Yong Dai et al.Download PDFPatent Trials and Appeals BoardAug 29, 201911787381 - (D) (P.T.A.B. Aug. 29, 2019) 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. 11/787,381 04/16/2007 Yong Dai AM102516 2636 25291 7590 08/29/2019 Pfizer Inc. Attn:Legal Patent Department, Chief IP Counsel 235 East 42nd Street NEW YORK, NY 10017 EXAMINER BROWE, DAVID ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 08/29/2019 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): ~IPGSMadisonDocketing@pfizer.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte YONG DAI, ALAN M. GOLDBERG, MICHAEL A. GOODE, RAYMOND ALAN BARTOLUCCI, and JAMES O. FRAZIER1 __________ Appeal 2018-004817 Application 11/787,381 Technology Center 1600 __________ Before ERIC B. GRIMES, DEBORAH KATZ, and RYAN H. FLAX, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a composition for lubricating a solid dosage form, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as “Wyeth, LLC (formerly called ‘Wyeth’), which is a wholly owned entity of Pfizer Inc.” Appeal Br. 3. Appeal 2018-004817 Application 11/787,381 2 STATEMENT OF THE CASE The Specification states that compounds like magnesium stearate are commonly used to facilitate tableting of pharmaceutical compositions. Spec. ¶ 2. However, “use of magnesium stearate as a lubricant does have several disadvantages.” Id. ¶ 3. “The present invention provides a composition comprising a matrix with embedded liquid lubricants. The embedded liquid lubricants serve to provide lubrication for tableting of the composition.” Id. ¶ 14. Claims 52–54 are on appeal and read as follows: 52. A composition for lubricating a solid dosage form comprising an embedded lubrication matrix consisting essentially of vitamin E dispersed in an admixture of starch and maltodextrin and optionally a processing aide, wherein the weight ratio of vitamin E to the admixture of starch and maltodextrin is 1:1 and further the solid dosage form is free of stearate. 53. The embedded lubrication matrix composition of claim 52, wherein the embedded lubrication matrix contains a processing aide. 54. The embedded lubrication matrix composition of claim 53, wherein the processing aide is silicon dioxide. DISCUSSION The Examiner has rejected claims 52–54 under 35 U.S.C. § 103(a) as obvious based on Chen2 and Schmidt.3 Final Action4 5. The Examiner finds 2 US 2002/0127303, pub. Sept. 12, 2002. 3 US 4,603,143, iss. July 29, 1986. 4 Office Action mailed March 22, 2017. Appeal 2018-004817 Application 11/787,381 3 that Chen discloses “a powder composition for vitamin tablets comprising a matrix of vitamin E dispersed in an admixture of ‘starch’ (e.g. modified food starch) and maltodextrin.” Id. at 6. The Examiner finds that, in Chen’s composition, “the vitamin E (i.e. the fat-soluble substance) can be present in an amount of up to about 40 wt%; the admixture of ‘starch’ and maltodextrin is present in the amount of about 40%.” Id. The Examiner finds that Chen does not “disclose that the weight ratio of vitamin E to the admixture of ‘starch’ and maltodextrin is 1:1, and that the composition further comprises silicon dioxide.” Id. However, the Examiner finds that Schmidt discloses “a powder composition for vitamin tablets comprising a matrix of 40–60 wt% vitamin E and a silicon material, specifically silicon dioxide,” and discloses that “a more stable and free- flowing vitamin E powder can be prepared by employing at least 40 wt% vitamin E with silicon dioxide as a processing aide.” Id. at 6–7. The Examiner concludes that it would have been obvious to employ about 40 wt% vitamin E with silicon dioxide in the Chen et al. composition, with the reasonable expectation of success that the resulting vitamin E powder will be more stable and free-flowing. The resulting vitamin E powder will thus contain about 40 wt% vitamin E and about 40 wt% of the admixture of “starch” and maltodextrin; thus, the weight ratio of vitamin E to the admixture of “starch” and maltodextrin is about 1:1. Id. at 7. We agree with the Examiner that the composition of claim 52 would have been obvious based on the cited references. Chen discloses compositions comprising a fat-soluble substance (1–40 wt %) and an emulsifier (0.1–30 wt %), “encapsulated in a carbohydrate matrix composed Appeal 2018-004817 Application 11/787,381 4 of maltose or maltose syrup, or a mixture of low-molecular weight carbohydrates, optionally in combination with 0.1 wt% to about 50 wt% of a high-molecular weight carbohydrate.” Chen ¶ 6. The fat-soluble substance can be a vitamin, such as vitamin E. Id. ¶ 7. The high-molecular weight carbohydrate can be “maltodextrin, which, when present, is used at a level of 0.1 wt % to about 50 wt %.” Id. ¶ 11. Suitable emulsifiers include a “chemically modified starch obtainable . . . under the tradename CAPSUL.” Id. ¶ 13. The compositions disclosed by Chen thus include those that comprise vitamin E as the fat-soluble substance (1–40 wt %) and CAPSUL (a modified starch) as the emulsifier (0.1–30 wt %), encapsulated in a carbohydrate matrix comprising maltodextrin as the high molecular weight carbohydrate (0.1–50 wt %), as well as maltose. The combined weight percent of modified starch, as emulsifier (0.1– 30 wt %), and maltodextrin (0.1–50 wt %) is 0.2–80 wt %, and therefore includes the full range of 1–40 wt % vitamin E disclosed by Chen. Thus, Chen’s ranges include, and would have made obvious, amounts that would result in a 1:1 ratio of vitamin E and the admixture of starch and maltodextrin. “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Although Chen states that “stearyl and oleyl esters” are suitable emulsifiers (Chen ¶ 13), it does not disclose a requirement for stearate, and thus makes obvious a composition free of stearate. Taken as a whole, Chen therefore would have made obvious the composition of claim 52. Appeal 2018-004817 Application 11/787,381 5 Schmidt discloses “a free-flowing, fat-soluble vitamin-containing powder which has improved stability comprising: (a) at least one fat-soluble vitamin material, and (b) a silicon containing material predominately in the form of substantially discrete agglomerates.” Schmidt 1:38–43. “[T]he resulting powders contain from about 40 to 60 percent by weight activity.” Id. at 3:11–12. Schmidt discloses that its “preferred embodiment . . . is a free-flowing, substantially non-agglomerated . . . , high density vitamin E powder.” Id. 2:50–53. Schmidt exemplifies compositions comprising vitamin E and hydrated silicon dioxide. See, e.g., id. at 4:12–28. Based on the teachings of Chen and Schmidt, it would have been obvious to include silicon dioxide in Chen’s vitamin E composition to get a free-flowing powder with improved stability, as disclosed by Schmidt. The combined references therefore would have made obvious the compositions of claims 53 and 54. Appellants argue that “this application has been previously appealed” and, “[t]he PTAB decision with regard to claims 52–54 was a complete reversal of the examiner’s rejection of those claims.” Appeal Br. 9–10. Appellants argue that “[b]ased on MPEP 1214.04, the PTAB reversal brought those claims up for immediate action. . . . ; however, the Examiner did not immediately allow those claims.” Id. at 10. Appellants thus argue that “[t]he new 35 U.S.C. §103(a) rejection of claims 52–54 under the Chen and Schmidt references is not consistent with the PTAB’s decision regarding those claims.” Id. at 10–11. This argument is unpersuasive. As Appellants acknowledge, the “previous 35 U.S.C. §103(a) rejection [was] over the cited references of Appeal 2018-004817 Application 11/787,381 6 Cherukuri in view of Schmidt [] and Valentine.” Id. at 9. The rejection on appeal now, based on Chen and Schmidt, is therefore not inconsistent with the previous reversal of a rejection based on different evidence. Appellants also argue that “Chen discloses a preferred composition in which fat-soluble vitamin, an emulsifier and an antioxidant are encapsulated in a carbohydrate matrix. Chen’s specification does not describe how the ingredients are encapsulated. The dictionary definition of ‘encapsulate’ is ‘to enclose in or as if in a capsule.’” Appeal Br. 12. Appellants argue that the “embedded lubrication matrix” of the claims is described in the Specification as an oily liquid finely dispersed in an oil insoluble material, where the matrix appears to be dry, not oily, and is free-flowing. Id. at 12– 13. Appellants argue that the recited “embedded lubrication matrix would not have been obvious to one of skill in the art based on Chen’s disclosure of an oil-in-water emulsion which is encapsulated in a carbohydrate matrix.” Id. at 13. This argument is not persuasive. Chen describes a method of making its compositions as follows: Generally the low-molecular weight carbohydrates optionally in combination with high-molecular weight carbohydrates [e.g., maltodextrin] are first dissolved in water. . . . Then the antioxidant and the emulsifier [e.g., CAPSUL] are added. The so called carbohydrate matrix is obtained in this manner. Then, the fat soluble substance [e.g., vitamin E] . . . is mixed with an antioxidant, if desired, and the resulting mixture is gradually added to the aqueous phase while the mixture is homogenized with a mixer to form an oil in water emulsion. . . . The conversion of a thus-manufactured emulsion into a dry powder can be effected by methods known in the art, e.g., by spray drying. Appeal 2018-004817 Application 11/787,381 7 Chen ¶¶ 18–19. Thus, Chen describes forming a carbohydrate matrix that includes a high-molecular weight carbohydrate such as maltodextrin and an emulsifier such as CAPSUL (a modified starch), then adding vitamin E while mixing to form an oil-in-water emulsion, which is spray dried. Appellants have not shown, by evidence or sound technical reasoning, that the claimed embedded lubrication matrix differs structurally from Chen’s composition. Appellants also argue that the “claimed composition is free of stearate. . . . [T]he term ‘stearate’ is not mentioned in Chen’s disclosure. It would not have been obvious to one of skill in the art to prepare Applicants’ composition which does not contain stearate based on Chen’s disclosure.” Appeal Br. 13. This argument is not persuasive. The fact that Chen does not mention stearate in its disclosure is evidence that there would have been no reason to include stearate in Chen’s composition. The lack of any expressed need for stearate would have made obvious a composition free of stearate based on Chen’s disclosure. Appellants also argue that Schmidt’s composition is a powder containing only the fat- soluble vitamin and a silicon-containing absorbent material. . . . The particulate material containing silicon used by Schmidt is not used as a processing aide in combination with other ingredients. It would not have been obvious to one of skill in the art to combine Chen’s oil-in-water emulsion with Schmidt’s fat-soluble vitamin and silicon absorbent material to prepare Applicants’ embedded lubrication matrix. Appeal Br. 13. Appellants conclude that “[t]he Examiner has erroneously reached a conclusion of obviousness by viewing the prior art from the Appeal 2018-004817 Application 11/787,381 8 perspective of one who already knows the claimed invention, rather than as one of ordinary skill in the art at the time of the invention.” Id. at 14. This argument is not persuasive. Schmidt discloses that combining a fat-soluble vitamin, such as vitamin E, with a silicon-containing material, such as silicon dioxide, results in “a free-flowing, fat-soluble vitamin- containing powder which has improved stability.” Schmidt 1:38–40. Schmidt therefore supports a reasonable expectation that including silicon dioxide in Chen’s composition (a vitamin E-containing powder) would also result in a free-flowing powder with improved stability. Appellants have not provided evidence or persuasive technical reasoning to show otherwise. Finally, Appellants argue that they “have claimed silicon dioxide as an optional processing aide.” Reply Br. 7. Appellants argue that the Specification “states, ‘Typically, the processing silicon dioxide processing aid would be included in an amount of about 0.2 to 2.5%.’” Id. (quoting Spec. ¶ 52). In contrast, Appellants argue, “silicon dioxide is not a mere processing aid in the Schmidt ’143 composition; it is a main ingredient of the composition.” Id. This argument is also unpersuasive. The claims do not recite any limit on the amount of processing aid(e) or silicon dioxide that may be included in the claimed composition. Nor have Appellants pointed to any definition in the Specification that would justify interpreting the claim language to impose a cap on the amount of silicon dioxide: the Specification’s statement that silicon dioxide would “typically” be included in certain amounts does not mean that amounts outside the recited range are not encompassed by the claim language. Appeal 2018-004817 Application 11/787,381 9 SUMMARY We affirm the rejection of claims 52–54 under 35 U.S.C. § 103(a) based on Chen and Schmidt. 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 Copy with citationCopy as parenthetical citation