Johnson & Johnson Consumer Inc.

Patent Trials and Appeals BoardMay 3, 2021

2020004358 (P.T.A.B. May. 3, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/832,394 03/15/2013 Der-Yang Lee MCP5229USNP 7533 27777 7590 05/03/2021 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 EXAMINER GOTFREDSON, GAREN ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 05/03/2021 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pair_jnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DER-YANG LEE and SHUN POR LI Appeal 2020-004358 Application 13/832,394 Technology Center 1600 Before RACHEL H. TOWNSEND, DEVON ZASTROW NEWMAN, and MICHAEL A. VALEK, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims to a pharmaceutical formulation as failing to comply with the written description requirement, as being obvious, and for non-statutory double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Johnson & Johnson Consumer Inc. (Appeal Br. 2.) Appeal 2020-004358 Application 13/832,394 2 STATEMENT OF THE CASE Phenylephrine is an over-the-counter oral nasal decongestant and is widely used for the temporary relief of nasal congestion. (Spec. 1.) It is available in immediate release formulation as 10 mg tablets, and the dosing regimen is one tablet every four hours, not to exceed 60 mg in 24 hours. (Id. at 1–2.) According to Appellant’s Specification, “[l]ess frequent administration [of a medication] results in improved patient compliance.” (Id. at 4.) Appellant’s Specification also notes that “constant therapeutic plasma levels of active components can be more effective and even efficacious compared to the fluctuations seen when multiple doses of a conventional immediate release formulation are given.” (Id.) Appellant’s invention is directed at a sustained release formulation of phenylephrine. Claims 1–3, 8, and 18–27 are on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A pharmaceutical formulation, wherein said pharmaceutical formulation comprises two or more extended release particles, wherein said two or more extended release particles each comprise phenylephrine and a cation polystyrene sulfonate complex, wherein at least 90% of said cation polystyrene sulfonate comprises particle sizes of about 74 μm to about 177 μm prior to being combined with the phenylephrine, wherein said phenylephrine and cation polystyrene sulfonate complex is coated with a coating, wherein said two or more phenylephrine and cation polystyrene sulfonate complexes are not variably coated at different levels of coating and thus achieve a coating level, wherein the amount of the coating level as compared to the coated drug-resin complex is from 30% to 45% by weight, Appeal 2020-004358 Application 13/832,394 3 wherein the coating consists of cellulose acetate and hydroxypropylcellulose, wherein the coating consists of from 67% to 83% by weight cellulose acetate, wherein said extended release particles exhibit bioavailability for at least about 8 hours upon administration, wherein serum concentration of the extended release particles exhibit intersubject variability within the range depicted in Figure 2 upon administration to two or more subjects, and wherein the serum concentration of the extended release particles exhibit a second peak at about 12 hours after administration in said subjects. (Appeal Br. 16 (paragraphing added).) REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Challapalli US 2005/0112198 A1 May 26, 2005 Hall US 2007/0148239 A1 June 28, 2007 Pilgaonkar US 2013/0230587 A1 Sept. 5, 2013 REJECTIONS The following rejections made by the Examiner are before us on appeal:2 Claims 1–3, 8, and 18–27 are rejected under 35 U.S.C. § 112 (pre- AIA), first paragraph, as failing to comply with the written description requirement. 2 The Examiner’s rejection of the claims under 35 U.S.C. § 112, second paragraph made in the Final Action was withdrawn in the Answer. (Ans. 3.) Appeal 2020-004358 Application 13/832,394 4 Claims 1–3, 8, 18–21, and 23–27 are rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Pilgaonkar and Challapalli. Claim 22 is rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Pilgaonkar, Challapalli, and Hall. Claims 1–3, 8, and 18–27 on the ground of non-statutory obviousness- type double patenting as being unpatentable over the claims of copending Application No. 13/832,694 and Pilgaonkar. Claims 1–3, 8, and 18–27 on the ground of non-statutory obviousness- type double patenting as being unpatentable over the claims of copending Application No. 14/966,079 and Pilgaonkar or Hall. DISCUSSION I. Written Description The Examiner finds that the following negative limitation of claim 1, which was added during prosecution, “said two or more phenylephrine and cation polystyrene sulfonate complexes are not variably coated at different levels of coating,” is not supported by the Specification. (Final Action 3; Ans. 3.) We disagree with the Examiner’s finding. As Appellant points out (Appeal Br. 8), the Specification states that the coating applied to the resinate particles “can be layered” and “added in succession until the desired coating level is achieved.” (Spec. 16.) In other words, Appellant describes a manner by which multiple resinate particles can be coated to achieve a specific coating level. Moreover, the Specification describes coated resinate particles having a 35% coating level and a 40% coating level that underwent dissolution analysis. (Spec. 33–35 (Example 4 (Tables 10A and Table 10B)); Appeal Appeal 2020-004358 Application 13/832,394 5 Br. 7–8.) The Examiner agrees that the 35% coating level and a 40% coating level are “embodiments show[ing] phenylephrine resinate particles that have been coated to a coated level as described at paragraph 70.” (Ans. 4.) We agree that the Specification sufficiently describes resinate particles that are coated with the same level of coating at either 35% coating level or 40% coating level. We note that another way to state “are not variably coated at different levels of coating” is that the resinate complexes are coated to the same level of coating. And, the Specification describes two batches of particles each of which are not variably coated at different levels. Thus, contrary to the Examiner’s suggestion (Final Action 3), we are not presented with a Specification that is missing a “positive” disclosure upon which an exclusionary recitation cannot be based. The Examiner’s position that Appellant’s claim can be interpreted to encompass formulations where the only resin particles present have the same level of coating or where some of the particles are coated to one level, e.g. 35%, while others are coated to another level, e.g., 40% (Ans. 4) notwithstanding, we find that the “negative” limitation, which can be interpreted as the “two or more phenylephrine and cation polystyrene sulfonate complexes” being coated to the same level of coating, has a basis in the original disclosure. Consequently we reverse the Examiner’s rejection of claims 1–3, 8, and 18–27 under 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. II. Obviousness To address this dispute, we must first consider claim construction. The Examiner finds that that claim 1’s requirement that the formulation Appeal 2020-004358 Application 13/832,394 6 “comprises two or more extended release particles” where the “two or more extended release particles each comprise phenylephrine and a cation polystyrene sulfonate complex” and the “two or more phenylephrine and cation polystyrene sulfonate complexes are not variably coated at different levels of coating” is met by a composition that includes one set of phenylephrine and cation polystyrene sulfonate complexes that have the same level of coating even if that composition also comprises other phenylephrine and cation polystyrene sulfonate complexes that have a different level of coating from the first set. (Ans. 5.) Appellant does not dispute the foregoing claim interpretation and we agree with the Examiner that the claim language allows for such formulation. That is because “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). As the Examiner recognized, so long as the formulation includes a first set of two or more extended release particles that have the same level of coating of cellulose acetate and hydroxypropylcellulose, the claim does not exclude a second set of release particles having a level of coating that differs from the first set. Given the foregoing construction, we agree with the Examiner that Pilgaonkar’s teaching that the drug-resin complexes are variably coated at different levels of barrier coating does not preclude the reference from teaching or suggesting a composition that meets the limitations of claim 1. As the Examiner explains, and Appellant does not dispute, “Pilgaonkar expressly teaches that the composition comprises ‘at least two variably coated populations’ of drug-resin complexes, wherein the first population is Appeal 2020-004358 Application 13/832,394 7 variably coated from the second population (paragraph 42).” (Ans. 5.) In other words, Appellant does not dispute that Pilgaonkar teaches a first set of coated drug-resin complexes having one level of coating, which level varies from the second population, but the particles of the first set do not have a varying coating level from each other. Consequently, we do not find Appellant’s arguments regarding Pilgaonkar teaching away from the claimed composition because it teaches formulations having more than one set of drug-resin complexes that are variably coated at different levels of barrier coating of release modifier (Appeal Br. 11–12) persuasive of non- obviousness. As the Examiner also found (Final Action 5), Pilgaonkar teaches that the drug of the drug-resin complex can be phenylephrine (Pilgaonkar ¶ 15) and that the resin can be Amberlite® IRP693 (Id. ¶ 24), the latter of which is disclosed in Appellant’s Specification as being a resin that “may be used in accordance with the invention” (Spec. 14). The Examiner further finds that Pilgaonkar teaches the drug-resin complex may be coated with release modifiers that may comprise those recited in claim 1 (Final Action 54; Ans. 3 The Examiner relies on Challapalli for its express disclosure that Amberlite® IRP69 possesses particle sizes of 47–149 microns, (Final Action 7), which includes particles within the claimed range of about 74 to about 177 microns. 4 The Examiner identifies cellulose acetate and hydroxypropylmethylcellulose (Final Action 5 (citing Pilgaonkar ¶¶ 36 and 38)) rather than cellulose acetate and hydroxypropylcellulose in the Final Action, as recited in claim 1. However, we find this to be an inadvertent error, recognized by Appellant (Appeal Br. 13 (“Pilgaonkar, which only includes (1) phenylephrine, (2) cellulose acetate and (3) hydroxypropylcellulose in laundry lists”).) Indeed, Pilgaonkar recognizes cellulose acetate as a “[s]uitable polymeric water-insoluble Appeal 2020-004358 Application 13/832,394 8 6–7). (See Pilgaonkar ¶ 36 (listing water insoluble release modifiers including cellulose acetate), id. ¶ 38 (listing water soluble release modifiers including hydroxypropylcellulose).) Moreover, as the Examiner finds (Final Action 7) Pilgaonkar teaches that a combination of more than one release modifier may be used in combination. (Pilgaonkar ¶ 35.) In addition, as the Examiner finds, Pilgaonkar teaches “[t]he coated drug-resin complex may comprise 1–75% by weight of the coating (paragraph 42).” (Final Action 5.) And, as the Examiner finds, “Pilgaonkar expressly discloses coating the drug resin complexes with the release modifier at varying levels, and selecting particular proportions of the variably coated complexes in order to obtain a desired bioavailability (see paragraph 10).” (Id.; see also Pilgaonkar ¶ 42 (“Optimum coat weight and coat thickness may be determined”).) Appellant does not dispute that the claimed active agent and release modifiers are disclosed by Pilgaonkar. (Appeal Br. 13.) Appellant, however, contends that because Pilgaonkar includes a laundry list of release modifiers that can be used as coatings, as well as a laundry list of active agents, and does not disclose an example in which phenylephrine is administered, that it “does not provide any guidance that would lead one skilled in the art to the claimed invention.” (Id.) Moreover, Appellant argues that Pilgaonkar “recognized” that sustained release was difficult to achieve (Id. (citing Pilgaonkar ¶ 5).) release modifier” (Pilgaonkar ¶36) and hydroxypropylmethylcellulose and hydroxypropylcellulose as “[s]uitable water soluble release modifiers” (Id. ¶ 38). And the Examiner noted in the Answer that Pilgaonkar teaches cellulose acetate and hydroxypropylcellulose as examples of release modifiers that may be used as coatings. (Ans. 6–7.) Appeal 2020-004358 Application 13/832,394 9 We do not find these arguments persuasive. First, as the Examiner explained, Pilgaonkar’s recognition of the difficulty of achieving sustained release was not a conclusion with respect to the coated compositions it describes as achieving better sustained release properties, but rather with regard to “uncoated drug-resin complexes.” (Ans. 5.) Furthermore, the guidance of Pilgaonkar is that a number of active agents may be complexed with a cation exchange resin that is coated with at least one release modifier to provide sustained release compositions for up to 12 or 24 hour release5 for treatment or management of cold and/or flu like symptoms. (See, e.g., Pilgaonkar ¶ 54–55.) Phenylephrine is a well-known active agent for treatment of congestion (Id. ¶ 15) and congestion is a well-known symptom associated with cold and/or flu. Consequently, we disagree that Pilgaonkar does not guide one of ordinary skill in the art to select phenylephrine as the active agent. 5 We do not find Appellant’s argument that Pilgaonkar “only shows dissolution for dextromethorphan within T=0 to 6 hours” (Appeal Br. 11 (citing Pilgaonkar ¶¶ 65–66)) persuasive of non-obvious of the claimed composition. Even as to dextromethorphan, Pilgaonkar does not teach that drug release was complete at 6 hours. Notably, in none of the compositions tested was 100% of the drug released by 6 hours. The experiment simply evaluated various compositions over a six hour period to determine whether a formulation released the active from the complex satisfactorily over six hours, as compared to excessively retaining the active agent in the complex or releasing the agent too quickly in a six hour period. (Pilgaonkar ¶¶ 65–66 (concluding that composition C release “is neither too retarded nor too fast.”).) Thus, the experiment does not even demonstrate that dissolution only occurs up to 6 hours. And Pilgaonkar, in fact, teaches that it is desirable to provide sustained release of an anti-tussive, which dextromethorphan is (Pilgaonkar ¶ 15), for about 6 to about 24 hours (Id. ¶ 55). Appeal 2020-004358 Application 13/832,394 10 Moreover, regarding the choice of release modifiers, “[r]eading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put into the last opening in a jig- saw puzzle. It is not invention.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945); see also Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Furthermore, as a general rule, “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art [and obvious.]” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Accordingly, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Applied Materials, Inc., 692 F.3d 1289, 1295–96 (Fed. Cir. 2012) quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955). The motivation to optimize comes from the natural desire of those skilled in the art to experiment with, and improve upon, known conditions taught in the prior art. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). Here, Pilgaonkar recognizes that the selection of resins to use with an active agent is a result effective variable dependent on the active agent and the desired drug release characteristics, as is the coat weight and coating level to use. As the Examiner found (Ans. 7), Pilgaonkar teaches that the level of the coating (e.g., coat thickness) as well as the coat weight can be optimized “for each drug-resin complex” in order to obtain a desired release profile of the drug “and generally depends on the drug release characteristics of the resin for that particular active ingredient.” (Pilgaonkar ¶ 42.) Thus, we agree with the Examiner that the selection of the specific modifiers from the list of water insoluble and water soluble release modifiers taught by Appeal 2020-004358 Application 13/832,394 11 Pilgaonkar would have been obvious to one having ordinary skill in the art, as would the barrier layer thickness (i.e., the claimed amount of coating level %). The fact that Pilgaonkar “do[es] not provide biological data to demonstrate that its formulas (even the formulas it has exemplified) meet the challenges provided when administered in human subjects,” whereas the claimed invention “has been tested in humans” (Appeal Br. 13) also does not establish error in the Examiner’s rejection of the claims for obviousness. Scientific experimentation to confirm a prior art disclosure “does not give rise to a patentable invention.” PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1363–64 (Fed. Cir. 2007); cf. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–69 (Fed. Cir. 2007) (simply because the formation and properties of a new compound must be verified through testing does not mean that the compound satisfies the test for patentability “since the expectation of success need only be reasonable, not absolute”); In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Obviousness does not require absolute predictability.”). For these reasons, we determine that the Examiner has met its burden to articulate a sufficient prima facie showing of obviousness based on the cited references and are not persuaded by Appellant’s arguments to the contrary. Appellant’s unexpected results arguments are likewise unpersuasive. In particular, we agree with the Examiner (Ans. 9–10) that Appellant has not compared the claimed invention to the closest prior art. “Although it is well settled that comparative test data showing an unexpected result will rebut a prima facie case of obviousness, the comparative testing must be between Appeal 2020-004358 Application 13/832,394 12 the claimed invention and the closest prior art.” In re Fenn, 639 F.2d 762, 765 (CCPA 1981) (emphasis added). According to Appellant, the Specification shows that the claimed formulation upon administration did not have much intersubject variability in plasma concentration profiles, and had a secondary peak for all subjects at about 12 hours, neither of which was achieved with prior art compositions. (Appeal Br. 12 (referring to Figure 2 and Spec 10).) The prior art references to which Appellant refers are Ptacek6 and Montieth.7 (Appeal Br. 12.) As the Examiner explained, and Appellant does not dispute, the comparison Appellant makes is to “an immediate release stock solution of phenylephrine that is not coated with any release modifiers” and “an immediate release phenylephrine formulation whose structural composition and configuration is not disclosed by the reference” and a controlled release phenylephrine formulation for delivery within a desired location in the GI tract whose structural composition and configuration also is not disclosed by the reference. (Ans. 10.) Appellant has not established that the immediate release formulations of Ptacek and Montieth include a resinate-active agent complex as taught by Pilgaonkar. Nor has Appellant established that the controlled release formulation of Montieth includes a resinate-active agent complex as taught by Pilgaonkar. Appellant bears the burden of providing factual evidence of non- obviousness to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 6 Ptacek et al., Development and validation of a liquid chromatography- tandem mass spectrometry method for determination of phenylephrine in human plasma and its application to a pharmacokinetic study, 858J. Chromatography B, 263–268, (2007). (Id.) 7 Montieth et al., US 2008/0020055 A1, published Jan. 24, 2008. (Id.) Appeal 2020-004358 Application 13/832,394 13 688, 692 (Fed. Cir. 1990). Appellant has not met that burden here because Appellant has not established that formulations of Ptacek or Montieth are closer prior art than the resinate-active agent complex as taught by Pilgaonkar. Thus, Appellant has not established that it has presented comparative evidence to the closest prior art. Thus, for the foregoing reasons, we affirm the Examiner’s rejection of claim 1 as being obvious from Pilgaonkar and Challapalli. Claims 2, 3, 8, 18–21, and 23–27 have not been argued separately and stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appellant’s position that the Examiner’s obviousness rejection of claim 22 is in error relies on the arguments discussed above with respect to Pilgaonkar (Appeal Br. 13–14), which we do not find persuasive. Thus, we also affirm the Examiner’s rejection of claim 22 as being obvious from Pilgaonkar, Challapalli, and Hall. III. Non-Statutory obviousness-type double patenting Appellant does not contest the Examiner’s rejection of the claims for obviousness-type double patenting. (Appeal Br. 14.) Nor has Appellant indicated that a terminal disclaimer has been filed. Consequently, we summarily affirm the Examiner’s rejections of claims 1–3, 8, and 18–27 on the ground of non-statutory obviousness-type double patenting as being unpatentable over the claims of copending Application No. 13/832,694 or 14/966,079 and Pilgaonkar or Hall. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection to the Board, . . . the Board may treat any argument with respect to that ground of rejection as waived.”). Appeal 2020-004358 Application 13/832,394 14 DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 8, 18– 27 112, first paragraph Written Description 1–3, 8, 18– 27 1–3, 8, 18– 21, 23–27 103(a) Pilgaonkar, Challapalli 1–3, 8, 18– 21, 23–27 22 103(a) Pilgaonkar, Challapalli, Hall 22 1–3, 8, 18– 27 Provisional Obviousness-type Double Patenting 1–3, 8, 18– 27 1–3, 8, 18– 27 Provisional Obviousness-type Double Patenting 1–3, 8, 18– 27 Overall Outcome 1–3, 8, 18– 27 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED