Hovid BerhadDownload PDFPatent Trials and Appeals BoardMay 5, 20212020005622 (P.T.A.B. May. 5, 2021) Copy Citation 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. 14/742,864 06/18/2015 Bee Hong Ng 274751.110_CON 2174 42161 7590 05/05/2021 MEYER UNKOVIC & SCOTT LLP 535 Smithfield Street Suite 1300 Pittsburgh, PA 15222-2315 EXAMINER MCMILLIAN, KARA RENITA ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 05/05/2021 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte BEE HONG NG, WAI PENG CHOY, JIA WOEI WONG, JUNE LAY CHOO KHOO, DAVID SUE SAN HO, and KAH HAY YUEN __________ Appeal 2020-005622 Application 14/742,864 Technology Center 1600 __________ Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and TAWEN CHANG, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a pharmaceutical composition. The Examiner rejected the claims as obvious. 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 Hovid BHD (see Appeal Br. 3). 2 We have considered the Specification of June 18, 2015 (“Spec.” with the unnumbered pages numbered sequentially from the first page); Final Office Action of May 15, 2019 (“Final Act.”); Appeal Brief of Feb. 18, 2020 (“Appeal Br.”); Examiner’s Answer of May 26, 2020 (“Ans.”); and Reply Brief of July 27, 2020 (“Reply Br.”). Appeal 2020-005622 Application 14/742,864 2 Statement of the Case Background “Emulsions have been known to improve absorption of oil-soluble drugs” (Spec. 1). “[S]elf-emulsifying drug delivery systems (SEDDSs) have gained increasing interests in recent years due to many advantages they have over conventional emulsions” (id.). “[L]ike most SEDDS, the . . . pharmaceutical carrier was found to be effective- only if the surfactant concentration utilized was more than 50% by weight, with the preferred ratio of oleic acid to non-ionic surfactant ranging from 1:l to 1:4 w/w” (id. at 4). “The present invention led to . . . a pharmaceutical carrier comprising . . . a combination of edible or pharmaceutically acceptable fatty acids and . . . a combination of non-ionic surfactants to deliver a wide range of drugs” (id.). The Claims Claims 1, 4–8, 10, 11, and 13 are on appeal.3 Claim 1 is representative and reads as follows: 1. A pharmaceutical composition comprising: a solvent comprising an edible and pharmaceutically acceptable fatty acid; a drug; and a non-ionic surfactant, wherein the pharmaceutical composition is a self- emulsifying drug delivery system, wherein the drug is dissolved in the solvent, wherein the fatty acid and non-ionic surfactant are mixed in a ratio ranging from 9.5:0.5 w/w to 2:1 w/w. 3 We limit our consideration of the merits of the appealed rejection to the elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Thus, we read the claims as limited to the oleic acid as the fatty acid, ibuprofen as the drug and Cremophor EL as the surfactant (see Final Act. 2). Appeal 2020-005622 Application 14/742,864 3 The Rejection The Examiner rejected claims 1, 4–8, 10, 11, and 13 under 35 U.S.C. § 103(a) as obvious over Patel4 (Final Act. 3–6). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that Patel renders the claims obvious? Findings of Fact 1. Patel teaches “pharmaceutical compositions for the improved delivery of hydrophobic compounds” (Patel 1:9–10). 2. Patel teaches “the present invention provides a clear aqueous dispersion containing a hydrophilic surfactant, a hydrophobic surfactant and a hydrophobic therapeutic agent” (Patel 4:9–12). 3. Patel teaches “a combination of a hydrophilic surfactant and a hydrophobic surfactant can solubilize therapeutically effective amounts of hydrophobic therapeutic agents without recourse to the use of triglycerides” (Patel 4:55–58). Patel explains that “[o]ne skilled in the art will appreciate that a hydrophobic therapeutic agent may have a greater solubility in the pre- concentrate carrier than in the aqueous dispersion” (Patel 27:43–45). 4. Patel teaches “[s]pecific non-limiting examples of hydrophobic therapeutic agents that can be used in the pharmaceutical compositions of the present invention include . . . ibuprofen” (Patel 22:1–10). 5. Patel teaches “preferred hydrophilic surfactants are PEG-35 castor oil” and Table 5 teaches that PEG-35 castor oil is Cremophor EL (see Patel 8:66–9:1 and Table 5). 4 Patel et al., US 6,294,192 B1, issued Sept. 25, 2001. Appeal 2020-005622 Application 14/742,864 4 6. Patel teaches that “the hydrophobic surfactant can be any hydrophobic surfactant suitable for use in pharmaceutical compositions” including oleic acid esters (see Patel 5:63–65; 6:23–25). Patel also specifically claims “wherein the hydrophobic surfactant is selected from the group consisting of . . . oleic acid” (Patel 51:36–38, claim 29). 7. Patel teaches that “[f]or some particular surfactant combinations, cloudy solutions result when the amount of hydrophobic surfactant is greater than about 60% by weight, based on the amount of hydrophilic surfactant. A preferred range for these surfactants is about 1% to about 60%” (Patel 21:27–31). Patel teaches “[a]ddition of optional excipients as described below can further increase the maximum relative amount of hydrophobic surfactant that can be used” (Patel 21:33–35). 8. Patel teaches, however, that “any aqueous dispersion having the properties described above is within the scope of the present invention regardless of the specific relative amounts of hydrophobic and hydrophilic surfactants” (Patel 21:14–17). 9. Patel teaches “it is expected that the amount of hydrophobic surfactant will generally be less than about 200% by weight, based on the amount of hydrophilic surfactant, and more specifically, in the range of about 1 % to 200%” (Patel 21:16–21). 10. Patel teaches “the particular combination of surfactants used can be optimized for a specific hydrophobic therapeutic agent to more closely match the polarity distribution of the therapeutic agent, resulting in still further enhanced solubilization” (Patel 30:63–67). 11. Patel teaches “the pharmaceutical compositions of the present invention can optionally include additional compounds to enhance the Appeal 2020-005622 Application 14/742,864 5 solubility of the hydrophobic therapeutic agent in the carrier system” (Patel 25:15–17). Principles of Law A prima facie case for obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003), and “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 We adopt the Examiner’s findings of fact and conclusion of law (see Final Act. 3–6; FF 1–11) and agree that Patel renders claim 1 obvious. We address Appellant’s arguments below. Appellant contends “Patel teaches that the drug is solubilized by micelles, which is a structure formed by a combination of two separate surfactants. In contrast, Claim 1 specifies that the drug is dissolved by any single component (i.e. a fatty acid)” (Appeal Br. 6). We find this argument unpersuasive because Patel teaches that “a combination of a hydrophilic surfactant and a hydrophobic surfactant can solubilize therapeutically effective amounts of hydrophobic therapeutic agents” (FF 3). Patel teaches the hydrophobic therapeutic agent may be more soluble in this pre-concentrate carrier composed of a fatty acid, a drug, and a non-ionic surfactant in a ratio of 2:1 w/w (FF 3–6, 9). We agree with the Examiner that because Patel suggests “the same solvent as claimed which is oleic acid, in combination with the same hydrophobic drug as claimed which is ibuprofen, said solvent (oleic acid) Appeal 2020-005622 Application 14/742,864 6 will necessarily dissolve the ibuprofen as claimed,” resulting in a composition that is structurally identical to the composition recited in claim 1 (Ans. 8–9; citing In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”)). Appellant provides no evidence demonstrating a structural difference between the claimed composition and that rendered obvious by Patel. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, . . . the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). Appellant contends the Patel reference fails to teach oleic acid as a component of the pharmaceutical composition. Rather, Patel teaches ester derivatives of fatty acids for use as a surfactant. A person having skill in the art would recognize that fatty acid derivatives, particularly the fatty acid esters, have markedly different properties than fatty acids (Appeal Br. 7). Appellant acknowledges that claims 29 and 30 of Patel expressly list oleic acid but contends that, because “claims 29-30 are presented as Markush groups” and “[b]ase fatty acids would not have similar properties and it would be improper to group them with the other compounds identified in claims 29-30,” they must be in derivative form because otherwise the claims would comprise improper Markush groups (see Appeal Br. 8). We find this argument unpersuasive because claim 29 of Patel expressly teaches the use of oleic acid as a hydrophobic surfactant (FF 6). The evidence does not support Appellant’s position that the recitation of Appeal 2020-005622 Application 14/742,864 7 oleic acid is an improper Markush group because MPEP § 706.03 notes that a proper Markush group includes situations where there is a common function and Patel teaches that oleic acid shares the common function of serving as a hydrophobic surfactant (FF 6) with other hydrophobic surfactants. To the extent that Appellant is arguing that the only disclosure of oleic acid is in a claim of Patel, we note that a claim is “itself adequate ‘written description’ of the claimed invention. It was equally a ‘written description’ whether located among the original claims or in the descriptive part of the specification.” In re Gardner, 480 F.2d 879, 879–80 (CCPA 1973).5 Appellant contends “Patel is not enabling for teaching fatty acids used in a pharmaceutical composition. As noted above, the specification of Patel fails to teach oleic acid as a component of the pharmaceutical composition” (Appeal Br. 8). We are not persuaded. A “prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant.” In re Morsa, 713 F.3d 104, 109 (Fed. Cir. 2013). The prior art is enabling if “a person of ordinary skill in the art could make or use the claimed invention without undue experimentation based on the disclosure of that particular document.” Id. at 110. Here, Appellant provides no specific evidence or persuasive reasoning as to why undue experimentation would have been required for an ordinary artisan to follow the disclosure of Patel and prepare a composition of 5 We note, but need not rely upon, the recitation in Patel’s original filed claim 31 of oleic acid as in the group of hydrophobic surfactants (see US application 09/258,654, now US 6,294,192, filed Feb. 26, 1999). Appeal 2020-005622 Application 14/742,864 8 ibuprofen, Cremophor EL, and oleic acid. Simply stating that Patel’s specification does not exemplify this embodiment is not sufficient because working “examples are not required to satisfy section 112, first paragraph.” In re Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982). And Patel provides a number of working examples using forms of Cremophor and oils (see Patel Tables 19–26). All Appellant presents is attorney argument, but “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Appellant contends “Patel sets the limit for non-cloudy compositions at .6:1 w/w, well below the range recited in Claim 1 of the present invention. Patel teaches against cloudy formulations because ‘such a system would suffer from many of the same disadvantages as conventional prior art formulations, as described above’” (Appeal Br. 9; citing Patel 20:3–5). Based on this, Appellant contends “Patel teaches away from a composition having a ratio of fatty acid to non-ionic surfactant of 9.5:0.5 w/w to 2:1 w/w (i.e. 95% to 66% fatty acid, total weight). Patel teaches that the ratio of hydrophobic surfactant to hydrophilic surfactant is less than 2:1 w/w” (id.). We find this teaching away argument unpersuasive. While Patel teaches that some combinations result in cloudy solutions (FF 7), Appellant identifies no evidence in Patel suggesting that a 2:1 w/w ratio of ibuprofen, Cremophor EL, and oleic acid would result in a cloudy solution. Thus, Patel does not teach away because Patel does not criticize, discourage, or Appeal 2020-005622 Application 14/742,864 9 otherwise discredit this particular obvious composition. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). In addition, Patel specifically teaches a range for the two components of 2:1 w/w (i.e. 200% by weight of hydrophobic surfactant based on the amount of hydrophilic surfactant) (FF 9) and explains that if a higher amount of hydrophobic surfactant is desired, the “[a]ddition of optional excipients as described below can further increase the maximum relative amount of hydrophobic surfactant that can be used” (FF 7). As claim 1 uses the open transitional phrase “comprising,” claim 1 encompasses compositions with the 2:1 w/w ratio that include optional excipients in the composition that allow it to remain clear. We note that a “given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In this case, the advantage identified by Patel includes improved delivery of the hydrophobic drug such as ibuprofen (FF 1). Appellant asserts the disadvantage that the combination might, at a 2:1 w/w ratio, result in a cloudy solution, but provides no evidence that such a cloudy solution would have been expected to occur. We agree with the Examiner (see Final Act. 11–12) that Patel recognizes the need for optimization because it teaches that “the particular combination of surfactants used can be optimized for a specific hydrophobic therapeutic agent to more closely match the polarity distribution of the therapeutic agent, resulting in still further enhanced solubilization” (FF 10). Appellant provides no evidence of secondary considerations, such as unexpected results, to demonstrate that their selection of the particular species from the Appeal 2020-005622 Application 14/742,864 10 genera of fatty acids, surfactants, and active pharmaceuticals in the Specification is anything other than routine (see Spec. 7–8). In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Conclusion of Law A preponderance of the evidence of record supports the Examiner’s conclusion that Patel renders the claims obvious. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4–8, 10, 11, 13 103(a) Patel 1, 4–8, 10, 11, 13 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 Copy with citationCopy as parenthetical citation