Ex Parte Petereit et alDownload PDFPatent Trial and Appeal BoardJul 19, 201612678429 (P.T.A.B. Jul. 19, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/678,429 05/07/2010 Hans-Ulrich Petereit 22850 7590 07/21/2016 OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P. 1940 DUKE STREET ALEXANDRIA, VA 22314 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. 354909USOPCT 8386 EXAMINER CHICKOS, SARAH J ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 07/21/2016 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): patentdocket@oblon.com oblonpat@oblon.com ahudgens@oblon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HANS-ULRICH PETEREIT, HEMA RA VISHANKAR, and ASHWINI SAMEL 1 Appeal2014-000428 Application 12/678,429 Technology Center 1600 Before ERIC B. GRIMES, ULRIKE W. JENKS, and TIMOTHY G. MAJORS, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a pH-dependent controlled release pharmaceutical. The Examiner rejects the claims as obvious and, provisionally, on the grounds of non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm the double patenting rejections. 1 According to Appellants, the Real Party in Interest is Evonik Degussa GmbH. (App. Br. 1.) Appeal2014-000428 Application 12/678,429 STATEMENT OF THE CASE The Specification explains that "[a] problem exists in that the ... release of active compound can be altered by the general living habits, thoughtlessness or by addictive behaviour [sic] of the patients with respect to the use of ethanol or ethanol-containing drinks" (Spec. 11: 30-34). "Ethanol resistant pharmaceutical formulations are formulations with release kinetics not significantly affected in the presence of ethanol" (Spec. 11: 3--4). Claims 1-7, 9-14, and 18 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. A pH-dependent controlled release pharmaceutical composition, comprising a core, comprising at least one pharmaceutical active ingredient, with the exception of opioids, wherein the core is coated by at least one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95 % by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and ii) 5---60 % by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, wherein the coating layer further comprises 110 to 250 % by weight, calculated on dry weight of the polymer mixture, of a non-porous inert lubricant and the coating layer is present in an amount of at least 60 % by weight calculated on the weight of core, and wherein, under in-vitro conditions according to USP paddle, 100 rpm, buffered at pH 6.8 in a medium with and without the addition of 40 % (v/v) ethanol: 2 Appeal2014-000428 Application 12/678,429 when the pharmaceutical active ingredient is released to a degree of less than 20 %, the difference in the release rate with the addition of 40 % (v/v) ethanol is not more than plus or minus 15 % of the corresponding release value without 40 % (v/v) ethanol, and when the pharmaceutical active ingredient is released to a degree of 20-80 %, the difference in the release rate with the addition of 40 % (v/v) ethanol is not more than plus or minus 30 % of the corresponding release value without 40 % (v/v) ethanol. (App. Br. Claims Appendix.) Appellants seek review of the following rejections: A. claims 1-7 and 10-14 under 35 U.S.C. § 103(a) as unpatentable over Chen2 in view of Cicero3; B. claim 9 under 35 U.S.C. § 103(a) as unpatentable over Chen in view of Cicero and further in view ofBaichwal '361 4 ; C. claims 1-14, provisionally, on the ground of nonstatutory obviousness-type double patenting over claims 1-14 of copending U.S. Application No. 12/678,406 in view of Cicero and Baichwal '361; D. claims 1-14, provisionally, on the ground of nonstatutory obviousness-type double patenting over claims 1-37 of copending U.S. Application No. 13/203,760 in view of Chen, Cicero, and Baichwal '361;5 2 Chen et al., US 2003/0077297 Al, published Apr. 24, 2003 ("Chen"). 3 Cicero et al., Trends in Abuse of OxyContin® and Other Opioid Analgesics in the United States: 2002-2004, 6 J. Pain 662----672 (2005) ("Cicero"). 4 Baichwal et al., US 2003/0228361 Al, published Dec. 11, 2003 ("Baichwal '361"). 5 According to USPTO records, the '760 application went abandoned on July 14, 2016, so this ground of rejection is moot. 3 Appeal2014-000428 Application 12/678,429 E. claims 1-14, provisionally, on the ground of nonstatutory obviousness-type double patenting over claims 1-32 and 35 of copending U.S. Application No. 13/256,694 in view of Chen, Cicero, and Baichwal '361 · ' F. claims 1-14, provisionally, on the ground of nonstatutory obviousness-type double patenting over claims 1-21 of copending U.S. Application No. 13/120,112 in view Baichwal '361; G. claims 1-14, provisionally, on the ground of nonstatutory obviousness-type double patenting over claims 1-21 of copending U.S. Application No. 13/062,591 in view of Cicero and Baichwal '361; and H. claims 1 and 18 under 35 U.S.C. § 103(a) as unpatentable over Chen in view of Baichwal '635 6 and Cicero. A. Obviousness over Chen in view of Cicero The Examiner finds that Chen produces delayed release pharmaceutical compositions containing the claimed components and relies on Cicero to disclose the need to develop compositions that are resistant to abuse potential (see Final Act. 4--8; Ans. 3-9). The Examiner further finds that "[t]he release profile necessarily follows from the structure of the polymer blend as evidenced by the Example 7 results in the table on page 44 of the specification. This particular polymer blend with its particular make up of polymers necessarily will have the recited release profile, as the specification demonstrates" (Ans. 5). The Examiner concludes that "a prima facie case of obviousness exists because Chen discloses a pharmaceutical 6 Baichwal et al., US 2003/0091635 Al, published May 15, 2003 ("Baichwal '635"). 4 Appeal2014-000428 Application 12/678,429 composition that has a core of opioid active ingredient, oxycodone, covered by a coating of a polymer blend of Eudragit S and polyvinyl acetate phthallate [sic] along with talc" (Ans. 4). Appellants contend that Chen "neither discloses nor suggests the combination of two different polymers each having different properties as a coating layer for a delayed release formulation such as theirs, nor the particular problem to which the present invention is directed, i.e., susceptibility to the influence of ethanol on the release of an active compound, as discussed above" (App. Br. 5---6; see also Reply Br. 2 ("neither [reference] discloses nor suggests the particular combination of i) a water insoluble essentially neutral vinyl polymer or copolymer, and ii) an anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, as required by the present claims")). The issue is: Does the evidence of record support the Examiner's conclusion that the combination of references teaches a composition with a drug release profile as presently claimed? Findings of Fact FF 1. Chen teaches the desire for making pharmaceutical formulations with a "reduced impact of food on drug absorption" (Chen i-f 11 ). Chen teaches the production of delayed release formulations for release of the active in the lower intestinal tract more distal to that which would have been accomplished if there had been no delayed release feature. The preferred method for delay of release is coating. Such coatings should be applied at a sufficient thickness such that the entire coating does not dissolve in the gastrointestinal 5 Appeal2014-000428 Application 12/678,429 fluids at pH below about 5, but does dissolve at pH about 5 and above. (Chen iT 301.) FF2. Chen teaches the use of acrylic polymers such as "[t]he Eudragit® series E, L, S, RL, RS, and NE .... The Eudragit® series L, L-30D, and S are insoluble in the stomach and dissolve in the intestine" (Chen iT 303). FF3. Chen teaches that "[p]referred coating materials include shellac, acrylic polymers, cellulosic derivatives, polyvinyl acetate phthalate, and mixtures thereof More preferred materials include Eudragit series E, L, S, RL, RS, NE, L, L300, S, and 100-55, cellulose acetate phthalate" (Chen iT 309 (emphasis added)). FF4. Chen teaches: Eudragit Sis insoluble at pH below 5.5, but unlike Eudragit L- 30-D, is poorly soluble in gastrointestinal fluids having pH of 5. 5-7. 0, such as is present in the small intestine fluids. This copolymer is soluble at pH 7.0 and above (i.e., the pH generally found in the colon). Eudragit Scan be used alone as a coating to provide delivery beginning at the large intestine via a delayed release mechanism. In addition, Eudragit S, being poorly soluble in intestinal fluids below pH 7, can be used in combination with Eudragit L-30-D, which is soluble in intestinal fluids above pH 5.5, in order to effect a delayed release composition. The more Eudragit L-30 D used, the more proximal the release and delivery begins, and the more Eudragit S used, the more distal the release and delivery begins[. ] Both Eudragit L-30-D and Eudragit Scan be substituted with other pharmaceutically acceptable polymers that have similar pH solubility characteristics. (Chen iT 308). 6 Appeal2014-000428 Application 12/678,429 FF5. Chen teaches that the coatings usually "contain a plasticizer and possibly other coating excipients such as colorants, talc, and/or magnesium stearate, which are well known in the art." (Chen i-f 305). FF6. Cicero teaches OxyContin abuse is a pervasive problem in this country, but [] it needs to be considered in the context of a general pattern of increasing prescription drug abuse. . . . Steps need to be taken to reduce prescription drug abuse, but very great care needs to be exercised in the nature of these actions so the legitimate and appropriate use of these drugs in the treatment of pain is not compromised as a result. (Cicero Abstract.) Principle of Law "An examiner bears the initial burden of presenting a prima facie case of obviousness." In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011 ). In satisfying this initial burden, "[i]t is impermissible to use the claimed invention as an instruction manual or 'template' to piece together the teachings of the prior art so that the claimed invention is rendered obvious." In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). Stated differently, to establish obviousness, there must be "an apparent reason to combine the known elements in the fashion" recited in the claims. KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Appellants contend that merely identifying the individual elements in Chen is not sufficient to arrive at the claimed pharmaceutical composition with a coating having a mixture of polymers to achieve a particular drug release profile under in-vitro conditions (see Reply Br. 2; see also App. Br. 5 (Chen "contains an 'omnibus' or 'kitchen sink'-type disclosure of delivery 7 Appeal2014-000428 Application 12/678,429 systems and components thereof"). However, Appellants contend that the Examiner "ignored" the following claim limitation: when the pharmaceutical active ingredient is released to a degree of less than 20 %, the difference in the release rate with the addition of 40 % (v/v) ethanol is not more than plus or minus 15 % of the corresponding release value without 40 % (v/v) ethanol, and when the pharmaceutical active ingredient is released to a degree of 20-80 %, the difference in the release rate with the addition of 40 % (v/v) ethanol is not more than plus or minus 30 % of the corresponding release value without 40 % (v/v) ethanol. (App. Br. 7.) The Examiner finds that the claims do not recite the problem with respect to ethanol susceptibility for release in the presence of alcohol (see Ans. 6 ("there is no recitation of the problem in the claims and this recognition is not required by the language of the claims")). The Examiner finds that "the amounts of the polymers and talc in the coating are results- effective variables, the determination of the optimum ranges of their amounts would be no more than routine experimentation" (Final Act. 6). On the record before us, we find that Appellants have the better position. We do not agree with the Examiner's interpretation that claim 1 does not require measuring the release of the active compound in the presence or absence of ethanol (Ans. 6). We agree with Appellants that the in-vitro conditions and release characteristics as recited in claim 1 describe ethanol resistance as defined in the Specification (Spec. 11: 10-15). Accordingly, claim 1 requires a coating layer made up of a polymer mixture and an inert lubricant, and the coating layer is applied to a core containing the active. The claim additionally requires that the pharmaceutical 8 Appeal2014-000428 Application 12/678,429 formulation exhibit the characteristics claimed when tested under conditions with or without ethanol and the difference in release profiles of the active agent is less than either 15% or 30 % depending on how much of the active agent has already leached out of the product. Chen discloses the production of delayed release formulations (FF 1) and even suggests that food does not affect the drug absorption or release from the formulation (FF 1 ). The Examiner finds, and Appellants do not contest, that Chen teaches the individual components of the claimed composition (FF1-FF5; Reply Br. 2). Chen even encourages the use of formulations that release the active only when the gastrointestinal fluids are above pH 5; in other words once the pharmaceutical hits the colon (FF 1 and FF4). Additionally, the Examiner identified polyvinyl acetate phthalate as a composition that meets the requirement of a "water insoluble essentially neutral vinyl polymer or copolymer" (Final Act. 4 ("[p ]olyvinyl acetate phthalate is a water insoluble essentially neutral vinyl polymer")), and Chen even suggests that the coating materials can contain a mixture of acrylic polymers and polyvinyl acetate phthalate (FF3). The Examiner finds that "Cicero teaches that opioid analgesic abuse has reached national epidemic proportions and there is a need to take steps to prevent it" (Ans. 7). Although we agree with the Examiner that Cicero does teach that drug abuse is a problem and developing ways of preventing abuse are necessary (FF6), however, we find that Cicero does not teach any solution to achieve this desired result. Cicero also does not direct us to a particular drug release profile, let alone a drug release profile in the presence or absence of ethanol. We recognize that Chen desires to produce drug formulations that are not affected by food, and Chen achieves this by 9 Appeal2014-000428 Application 12/678,429 disclosing delayed release formulations that would not dissolve until the formulation is in an environment above pH 5 (FFl and FF4). However, merely suggesting formulations that release the active ingredient in the colon does not provide sufficient insight into how such formulations will behave in the presence of ethanol. Thus, neither Chen nor Cicero direct us to the problem of formulating a composition to have a particular release profile in the presence or absence of alcohol. We understand the Examiner's position is that the amounts of the polymers as recited in the claims "is a results-effective variable" and formulating a coating would thereby be obvious (Final Act. 5). Although we agree with the Examiner's general position that once you know the end result you are trying to achieve, in this case a particular release profile of the active in the presence and absence of ethanol, the ordinarily skilled artisan would know how to formulate such a coating based on the teachings of Chen. What is missing, however, from the Examiner's rejection is some articulated rationale that explains why one of ordinary skill would want to achieve the particular drug release profile recited in the claims. In other words, it is not clear based on the references and the Examiner's reasoning that one of ordinary skill would have recognized that a formulation that is resistant to abuse would need to encompass the particular release rate in the presence of ethanol as claimed. A rejection for obviousness must include "articulated reasoning with some rational underpinning to support the legal conclusion." KSR, 550 U.S. at 418, quoting In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006). We conclude that the preponderance of the evidence of record does not support the Examiner's conclusion that the combination of Chen and 10 Appeal2014-000428 Application 12/678,429 Cicero teaches a pH-dependent pharmaceutical formulation as recited in claim 1. Accordingly, we reverse the rejection of claims 1-7 and 10-14 under 35 U.S.C. § 103(a) that rely on the teachings of Chen and Cicero. B. Obviousness over Chen, Cicero, and Baichwal '361 Claim 9 depends from claim 1 and further recites that the pharmaceutical active ingredient is metoprolol. The rejection of claim 9 relies upon the underlying obviousness rejection over Chen and Cicero. Having reversed the rejection of claim 1 based on the combination of Chen and Cicero (see A. above), we necessarily reverse this obviousness rejection further including Baichwal '361, since Baichwal '361 is not relied upon to teach a "coating layer" that is resistant to ethanol as required by claim 1. Accordingly, we reverse the rejection of claim 9 that relies on the combination of Chen, Cicero, and Baichwal '361. C. Obviousness-Type Double Patenting over '406 The issue is: Does the evidence of record support the Examiner's conclusion that the claims on appeal and the claims of the '406 application are not patentably distinct? Findings of Fact FF7. Claim 1 of the '406 application recites: A pH-dependent controlled release pharmaceutical composition, comprising a core, comprising at least one pharmaceutical active ingredient, which is an opioid, wherein the core is coated by at least one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of 11 Appeal2014-000428 Application 12/678,429 i) 40 - 95 % by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and ii) 5 - 60 % by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, wherein the coating layer further comprises 110 to 250 % by weight, calculated on dry weight of the polymer mixture, of a non-porous inert lubricant and the coating layer is present in an amount of at least 60 % by weight calculated on the weight of core, and wherein, under in-vitro conditions according to USP paddle, 100 rpm, buffered at pH 6.8 in a medium with and without the addition of 40 % (v/v) ethanol: when the pharmaceutical active ingredient is released to a degree of less than 20 % without the addition of 40 % (v/v) ethanol, the difference in the release rate with the addition of 40 % (v/v) ethanol is not more than plus or minus 15 % of the corresponding release value without 40 % (v/v) ethanol, and when the pharmaceutical active ingredient is released to a degree of20 - 80 % without the addition of 40 % (v/v) ethanol, the difference in the release rate with the addition of 40 % (v/v) ethanol is not more than plus or minus 30 % of the corresponding release value without 40 % (v/v) ethanol. (Reply filed May 24, 2013 in the '406 application (emphasis added).) Principles of Law Obviousness-type double patenting is a judge-made doctrine that prevents an extension of the patent right beyond the statutory time limit. ... Its purpose is to prevent an unjustified extension of the term of the right to exclude granted by a patent 12 Appeal2014-000428 Application 12/678,429 by allowing a second patent claiming an obvious variant of the same invention to issue to the same owner later. In re Berg, 140 F.3d 1428, 1431 (Fed. Cir. 1998) (citation omitted). "Because nonstatutory double patenting compares earlier and later claims, an earlier patent's disclosure is not available to show nonstatutory double patenting. Of course, the earlier patent's disclosure may register on the patentability scale if that patent qualifies as prior art under 35 U.S.C. § 102." Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385 (Fed. Cir. 2003) (citation omitted). Analysis Appellants contend that "[ w ]ithout the present disclosure as a guide, one of ordinary skill in the art would not have substituted the opioid of the '406 application with a non-opioid" (App. Br. 8). As explained by the Examiner, the claims of the '406 application "differ from those of the instant application because they are directed to an opioid containing core," however, this deficiency is rectified by the teachings of Cicero and Baichwal '361 (Ans. 11). Specifically, Baichwal '3 61 teaches a need "to provide a sustained release oral dosage form that provides for the sustained release of metoprolol tartrate suitable for once-a-day administration" (Baichwal '361 i-f 16). Baichwal '361 states that "the coating layer may comprise an enteric coating material" (Baichwal '361 i-f 106). "Metoprolol is a beta1-selective ( cardioselective) adrenoceptor blocking agent. It reduces oxygen demand of the heart, slowing the heart rate and reducing cardiac output at rest and upon exercise; reduces systolic blood pressure; and can also be used in the treatment of migraine or cluster headache, among other things" (Baichwal '361 i-f 65). Metoprolol is a beta 13 Appeal2014-000428 Application 12/678,429 blocker and not an opioid. We find no error with the Examiner's rationale that it would have been obvious to formulate metoprolol into a pH- dependent controlled release pharmaceutical as claimed because Baichwal '3 61 already suggests the need of producing a sustained release formulation. We affirm the rejection. The Examiner has provided a reasoned basis for concluding that the claims on appeal here are not patentably distinct from those of the '406 application, and Appellants have provided no reasoned basis for concluding otherwise. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) ("After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument."). E.-G. Obviousness-Type Double Patenting With respect to the obviousness-type double patenting rejections of claims 1-14 of the present application based on the claims in copending applications '694, '112, and '591, Appellants request that these rejections be withdrawn because the present application is the earlier-filed application. MPEP 804 (I)(B)(l) provides: If a "provisional" nonstatutory double patenting rejection is the only rejection remaining in an application having the earliest effective U.S. filing date (including any benefit claimed under 35 U.S.C. 120, 121, 365(c), or 386(c)) compared to the reference application( s ), the examiner should withdraw the rejection in the application having the earliest effective U.S. filing date and permit that application to issue as a patent, thereby converting the "provisional" nonstatutory double patenting rejection in the other application(s) into a 14 Appeal2014-000428 Application 12/678,429 nonstatutory double patenting rejection when the application with the earliest U.S. effective filing date issues as a patent. We agree with the Examiner's position that according to the MPEP it is appropriate to maintain the "provisional" double patenting rejections until such a time that these "provisional" rejections are the only rejections remaining (Ans. 13). We note that at this time, the provisional double patenting rejections over copending applications'694, '112, and '591 are not the only rejections remaining in this application (see section C. above), therefore, it remains appropriate to maintain these rejections. H. Obviousness over Chen, Baichwal '635, and Cicero The Examiner finds that "Chen teaches a core covered by a coating of a polymer blend of Eudragit S and polyvinyl acetate phthallate [sic] along with talc" (Final Act. 28). The Examiner acknowledges that "Chen does not teach methyl acrylate," however, "[t]hese deficiencies are made up for with the teachings of Baichwal et al. and Cicero" (Final Act. 28). Baichwal '635 provides a "sustained release coating [that] contains methyl acrylate" (Final Act. 29). The Examiner's position is that "[w]ith respect to the release properties under in-vitro conditions according to USP claimed in claim 1, the composition taught by Chen is the same as the claimed composition, thus the composition taught by Chen would necessarily possess the release profile recited in claim 1" (Final Act. 30). Appellants contend that "Baichwal et al '63 5 does not remedy the deficiencies in the combination of Chen et al and Cicero et al, since Baichwal et al '63 5 evidences no advantage in the use of any of their six 15 Appeal2014-000428 Application 12/678,429 delivery systems, [and] does not recognize the problem to which the present invention is addressed" (App. Br. 11 ). The Examiner is relying on Chen for the same reasons as discussed above (see A.), and takes the position that a composition and all of its properties are inseparable (Final Act. 30 ("[w]ith respect to the release properties under in-vitro conditions according to USP claimed in claim 1, the composition taught by Chen is the same as the claimed composition, thus the composition taught by Chen would necessarily possess the release profile recited in claim 1 ").) The problem with this rationale is that the Examiner has not identified in Chen or the other references a composition that falls within the claims containing the polymer mixture and talc. The Examiner's position is that Chen discloses all the components as claimed and even suggests mixtures thereof (see FF1-FF5). Merely suggesting mixtures is not sufficient. What is missing from the Examiner's rejection is an articulated rationale that explains why one would combine the components within the ranges as claimed. In other words, it is not clear based on the references and the Examiner's reasoning that one of ordinary skill would have recognized a need to formulate a composition with the drug release rate as claimed. A rejection for obviousness must include "articulated reasoning with some rational underpinning to support the legal conclusion." KSR, 550 U.S. at 418, quoting Kahn, 441 F.3d at 988. Merely identifying that the individual components of Chen could be adjusted to fall within the claimed range and that they could even contain mixtures of the components is not sufficient to explain why they should be formulated to fall within the claimed ranges. Chen does not disclose a single composition that meets the requirements of the coating with the polymer mixture and 16 Appeal2014-000428 Application 12/678,429 lubricant as claimed, thus, the Examiner's argument that chemical compounds cannot have mutually exclusive properties is not persuasive. Neither Chen nor the other references explain why the ordinary artisan would want to have a pharmaceutical release profile as recited in the claims. Without this knowledge, the ordinary artisan would not have a drug release profile goal toward which to formulate the composition and without such a goal it would not have been obvious to make the adjustments of the varying components to arrive at the claimed composition. We conclude that the preponderance of the evidence of record does not support the Examiner's conclusion that the combination of Chen, Baichwal '635, and Cicero teaches a pH-dependent pharmaceutical formulation as recited in claim 1 and dependent claims thereto. We thus reverse the rejections under 35 U.S.C. § 103(a) that rely on the teachings of Chen and Cicero. SUMMARY We reverse the rejection of claims 1-7 and 10-14 under 35 U.S.C. § 103(a) over Chen in view of Cicero. We reverse the rejection of claim 9 under 35 U.S.C. § 103(a) over Chen in view of Cicero and further in view ofBaichwal '361. We affirm the provisional rejection of claims 1-14 on the ground of nonstatutory obviousness-type double patenting over claims 1-14 of the '406 application. The provisional rejection of claims 1-14 on the ground of nonstatutory obviousness-type double patenting over claims 1-37 of the '7 60 application is moot. 17 Appeal2014-000428 Application 12/678,429 We atlirm the provisional rejection of claims 1-14 on the ground of nonstatutory obviousness-type double patenting over claims 1-32 and 35 of the '694 application. We affirm the provisional rejection of claims 1-14 on the ground of nonstatutory obviousness-type double patenting over claims 1-21 of the '112 application. We affirm the provisional rejection of claims 1-14 on the ground of nonstatutory obviousness-type double patenting over claims 1-21 of the '591 application. We reverse the rejection of claims 1and18 under 35 U.S.C. § 103(a) as over Chen in view ofBaichwal '635 and Cicero. TIME PERIOD FOR RESPONSE 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-IN-PART 18 Copy with citationCopy as parenthetical citation