Ex Parte MyattDownload PDFBoard of Patent Appeals and InterferencesDec 27, 201110263516 (B.P.A.I. Dec. 27, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte GRAHAM JOHN MYATT __________ Appeal 2011-008375 Application 10/263,516 Technology Center 1600 __________ Before TONI R. SCHEINER, LORA M. GREEN, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a composition comprising an inner core and three surrounding layers. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-008375 Application 10/263,516 2 STATEMENT OF THE CASE The Specification states that the compositions of the claimed invention “are particularly useful wherein the composition comprises a component that is susceptible to moisture or may otherwise be compromised by environmental factors. The compositions comprise an inner core and at least two surrounding layers, wherein the surrounding layers protect the inner core from moisture or such other factors.” (Spec. 1, ll. 8-12.) Claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 are on appeal. Claim 1, the only independent claim, is representative and reads as follows: 1. A composition comprising: (a) an inner core comprising one or more components, including bacteria, wherein at least one or more components has a water activity of about 0.3 or less as measured at a temperature of from about 20°C to about 25°C; (b) a capsule layer which is joined to the inner core; (c) an inner layer which is joined to the inner core, wherein the inner layer is selected from the group consisting of continuous coatings which are insoluble at a pH of about 3 or less, continuous coatings having a coating weight of from about 3 mg/cm2 to about 25 mg/cm2, and combinations thereof; and wherein the inner layer is an anionic copolymer selected from the group consisting of methacrylic acid, methacrylate, acrylic acid, acrylate and combinations thereof; and (d) an outer layer which is joined to the inner core, wherein the outer layer is a continuous hydrophobic coating comprising a material selected from the group consisting of fatty acids, fatty acid derivatives, polymers, and mixtures thereof; and which exhibits a water vapor transmission rate of less than about 200 mg/m2/24 hours; wherein the inner layer is a preceding layer relative to the outer layer. Appeal 2011-008375 Application 10/263,516 3 The Examiner rejected the claims as follows: • claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 under 35 U.S.C. § 103(a) as unpatentable over Kim1 in view of Freeman,2 Colorcon,3 Signorino,4 Mills,5 Pozzi,6 Yamishita ‘561,7 Yamishita ‘641,8 and Sudoma;9 and • claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 under 35 U.S.C. § 103(a) as unpatentable over Yamishita ‘641in view of Kim, Freeman, Colorcon, Signorino, Mills, Pozzi, Yamishita ‘561, and Sudoma. OBVIOUSNESS The Issue I. The Rejection over a combination including Kim as the primary reference. The Examiner’s position is that Kim taught a composition comprising an inner core comprising Lactobacillus acidophilus, Lactobacillus bifidus, and Streptococcus faecalis surrounded by a continuous inner layer of 1 Patent Application Publication No. WO 99/20745 by Dong Kim et al., published Apr. 29, 1999. 2 Freeman LLC, All About Zein (2005), http://www.freemanllc.com/zein.htm. 3 Colorcon, Opalgos®, Technical Data Sheet (2003). 4 US Patent No. 3,738,952 issued to Charles A. Signorino, Jun. 12, 1973. 5 John S. Mills and Raymond White, Natural Resins and Lacquers, 2 THE ORGANIC CHEM. OF MUSEUM OBJECTS, 115-118 (1987). 6 Patent Application Publication No. GB 2 245 492 A by Franco Pozzi et al., published Aug 1, 1992. 7 Patent Application Publication No. JP 03-076,561, Teiji Yamashita, published Apr. 2, 1991. 8 US Patent No. 6,030,641 issued to Sadaji Yamashita et al., Feb. 29, 2000. 9 US Patent No. 4,927,763 issued to A. Louis Sudoma et al., May 22, 1990. Appeal 2011-008375 Application 10/263,516 4 alginate, which was surrounded by a layer of Opaglos® liquid shellac, corn zein, and glycerine. (Ans. 5.) The Examiner found that Kim also taught that the inner layer may comprise hydroxypropylmethylcellulose (HPMC). (Id.) The Examiner found that Freeman provided evidence that zein is hydrophobic. (Id.) Additionally, the Examiner found that Colorcon provided evidence that Opaglos® is a modified shellac composition. (Id.) The Examiner cited Signorino as evidence that Opaglos® comprises shellac and polyvinylpyrrolidone. (Id.) Also, the Examiner cited Mills “as evidence that shellac inherently comprises various fatty acids and fatty acid derivatives, including aleuritic acid, butolic acid, jalaric acid, and laccijalaric acid.” (Id.) The Examiner found that Kim did not teach that its composition comprised “an outer layer comprising a fat or wax,” or “a core surrounded by three layers,” i.e., including a capsule layer. (Id. at 6.) The Examiner found that Pozzi taught delayed-release, multi-layered pharmaceutical compositions comprising an inner core that comprises a drug within a protective inner layer that is surrounded by a hydrophobic outer layer. (Id.) The Examiner found that Pozzi disclosed that the protective inner layer comprised HPMC and that the outer layer comprised carnauba wax and beeswax. (Id.) Additionally, the Examiner found that Pozzi taught that the composition may take the form of various types of tablets or capsules. (Id.) According to the Examiner, a person of ordinary skill in the art at the time the invention was made would have been motivated to include “the protective HPMC capsule layer of Pozzi” in the composition of Kim because Pozzi taught that such a layer aids in timed release of ingredients of the inner Appeal 2011-008375 Application 10/263,516 5 core and because Kim taught that HPMC was an appropriate material for encapsulating bacteria. (Id. at 8.) Therefore, the Examiner concluded that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to include an additional layer between the inner core and the inner layer of Kim because Pozzi taught that such a layer protects the active ingredients of the inner core. (Id. at 9.) The Examiner did not make any additional findings or conclusions regarding the outer layer in the combination. Appellant’s contentions include an assertion that “[t]he cited references do not teach or suggest all of the claim limitations of independent claim 1 ….” (App. Br. 6.) In particular, Appellant asserts (App. Br. 8) that Kim did not teach or suggest the claim limitations for the outer layer, i.e., “wherein the outer layer is a continuous hydrophobic coating …and which exhibits a water vapor transmission rate of less than about 200 mg/m2/24 hours ….” (Claim 1.) II. The Rejection over a combination including Yamashita ‘641 as the primary reference. The Examiner found that Yamashita ‘641 taught capsules comprising a core of Bifidobacterium longum surrounded by a gelatin capsule, which was surrounded by a coating of hardened oil, which was surrounded by a polysaccharide/polyhydric alcohol coating comprising carrageenan, glucomannan, guar gum, and alginic acid. (Ans. 10-11.) The Examiner found that Yamashita ‘641 did not teach a composition comprising “an outer layer comprising a fat or wax.” (Id. at 11.) The Examiner repeated the findings for Kim, Freeman, Colorcon, Signorino, Mills and Pozzi as set forth in the rejection including Kim as the Appeal 2011-008375 Application 10/263,516 6 primary reference. (Ans. 11-12.) The Examiner additionally found that Kim taught that the composition of the inner layer and the outer layer may vary. (Id. at 11.) According to the Examiner, the selection of outer layer material “would have been a routine matter of optimization on the part of the artisan of ordinary skill ….” (Id. at 13.) The Examiner found that Kim taught that “corn zein may be used as the outer layer of sustained-release compositions of bacteria.” (Id. at 13-14.) Additionally, the Examiner concluded that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to substitute the protective HPMC capsule layer of Pozzi for the gelatin layer between the inner core and the inner layer of Yamashita ‘641 (i.e., the capsule layer) because Pozzi taught that such a layer protects the active ingredients of the inner core and Kim taught that HPMC was an appropriate material for encapsulating bacteria. (Id. at 14.) The Examiner did not make any additional findings or conclusions regarding the outer layer in the combination. Appellant’s contentions include an assertion that “[t]he cited references do not teach or suggest all of the claim limitations of independent claim 1” (App. Br. 11) in particular, the recited outer layer. Appellant asserts that the Examiner acknowledged that neither Yamashita nor Kim taught “an outer layer comprising fat or wax ….” (Id.) Further, Appellant asserts that “Kim provides no teaching, suggestion, predictability or expectation of success with adding other than water-miscible coatings to compositions of or similar to Kim.” (Id. at 11-12.) The issue is whether the Examiner has established that the cited references would have led a skilled artisan at the time of the invention to Appeal 2011-008375 Application 10/263,516 7 arrive at composition comprising an outer layer “wherein the outer layer is a continuous hydrophobic coating …and which exhibits a water vapor transmission rate of less than about 200 mg/m2/24 hours.” Findings of Fact 1. We agree with the Examiner’s explicit findings regarding the scope and content of the prior art references (see Ans. 4-15) except that we additionally find: 2. Kim’s exemplary formulation of an outer layer (i.e., second coating- solution) comprising Opaglos®, Zein, and glycerine, additionally comprised 80% ethanol. (Kim 11, Ex. 2.) 3. Kim’s exemplary formulation of an outer layer (i.e., second coating- solution) comprising Zein, additionally comprised 80% ethanol and glycerine. (Kim 13, Ex. 5.) Principles of Law A conclusion that the claimed subject matter is prima facie obvious must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention. See In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). Analysis We agree with Appellant (App. Br. 6, 11) that the Examiner has not established a prima facie case of obviousness for the rejection including Kim as the primary reference, or for the rejection including Yamashita ‘641 as the primary reference. Specifically, the Examiner has not provided evidence that a skilled artisan at the time of the invention would have combined the Appeal 2011-008375 Application 10/263,516 8 references to arrive at the claimed composition comprising an outer layer “wherein the outer layer is a continuous hydrophobic coating …and which exhibits a water vapor transmission rate of less than about 200 mg/m2/24 hours,” as recited in independent claim 1. See Fine, 837 F.2d at 1074. I. The Rejection over a combination including Kim as the primary reference. With respect to the rejection involving Kim as the primary reference, the Examiner found that Kim disclosed a composition comprising an outer layer comprising some components known to be hydrophobic, i.e., liquid shellac and corn zein. (Ans. 5-6, 11.) However, the Examiner did not find that these components provided or even suggested an outer layer that was a hydrophobic coating. (Id.) Indeed, the Examiner also found that Kim’s outer layer also comprised glycerine. (Id.) Further, Kim disclosed that the outer layer (i.e., second coating) additionally comprised 80% ethanol. (FF- 2.) Additionally, as Appellant has correctly asserted, Kim disclosed that water-miscible coating materials could be used in the outer layer of its composition. (App. Br. 7.) Thus, the Examiner did not establish that Kim taught or suggested a composition comprising an outer layer that was a continuous hydrophobic coating, as required by the claims. Moreover, while the Examiner found that Pozzi disclosed a composition comprising an outer layer comprising carnauba wax and beeswax, the Examiner’s combination did not include substituting or combining Pozzi’s outer layer with Kim’s outer layer, or otherwise modifying Kim’s outer layer. (See Ans. 5-9.) Rather, the Examiner relied on Pozzi in the combination as providing a “protective capsule layer.” (See, e.g., Ans. 6, 14.) Further, the rejection does not provide any explanation or Appeal 2011-008375 Application 10/263,516 9 reasoning, supported by the evidence, that a skilled artisan would have been motivated to combine Kim and Pozzi with a reasonable expectation of successfully arriving at the claimed outer layer. (Id. at 5-9.) Regarding water vapor transmission rate, the Examiner did not make any findings regarding this claim limitation. (Id.) In the Response, the Examiner stated that “the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” (Id. at 18-19, citing Ex parte Obiaya, 227 USPQ 58, 60 (BPAI 1985), aff’d mem., 795 F.2d 1017 (Fed. Cir. 1986)). However, as discussed, the Examiner has not established that the differences between the combined prior art and the claimed invention would have been “otherwise” obvious. Consequently, the Examiner did not establish that the combined prior art inherently or implicitly taught or suggested an outer layer which exhibits the recited water vapor transmission rate. Accordingly, we reverse the obviousness rejection over the combination including Kim as the primary reference. II. The Rejection over a combination including Yamashita ‘641 as the primary reference. In the rejection including Yamashita ‘641 as the primary reference, the Examiner did not find that Yamashita disclosed an outer layer as recited in independent claim 1. (See Ans. 10-12.) Regarding water vapor transmission rate, the Examiner did not make any findings regarding this claim limitation. (Id. 10-15.) Rather, the Examiner found that the selection of outer layer material “would have been a routine matter of optimization on the part of the artisan of ordinary skill ….” (Id. at 13.) According to the Appeal 2011-008375 Application 10/263,516 10 Examiner, Kim taught that corn zein may be used as the outer layer of sustained-release compositions of bacteria. (Id. at 13-14.) However, in Kim’s exemplary formulation of an outer layer comprising Zein-DP, Kim disclosed the coating-solution additionally comprised 80% ethanol and glycerine. (FF-3.) Moreover, as discussed, Kim taught that its outer layer may comprise water-miscible material. (See App. Br. 7.) Consequently, we do not find that the Examiner established that Kim’s teaching to use a coating composition comprising corn zein taught or suggested a hydrophobic coating. Nor did the Examiner rely on Pozzi in the combination as teaching or suggesting an outer layer, as recited in independent claim 1. (See Ans. 13-14)(combining Pozzi to provide a “protective HPMC capsule layer”). Accordingly, we reverse the obviousness rejection including Yamashita ‘641 as the primary reference. CONCLUSIONS OF LAW The Examiner has not established that the cited references would have led a skilled artisan at the time of the invention to arrive at a composition comprising an outer layer “wherein the outer layer is a continuous hydrophobic coating …and which exhibits a water vapor transmission rate of less than about 200 mg/m2/24 hours.” SUMMARY We reverse the rejection of claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 under 35 U.S.C. § 103(a) as unpatentable over Kim in view of Freeman, Colorcon, Mills, Pozzi, Yamishita ‘561, Yamishita ‘641, and Sudoma; and Appeal 2011-008375 Application 10/263,516 11 we reverse the rejection of claims 1, 2, 4, 5, 9-13, 15, 16, 21-25, 27, 28, and 33-35 under 35 U.S.C. § 103(a) as unpatentable over Yamishita ‘641in view of Kim, Freeman, Colorcon, Signorino, Mills, Pozzi, Yamishita ‘561, and Sudoma. REVERSED cdc Copy with citationCopy as parenthetical citation