Ex Parte JIADownload PDFPatent Trial and Appeal BoardOct 20, 201611279925 (P.T.A.B. Oct. 20, 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 10/20/2016 SEED INTELLECTUAL PROPERTY LAW GROUP LLP 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 10/20/2016 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 JIA1 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 REQUEST FOR REHARING Appellant filed a Request for Rehearing ("Request") under 37 C.F.R. § 41.52 for our Decision mailed May 11, 2016, in which we affirmed the Examiner's rejection of claims 1, 7, and 10-21 as obvious. Appellant asserts the decision was in error because the Board "misapprehended or overlooked certain arguments and factual evidence" presented in the Appeal and Reply Brief. Req. Reh'g 2. We have considered the arguments presented by Appellant and are persuaded that we overlooked certain arguments. As such, we grant Appellant's Request for Rehearing and modify our opinion to reflect consideration of Appellant's 1 Appellant identifies the Real Party in Interest as Unigen Pharmaceuticals, Inc. Appeal Br. 2. Appeal2014-004742 Application 11/279,925 arguments. Our consideration of the arguments that were overlooked does not change our decision to affirm the Examiner's rejection based on 35 U.S.C. § 103(a). 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 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, and 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 2 Appeal2014-004742 Application 11/279,925 Flavonoid Components from Scutellariae Radix, 32 Chem. Phann. 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 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 3 Appeal2014-004742 Application 11/279,925 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 35 U.S.C. § 103(a). 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. 4 7 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. 4 Appeal2014-004742 Application 11/279,925 FF8. Marti teaches the preparation of pure catechin from the "wooden parts of Acacia catechu with hot water, evaporating the extract and purifying the resulting residue ... further by recrystallization from water and drying the crystals." Id. FF9. Marti discloses that catechin is an astringent. Marti col. 1, 1. 40. FF 10. The instant Specification discloses initial Scutellariae extracts as containing from 0.1 % flavonoids to 24.5 % flavonoids. Spec. 55, Table 10. FF 11. The instant Specification discloses initial extracts of Acacia having from 0.2% to 14.8 % flavans. Spec. 53, Table 8. Principles of Law "[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). "[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 be familiar with them." In re Rosselet, 347 F.2d 847, 851 (CCPA 1965) (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 5 Appeal2014-004742 Application 11/279,925 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 (CCP A 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 (CCP A 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). 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 6 Appeal2014-004742 Application 11/279,925 wogonin and baicalein. FF2. 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. FF5---6. Marti teaches that catechin is contained in Acacia extracts. FF7-8. 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 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. FF5-9. Appellant next argues that the references fail to teach the use of enriched extracts. Appeal Br. 16. This argument is also not persuasive. 7 Appeal2014-004742 Application 11/279,925 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. Appellant argues that mere extraction does not inevitably lead to concentration or enrichment citing the Board's decision in Ex parte Jia, Appeal No. 2011-004053 ("Jia"). Appeal Br. 11; Reply Br. 5; Req. Reh'g 2. We note that the discussion in Jia referenced by Appellant deals with different references and different statutory provisions and is not controlling here. Moreover, in the analysis which follows, we use the definition for enriched put forth by Appellant. We do not equate extraction with enrichment. 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 as interpreted in light of the Specification, 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. FF5. According to Table 10, such an extract would have 19.61 % flavonoids whereas a water extract would have only 0.09% flavonoids. One skilled in the art reading the claims in light of the 8 Appeal2014-004742 Application 11/279,925 Specification would understand that the 70% methanol extract of Kubo is enriched vis a vis a water extract. Appellant argues that the Board engaged in impermissible hindsight in its analysis of the term enriched. Req. Reh'g 4--5. We disagree. As discussed above, the Board used the Specification to help construe the meaning of the term enriched. This is not an impermissible use of hindsight. Appellant also argues that Rosenbloom does not specifically teach the use of baicalin, 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. In the Request, Appellant points out that the Board failed to address the issue of whether Marti discloses an enriched extract of catechin. Req. Reh'g 6-7. Appellant argues that Marti does not disclose an enriched extract of catechin. Req. Reh'g 6-7. We are unpersuaded. As the Examiner noted, Marti discloses preparation of pure catechin from an extract from Acacia catechu. FF8. We agree with the Examiner that a pure extract of catechin meets the definition of an enriched extract. Ans. 5. Appellant argues that a purified compound is not the same as an extract. Reply Br. 6. Appellant, however, offers no evidence, other than attorney argument to support this position. We therefore find this argument 9 Appeal2014-004742 Application 11/279,925 unpersuasive. "Attorneys' argument is no substitute for evidence." Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Even if we were to accept Appellant's position that a pure compound is not an extract, we remain unpersuaded. Marti teaches that the pure compound is prepared by drying or evaporating an extract from Acacia catechu. FF8. One skilled in the art would understand that at some point during the evaporation process there exists an intermediate extract that has "an increased proportion or amount of' catechin that would be useful for treating inflammation. Thus, Marti teaches an enriched extract. 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 the request, Appellant argues that the board misapprehended the evidence of synergistic results. Req. Reh' g 8. For the reasons discussed 2 Declaration of Qi Jia, dated Nov. 6, 2006, filed Oct. 19, 2006. 10 Appeal2014-004742 Application 11/279,925 above, we are not persuaded. Moreover, as discussed below, Appellant's evidence of unexpected results is not commensurate with the scope of the claims. In the Request, Appellant argues that the Board failed to consider all of the evidence of unexpected results, specifically the discussion at pages 5- 8 of the Jia Declaration. Req. Reh'g 10. The Declaration at pages 5-8 refers to Univestin without identifying which Univestin composition is being discussed. Jia Deel. 5-8. As noted below, the Declaration identifies at least two different Univestin compositions, one of which is not within the scope of the present claims. Since it is unclear which compound is being discussed at the cited pages, the evidence is unpersuasive. In addition, we agree with the Examiner that the evidence of unexpected results is not commensurate with the scope of the claims. The Declaration only identifies three specific formulations, two containing Univestin and the other Soliprin. Jia 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 offlavonoids 3 Jia, US 2004/0220119 Al (published Nov. 4, 2004). Cited in the Jia Declaration as describing the composition of Soliprin. Jia Deel. 9. 11 Appeal2014-004742 Application 11/279,925 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. Appellant offers no evidence that the extracts from Oroxylum and Unicaria 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 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. 12 Appeal2014-004742 Application 11/279,925 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. In the Request Appellant argues that the ranges in claims 14 and 15 that the Declaration reports unexpected results for two ratios which fall within the ranges recited in claims 14 and 15. We are unpersuaded as the data is not commensurate with the scope of the claims. Appellant has not shown any persuasive evidence that the unexpected results would be seen throughout the range including the endpoints. CONCLUSION We have considered the arguments raised by Appellant in the Request, but find none of them persuasive that our original Decision overlooked any points raised by Appellant resulting in error. We have reconsidered our Decision but decline to grant the relief requested. This decision on Appellant's "Request for Rehearing" is deemed to incorporate our earlier Decision by reference. See 37 C.F.R. § 41.52(a)(l). DECISION We have granted Appellant's request to the extent that we have reconsidered our Decision and modified the Decision to clarify our rationale for affirming the Examiner's rejections. However, we deny the request with respect to making any changes to the outcome of the decision. We thus reiterate that that the Examiner's decision rejecting claims 1, 7, and 10-21 under 35 U.S.C. § 103(a) as unpatentable over Rosenbloom in view of Kubo and Marti remains AFFIRMED. 13 Appeal2014-004742 Application 11/279,925 Requests for extensions of time are governed by 37 C.F.R. § 41.52(b). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). REHEARING GRANTED-IN-PART 14 Copy with citationCopy as parenthetical citation