MW ENCAP LIMITED

Patent Trials and Appeals BoardJun 17, 2021

2020006010 (P.T.A.B. Jun. 17, 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. 14/906,507 01/20/2016 Chris Porter 9156-94439-02 8158 120501 7590 06/17/2021 Klarquist Sparkman, LLP (Capsugel) 121 SW Salmon Street, Suite 1600 Portland, OR 97204 EXAMINER VU, JAKE MINH ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 06/17/2021 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): docketing@klarquist.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CHRIS PORTER, PETER SCAMMELLS, HYWEL WILLIAMS, and YASEMIN SAHBAZ ____________ Appeal 2020-006010 Application 14/906,507 Technology Center 1600 ____________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and ULRIKE W. JENKS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 32–40, 42, 45–47, 51, 58, 63, 65–72 (Final Act.2 2).3 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “MW Encap Limited” (Appellant’s March 9, 2020, Appeal Brief (Appeal Br.) 3). 2 Examiner’s August 14, 2019, Final Office Action. 3 Pending claims 52–56 stand withdrawn from consideration (see Final Act. 2). Appeal 2020-006010 Application 14/906,507 2 STATEMENT OF THE CASE Appellant’s disclosure “relates generally to ionic salts, particularly to low melting salts, such as ionic liquids, of poorly water soluble drugs and their use in drug delivery” (Spec. 1:6–7). Appellant’s independent claim 32 is reproduced below: 32. An oral dosage form comprising a capsule containing a lipid formulation of a poorly water soluble drug (PWSD) having a water solubility of about 100 mg/ml or less, the lipid formulation comprising a low melting ionic salt of the PWSD and a counterion, together with a nonaqueous lipid vehicle comprising a mono, di or tri-glyceride or a combination thereof, containing less than 5% water, wherein the PWSD is capable of forming a cation and the counterion is an anion; wherein the low melting ionic salt of the PWSD is an ionised form of the PWSD and has a melting temperature lower than that of the non-ionised PWSD, wherein the low melting ionic salt of the PWSD is at least twice as soluble in the non-aqueous lipid vehicle as the non-ionized PWSD; and wherein the counterion is a carboxylic acid (RC(O)O-), a phosphate (ROP(O)O2-), a phosphonate (RP(O)O2-), a sulfonate (RS(O)2O-), a sulfate (ROS(O)2O-), a tetrazolyl (R-tetrazolate), a bis(sulfonyl)imide (RSO2-N--SO2R), or a mixture thereof, where R is an optionally substituted hydrocarbon group having at least 2 carbon atoms. (Appeal Br. 11.) Appeal 2020-006010 Application 14/906,507 3 Grounds of rejection before this Panel for review: I. Claims 32–40, 42, 45–47, 51, 58, 63, 65–68, and 70–72 rejected under 35 U.S.C. § 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Rogers.4 II. Claims 32–40, 42, 45–47, 51, 58, 63, 65–72 rejected under 35 U.S.C. § 103 as unpatentable over the combination of Rogers and Nanjwade.5 FACTUAL FINDINGS (FF) FF 1. Rogers’ disclosure “generally relates to ionic liquids and to methods of preparing ionic liquid compositions of active pharmaceutical, biological, nutritional, and energetic ingredients” (Rogers ¶ 2; see generally Ans. 4). FF 2. Rogers discloses a composition comprising itraconazole, which is insoluble in water, and docusate, a counter ion within the scope of Appellant’s claimed invention (see Rogers ¶ 390; cf. Spec. 13:28–31; see also Spec. 32:1–15 (Disclosing a formulation within the scope of Appellant’s claim invention, which is “Itraconazole dioctylsulfosuccinate (docusate)” (emphasis omitted)); Ans. 4). FF 3. Rogers discloses that compounds within the scope of its disclosure “can be incorporated into a delivery device,” such as “microcapsules” and “gel capsules” (Rogers ¶ 427; see also Ans. 4). 4 Rogers et al., US 2007/0093462 A1, published Apr. 26, 2007. 5 Basavaraj K. Nanjwade et al., Functions of Lipids for Enhancement of Oral Bioavailability of Poorly Water-Soluble Drugs, 79 Sci. Pharm. 705–727 (2011). Appeal 2020-006010 Application 14/906,507 4 FF 4. Rogers discloses that pharmaceutical formulations within the scope of its disclosure “can be administered in a number of ways,” including topically, orally, and parenterally” (Rogers ¶ 419; see also Ans. 4). FF 5. Rogers discloses that “methods of administration can include incorporating the disclosed ionic liquid composition in to a food stuff or beverage, which can be ingested by a subject” (Rogers ¶ 441; see Ans. 11). FF 6. Rogers discloses that topical formulations can include oily bases and parenteral formulations may be prepared with non-aqueous solvents such as olive oil (Rogers ¶¶ 423–424; cf. Spec. 16:24–27 (Appellant discloses that “olive oil” is an example of an oil or lipid, which may be used in its invention); see also Ans. 4). FF 7. Examiner finds that Rogers “does not teach using a specific lipid vehicle, such as coconut oils or hydrolysed coconut oil” (Ans. 5). FF 8. Nanjwade discloses that “[l]ipid-based drug delivery systems . . . represent one of the most popular approaches to overcome the absorption barriers and to improve the bioavailability of poorly water-soluble drugs” (Nanjwade, Abstract). FF 9. Nanjwade discloses oral capsule formulations of poorly water- soluble drugs together with water-insoluble triglycerides, such as olive oil, and medium chain triglycerides of coconut oil (Nanjawade, Introduction). FF 10. Williams: [B]elieve[s] that the low melting ionic salt [form of a PWSD, as set forth in Appellant’s claim 32,] provides a much higher active loading in the lipid formulation because the low melting Appeal 2020-006010 Application 14/906,507 5 ionic salt has a much higher solubility in the lipid vehicle than the non-ionized drug or other salts of the drug. (Williams Decl.6 ¶ 8; see also id. ¶ 9 (Williams exemplifies two PWSDs formulated either as: (i) a HCl or citrate salt, (ii) a non-ionized free base, or (iii) formulated according to Appellant’s claimed method, wherein, in contrast to formulating the PWSD as (i) a HCl or citrate salt or (ii) a non- ionized free base, formulating the PWSD according to Appellant’s claimed invention resulted in a single 00 capsule that comprises a clinical dose of the PWSD).) Rejection I: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Rogers teaches Appellant’s claimed invention or, in the alternative, Examiner’s conclusion of obviousness? ANALYSIS Examiner reasons that Rogers anticipates or, in the alternative, makes obvious Appellant’s claimed invention (see FF 1–5). We are not persuaded. As Appellant explains, Examiner failed to establish an evidentiary basis on this record to support a finding or conclusion that Rogers teaches or makes obvious, respectively, the use of a lipid vehicle such as an oil in oral dosage formulations (see Appeal Br. 7–8; Reply Br. 3; see also Reply Br. 2 (Rogers “does not disclose a lipid vehicle filled oral capsule”); cf. FF 6 (including oil in topical and parenteral formulations). Because the hallmark of anticipation is prior invention, the prior art reference – in order to anticipate under 35 U.S.C. 6 Williams Declaration, signed May 22, 2018. Appeal 2020-006010 Application 14/906,507 6 § 102 – must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements “arranged as in the claim.” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983). Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). For a finding of anticipation, “it is not enough that the prior art reference . . . includes multiple, distinct teachings that [an ordinary] artisan might somehow combine to achieve the claimed invention.” Id. at 1371. Therefore, we are not persuaded by Examiner’s assertion that “non-aqueous lipid[] carriers, such as vegetable oils, are well-known in the art,” in view of Nanjwade (Ans. 10; see Reply Br. 2 (Appellant contends “simply stating that prior art might have lipid vehicles (stating ‘if needed see NANJWADE reference’) again misses the point of the invention as well as the failures of the cited prior art”)). In sum, we find that the evidence of record fails to support a finding, or conclusion, that Rogers alone teaches, or makes obvious, respectively Appellant’s claimed invention. CONCLUSION The preponderance of evidence on this record fails to support Examiner’s finding that Rogers teaches Appellant’s claimed invention or, in the alternative, conclusion of obviousness. The rejection of claims 32–40, 42, 45–47, 51, 58, 63, 65–68, 70–72 under 35 U.S.C. § 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over Rogers is reversed. Appeal 2020-006010 Application 14/906,507 7 Rejection II: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS Based on the combination of Rogers and Nanjwade, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to prepare Rogers’ oral capsule formulations in Nanjwade’s “[l]ipid-based drug delivery systems . . . to overcome the absorption barriers and to improve the bioavailability of poorly water- soluble drugs,” wherein such lipid-based drug delivery systems include, inter alia, triglycerides, such as olive oil (see Ans. 5–6; see also FF 1–9). Rogers discloses dosage formulations comprising oils, such as olive oil, (see FF 6), therefore, we are not persuaded by Appellant’s contention that Rogers teaches away from formulations comprising an oil, such as olive oil (Appeal Br. 9). For the same reason, we are not persuaded by Appellant’s contention that a person of ordinary skill in this art would not have combined Nanjwade’s disclosure of “lipid vehicles to overcome absorption barriers and to improve the bioavailability of PWSDs,” because “Rogers discloses that forming an ionic liquid of a PWSD is sufficient to address these concerns” (id. (citing Rogers ¶¶ 17, 405, 413)). For the reasons discussed above, we find that the combination of Rogers and Nanjwade makes obvious the oral dosage formulations comprising a capsule containing a lipid formulation (see FF 1–9) and, therefore, are not persuaded by Appellant’s contention to the contrary (Appeal Br. 9–10). Appeal 2020-006010 Application 14/906,507 8 To be complete, we acknowledge Williams’ assertions regarding improvements to capsule loading, but do not find a requirement in Appellant’s claim 32 related to the incorporation of a particular amount of PWSD into a particular sized capsule (FF 10). Thus, we find that the evidence presented by Willams is not commensurate in scope with Appellant’s claimed invention. See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (In order to be persuasive of non-obviousness, “[e]vidence of secondary considerations must be reasonably commensurate with the scope of the claims.”). CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 32 under 35 U.S.C. § 103 as unpatentable over the combination of Rogers and Nanjwade is affirmed. Claims 33–40, 42, 45–47, 51, 58, 63, and 65–72 are not separately argued and fall with claim 32. Appeal 2020-006010 Application 14/906,507 9 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 32–40, 42, 45–47, 51, 58, 63, 65– 68, 70–72 102(a)(1)/103 Rogers 32–40, 42, 45– 47, 51, 58, 63, 65–68, 70–72 32–40, 42, 45–47, 51, 58, 63, 65– 72 103 Rogers, Nanjwade 32–40, 42, 45–47, 51, 58, 63, 65–72 Overall Outcome 32–40, 42, 45–47, 51, 58, 63, 65–72 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). See 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED