Ex Parte Dinh et alDownload PDFBoard of Patent Appeals and InterferencesSep 23, 200911138545 (B.P.A.I. Sep. 23, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Ex parte THOMAS Q. DINH, RODOLFO PADUA, and JESUS CASAS-BEJAR, Appellants ____________________ Appeal 2009-002314 Application 11/138,5451 Technology Center 1600 ____________________ Decided: September 24, 2009 ____________________ Before CAROL A. SPIEGEL, RICHARD M. LEBOVITZ, and FRANCISCO C. PRATS, Administrative Patent Judges. SPIEGEL, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134 from an Examiner's final rejection of all pending claims, claims 1-6, 8-12, 14-23, and 44-48. We have jurisdiction under 35 U.S.C. §§ 6 and 134. We REVERSE. 1 Application 11/138,545 ("the 545 application" or "Spec."), Medical Device Having a Surface Including a Biologically Active Agent Therein, and Methods, was filed 26 May 2005 and claims benefit of application 60/574,739, filed 27 May 2004, under 35 U.S.C. § 119. The real party in interest is the assignee, MEDTRONIC INC. (Appeal Brief filed 31 March 2008 ("App. Br.") at 2). Appeal 2009-002314 Application 11/138,545 2 I. Statement of the Case The subject matter on appeal is directed to methods of preparing a medical device having an exposed porous surface which contains a biologically active agent. The methods involve heating the porous surface to encapsulate the active agent therein in order to provide a controlled release of the active agent from the device. Claims 1, 8, 14, and 44, all of the independent claims on appeal, are illustrative and read (App. Br. Claims App'x A1-A4 and A6): 1. A method of preparing a medical device comprising: providing a device comprising a porous exposed surface, wherein at least a portion of the pores contain a biologically active agent; and heating at least the porous exposed surface at a temperature of about 30oC to about 100oC to at least partially collapse the porous surface and encapsulate the biologically active agent. 8. A method of preparing a medical device comprising: coating a surface of a device with a porous polymeric coating; at least partially loading the porous polymeric coating with a biologically active agent; and heating at least the porous polymeric coating to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent. 14. A method of preparing a medical device comprising: applying a coating composition comprising a polymer and a water soluble porogen to at least a portion of a surface of a device; Appeal 2009-002314 Application 11/138,545 3 removing at least a portion of the water soluble porogen to form a porous polymeric coating on at least a portion of the surface of the device; at least partially loading the porous polymeric coating with a biologically active agent; and heating at least the porous polymeric coating to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent. 44. A method of controlling the release rate of a biologically active agent from a polymeric coating, the method comprising: providing a device comprising an exposed surface comprising a porous polymeric coating, wherein at least a portion of the pores contain a biologically active agent; and heating at least the porous polymeric coating at a temperature of about 30oC to about 100oC to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent to control the release rate of the biologically active agent from the exposed surface. The device may be a stent, graft, catheter, guide wire, heart valve, bone or spine implant, or microsphere (Spec. 7:30-33). The porous surface is typically prepared by coating a surface of the device with an organic polymer having a glass transition temperature ("Tg") of no greater than 70oC (id. 8:10-27). Preferred polymers include polycaprolactone, poly(lactide-co- glycolide), polyvinyl acetate, polyvinyl acetate, cellulose acetate, and (meth)acrylate polymers (id. 8:28-9:2). The biologically active agent can be contacted with the porous surface of the device, e.g., by immersion in a solution or dispersion of the active agent, to load the active agent at the Appeal 2009-002314 Application 11/138,545 4 desired level (id. 10:20-24). The active agent is then encapsulated in the polymeric coating using heat (id. 11:24-25), preferably by heating in air at a temperature of at least about 5oC above the Tg of the polymer in the polymeric coating, typically at about 30oC to about 100oC (claims 1 & 44) for about 30 seconds to about 60 minutes (id. 11:33-12:4). The active agent may be a drug, a DNA or RNA based agent, such as a plasmid DNA or miRNA, a vector, a stem cell, an antineoplastic agent, an antithrombogenic agent, a cytokine, or a growth factor (id. 10:31-11:5). The Examiner has rejected (A) claims 1-5 and 44-47 under 35 U.S.C. § 102(e) as anticipated by Sirhan2 in light of Seibold3 and Gunatillake4 (Ans.5 4-5); (B) claims 1-6 and 44-48 under 35 U.S.C. § 103(a) as obvious over Sirhan, Seibold, Gunatillake, and Klugherz6 (Ans. 6); (C) claims 8-12 under 35 U.S.C. § 103(a) as obvious over Ding7, Sirhan, Seibold, and Gunatillake (Ans. 7-8); and, 2 U.S. Patent 7,077,859 B2, Apparatus and Methods for Variably Controlled Substance Delivery from Implanted Prosthesis, issued 18 July 2008 to Sirhan et al. based on application 10/017,500, filed 14 December 2001 ("Sirhan"). 3 U.S. Patent 6,890,699 B2, Polymer Material Having a Low Glass Transition Temperature for Use in Chemically Amplified Photoresists for Semiconductor Production, issued 10 May 2005 to Seibold et al. based on application 10/377,893, filed 28 February 2003 ("Seibold"). 4 Gunatillake et al., "Biodegradable Synthetic Polymers for Tissue Engineering," 5 European Cells and Materials 1-16 (2003) ("Gunatillake"). 5 Examiner's Answer mailed 11 June 2008 ("Ans."). 6 Klugherz et al., "Gene delivery from a DNA controlled-release stent in porcine coronary arteries," 18 Nature 1181-1184 (2000) ("Klugherz"). Appeal 2009-002314 Application 11/138,545 5 (D) claims 8-12 and 14-23 under 35 U.S.C. § 103(a) as obvious over Ding, Sirhan, Seibold, Gunatillake, and Wan8 (Ans. 8). Appellants argue that Sirhan fails to teach or suggest heating a porous exposed surface/polymeric coating at a temperature of about 30oC to about 100oC to at least partially collapse the surface/coating and encapsulate the active agent and, therefore, does not anticipate or render obvious any of claims 1, 8, 14, and 44 (App. Br. 7 and 10; Reply Br.9 2-4). Appellants further argue that since Sirhan teaches that a nonporous rate-controlling element is disposed between the source of the active agent and the porous rate-controlling element, Sirhan effectively teaches away from a porous polymeric coating containing a drug in at least a portion of its pores (App. Br. 13; Reply Br. 4-6). According to Appellants, the Examiner admitted that Ding fails to teach a porous polymeric coating to collapse and encapsulate the drug and relies on Sirhan, Seibold, and Gunatillake to remedy the deficiency in Ding (App. Br. 16-19, 22-23). Appellants again argue that Sirhan not only fails to teach or suggest heating at least a porous polymeric coating to at least partially collapse a surface thereof and encapsulate an active agent, but also effectively teaches away from a porous polymeric coating in which at least a portion of pores contain a drug (App. Br. 16-19, 22-24). According to Appellants none of Seibold, Gunatillake, or Wan remedies the deficiencies 7 U.S. Patent 6,652,581 B1, Medical Device with Porous Release Surface for Controlled Drug Release and Method of Making the Same, issued 25 November 2003 to Ni Ding ("Ding"). 8 Wan et al., "Plasticizers and their effect on microencapsulation process by spray-drying in an aqueous system," 9 Journal of Microencapsulation 53-62 (1992) ("Wan"). 9 Reply Brief filed 30 July 2008 ("Reply Br."). Appeal 2009-002314 Application 11/138,545 6 in Ding (App. Br. 19, 25). Furthermore, according to Appellants, modifying Ding to include heating the porous polymeric coating to collapse it and encapsulate the drug would change the principle of operation of Ding (App. Br. 19-20, 25; Reply Br. 6-7). Therefore, at issue is whether Appellants have shown that (i) the Examiner erred in finding that Sirhan teaches or suggests a heating step as recited in independent claims 1, 8, 14, and 44; (ii) Sirhan teaches away from the claimed invention by teaching a nonporous rate-controlling element disposed between the source of the active agent and the porous rate-controlling element; and, (iii) the Examiner failed to provide an articulated reason for modifying Ding according to the teachings of Sirhan, Seibold, and/or Gunatillake. III. Findings of Fact ("FF") The following findings of fact are supported by a preponderance of the evidence of record. A. Sirhan [1] In one embodiment, Sirhan describes a device comprising a structure, such as, a stent or a graft; a source of at least one therapeutic agent, such as an immunosuppressant, an anti-inflammatory, an antiproliferative, an anti-migratory agent, and an anti-neoplastic; and, a rate-controlling element disposed or formed adjacent to at least a portion of the structure, the latter which controls the rate at which the agent becomes available to the tissue (Sirhan 4:8-17, 28-35; 9:29-35). [2] The therapeutic agent is, at least in part, "associated with" the structure and/or the rate-controlling element so as to become available to a susceptible tissue site once the device has been introduced into a Appeal 2009-002314 Application 11/138,545 7 corporeal body (Sirhan 4:12-17). Sirhan broadly defines "associated with" to encompass directly or indirectly coupled to, connected to, disposed on, disposed within, attached to, bonded to, adjacent to, entrapped in, and the like (Sirhan 4:17-21). [3] For example, a source 25 of therapeutic agent may be disposed on some areas 73, 94, 97 or on all the tissue or luminal facing sides of the structure 16 (Sirhan 22:41-57; Figures 6A-6F). [4] The rate-controlling element may be (a) non-degradable, partially degradable, and/or substantially degradable; (b) synthetic or natural; (c) polymeric, nonpolymeric, ceramic, and/or metallic; and (d) porous and/or nonporous in morphology (Sirhan 6:9-15). [5] Suitable biodegradable rate-controlling element materials include polycaprolactone (Sirhan 8:19-29). [6] "Preferably, when the device comprise[s] a porous rate-controlling element, at least one layer of a nonporous rate-controlling element is disposed between the source and the porous rate-controlling element" (Sirhan 6:16-19). [7] For example, Example 2 of Sirhan describes loading a drug onto a grooved stent by dipping or spraying the stent in an alcoholic solution of the drug; drying the stent, resulting in the drug remaining on the stent surface and in the stent grooves, which serves as a reservoir for the drug; and, then vacuum depositing a layer of parylene on the stent to serve as a rate-controlling barrier (Sirhan 35:15-35). [8] Example 3 of Sirhan describes spraying a methanol solution of therapeutic agent on a stent, evaporating the solvent, and then spraying or depositing a matrix or barrier (silicone, polyurethane, Appeal 2009-002314 Application 11/138,545 8 polytetrafluoroethylene, parylast, parylene) on the stent covering the therapeutic agent (Sirhan 35:37-46). [9] According to Sirhan, a layer of parylene C, which has a Tg of approximately 80 to 100oC, may be deposited as a porous rate- controlling element at a temperature , depending upon the morphology desired. Specifically, as the deposition temperature increases, the crystallinity of the polymer film increases and becomes more conformationally ordered, whereas as the deposition temperature decreases, the crystallinity decreases and the film becomes more amorphous. When the temperature is decreased even further, e.g., from -40oC to near liquid nitrogen temperatures (-196oC), the rate- controlling element becomes increasingly amorphous and porous. On the other hand, annealing the film at 205oC in nitrogen gas for about two hours usually changes the film to a nonporous morphology. (Sirhan 33:35-62.) B. Seibold [10] Seibold is directed to polymers used in photoresists for semiconductor production (Seibold 1:12-14). [11] According to Seibold, [i]n order to improve the properties of the photoresist film, the resist film is generally heated briefly after application, so that the solvent evaporates. … If a temperature which is above the glass transition temperature of the polymer is chosen, the polymer or the resist softens and a rearrangement of the polymer chain occurs, so that a homogeneous film is formed. Cavities of [sic] pores which are formed during application of the photoresist or during evaporation of the solvent are Appeal 2009-002314 Application 11/138,545 9 predominantly closed. However, if the polymer contained in the photoresist has too high a glass transition temperature, no rearrangement of the polymer chains occurs … and the resist film still has cavities which … form [diffusion] barriers …. [Seibold 2:54-3:2.] C. Gunatillake [12] Gunatillake reviewed the major classes of biodegradable polymers (Gunatillake p. 2, col. 1, last para.). [13] According to Gunatillake, polycaprolactone is a semicrystalline polymer with a Tg of about -60oC and a melting point of about 59 to 64oC (Gunatillake p. 5, col. 1, para. 3; see also p. 11, Table 2 Poly(caprolactone)). D. Klugherz [14] Klugherz formulated a plasmid DNA polylactic-polyglycolic acid ("PLGA") coronary stent coating that provided localized gene delivery and expression when inserted into pigs (Klugherz p. 1181, col. 1, para. 2; p. 1183, col. 2, para. 4; p. 1184, col. 1, para. 4). [15] Specifically, a plasmid DNA-GFP was emulisified in a PLGA chloroform solution and then coated in multiple thin layers interrupted by evaporation onto the stents (Klugherz p. 1183, col. 2, para. 4). E. Ding [16] Ding discloses medical devices having a porous coating comprising a plurality of voids therein covering a surface of the device, wherein the voids are loaded with a biologically active agent, e.g., a drug or a gene or nucleic acid, using electrophoresis, for controlled release when the device is implanted or inserted into a body lumen (Ding 2:19-63; 7:1- 21). Appeal 2009-002314 Application 11/138,545 10 [17] The porous coating may be formed from polycaprolactone (Ding 4:1- 4, 19). [18] In one method for forming a porous coating, a mixture comprising a polymer, an elutable particulate material (a porogen), and a solvent are applied to a portion of the device and then the device is exposed to an aqueous or oganic solvent to elute the particulate material from the polymer to form a plurality of voids in the polymer (Ding 5:31-37). [19] To load the drug in the porous surface of the stent, the polymer coated stent is placed in a solution or suspension of the drug, along with an electrode. The electrode is selected such that the stent will be charged opposite of the drug when an electric current is applied to the system. Application of the electric current forces the charged drug molecules to move into the pores of the stent. [Ding 6:1-40.] F. Wan [20] Wan investigated the effect of five different plasticizers on a spray drying method of producing theophylline microcapsules which used an aqueous hydroxypropylmethylcellulose polymer (Wan abstract). [21] "Generally, the incorporation of a plasticizer is important as it enhances the formation of spherical and smooth-surfaced microcapsules" (Wan 53, last sentence). [22] Microparticles formed in the presence of a citric acid plasticizer showed the slowest drug release (Wan abstract). III. Discussion A. Legal principles “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.†In re Appeal 2009-002314 Application 11/138,545 11 Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). "Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set circumstance is not sufficient." In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). "Section 103 forbids issuance of a patent when the 'differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.'" KSR Int'l co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including (1) the scope and content of the prior art, (2) any differences between the claimed subject matter and the prior art, (3) the level of skill in the art, and (4) where in evidence, so-called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). In KSR, the Supreme Court emphasized that "rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). B. The anticipation rejection Rejected independent claims 1 and 44 require providing a device having a porous exposed surface or an exposed surface comprising a porous polymeric coating, respectively, which already contains a biologically active agent in at least a portion its pores. Both claims 1 and 44 require subsequently heating the porous surface/coating at a temperature of about Appeal 2009-002314 Application 11/138,545 12 30oC to about 100oC to at least partially collapse the porous surface/coating, thereby encapsulating the biologically active agent. As pointed out by Appellants, Sirhan fails to disclose an express embodiment meeting all of the limitations recited in claims 1-5 and 44-47 (App. Br. 8). Instead, the Examiner relies on various disclosures in Sirhan to find that various claim limitations at issue are taught by Sirhan (Ans. 14). For example, the Examiner finds that Sirhan (i) teaches a stent having a porous polymeric coat consisting of polycaprolactone on its surface and (ii) teaches heating a porous polymeric coat at a temperature lower than, equal to, or higher than its Tg, wherein the Tg for the polymeric coat is 80-100oC, i.e., at column 33, lines 40-48 and column 33, line 63 through column 34, line 1 (Ans. 4 and 14). However, the Tg for polycaprolactone is -60oC (FF 13) and the Examiner has provided no nexus between polycaprolactone's Tg of -60oC and heating polycaprolactone at a temperature of about 30oC to about 100oC as recited claims 1-5 and 44-47. In addition, as pointed out by Appellants (App. Br. 9; Reply Br. 2-3), the portion of Sirhan cited by the Examiner for the second teaching is directed to methods of depositing a parylene C polymeric layer to obtain a desired morphology, ranging from porous to nonporous (FF 9). Notably, the disclosure at columns 33-34 of Sirhan pointed to by the Examiner is devoid of any teaching or suggestion that the parylene C layer being deposited already contains a biologically active agent or that an agent will be loaded into the pores of the parylene C layer once the desired layer has been deposited, followed by further modification of the porosity of the parylene C layer. This disclosure is consistent with the examples in Sirhan wherein a drug layer/reservoir is deposited onto a stent and then a rate-controlling or barrier layer of parylene Appeal 2009-002314 Application 11/138,545 13 is overlaid on top of deposited drug (FF 7 and 8). The Examiner has not explained how a method of depositing a polymeric layer having a desired porosity inherently teaches heating a porous surface/coating containing a biologically active agent at a temperature of about 30oC to about 100oC to at least partially collapse the porous surface/coating in order to encapsulate the biologically active agent. Inherency and obviousness are distinct concepts. Thus, we agree with Appellants that the Examiner has erred in finding that Sirhan teaches the heating step recited in claims 1 and 44 and claims dependent thereon. Consequently, we reverse the rejection of claims 1-5 and 44-47 under § 102. C. The obviousness rejections 1. of claims 1-6 and 44-48 over Sirhan, Seibold, Gunatillake, and Klugherz According to the Examiner, "[t]he teachings of Sirhan … taken with Seibold … and Gunnatillake … are applied as above for claims 1-5, and 44- 47" (Ans. 6). The Examiner has failed to provide any meaningful separate obviousness analysis of claims 1-5 and 44-47. Claims 6 and 48 recite a Markush group of biologically active drugs which includes not only members taught by Sirhan, e.g., immunosuppressants, anti-inflammatories, anti-migratory agents, and anti- neoplastic agents (FF 1), but also members not taught by Sirhan, specifically plasmid DNA. The Examiner relies on Klugherz as teaching a plasmid DNA PLGA stent (Ans. 6; FF 14-15). We reverse the rejection of claims 1-6 and 44-48 under § 103 over the combined teachings of Sirhan, Seibold, Gunatillake, and Klugherz for the same reasons given above as to the rejection under § 102. The Examiner has Appeal 2009-002314 Application 11/138,545 14 failed to show that each and every limitation of the claim is described or suggested by the prior art or would have been obvious based on the knowledge of those of ordinary skill in the art. In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). Specifically, the Examiner has failed to provide a factual basis establishing that the heating step of claims 1 or 44 is described or suggested by the prior art or would have been obvious based on the knowledge of those of ordinary skill in the art. 2. of claims 8-12 over Ding, Sirhan, Seibold, and Gunatillake According to the Examiner, Ding teaches coating a surface of a stent with a porous polymeric coating, such as polycaprolactone, and loading the coating with a biologically active agent, such as a gene (Ans. 7). The Examiner acknowledges that Ding does not teach heating the porous polymeric coating to collapse its pores, thereby encapsulating the drug (Ans. 7). However, the Examiner finds that Sirhan teaches heating a porous polymeric coat at a temperature below, at, or above its Tg and that Seibold and Gunatallike each teach that heating above Tg completely eliminates the pores of polymers with low Tgs, such as polycaprolactone (Ans. 7). The Examiner concludes that it would have been obvious to modify the method of Ding by adding the heating step of Sirhan in order to control the delivery of drug from the polymeric matrix (Ans. 8). According to the Examiner, "[b]ased on the teachings of the art, one of skill would have known to modulate the release of the drug from the polymeric matrix by controlling its porosity" (Ans. 8). However, while the Examiner relies on "the teachings of the art" as the basis for concluding that one of ordinary skill in the art would have Appeal 2009-002314 Application 11/138,545 15 known to control drug release from a polymeric matrix by controlling the porosity of the matrix, the Examiner has failed to point to any particular teaching or suggestion in the art of record to support her conclusion. For example, the Examiner has failed to point out how Ding teaches or suggests controlling drug release from its stent. Alternatively, the Examiner has failed to articulate reasoning with some rational underpinning to support her legal conclusion of obviousness. Rejections on obviousness grounds cannot be sustained by mere conclusory statements. KSR, 550 U.S. at 418. Moreover, Ding uses an electric current to force feed drug into the open pores on the surface of its stent and it is from these pores that the drug is released (FF 16 and 19). Appellants argue that heating the porous polymeric coating of Ding to close the pores and encapsulate the drug would require that drug release occur through a different principle of operation, e.g., polymer degradation (App. Br. 19-20, Reply Br. 6-7). In response, the Examiner merely stated that "the principle of operation of Ding's invention is controlled drug release" and "the proposed modification would still result in controlled drug release" (Ans. 26). However, the Examiner did not address the effect of her proposed modification of the Ding stent with any particularity. For example, the Examiner has not explained why one of ordinary skill in the art would have used a porogen to create pores as taught by Ding (FF 18) and then have used heat to destroy the created pores as proposed. It may well be that collapsing the drug-filled pores increases mechanical stress on drug-laden parts of the stent to an unacceptable extent or that the speed of drug delivery is controlled by how deep into the porous polymeric coating of Ding the drug is electrophoresed. Thus, the Examiner's response to Appellants' argument is not a reasoned response, but merely an Appeal 2009-002314 Application 11/138,545 16 unsupported conclusion. Accordingly, we reverse the rejection of claims 8- 12 under § 103 over the combined teachings of Ding, Sirhan, Seibold, and Gunatillake. 3. of claims 8-12 and 14-23 over Ding, Sirhan, Seibold, Gunatillake, and Wan According to the Examiner, "[t]he teachings of Ding taken [sic, with], Sirhan …, Seibold …, and Gunnatillake … are applied to claims 8-12, 14, 16, 18-20, and 23 as set forth above" (Ans. 8). However, the combined teachings of Ding, Sirhan, Seibold, and Gunatillake have not been previously applied to claims 14, 16, 18-20, and 23 under § 103. The Examiner has failed to provide any meaningful obviousness analysis with underlying factual determinations regarding these claims. We also reiterate the reversal of the rejection of claims 8-12 under § 103 over the combined teachings of Ding, Sirhan, Seibold, and Guanatillake for the reasons given above. The remaining claims, claims 15, 17, 21, and 22, all depend from independent claim 14. However, the § 103 rejection of claim 14 over Ding, Sirhan, Seibold, Gunatillake, and Wan is the only rejection of claim 14 on appeal; and, again, the Examiner has failed to provide an obviousness analysis for claim 14 (Ans. 4-8). Consequently, we reverse the rejection of claims 8-12 and 14-23 under § 103 over Ding, Sirhan, Seibold, Gunatillake, and Wan. D. Conclusion In conclusion, Appellants have shown that the Examiner erred in finding that Sirhan teaches or suggests a heating step as recited in the independent claims on appeal, claims 1, 8, 14, and 44. Since Sirhan fails to Appeal 2009-002314 Application 11/138,545 17 teach or suggest a heating step as recited in claims 1, 8, 14, and 44, the issue of whether or not Sirhan teaches away from the claimed invention is moot. Finally, Appellants have shown that the Examiner failed to provide an articulated reason for modifying Ding according to the teachings of Sirhan, Seibold, and/or Gunatillake. IV. Order Upon consideration of the record, and for the reasons given, it is ORDERED that the decision of the Examiner to reject claims 1-5 and 44-47 under 35 U.S.C. § 102(e) as anticipated by Sirhan in light of Seibold and Gunatillake is REVERSED; FURTHER ORDERED that the decision of the Examiner to reject claims 1-6 and 44-48 under 35 U.S.C. § 103(a) as obvious over the combined teachings of Sirhan, Seibold, Gunatillake, and Klugherz is REVERSED; FURTHER ORDERED that the decision of the Examiner to reject claims 8-12 under 35 U.S.C. § 103(a) as obvious over the combined teachings of Ding, Sirhan, Seibold, and Gunatillake is REVERSED; FURTHER ORDERED that the decision of the Examiner to reject claims 8-12 and 14-23 under 35 U.S.C. § 103(a) as obvious over the combined teachings of Ding, Sirhan, Seibold, Gunatillake, and Wan is REVERSED; and, FURTHER ORDERED that no time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). REVERSED Appeal 2009-002314 Application 11/138,545 18 ack cc: MUETING, RAASCH & GEBHARDT, P.A. P.O. Box 581336 Minneapolis, MN 55458-1336 Copy with citationCopy as parenthetical citation