Ex Parte Hassan et al

Patent Trial and Appeal BoardDec 20, 2012

10529984 (P.T.A.B. Dec. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte EMADELDIN M. HASSAN, AQEEL A. FATMI, and NACHIAPPAN CHIDAMBARAM __________ Appeal 2011-013217 Application 10/529,984 Technology Center 1600 __________ Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants request rehearing of the Decision on Appeal entered October 10, 2012, which affirmed rejections of all the claims on grounds of obviousness over a patent to Okajima and other references. We have reconsidered the issues as requested, but adhere to the decision affirming the rejections. Appeal 2011-013217 Application 10/529,984 2 BACKGROUND Appellants claim an enteric soft capsule shell formed from a gel mass. The Patent Examiner rejected all the claims over Venkateswara combined with other references, and rejected all the claims over Okajima combined with other references. This Board reversed the rejections based on Venkateswara, but affirmed the rejections based on Okajima. Briefly, Appellants’ enteric capsule shell comprises an acid-insoluble polymer and a water soluble polymer in a ratio of from 30:70 to 45:55 by weight. Okajima described enteric capsule shells comprising the same polymers, but in different ratios. The Examiner found that “the percentage of specific components present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize.” (Ans. 14.) We agreed with the Examiner and affirmed. (Dec. 6- 7.) Appellants request rehearing on the grounds that: (1) “the Board misapprehended or overlooked that even if optimization of Okajima’ s teachings was undertaken, Appellants’ claimed ratios of acid insoluble polymer to film-forming polymer are entirely contrary to the reasonable expectations of a person having ordinary skill in the art;” and (2) “the Board overlooked the fact that Okajima does not teach all the elements specified in Appellants' claims and no combination of the asserted secondary references cures the deficiencies of Okajima.” (R’hrg Req. 1-2.) Appeal 2011-013217 Application 10/529,984 3 DISCUSSION Okajima gave three working examples of its enteric capsules. (Okajima, cols. 5-6.) In Okajima’s example capsules, the weight ratios of acid-insoluble polymer to water soluble polymer were 85:40, 50:50, and 96:27, as Appellants calculate them. (R’hrg Req. 3, Table 1.) None of Okajima’s example ratios overlaps Appellants’ 30:70 to 45:55 ratio range. Thus, Appellants first argue that “Okajima's teachings do not establish a prima facie case of obviousness because there is no overlap.” (R’hrg. Req. 1.) This argument alone does not defeat the Examiner’s case because, as Appellants later acknowledge, “a prima facie case of obviousness exists when the claimed range and the prior art range do not overlap, but are close enough such that one having ordinary skill in the art would have expected them to have the same properties.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003), citing Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985). Appellants next present arguments addressing whether Okajima’s 50:50 ratio was close enough to Appellants’ 45:55 ratio that one having ordinary skill would have expected capsules made with those ratios to have the same enteric properties. According to Okajima, “the term ‘enteric properties’ means the properties of being soluble in or disintegrated by the alkaline intestinal secretions but being substantially insoluble or resistant to solution in the acid secretions of the stomach.” (Okajima, col. 1, ll. 25-29.) Okajima’s three working examples demonstrated the “substantially insoluble” property with testing in artificial gastric juice. For the Example 2 capsule made with a 50:50 ratio, no dissolution was seen when the capsule was subjected to artificial gastric juice. (Okajima, col. 5, ll. 63-68.) The Appeal 2011-013217 Application 10/529,984 4 Examiner found Okajima’s Example 2 sufficient to indicate that capsules having a 45:55 ratio would have been expected to have the same properties. Appellants contend “a person having ordinary skill would not reasonably expect Appellants' compositions to have useful enteric properties because the ratios of enteric polymer to film-forming polymer are inverted (i.e., Okajima's compositions contain equal or excess enteric polymer).” (R’hrg. Req. 2). According to Appellants, “Okajima’s compositions are entirely different from Appellants’ because Appellants’ claimed compositions always contain an excess of film-forming polymer.” (Id.) These arguments stress that there is a difference between 50:50 and 45:55, but don’t supply evidence that a person of ordinary skill in the art would have thought that 50:50 and 45:55 are so different that the latter composition would not have been substantially insoluble or resistant to solution in the acid secretions of the stomach. What is needed here is evidence, not argument. Appellants also contend that “[o]ne having ordinary skill in the art would take Okajima as teaching that the quantity of enteric polymer must be at least equal to the quantity of acid soluble polymer (i.e., 50:50), and preferably higher (i.e., 68:32 or 78:22).” (Id. at 4.) Okajima itself did not make such statements. Appellants do not point to a disclosure by Okajima suggesting that the working examples were intended to probe the limits of workable ratios for enteric properties. It appears that Okajima was addressing a problem with dip-molding and described the objects of its invention as “improved enteric capsules,” “enteric capsules having improved elasticity,” “improved retention of enteric capsules when subjected to prolonged storage,” and “methods for manufacturing such improved enteric Appeal 2011-013217 Application 10/529,984 5 capsules.” (Okajima col. 3, ll. 26-68.) Beyond making the assertion, Appellants do not explain how a person of ordinary skill in the art would find Okajima’s actual disclosure as setting a lower limit on the ratio. We find this argument unpersuasive because what a reference teaches is a question of fact, but we see no evidence to support Appellants’ reading. Appellants again review the Specification’s disclosure, stressing its disclosure of minimum effective levels of enteric polymer. (R’hrg. Req. 4.) The Examiner’s contention, however, was that Okajima’s 50:50 ratio was close enough to Appellants upper limit of 45:55 to indicate the obviousness of at least Appellants’ upper range. Appellants contend that Okajima “teaches away” from Appellants’ claimed compositions, and that Okajima “cautions against making changes to the compositions.” (Id. at 4-5.) “Whether an invention has produced unexpected results and whether a reference teaches away from a claimed invention are questions of fact.” Peterson, 315 F.3d at 1328 (citations omitted). A passage Appellants cite (id. at 5) to support their argument is found in this paragraph of Okajima: Although it is known in the prior art that the mentioned polymers have enteric properties and can be used for the surface coating of pharmaceutical formulations such as tablets and granules, it is surprising that satisfactory pharmaceutical capsules can be manufactured by incorporating the polymer throughout the capsule wall itself. This is because the commercial manufacture of pharmaceutical capsules is such a sensitive operation that it is adversely affected by almost any change in the conventional ingredients or operating conditions. (Okajima col. 4, ll. 57-66.) The passage touts the surprising nature of Okajima’s invention incorporating the polymer throughout the capsule wall, Appeal 2011-013217 Application 10/529,984 6 when considered against the sensitivity of commercial manufacturing processes. There is no evidence that changes in the ratios of polymers being incorporated in the capsule wall, such as from 50:50 to 45:55, would face the same uncertainty. Finally, Appellants contend that “the result effective variables for optimization are not as clearcut as the Examiner and the Board assert. Moreover, each of the Okajima Examples has a different composition and a different ratio of enteric to film-forming polymer.” (R’hrg. Req. 6.) We continue to agree with the Examiner that Okajima’s example compositions demonstrate that the polymer ratio can be varied, widely, with the reasonable expectation of retaining enteric properties. SUMMARY We deny the requested relief. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). DENIED lp