Ex Parte Zhang et alDownload PDFBoard of Patent Appeals and InterferencesMar 30, 201111122265 (B.P.A.I. Mar. 30, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte DE-CHENG ZHANG, CAN-JUN LI, JIA-SHI ZHU, and HOWARD SUN ____________ Appeal 2010-011750 Application 11/122,265 Technology Center 1600 ____________ Before TONI R. SCHEINER, DONALD E. ADAMS, and JEFFREY N. FREDMAN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1-14.1 We have jurisdiction under 35 U.S.C. § 6(b). 1 Pending “[c]laims 15-46 have been withdrawn subject to a[] restriction requirement” (App. Br. 5). Appeal 2010-011750 Application 11/122,265 2 STATEMENT OF THE CASE The claims are directed to a method of inhibiting IL-5 secretion in a subject. Claim 1 is representative and is reproduced below: 1. A method of inhibiting IL-5 secretion in a subject comprising: (a) providing a composition consisting essentially of a therapeutically effective amount of reishi extract, and (b) administering the composition to the subject. The rejections presented by the Examiner follow: 1. Claims 1, 3, 13, and 14 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Soo.2 2. Claims 2 and 4-12 stand rejected under 35 U.S.C § 103(a) as unpatentable over the combination of Soo, Chung,3 and Hobbs.4 We affirm. Anticipation: ISSUE Does the preponderance of evidence on this record support the Examiner’s finding that Soo teaches the claimed invention? FACTUAL FINDINGS FF 1. Soo teaches the treatment of patients with reishi fruit extract (Soo 406-410; Ans. 4). FF 2. Soo teaches that the effective dose of reishi extract ranges from 1.5 - 9 grams per day (Soo 405: Abstract). 2 Teow Sun Soo, Effective Dosage of Ganoderma Nutriceuticals in the Treatment of Various Ailments, Abstract, Taipei International Convention Center (TICC), 403-412 (1996). 3 Chung et al., US 6,893,641 B2, issued May 17, 2005. 4 MUSHROOMS: An Exploration of Tradition, Healing, & Culture 96-107 (Christopher Hobbs, L.Ac., ed., Botanica Press, Santa Cruz, California, U.S.) (1995). Appeal 2010-011750 Application 11/122,265 3 FF 3. Appellants disclose that the term “‘therapeutically effective amount’ refers to a non-toxic, but sufficient amount of an active agent, to achieve therapeutic results in treating a condition for which the active agent is known to be effective” (Spec. 5: 17-19). FF 4. Appellants disclose that “the reishi composition may be administered in an amount and frequency sufficient to provide a daily dosage of from about 1 to 2 grams of reishi extract” (Spec. 12: 22-24). ANALYSIS Appellants contend that while Soo teaches the administration of reishi extract in amounts necessary to treat a variety of ailments, the Examiner failed to establish that Soo teaches the administration of an amount of reishi extract that is effective to inhibit IL-5 secretion (App. Br. 11). We are not persuaded. Instead, we agree with the Examiner’s rationale that Soo’s administration of an amount of reishi extract to achieve therapeutic results in treating a condition for which the reishi extract is known to be effective (i.e., a therapeutic amount of reishi extract as the term is defined by Appellants) will “inherently inhibit IL-5 secretion in a subject” (Ans. 3; see also FF 3). More specifically, we find that Soo’s teaching of an effective dosage in the range of from 1.5-9 grams per day encompasses Appellants’ disclosed range of about 1-2 grams per day (Cf. FF 2 and FF 4). For the foregoing reasons we are not persuaded by Appellants’ contentions regarding the treatment of asthma and/or allergy (App. Br. 11-13; Reply Br. 6-9). CONCLUSION OF LAW The preponderance of evidence on this record supports the Examiner’s finding that Soo teaches the claimed invention. The rejection of claim 1 under 35 U.S.C. § 102(b) as being anticipated by Soo is affirmed. Appeal 2010-011750 Application 11/122,265 4 Because they are not separately argued, claims 3, 13, and 14 fall together with claim 1. Obviousness: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? FACTUAL FINDINGS FF 5. The Examiner relies on Soo as discussed above (Ans. 4; see FF 1-2; see also FF 3-4). FF 6. The Examiner finds that Soo fails to teach a “composition including cracked reishi spores, polysaccharides, triterpenes, particular dosages or percentages of the reishi extract” (id.). FF 7. The Examiner relies on Chung to teach the oral administration of Ganoderma lucidum (e.g., reishi) spores to treat immunological disorders in mammals (id.). FF 8. The Examiner relies on Hobbs to teach “that polysaccharides and triterpenes are naturally found in the spores of Ganoderma lucidum” (Ans. 5). FF 9. Soo suggests that it is Of primary importance . . . [that] the source of G. lucidum, whether it is cultivated or from the wild, the strain and species used, the stage of maturation and the method of extraction of the product. If all products used are standardized then it will facilitate to help define the optimal dosage. (Soo 410: Conclusion.) Appeal 2010-011750 Application 11/122,265 5 FF 10. Soo suggests that reishi extract can be used to treat immunological disorders in mammals (Soo 409: “Lupus erythematosis” and 410: “Immunopotentiating effects”). ANALYSIS Appellants provide separate arguments for the following groups of claims: (I) claims 2, 4, and 9; and (II) claims 5-8 and 10-12. Claims 2 and 10 are representative. Claim 2: Claim 2 depends from and further limits the composition of claim 1 to include a cracked reishi spore extract. Having found no defect in Soo, we are not persuaded by Appellants’ contention that “Chung and Hobbs do not cure the defects of Soo” (App. Br. 16). We are also not persuaded by Appellants’ contention that Soo teaches away from the use of cracked reishi spores as taught by Chung (App. Br. 16- 18). Notwithstanding Appellants’ contentions to the contrary we do not find Soo to teach away from the use of cracked reishi spores simply because Soo utilizes reishi fruit extract and suggests that standardization of an optimal dosage will benefit from, inter alia, consistency in the stage of maturation and the method of extraction of the product (FF 9). Claim 10: We recognize, but are not persuaded by Appellants contentions with regard to claims 1 and 2 for the reasons set forth above (see App. Br. 18; see also Rely Br. 10). We also recognize Appellants’ recitation of the claim limitations of claims 5-8 and 10-12 (App. Br. 18-19). Appellants contend, however, that Appeal 2010-011750 Application 11/122,265 6 the various “ratios/amounts” found within these claims are not a matter of routine optimization because the Examiner has not established that IL-5 secretion can be inhibited “with a therapeutically effective amount of reishi” (App. Br. 19; Reply Br. 10-12). We find claim 10 representative of the claim grouping on this narrow issue. Claim 10 depends from and further limits the reishi extract of claim 1 to comprise (a) at least one triterpene compound, and (b) at least one polysaccharide compound. Appellants contend that no reference on this record suggests the treatment of IL-5 secretion with a reishi extract composition and therefore, no manner of optimization of a composition suggested by the combination of Soo, Chung, and Hobbs would suggest the invention of claim 10 (see App. Br. 19-20). We are not persuaded. The claimed method requires the administration of a reishi extract to a subject. Soo meets this requirement of the claim (FF 1 and 5). Soo suggests that reishi extract can be used to treat immunological disorders in mammals (FF 10). Chung also suggests the oral administration of Ganoderma lucidum, otherwise known as reishi, spores to mammals to treat immunological disorders (FF 7). Accordingly, we find no error in the Examiner’s reliance on Soo and Chung to suggest the treatment of immunological disorders in mammals with any of reishi fruit extract, reishi spores, or a combination of both. Claim 10 requires the reishi extract to comprise (a) at least one triterpene compound and (b) at least one polysaccharide compound. There is no dispute on this record that Hobbs teaches “that polysaccharides and triterpenes are naturally found in the spores of Ganoderma lucidum” (FF 8). Appeal 2010-011750 Application 11/122,265 7 All that remains is the requirement in claim 10, through its dependence on claim 1, that the amount of reishi extract composition be therapeutically effective. According to Appellants’ Specification, the term “‘therapeutically effective amount’ refers to a non-toxic, but sufficient amount of an active agent, to achieve therapeutic results in treating a condition for which the active agent is known to be effective” (FF 3 and 5). Since the combination of Soo, Chung, and Hobbs suggests the administration of an amount of a reishi extract composition that is non-toxic, but is sufficient to achieve a therapeutic result in treating a condition for which the reishi extract is known to be effect – i.e., an immunological condition – the requirement for a therapeutically effective amount of reishi extract is suggested by the combination of references relied upon by the Examiner. Taken together, claim 10 is, at best, the recognition of a new benefit - inhibition of IL-5 secretion - in the old process of treating immunological conditions with a therapeutically effective amount of a reishi extract composition. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990). Accordingly, we are not persuaded by Appellants’ contentions to the contrary. CONCLUSION OF LAW The preponderance of evidence on this record supports a conclusion of obviousness. The rejection of claims 2 and 10 under 35 U.S.C § 103(a) as unpatentable over the combination of Soo, Chung, and Hobbs is affirmed. Because they are not separately argued claims 4 and 9 fall together with claim 2; and claims 5-8, 11, and 12 fall together with claim 10. Appeal 2010-011750 Application 11/122,265 8 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 DEA cdc Copy with citationCopy as parenthetical citation