Broomhead, Jonathan et al.

Patent Trials and Appeals BoardSep 10, 2019

14044546 - (D) (P.T.A.B. Sep. 10, 2019)

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. 14/044,546 10/02/2013 Jonathan Broomhead 28958.07.0016 8678 23418 7590 09/10/2019 VEDDER PRICE P.C. 222 N. LASALLE STREET CHICAGO, IL 60601 EXAMINER LIU, SUE XU ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 09/10/2019 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): ABUFALINO@VEDDERPRICE.COM ipdocket@vedderprice.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JONATHAN BROOMHEAD, FANG CHI, RON CRAVENS, GEORGE ROBERT GOSS, RICHARD JAFFEE, SARA LEANN JOHNSTON, MICHAEL MCPHERSON, and RONDA JEAN WILLIAMS (APPLICANT: OIL-DRI CORPORATION OF AMERICA) ____________ Appeal 2019–003471 Application 14/044,5461 Technology Center 1600 ____________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and MICHAEL A. VALEK, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 87–152 (App. Br. 5). Examiner entered a rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants identify “Oil-Dri Corporation of America” as the real party in interest (App. Br. 3). Appeal 2019–003471 Application 14/044,546 2 STATEMENT OF THE CASE Appellants’ disclosure “relates to a mixture of clay, a yeast product and optionally, glutamate, and uses thereof, in particular for decreasing effects of an enteric disease” (Spec.2 ¶ 3). Claims 87 and 126 are representative and reproduced below: 87. A method for treating an enteric disease comprising a bacterial enteric disease comprising Necrotic Enteritis (NE) or mitigating the effects of exposure to a bacterial enteric disease causing organism comprising a Clostridium in an avian or pig susceptible to the enteric disease comprising administering to the avian or pig a composition comprising a mixture of 50 to 80% (w/w) of a Clostridium-toxin adsorbing smectite clay as a first ingredient of the composition, 10% (w/w) to about 35% (w/w) of a second ingredient of the composition consisting essentially of whole yeast, non-whole yeast yeast mannan, non- whole yeast yeast mannan oligosaccharide, non-whole yeast yeast beta glucan, non-whole yeast yeast cell component, non- whole yeast yeast cell wall or citric acid press cake, and about 5% (w/w) to about 10% (w/w) of a glutamate as a third ingredient of the composition, wherein the administering of the composition is from 100 to 1000 mg/kg body weight / day or the administering is through the composition being present in a feed in an amount comprising about 0.05% (w/w) to about 0.50% (w/w) of the feed, to thereby treat the bacterial enteric disease or mitigate the effects of exposure to the bacterial enteric disease causing organism comprising a Clostridium. (App. Br. 22 (emphasis added).) 126. A feed comprising a composition for treating an enteric disease comprising a bacterial enteric disease comprising Necrotic Enteritis (NE) or mitigating the effects of exposure to a bacterial enteric disease causing organism comprising a Clostridium in an avian or pig susceptible to the enteric disease comprising a mixture of 50 to 80% (w/w) of a Clostridium- toxin adsorbing smectite clay as a first ingredient of the 2 Appellants’ October 2, 2013 Specification. Appeal 2019–003471 Application 14/044,546 3 composition, 10% (w/w) to about 35% (w/w) of a second ingredient of the composition consisting essentially of whole yeast, non-whole yeast yeast mannan, non-whole yeast yeast mannan oligosaccharide, non-whole yeast yeast beta glucan, non-whole yeast yeast cell component, non-whole yeast yeast cell wall or citric acid press cake, and about 5% (w/w) to about 10% (w/w) of a glutamate as a third ingredient of the composition, wherein the composition is present in the feed in an amount comprising about 0.05% (w/w) to about 0.50% (w/w) of the feed. (Id. at 25–26 (emphasis added).) Claims 87–152 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Holzgraefe,3 Darlington,4 Amlan,5 Hofshagen,6 Weese,7 Howes,8 and Watanabe.9 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 3 Holzgraefe et al., US 2007/0048432 A1, published Mar. 1, 2007. 4 Darlington, Jr., et al., US 2010/0272769 A1, published Oct. 28, 2010. 5 Amlan International, Calibrin-Z, available at http://web.archive.org/web/20091019094809/http://www.amlan.com/cal- z.html, last accessed June 27, 2015. 6 Hofshagen et al., Toxin Production by Clostridium Perfringens Isolated from Broiler Chickens and Capercaillies (Tetrao urogallus) with and without Necrotizing Enteritis, 36 Avian Dis. 837–43 (1992). 7 Weese et al., Evaluation of the Ability of Di-tri-octahedral Smectite to Adhere to Clostridium difficile Toxins and Clostridium perfringens Enterotoxin In Vitro, 48 AAEP Proceedings 127–30 (2002). 8 Howes et al., US 6,045,834, issued Apr. 4, 2000. 9 Watanabe et al., EP 2 314 172 A1, published Apr. 27, 2011. Appeal 2019–003471 Application 14/044,546 4 FACTUAL FINDINGS (FF) FF 1. Holzgraefe discloses methods and compositions for increasing production in animals by feeding the animals a composition which includes a soluble dextrin product. The composition may be fed to the animal in the form of a complete feed, a concentrate, a pre-mix, and a top-dress and may be in either a liquid or solid formulation. (Holzgraefe, Abstract (emphasis added); see Final Act.10 5.) FF 2. Holzgraefe discloses that its “soluble dextrin product may . . . be fed to the animal as a feed composition in conjunction with at least one other product, such as, for example, a mannanoligosaccharide product” (Holzgraefe ¶ 38 (emphasis added)). FF 3. Holzgraefe discloses that “[m]annanoligosaccharide products . . . comprise oligosaccharides” and that “[o]ligosaccharides suitable for use in combination with the soluble dextrin product according to certain non- limiting embodiments of the present disclosure may include, . . . yeast cultures” (Holzgraefe ¶ 39 (emphasis added); see id. ¶ 40 (Holzgraefe defines “the term ‘yeast culture’ . . . as the product comprising mycelium of yeast fermentation and the media on which it was grown, such as, for example, a presscake”); id. ¶ 42 (Holzgraefe’s presscake may be a “citric acid press cake”); see Final Act. 5.) FF 4. Holzgraefe discloses that “where the soluble dextrin product is fed to the animal in the form of a complete feed, the soluble dextrin product may comprise from 0.1% to 2.0% by weight of the complete feed product” (Holzgraefe ¶ 34; see id. ¶ 35 (Holzgraefe discloses “where the soluble dextrin product is fed to the animal in the form of a concentrate, the soluble 10 Examiner’s October 4, 2017 Final Office Action. Appeal 2019–003471 Application 14/044,546 5 dextrin product may comprise from 0.28% by weight to 10% by weight of the concentrate” and “[t]he concentrate may be used in the final complete feed at from 10% by weight to 35% by weight of the final complete feed composition”); id. ¶ 36 (Holzgraefe discloses “where the soluble dextrin product is in the form of a pre-mix, the soluble dextrin product may comprise from 2% by weight to 50% by weight of the pre-mix” and “added to the feed product in an amount comprising 2% by weight to 5% by weight of the final complete feed”); id. ¶ 37 (Holzgraefe discloses “where the soluble dextrin product is in the form of a top-dress . . . the soluble dextrin should be top-dressed on an animal feed composition or product in an amount that is equivalent to soluble dextrin concentrations of 0.1% to 2.0%, by weight”)). FF 5. Holzgraefe exemplifies nursery swine complete feed compositions comprising a mannanoligosaccharide product, CitriStimTM, at a concentration of 0.2% by weight of the composition (Holzgraefe ¶ 96; see generally Final Act. 5). FF 6. Holzgraefe discloses that the animal feed composition comprising the soluble dextrin is capable of decreasing the growth of E. coli, Salmonella, Clostridium and/or other harmful bacteria of combination of bacteria in the gastrointestinal tract, such as, for example, in the latter portions of the gastrointestinal tract (i.e., the large intestine) of an animal upon feeding the animal feed composition comprising the soluble dextrin to the animal. (Holzgraefe ¶ 50; see id. at 18: claim 5; see Final Act. 5.) FF 7. Examiner finds that Holzgraefe does not teach a composition comprising clay or monosodium glutamate (see Final Act. 5 and 6). Appeal 2019–003471 Application 14/044,546 6 FF 8. Darlington discloses layered phyllocilicates, such as smectite clay, “are useful for adsorbing and/or binding to and, thereby, inactivating viruses, bacteria and fungi” and “methods of inactivating a virus, bacteria or fungus and methods of treating a viral, bacterial or fungal infection” (Darlington, Abstract; id. ¶ 81; see Final Act. 5–6). FF 9. Darlington discloses that its layered phyllosilicates may be administered to avian and swine species (Darlington ¶ 24; see also id. ¶ 39 (Darlington discloses compositions comprising layered phyllosilicates and a therapeutic agent, such as, inter alia, an antimicrobial agent, an extracellular matrix component, a cellular component, and a biological agent); see also Final Act. 6). FF 10. Darlington’s preferred layered phyllosilicate is a smectite clay, including but not limited to a montmorillonite clay, that is predominantly (greater than about 50% by weight) sodium or calcium (sodium or calcium ions outnumber any other cation in the interlayer spaces between adjacent clay platelets) montmorillonite clay so that the concentration of clay dispersed in water can be as high as about 15% by weight. (Darlington ¶ 81; see Final Act. 5–6.) FF 11. Darlington discloses that its layered phyllosilicate material “is used to treat or prevent infections caused by Gram-positive bacilli including, . . . Clostridium sp. (e.g., Clostridium botulinum, Clostridium botulinum, Clostnidium perfringens, Clostnidium tetani)” (Darlington ¶ 112; see Final Act. 6). FF 12. Examiner relies on Amlan to disclose “Calibrin-Z . . . a highly- refined montmorillonite sorbent mineral that has a high affinity and capacity Appeal 2019–003471 Application 14/044,546 7 to sequester the most common mycotoxins found in feed grains and forages worldwide, particularly zearalenone” (Final Act. 6). FF 13. Examiner relies on Hofshagen to disclose that “C. perfringens may be an important etiological factor in the development of necrotizing enteritis” (Final Act. 6). FF 14. Weese discloses that “di-tri-octahedral smectite was effective in neutralizing Clostridium difficile toxins A and B as well as Clostridium perfringens enterotoxin in vitro” and “may be a useful option for the treatment of clostridial colitis in horses” (Weese, Abstract; see Final Act. 6). FF 15. Howes discloses: A method of removing mycotoxins from animal feeds is described whereby a combination of a modified yeast cell wall extract and a mineral clay is fed to animals in amounts sufficient to inactivate mycotoxins present in the feeds. The yeast cell wall extract/clay mixture may be admixed with feeds, incorporated directly into pelleted feeds, or fed directly to animals. (Howes, Abstract; see Final Act. 6.) FF 16. Watanabe discloses: [A]n additive for livestock feed and constitutions of a feed composition for livestock to improve the feed conversion ratio and the body weight gain efficiency by increasing the feed intake of livestock. The feed intake of livestock can be increased by an additive for livestock feed, which comprises monosodium L-glutamate and L-tryptophan, wherein a mass ratio of free monosodium L-glutamate (provided that all converted into monosodium L-glutamate monohydrate) and free L-tryptophan (GLU/TRP ratio) is from 0.5 to 30. (Watanabe, Abstract; see Final Act. 6–7.) Appeal 2019–003471 Application 14/044,546 8 ANALYSIS Based on the combination of Holzgraefe, Darlington, Amlan, Hofshagen, Weese, Howes, and Watanabe, Examiner concludes, inter alia, that, at the time Appellants’ invention was made, it would have been prima facie obvious to formulate a composition, for administration to animals, comprising a citric acid presscake, as disclosed by Holzgraefe, smectite clay, as disclosed by Darlington, and monosodium L-glutamate, as taught by Watanabe (see Final Act. 7–8). In this regard, Examiner reasons that “[r]outine optimization of concentrations based on the suitable amounts already disclosed in the prior art references is also prima facie obvious and reasonably expected to succeed” (Final Act. 7–8). We are not persuaded. Initially, we note that Holzgraefe discloses that a citric acid presscake is an example of a mannanoligosaccharide product, which is distinct from Holzgraefe’s soluble dextrin product (see FF 1–3; cf. App. Br. 8 (Appellants contend that “the yeast relied on in . . . [Examiner’s Final Office Action] is only one of a laundry list of possible dextrins of the Holzgraefe composition”); Ans. 5 (Examiner finds that “[o]ne would be motivated to optimize the amount of yeast in order to make an effective composition which has sufficient amounts of dextrin product such as critric acid presscake that may be added to animal feed at a convenient effective amount[]”)). In addition, although Holzgraefe provides an extensive disclosure of concentration ranges for its dextrin product (see e.g., FF 4), Examiner does not identify a disclosure in Holzgraefe of the mannanoligosaccharide product, i.e. citric acid presscake, concentration. Nevertheless, we find that Appeal 2019–003471 Application 14/044,546 9 Holzgraefe discloses a composition comprising a mannanoligosaccharide product at a concentration of 0.2% by weight of the composition (see FF 5). Examiner, however, fails to identify an evidentiary basis on this record to support a conclusion that even if the citric acid press cake component of Holzgraefe’s composition was optimized, such optimization would have resulted in a citric acid presscake concentration within Appellants’ claimed range of 10% (w/w) to about 35% (w/w) (cf. Ans. 4–5 (Examiner incorrectly relies upon the concentration range provided for Holzgraefe’s dextrin product to establish a concentration range for Holzgraefe’s citric acid presscake). See In re Sebek, 465 F.2d 904, 907 (CCPA 1972) (Although “it may ordinarily be the case that the determination of optimum values for the parameters of a prior art process would be at least prima facie obvious, that conclusion depends upon what the prior art discloses with respect to those parameters.”). On this record, Examiner failed to establish an evidentiary basis to support a conclusion that optimizing Holzgraefe’s citric acid presscake concentration would result in the concentration recited in Appellants’ claims. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). Examiner further failed to establish an evidentiary basis to support a conclusion that any of Darlington, Amlan, Hofshagen, Weese, Howes, and Watanabe alone or in combination make up for the foregoing deficiency in Holzgraefe (see FF 8–16). Appeal 2019–003471 Application 14/044,546 10 For the foregoing reasons, we find that Examiner failed to establish a prima facie case of obviousness on this record. Therefore, we have not considered Appellants’ secondary evidence of non-obviouness (see Johnston Declarations11; see also App. Br. 12–19; Reply Br. 2–4). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 87–152 under 35 U.S.C. § 103(a) as unpatentable over the combination of Holzgraefe, Darlington, Amlan, Hofshagen, Weese, Howes, and Watanabe is reversed. REVERSED 11 First Declaration of Sara LeAnn Johnston, unsigned; Second Declaration of Sara LeAnn Johnston, signed August 4, 2016, and Third Declaration of Sara LeAnn Johnston, signed April 12, 2017.