Ex Parte JIADownload PDFPatent Trial and Appeal BoardMay 10, 201611279925 (P.T.A.B. May. 10, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111279,925 04/17/2006 QiJIA 500 7590 05/11/2016 SEED INTELLECTUAL PROPERTY LAW GROUP PLLC 701 FIFTH A VE SUITE 5400 SEATTLE, WA 98104 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. 920104.404Dl 8979 EXAMINER WANG, SHENGTIJN ART UNIT PAPER NUMBER 1627 MAILDATE DELIVERY MODE 05/11/2016 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 QI JIA 1 Appeal2014-004742 Application 11/279,925 Technology Center 1600 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to plant extracts used to treat inflammation, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. STATEMENT OF THE CASE The invention relates to compositions containing mixtures of Scutellaria and Acacia plant extracts. Spec. 55. The compositions are useful in treating 'joint discomfort and pain associated with conditions such as osteoarthritis, rheumatoid arthritis, and other injuries that result from 1 Appellant identifies the Real Party in Interest as Unigen Pharmaceuticals, Inc. Appeal Br. 2. Appeal2014-004742 Application 11/279,925 overuse." Id. at 1. Of particular interest are mixtures where the Scutellaria extract contains baicalin and the Acacia extract contains catechin or epicatechin. Id. at 55. Claims 1, 7, 10-21 are on appeal. Claim 1 is illustrative and reads as follows: 1. A composition comprised of a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin and an extract derived from Acacia enriched for flavans containing catechin or epicatechin. Appeal Br. 22 (Claims Appendix). The claims stand rejected as follows: Claims 1, 7, and 10-21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Rosenbloom, US 6,555,573 B2 (Issued Apr. 29, 2003)("Rosenbloom") in view of Kubo et al., Studies on Scutellariae Radix. VII. Anti-arthritic and Anti-inflammatory Actions of Methanolic Extract and Flavonoid Components from Scutellariae Radix, 32 CHEM. PHARM. BULL. 2724--2729 (1984)("Kubo") and Marti et al., US 4,515,804 (issued May 7, 1985)("Marti"). DISCUSSION Issue The Examiner has rejected claims 1, 7, and 10-21under35 U.S.C § 103(a) as unpatentable over Rosenbloom in view of Kubo and Marti. The Examiner finds that Rosenbloom discloses compositions containing wogonin, baicalein and catechin. Final Act. 5. The Examiner finds that 2 Appeal2014-004742 Application 11/279,925 Kubo teaches that Scutellaria extracts contain baicalin, baicalein and wogonin. Final Act. 6. The Examiner finds that Marti teaches that catechin is contained in Acacia extracts. Id. The Examiner goes on to find that "[t]herefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed the invention was made, to make use the extract of Scutellariae as the source of wogonin and the extract of Acacia catechu as the source of catechin in the composition." Id. Appellant contends that the cited references do not teach the combination recited in the claims. Appeal Br. 16. Appellant also argues that the references do not teach the use of enriched extracts as called for in the claims. Id. Appellant also argues that the Examiner failed to adequately explain why one of ordinary skill in the art would combine the teachings of the references to create the claimed composition. Id. With respect to claims 14 and 15 Appellant argues that Rosenbloom does not teach the recited ratios of extracts. Appeal Br. 17. Appellant also urges that since claim 3, which recites a specific ratio of extracts, was deemed allowable if rewritten in independent form, claims 14 and 15 should also be allowed. Id. Finally, Appellant points to the Declaration of Dr. Jia as containing evidence of non- obviousness in that it shows an unexpected synergistic effect of combining the recited extracts. Appeal Br. 17-18. The issue with respect to this rejection is whether the Examiner has established by a preponderance of the evidence that claims are obvious in view of Rosenbloom in combination with Kubo and Marti as defined by 3 5 U.S.C. § 103(a). 3 Appeal2014-004742 Application 11/279,925 Findings of Fact FF 1. Rosenbloom teaches a composition for the topical treatment of diabetic neuropathy comprising flavonoids and an antioxidant such as catechin. Rosenbloom col 3, 11. 24--29, col. 4, 11. 35-39; col 5, 11. 38-52. FF2. Among the flavonoids disclosed in Rosenbloom are wogonin and baicalein. Rosenbloom col. 4, 11. 47 and 66. FF3. Rosenbloom teaches that flavonoids have anti-inflammatory properties. Rosenbloom col. 5, 11. 11-14. FF4. Catechin is a flavan. Marti, col. 1, 11. 10-30. FF5. Kubo discloses a 70% methanol extract of Scutellariae radix which contains baicalin, wogonin and baicalein as major components. Kubo 2724. FF6. Kubo teaches that extracts containing baicalin, wogonin and baicalein exhibit anti-inflammatory properties. Kubo 2728. FF7. Marti discloses that catechin is contained in extracts of Acacia catechu. Marti col. 1, 11. 29-42. FF8. Marti discloses that catechin is an astringent. Marti col. 1, 1. 40. FF9. The instant specification discloses initial Scutellariae extracts as containing from 0.1 % flavonoids to 24.5 % flavonoids. Spec. 55, table 10. FF 10. The instant specification discloses initial extracts of Acacia having from 0.2% to 14.8 % flavans. Spec. 53, table 8. Principles of Law "[T]he test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to 4 Appeal2014-004742 Application 11/279,925 be familiar with them." In re Rosselet, 347 F.2d 847, 851(CCPA1965) (emphasis in original). "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). "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Synergism is not per se unexpected. See In re Diamond, 360 F. 2d 214, 218 (CCPA 1966). "What section 103 requires is 'unexpected synergism' ... " (id. at 216 n. 7); "we attribute no magic status to synergism per se since it may be expected or unexpected" (id. at 218). "It is well established that the objective evidence of nonobviousness must be commensurate in scope with the claims." In re Lindner, 457 F.2d 506, 508 (CCPA 1972). "To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention." Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). 5 Appeal2014-004742 Application 11/279,925 Analysis Claim 1 is representative of the rejected claims and recites a composition that contains a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin, as well as an extract derived from Acacia enriched for flavans containing catechin or epicatechin. We agree with the Examiner that the claimed mixture would have been obvious to one of ordinary skill in the art at the time the invention was made. Rosenbloom discloses a therapeutic topical mixture that contains both flavonoids and an antioxidant such as catechin. FF 1. The flavonoids disclosed in Rosenbloom include Free B-ring flavonoids, specifically wogonin and baicalein. FF.2. Although Rosenbloom's compounds are not in the form of the extracts recited in claim 1, Kubo teaches the use of Scutellaria extracts, which contain wogonin, baicalein and baicalin, as anti- inflammatory agents. FF 4--5. Marti teaches that catechin is contained in Acacia extracts. FF6-7. Thus, it would have been obvious for one skilled in the art to substitute the Scutellaria and Acacia extracts taught by Kubo and Marti for the flavonoids and flavans used in Rosenbloom. In particular, we agree with the Examiner that one skilled in the art would have reasoned that it would have been obvious to combine the extracts of Kubo and Marti because the extracts contain the active ingredients that Rosenbloom teaches should be combined for use in treating diabetic neuropathy. Appellant argues that Rosenbloom lists several preferred compounds, none of which are Free B-ring Flavonoids and that Rosenbloom itself does not teach the claimed two-component mixture. Appeal Br. 16. We are unpersuaded. While Rosenbloom teaches a three component mixture, claim 6 Appeal2014-004742 Application 11/279,925 1 uses the transitional term "comprised of' which is open ended. Thus claim 1 does not exclude the presence of other compounds such as a nerve growth factor as taught by Rosenbloom. Next, as the Examiner pointed out, Rosenbloom teaches the use of Free B-ring flavonoids, including wogonin and baicalein. FF2. That Rosenbloom does not, by itself, teach the combination of the extracts as recited in the instant claims does not negate a finding of obviousness. The missing elements are taught by Kubo and Marti. FF4-7. Appellant next argues that the references fail to teach the use of enriched extracts. Appeal Br, 16. This argument is also not persuasive. Appellant has not pointed to any specific definition of the term enriched in the specification, but instead relies on the common meaning of the term which is "having an increased proportion or amount of a desired ingredient." Appeal Br. 9. Appellant argues that one skilled in the art reading the present specification would understand that enriched extracts are those containing more flavonoids or flavans than a regular extract and that neither Kubo nor Marti disclose enriched extracts. Reply Br. 5-7. Using Appellant's definition of enriched, one skilled in the art would see that, the use of methanol, either alone or mixed with water, produces Free B-ring Flavonoid containing extracts that have more than 100 times the amount of flavonoids than extracts prepared with water alone. Spec. 55, table. 10. Thus, using Appellant's definition of enriched, an alcohol extract is "enriched" when compared to a water based extract. Kubo teaches the use of a 70% methanol extract like that listed in table 10. FF4. According to Table 10, such an extract would have 19.61 % flavonoids whereas a water 7 Appeal2014-004742 Application 11/279,925 extract would have only 0.09% flavonoids. The 70% methanol extract of Kubo is enriched vis a vis a water extract. Appellant also argues that Rosenbloom does not specifically teach the use ofbaicalin, but only wogonin and baicalein. Reply Br. 8-9. Appellant also points out that the examiner mistakenly equates wogonin with baicalin. Id. While we agree with Appellant's points, they do not disturb the conclusion of obviousness. As shown in Kubo, extracts of Scutellaria contain baicalin as well as wogonin and baicalein. FF5. Thus, the use of a Scutellaria extract necessarily contains baicalin. Appellant next points to evidence of synergism obtained using the mixture of the two extracts as evidence of non-obviousness. Appeal Br. 17- 18. The evidence of synergism does not rebut the Examiner's finding of obviousness. Appellant has offered no specific evidence as to whether the synergistic effect is unexpected other than to say that it is greater than the results if the effects were cumulative. No explanation is offered as to why one would expect the effect to be merely cumulative other than the assumption by the inventor that it would be cumulative. Jia Deel. 2. 2 ("assuming for the sake of argument that the efficacy is additive.") Absent some evidence as to why the synergistic effect would be unexpected, synergism alone does not show that the claimed compositions are not obvious. In re Diamond, 360 F.2d at 218. In addition, we agree with the examiner that the evidence of unexpected results is not commensurate with the scope of the claims. The 2 Declaration of Qi Jai, dated Nov. 6, 2006, filed Oct. 19, 2006. 8 Appeal2014-004742 Application 11/279,925 Declaration only identifies three specific formulations, two containing Univestin and the other Soliprin. Jai Deel. 2, 9. One Univestin sample uses extracts from plants other that Scutellariae and Acacia falling outside the scope of the instant claims. Deel. 2-4. The remaining formulations contain 75.7 % Free B-ring flavonoids and 10.3 % flavans. Spec. 56, Table 11, US 20040220119 Al, Table 103. As discussed above, claim 1 used the term "enriched" which is not associated with a specific amount and can be read as embracing amounts of Free B-ring flavonoids as low as 19 .61 %. In addition, only two ratios of flavonoids to flavans are discussed in the Declaration, 80:20 and 15:85. Claim 1 is silent as to the ratio of flavonoids to flavans. Thus the evidence of synergism is not commensurate with the scope of the claims. In re Lindner, 457 F.2d at 508. We also agree with the Examiner that the experiments do not compare the claimed composition with the closest prior art. The claims and the prior art both call for extracts from Scutellariae and Acacia. The comparative examples in the Declaration use extracts from Oroxylum indicum and Unicaria gambir. Deel. 2-4. Appellants offer no evidence that the extracts from Oroxylum and Uncaria would be the same as extracts from Scutellariae and Acacia. Thus the comparisons in the Jia Declaration do not compare the claimed invention with the closest prior art. For the reasons discussed, Appellant does not persuade us that the Examiner failed to show that the composition recited in claim 1 would have been obvious. Claims 7, 10-13 and 16-21 fall with claim 1 because they 3 Jai, US 20040220119 Al (published Nov. 24, 2004). Cited in the Jai Declaration as describing the composition of Soliprin. Jai Deel. 9. 9 Appeal2014-004742 Application 11/279,925 were not argued separately. 37 C.F.R. § 41.37(c)(iv). Turning to claims 14 and 15, we agree with the Examiner that the ratios recited in the claims are embraced by the proportions recited in Rosenbloom. Final Act. 6. Even assuming, as Appellant points out in the Reply Brief (Reply Br. 9, n.13), that the correct amounts of flavonoids and flavans recited in Rosenbloom are 0.002% to 0.04% for flavonoids and 0.001 % to 0.05% for flavans, these values encompass ratios that fall within the 85:15 to 20:80 range recited in claim 14. Appellant argues that since the Examiner has indicated that claim 3 would be allowed if rewritten in independent form, claims 14 and 15 should also be allowed. Appeal Br. 17. We do not agree. Claim 3 recites a specific ratio of 85: 15 which is not taught or suggested by Rosenbloom. Appeal Br. 22. Claims 14 and 15 recite a range of ratios which encompass the range of ratios taught in Rosenbloom. While claim 13 may be patentable, claims 14 and 15 are not. Conclusion of Law We find that the Examiner has established by a preponderance of the evidence that claims 1, 7, and 10-21 are unpatentable as obvious over Rosenbloom in view of Kubo and Marti as defined by 35 U.S.C. § 103(a). SUMMARY We affirm the rejection of claims 1, 7 and 10-21under35 U.S.C. § 103(a) as unpatenable over Rosenbloom in view of Kubo and Marti. AFFIRMED 10 Copy with citationCopy as parenthetical citation