan teaches that the polymer is prepared by mixing the monomers and then a “crosslinker, such as hexanedioldimethacrylate, and a thermal or UV initiator, such as benzoin methyl ether or azobisisobutylnitrile (AIBN), are added and the formulation is stirred as polymerization proceeds” (Phan, col. 5, ll. 4-8; FF 7). Phan teaches that after the bioactive agent is added to the polymer mixture, the mixture is stirred. In concord, the Specification teaches that “[p]olymer formulations can be prepared using these solutions that may include radiopaque agents, drugs or combinations thereof. These formulations are tumbled and mixed to prepare uniform dispersions” (Spec. 59, ll. 4-7; FF 1). Thus, when Phan combines the monomer components with a bioactive agent using a stirring process just as the Specification combines the drugs with monomers and mixes them to prepare uniform dispersions (FF 1), the result of the Phan stirring process is reasonably interpreted as inherently producing uniform dispersions. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his Appeal 2011-005067 Application 11/327,700 8 claimed product.… Whether the rejection is based on „inherency‟ under 35 U.S.C. § 102, on „prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO‟s inability to manufacture products or to obtain and compare prior art products.) Appellant contends that “these methods disclosed in Phan do not form a blended composition and are not used to create a blend. Specifically the methods described in Phan do not disclose dissolving two materials and putting them into solution together to form a homogeneous, uniformly blended composition” (App. Br. 5). Appellant defines “a „Polymer Blend‟ or a „Polymer Mixture‟ as a member of a class of materials analogous to metal alloys, in which at least two polymers are blended together to create a new material with different physical properties” (Reply Br. 3). We are not persuaded. Phan expressly teaches adding the bioagent prior to polymerization (FF 4) at the step of “mixing the monomers methyl methacrylate, polyethyleneglycol methacrylate, butylmethacrylate in a 2:1.5:1 ratio. A crosslinker, such as hexanedioldimethacrylate, and a thermal or UV initiator, such as benzoin methyl ether or azobisisobutylnitrile (AIBN), are added and the formulation is stirred as polymerization proceeds” (Phan, col. 5, ll. 2-7; FF 7). Using Appellant‟s own understanding of “blended composition” as a composition where ingredients “are blended (put into solution together) to create a new homogeneous material with different physical properties” (App. Br. 4), Phan‟s mixture of the biological agent with monomers, crosslinkers and initiators to form a memory polymer is reasonably interpreted as a “blended composition” (FF 4-7). See, e.g., In Appeal 2011-005067 Application 11/327,700 9 re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.”). Appellant‟s alternate definition of a “polymer blend” represents a limitation which is not found in claim 1. Claim 1 does not require the use of two different polymers, nor does claim 1 define the “blended composition” as a “polymer blend”. Thus, the “polymer blend” argument is not directed to the claim as written. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). As a final point, there can be no doubt that the final blended polymeric composition of Phan differs significantly in physical properties from the starting materials. Appellant contends that “Phan does not disclose an implantable drug delivery device formed from a solvent cast film strip wound into a helical pattern to form a tubular structure” (App. Br. 5-6). We are not persuaded. Phan expressly teaches a flat strip (Figure 3A; FF 5) which is wound into a helical pattern to form a tubular structure (Figure 3C; FF 5). Phan teaches that as “seen in FIG. 3A, segment 92 in its memory condition is a flat strip having the shape of a parallelogram” (Phan, col. 7, ll. 10-14; FF 5). Phan teaches that the flat strip “segment is placed into its closed, high-curvature condition by activating the polymer transition and winding the segment around a balloon catheter” (Phan, col. 7, ll. 14-17; FF 6) to form a helical pattern as shown in Figure 3C (FF 5). It is “well settled that the presence of process limitations in product claims, which product does not otherwise patentably distinguish over the prior art, cannot Appeal 2011-005067 Application 11/327,700 10 impart patentability to that product.” SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1318 (Fed. Cir. 2006) (quoting In re Stephens, 345 F.2d 1020, 1023 (CCPA 1965). Appellant has provided no evidence that the process of “solvent casting” differentiates the product from that of Phan. Conclusion of Law The evidence of record supports the Examiner‟s finding that the therapeutic agent of Phan is inherently “uniformly distributed throughout the bioabsorbable polymer” as required by claim 1. B. 35 U.S.C. § 103(a) over Phan and Whitbourne The Examiner finds that “Whitbourne et al. teaches a stent coating used to deliver drugs including a bulk erosion polymer (hydrophilic polymer) and surface erosion polymer (hydrophobic polymer), this allows the coating to deliver virtually any drug” (Ans. 5). The Examiner finds it obvious to “make the polymer strip, as taught by Phan et al., from a combination of bulk erosion polymer (hydrophilic polymer) and surface erosion polymer (hydrophobic polymer), as taught by Whitbourne et al., in order to allow the polymer strip stent to deliver virtually any drug” (Ans. 5). The Examiner provides sound fact-based reasoning for combining Whitbourne with Phan. We adopt the fact finding and analysis of the Examiner as our own. Appellant argues the underlying anticipation rejection over Phan, but Appellant does not identify any material defect in the Examiner‟s reasoning for combining Whitbourne with Phan. Since Appellant only argues the underlying rejection of Phan which we affirmed above, we affirm this rejection for the reasons stated by the Examiner. Appeal 2011-005067 Application 11/327,700 11 C. 35 U.S.C. § 103(a) over Brown and Michal The Examiner finds that “Brown teaches a strip (12), as can be seen in fig. 5, that can be wound into a helical stent comprising a plurality or cells” (Ans. 5). The Examiner finds that “the opposed ends (end connectors 36), of the strip (12), as can be seen in fig. 7, can extend from any angle (including about 10 to about 30 degrees) with respect to the opposed sides” (Ans. 5). The Examiner finds that Brown teaches that the “strip maybe made from bioabsorbable polymer (paragraph [0080]) and may comprise a therapeutic agent coating” (Ans. 5). The Examiner finds that “Michal teaches a stent coating made from bioabsorbable polymer that has the drug distributed uniformly throughout it” (Ans. 6). The Examiner finds it obvious “to replace the therapeutic agent coating, as taught by Brown, with the therapeutic agent coating, as taught by Michal, as the two coatings are obvious substitutes for each other” (Ans. 6). The Examiner finds that the “Examiner can consider the coating of bioabsorbable polymer and uniformly distributed therapeutic agent to be the tubular structure made up of a strip with struts and polygonal openings as the coating will assume the same shape/ geometry of the stent over which it is applied” (Ans. 6). Appellant contends that “Brown only discloses a stent having therapeutic agents that are placed on the stent in the form of a coating. . . . Similarly, Michal only teaches a drug/polymer coating over a stent structure” (App. Br. 7). Appellant contends that it “is the coating in Michal that is formed from a mixture of a polymer and the select drug to form a matrix coating, and not the stent structure” (App. Br. 8). Appeal 2011-005067 Application 11/327,700 12 The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s finding that Brown and Michal render obvious the device of claim 1? Findings of Fact 8. Brown teaches that the use of stents in bodily lumen is well known. A stent is typically delivered in an unexpanded state to a desired location in a bodily lumen via a medical device such as a catheter. Once the stent is at the desired bodily location, it is either expanded with a balloon or other suitable device (Brown 1 ¶ 0001). 9. Figure 5 of Brown is reproduced below: “FIG. 5 shows another embodiment of an unwound strip or ribbon 12 which may be wound to form a helical stent” (Brown 3 ¶ 0047). Appeal 2011-005067 Application 11/327,700 13 10. Figure 6 of Brown is reproduced below: “FIG. 6 shows an embodiment of a ribbon 12 having tapered end portions 38 wound helically to form a stent 10” (Brown 3 ¶ 0049). 11. Brown teaches that any “suitable stent material may be used in the manufacture of the inventive stents. Examples of such materials include polymeric materials . . . Suitable polymeric materials include thermotropic liquid crystal polymers (LCP's), shape memory polymers, bioabsorbable polymers and the like” (Brown 5 ¶ 0080). 12. Brown teaches that in “some embodiments the stent 10 may comprise one or more therapeutic agents. In some embodiments the agent is placed on the stent in the form of a coating. In at least one embodiment the coating includes at least one therapeutic agent and at least one polymer agent” (Brown 5-6 ¶ 0084). 13. Michal teaches “a drug delivery matrix coating, to an implantable device comprising the drug delivery matrix coating” (Michal, col. 1, ll. 6-8). Appeal 2011-005067 Application 11/327,700 14 14. Michal teaches that: a selected drug is intimately mixed with the polymeric coating material of the present invention in order to uniformly disperse the therapeutic drug in the polymeric material. For other embodiments, the drug is incorporated into a matrix such as a biodegradable polymer matrix. The specific method of uniformly dispersing the therapeutic drug in the polymer is variable, and depends upon the stability of the therapeutic drug to thermal processing. (Michal, col. 7, ll. 33-41). 15. Michal teaches that the “matrix coating is applicable to the surface of a stent using methods such as dipping, spraying, flowing, rolling and brushing. Thickness of the coating ranges from about 0.1 to about 3 mils. The thickness is adjustable by adjusting viscosity of the coating material prior to application” (Michal, col. 8, ll. 57-61). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. As noted by the Court in KSR, “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” 550 U.S. at 421. Analysis Brown teaches an implantable stent (FF 8) which comprises a tubular structure having a flat film coating with opposing sides and ends (FF 9, 12) Appeal 2011-005067 Application 11/327,700 15 which is wound into a helical pattern (FF 10). Brown teaches that “the coating includes at least one therapeutic agent and at least one polymer agent” (Brown 5-6 ¶ 0084; FF 12). Michal teaches that: a selected drug is intimately mixed with the polymeric coating material of the present invention in order to uniformly disperse the therapeutic drug in the polymeric material. For other embodiments, the drug is incorporated into a matrix such as a biodegradable polymer matrix. The specific method of uniformly dispersing the therapeutic drug in the polymer is variable, and depends upon the stability of the therapeutic drug to thermal processing. (Michal, col. 7, ll. 33-41; FF 14). Applying the KSR standard of obviousness to the findings of fact, we conclude that an ordinary artisan would have reasonably found it obvious to uniformly disperse the drug of Brown into the polymeric stent coating of Brown since Michal teaches uniform dispersion of drugs into polymeric coatings on stents (FF 14). Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appellant contends that “Brown only discloses a stent having therapeutic agents that are placed on the stent in the form of a coating. . . . Similarly, Michal only teaches a drug/polymer coating over a stent structure” (App. Br. 7). Appellant contends that it “is the coating in Michal that is formed from a mixture of a polymer and the select drug to form a matrix coating, and not the stent structure” (App. Br. 8). Appeal 2011-005067 Application 11/327,700 16 We are not persuaded. There is no requirement in claim 1 that the tubular structure wound into a helical pattern composed of a drug uniformly blended into a polymer must be the stent itself. Claim 1 is reasonably interpreted as encompassing any “device” which satisfies the structural requirements of the claim. In this case, the coating of Brown itself, as modified by Michal, satisfies the structural requirements of claim 1. The coating, after it has been applied to the flat stent, has opposed sides and ends, and is then wound into a helical pattern along with the stent (FF 8-11). Brown teaches that the coating is composed of a polymer and bioactive agent (FF 12) and Michal suggests uniform dispersion of the bioactive agent into a bioadsorbable polymer which composes a stent coating (FF 14). To the extent Appellants are contending that the tubular structure must be the stent itself, that is a limitation which is not claimed. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Appellant contends that “it cannot be said that every polymeric material that has an agent uniformly distributed throughout the polymer is a blend of the polymer and the agent” (App. Br. 8). We are not persuaded. Appellant does not identify, and we do not find, a specialized definition of “blended composition” in the Specification. Therefore, the Examiner properly applied the broadest reasonable interpretation of the term, consistent with the Specification which never limits the term “blended composition” to polymer blends. See, e.g., In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their broadest reasonable interpretation Appeal 2011-005067 Application 11/327,700 17 consistent with the specification.”). In addition, the Examiner has demonstrated with evidence that at least one meaning of blend is “an occurrence of thorough mixing”. 5 In contrast, Appellant‟s only evidence relates to “polymer blends” (see Reply Br. 3) and the claims do not specifically include a limitation to polymer blends. Conclusion of Law The evidence of record supports the Examiner‟s finding that Brown and Michal render obvious the device of claim 1. D. 35 U.S.C. § 103(a) over Brown, Michal, and Whitbourne The Examiner finds that “Whitbourne et al. teaches a stent coating used to deliver drugs including a bulk erosion polymer (hydrophilic polymer) and a surface erosion polymer (hydrophobic polymer), this allows the coating to deliver virtually any drug” (Ans. 6). The Examiner finds it obvious to “to make the coating, as taught by Brown as modified by Michal, from a combination of bulk erosion polymer (hydrophilic polymer) and surface erosion polymer (hydrophobic polymer), as taught by Whitbourne et al., in order to allow the coating to deliver virtually any drug” (Ans. 6-7). The Examiner provides sound fact-based reasoning for combining Whitbourne with Brown and Michal. We adopt the fact finding and analysis of the Examiner as our own. Appellant argues the underlying obviousness rejection over Brown and Michal, but Appellant does not identify any material defect in the Examiner‟s reasoning for combining Whitbourne with Brown and Michal. Since Appellant only argues the underlying rejection of 5 “Blend” Sensagent Dictionary, accessed 10/7/2010. Appeal 2011-005067 Application 11/327,700 18 Brown and Michal which we affirmed above, we affirm this rejection for the reasons stated by the Examiner. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 102(b) as anticipated by Phan. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 2, 12, 13, and 21 as these claims were not argued separately. We affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as obvious over Phan and Whitbourne. We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Brown and Michal. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 5-7, 12, 13, and 21as these claims were not argued separately. We affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as obvious over Brown, Michal, and Whitbourne. 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 alw