13979087 (P.T.A.B. Jul. 16, 2018)

Ex Parte Cade et al

Patent Trial and Appeal BoardJul 16, 2018

13979087 (P.T.A.B. Jul. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/979,087 07/10/2013 120501 7590 07/18/2018 Klarquist Sparkman, LLP (Capsugel) 121 SW Salmon Street, Suite 1600 Portland, OR 97204 FIRST NAMED INVENTOR Dominique Nicolas Cade 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 9156-93520-01 6318 EXAMINER BROWE, DAVID ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 07/18/2018 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 AS CChair@klarquis t. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte DOMINIQUE NICOLAS CADE and TAKAHISA TAKUBO Appeal2017-005348 Application 13/979,087 Technology Center 1600 Before JEFFREY N. FRED MAN, MICHAEL J. FITZPATRICK, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. Â§ 134(a) involving claims to a hard capsule shell. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. Statement of the Case Background "The present invention relates to new hard capsule shells and capsules comprising pullulan" (Spec. ,r 2). "One object of the present invention is ... new pullulan hard shells and capsules that . . . present improved characteristics in terms of shell mechanical properties" (Spec. ,r 10). 1 Appellants identify the Real Party in Interest as Capsugel Belgium NV (see App. Br. 3). Appeal2017-005348 Application 13/979,087 The Claims Claims 3-5, 7, 8, 11, and 18-21 are on appeal. 2 Claim 3 is representative and reads as follows: 3. A hard capsule shell comprising a setting system, and at least one pullulan, wherein the pullulan is substantially free of mono-, di-, and oligosaccharides, wherein the amount of mono-, di-, and oligosaccharides in the pullulan is less than 2.5% by weight of pullulan on a dry solid basis, and wherein the shell comprises between 65% and 99% of the pullulan by weight of the shell. The Issue The Examiner rejected claims 3-5, 7, 8, 11, and 18-21 under 35 U.S.C. Â§ I03(a) as obvious over Scott3 and Kato4 (Ans. 3). The Examiner finds that Scott discloses a "hard capsule shell comprising i) a setting system, ii) at least one pullulan, and iii) pharmaceutically or food acceptable surfactants, wherein the composition forms a film of uniform thickness of about 100 Âµm (i.e. less than about 250 Âµm)" (Ans. 3). The Examiner finds Scott discloses that "the pullulan employed is 'PI-20' (i.e. well known in the art to have an average molecular weight of 100-400 kDa), has a melt viscosity at 40-70Â°C of 100-2000 cPs, and is present in an amount of about 85-90 wt% of the hard capsule shell" (Ans. 3--4). The Examiner finds Scott does not "explicitly disclose that the pullulan comprises less than about 0.6% of mono-, di-, and oligosaccharides" (Ans. 4). 2 Claim 12 was withdrawn as nonelected (see App. Br. 13). 3 Scott et al., US 2005/0249676 Al, published Nov. 10, 2005. 4 Kato et al., US 4,004,977, issued Jan. 25, 1977. 2 Appeal2017-005348 Application 13/979,087 The Examiner finds Kato discloses that "pullulan obtained from typical commercial production processes contains impurities, such as mono-, di-, and oligosaccharides, as well as pigments" and that "impurity-free pullulan, containing less than 0.1 % of mono-, di-, and oligosaccharides, and that is colorless, can be obtained with ease on a mass production scale using only small amounts of select solvents" (Ans. 4). The Examiner finds: It is well known by anyone of ordinary skill in the art that mono-, di-, and oligosaccharides ( e.g. fructose, sucrose) serve as effective plasticizers (see Scott et al., Pgh. 0094). Since anyone of ordinary skill in the art would naturally want to employ impurity-free ingredients in pharmaceutical formulations, since Scott et al. disclose that for hard film formulations, such as hard capsule shells, the amount of plasticizer employed is zero or is minimized, because the presence of plasticizers facilitates flexibility (i.e. not hard or mechanically rigid) of the capsule film composition (Pghs. 0044, 0094), and since Kato et al. disclose that pullulan obtained from typical commercial production processes contains impurities, such as mono-, di-, and oligosaccharides, and that impurity-free pullulan, containing less than 0.1 % of mono-, di-, and oligosaccharides, can be obtained with ease on a mass production scale, one of ordinary skill in the art would be motivated to employ Kato et al.' s impurity-free pullulan comprising less than about 0.1 % (i.e. less than 0.6%) of mono-, di-, and oligosaccharides in Scott et al. 'shard capsule film composition, with the reasonable expectation that the resulting hard capsule shell will successfully exhibit the fullest possible degree of hardness (i.e. mechanical rigidity or toughness) (Ans. 4--5). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that Scott and Kato render the claims obvious? 3 Appeal2017-005348 Application 13/979,087 Findings of Fact 1. Scott discloses a "hard capsule shell" comprising "pullulan" and a "setting system" (Scott abstract, ,r 35). 2. Scott discloses that the shell comprises between 85-95% of pullulan by weight of the shell (Scott abstract). 3. Kato discloses a method of purifying pullulan that reduces residual sugars to below 2.6% and 0.6% by weight (Kato abstract, 3:42-50, 5:20- 35, Table II). Principles of Law A prima facie case for obviousness require "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Appellants contend a person of ordinary skill in the art looking to Scott ... would not even know: ( 1) to be concerned about pullulan at low moisture levels; (2) that pullulan had components causing deleterious effects at low moisture levels; or (3) that mono-, di-, and oligosaccharide components specific to pullulan were the cause of such deleterious effects. (App. Br. 5). Appellants contend the ordinary artisan "would not have any reason to expend additional effort and expenses needed to solve this unknown problem, and certainly would not have any expectation that there 4 Appeal2017-005348 Application 13/979,087 would be a benefit associated with expending the effort and expenses needed to solve the unrecognized problem" (App. Br. 9). The Examiner responds "anyone of ordinary skill in the art would naturally want to employ impurity-free ingredients in pharmaceutical formulations, such as a hard capsule shell. It is simply a universal standard to employ 'pharmaceutical grade', i.e. 'pure' or 'as pure as possible', ingredients in any pharmaceutical product" (Ans. 10). We agree with Appellant. While the reason to combine need not be found in the prior art, and implicit reasons that make a combination faster, cheaper, more durable or provide other benefits may provide basis for combining references, the Examiner provides neither a specific advantage due to using pullulan with reduced mono-, di-, or oligosaccharides nor an implicit benefit of such pullulan. See, e.g., DyStar Textilfarben GmbH & Co. v. CH Patrick Co., 464 F.3d 1356, 1366-68 (Fed. Cir. 2006). At best, the Examiner contends the ordinary artisan would implicitly recognize the absence of saccharides would give a "reasonable expectation that the resulting hard capsule shell will successfully exhibit the fullest possible degree of hardness (i.e. mechanical rigidity or toughness) without any unexpected side effect" (Ans. 5). However, the Examiner provides no evidence supporting the position that the absence of saccharide components would provide either the "fullest possible degree of hardness" or avoid "any unexpected side effect." Indeed, the evidence in the Cade 5 Declaration identifies "particular problems with brittleness" (Cade Deel. 6), suggesting that the fullest 5 Declaration of Dominique Nicolas Cade, dated Sept. 16, 2015. 5 Appeal2017-005348 Application 13/979,087 possible degree of hardness would have been undesirably brittle. Because plasticizers would, consistent with the Examiner's reasoning, have been expected to reduce rigidity and make the capsule softer and less brittle, there would be no reason to exclude such plasticizer components in the starting materials because such exclusion would have been expected to result in more brittle, rather than less brittle, capsule shells. Therefore, we conclude the Examiner has not provided a persuasive teaching, suggestion, or reason why the ordinary artisan would have select the purified pullulan of Kato for use in the hard capsule shells of Scott. Conclusion of Law The evidence of record does not support the Examiner's conclusion that Scott and Kato render the claims obvious. SUMMARY In summary, we reverse the rejection of claims 3-5, 7-8, 11, and 18- 21 under 35 U.S.C. Â§ 103(a) as obvious over Scott and Kato. REVERSED 6