Ex Parte LeBrun et alDownload PDFPatent Trial and Appeal BoardAug 21, 201813773971 (P.T.A.B. Aug. 21, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/773,971 02/22/2013 Jeffrey Richard LeBrun 86225 7590 08/23/2018 NYEMASTER GOODE P.C. 700 Walnut Street, Suite 1600 Des Moines, IA 50309-3899 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. 3007239-1031 (KEM 280) 3197 EXAMINER HENRY, MICHAEL C ART UNIT PAPER NUMBER 1673 NOTIFICATION DATE DELIVERY MODE 08/23/2018 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): ptomail@nyemaster.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEFFREY RICHARD LeBRUN, ROBERT LEVINE, and GEOFFREY PAUL HORST 1 Appeal2017-002781 Application 13/773,971 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, 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 an animal feed product, which have been rejected as obvious and as directed to patent- ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b ). We reverse. STATEMENT OF THE CASE "An over-dependence upon antibiotics in modem agriculture and human health has led to widespread antibiotic resistance and led to a desire 1 Appellants identify the Real Party in Interest as Algal Scientific Corporation. Appeal Br. 2. Appeal2017-002781 Application 13/773,971 for more natural ways to promote healthy immune function." Spec. ,r 4. "An example of a compound used to stimulate immune system activity is beta glucan." Id. ,r 7. "Beta glucan products are currently derived primarily from yeast." Id. The Specification discloses "a composition comprising an effective amount of beta glucan produced by an algae or protist such as Euglena, where the composition is used to improve the well-being of an animal. Lower-cost beta glucan feed additives produced using algae therefore provide affordable and natural alternatives to antibiotics." Id. ,r 19. "The beta glucan produced by Euglenoids is unique in its physical characteristics and is often referred to as 'paramylon. '" Id. ,r 46. "Euglena are capable of heterotrophic and photosynthetic metabolisms." Id. ,r 64. For example, "Euglena gracilis can be grown heterotrophically in a controlled environment (through the manipulation of carbon source, nutrient levels, pH, temperature, and other factors), centrifuged or filtered to remove it from the water, and dried." Id. ,r 80. Claims 17, 21, 24--26, 28, 40, 41, 45, and 49 are on appeal. Claim 17 is the only independent claim and reads as follows: Claim 17: An animal feed product comprising (i) heterotrophically grown Euglena comprising greater than 20 weight% beta-(1,3)-glucan, wherein the Euglena is grown and fermented in a fermenter under sterile conditions and dried to contain less than 10% moisture, and (ii) an animal feed component, wherein the beta-(1,3)-glucan is present in an amount from 0.001 % to 0.020% of the total weight of the animal feed product, and wherein the animal feed product is ingestible. 2 Appeal2017-002781 Application 13/773,971 The claims stand rejected as follows: Claims 17, 21, 26, 28, and 45 under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter (Ans. 2); Claims 17, 21, 24, 26, 28, 40, 41, and 45 under 35 U.S.C. § I03(a) as obvious based on Tuse, 2 Hayen, 3 and Takigawa4 (Ans. 4); Claim 25 under 35 U.S.C. § I03(a) as obvious based on Tuse, Hayen, Takigawa, and Matsuoka5 (Ans. 4); and Claim 49 under 35 U.S.C. § I03(a) as obvious based on Tuse, Hayen, Takigawa, and Shi6 (Ans. 4). I The Examiner has rejected claims 17, 21, 26, 28, and 45 under 35 U.S.C. § 101, on the basis that: The claims are drawn to a composition that has natural products as a claim limitation. . . . [T]his natural product is a judicial exception(s) that is recited or involved in the claim, and the features ... in addition to the judicial exception(s)[] in the claim do not result in the claim as a whole reciting something significantly different than the judicial exception itself. Ans. 2-3. Specifically, the use of animal feed component( s) which includes substances such as water, nutrients or supplements such as mineral and vitamins in the composition is common in the art, ... [ and] there is no significant difference between the claimed product 2 US 5,084,386; Jan. 28, 1992. 3 US 6,214,337 Bl; Apr. 10, 2001. 4 JP 2001275654 (A); Oct. 9, 2001. The record copy of Takigawa is in Japanese, but includes an English abstract. 5 US 5,174,821; Dec. 29, 1992. 6 US 2010/0272940 Al; Oct. 28, 2010. 3 Appeal2017-002781 Application 13/773,971 and the naturally occurring product comprising the same compounds of the same structure. Id. at 3. Appellants argue: Dr. Horst indicates that the Euglena recited in claim 17 is grown differently than Euglena found in nature, and is also structurally different from Euglena found in nature .... Fermentation makes it possible to grow Euglena having more than 20 weight% beta-(1,3)-glucan .... In contrast, Euglena found in nature that has been dried to contain less than 10% moisture does not have more than 20 weight% beta-(1,3)- glucan. Thus, the Euglena recited in claim 17 is structurally distinct from Euglena found in nature. Appeal Br. 3, citing the Horst Declaration. 7 Appellants also argue that "[b] ecause the E ugl ena recited in claim 1 7 contains a higher amount of beta- (1,3 )-glucan than Euglena found in nature, the Euglena recited in claim 17 has higher potency than Euglena found in nature. As such, the Euglena recited in claim 17 is also functionally different from Euglena found in nature." Id. at 4. We agree with Appellants that the rejection is not supported by a preponderance of the evidence. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) ("[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prim a f acie case of unpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the 7 Declaration under 37 C.F.R. § 1.132 of Geoffrey Horst, filed Nov. 16, 2015. 4 Appeal2017-002781 Application 13/773,971 record, by a preponderance of evidence with due consideration to persuasiveness of argument."). Here, Appellants have submitted declaratory evidence to show that "the Euglena of the current claims differs from Euglena found in nature." Horst Deel. ,r 3. That is, "Euglena found in nature does not grow by fermentation, nor under sterile conditions, and has not been dried to contain less than 10% moisture and to have more than 20 weight % beta-(1,3)- glucan. As such, [Dr. Horst] believe[s] that the Euglena of the current claims is structurally different from Euglena found in nature." Id. ,r 4. More specifically, "[t]he Euglena of the current claims is golden-yellow in color, as a product of fermentation. In contrast, Euglena found in nature is green in color, as a product of photosynthesis." Id. ,r 5. Dr. Horst's testimony is consistent with the Specification's disclosure. See Spec. ,r 23 ("Under optimized growth conditions, it is possible to achieve concentrations of beta glucan where the net beta glucan weight is greater than 20% to 80% of the total dry weight proportion of the biomass." ( emphasis added)); id. ,r 94 ("The Euglena can also be grown in an optimal manner such that the beta glucan portion of the algae product comprises greater than 20% of the algae biomass, as measured on a dry weight basis."). The Examiner responded that, "although Appellant claims that the Euglena is fermented, the said fermented Euglena is not considered different from the Euglena that occurs in nature especially since it is still referred to as Euglena." Ans. 11. The Examiner states that "it does not matter how the Euglena is grown, especially since it occurs in nature. The declaration has not indicated or provide any convincing data or information which clearly 5 Appeal2017-002781 Application 13/773,971 indicates that the claimed fermented Euglena is different from the Euglena that occurs in nature." Id. at 12. Appellants, however, have presented evidence that the Euglena recited in the claims differ from Euglena as they occur in nature. Dr. Horst has testified that Euglena found in nature is structurally different from the Euglena recited in the claims, at least because naturally occurring Euglena do not have more than 20 weight % B-(1,3)-glucan and are a different color from the Euglena required by the claims. The Examiner has not pointed to evidence supporting a contrary finding. The Examiner, however, reasons that "different species of Euglena would be expected to have different% by weight ofbeta-(1,3)-glucan such as more than 20 weight% beta-(1,3)-glucan." Ans. 13. The Examiner directs attention to Valensa, 8 "which indicates that Euglena having 65% weight beta-(1,3)-glucan ... can be obtained from nature or a natural source without any additional processing." Id. These lines of reasoning do not persuade us that the rejection is supported by a preponderance of the evidence. The Examiner does not point to any evidence of a species of Euglena having more than 20 weight% beta- (1,3)-glucan as it occurs in nature. Regarding Valensa, we do not find the evidence persuasive as support for the Examiner's position. Valensa discloses "a proprietary, new form of beta glucan for the human health 8 Valensa International, "Valensa Introduces 1,3 Beta Glucan Targeting Immune Health Formulations," http://www. pmewswire. com/news- releases/valensa-introduces-13-beta-glucan-targeting-immune-health- formulations-277583101.html. The Examiner made the reference of record as an appendix to the Office Action mailed Oct. 19, 2016. 6 Appeal2017-002781 Application 13/773,971 market. Called IMMUNUM™ PRO, the new ingredient is a harvested Euglena algae that delivers 2:65% 1,3 beta glucan by weight - the highest level of beta glucan provided by any natural source without additional processing." Valensa 1. However, Valensa also states that "IMMUNUM PRO harvesting is carried out via a proprietary closed-reactor technology for growing Euglena algae with a high 1,3 beta content." Id. at 2. Thus, Valensa does not provide evidence that Euglena grown under natural conditions has a B-(1,3)-glucan content of more than 20 weight%. In summary, we conclude that the rejection under § 101 is not supported by a preponderance of the evidence of record. We therefore reverse that rejection. II The Examiner has rejected all of the claims as obvious based on Tuse, Hayen, and Takigawa, either by themselves or combined with either Matsuoka or Shi. The same issue is dispositive for all of the obviousness rejections. The Examiner finds that Tuse discloses beta-(1,3)-glucan obtained from Euglena. Ans. 4. The Examiner finds that Tuse also discloses that beta-(1,3)-glucan is an immunostimulant (id. at 5) and discloses compositions comprising 0.01 to 1.0% by weight beta-(1,3)-glucan (id. at 4). The Examiner also finds that Tuse discloses that Euglena can be grown so that "the cell mass of the Euglena compris[ es] 70% to 90% beta-1,3-glucan ... on a dry weight basis." Id. at 5. The Examiner finds that Tuse does not disclose an animal feed composition that comprises Euglena cells, but Hayden discloses that "a beta- 7 Appeal2017-002781 Application 13/773,971 glucan can be added to an animal feed that is administered to animals" and Takigawa discloses that "Euglena algae (algae biomass) are edible algae that can be used as food proteins and livestock feed (animal feed)." Id. at 5---6. The Examiner concludes that the claimed product would have been obvious based on these disclosures. Id. at 6-7. Appellants argue, among other things, that they have presented evidence that "low doses ofbeta-(1,3)-glucan unexpectedly provide a more positive effect on animal health than do larger amounts ofbeta-(1,3)- glucan." Appeal Br. 8. Appellants cite the Levine Declaration9 as evidence that the dose of Euglena beta-(1,3)-glucan recited in the claims results in better feed conversion ratios and antibody titers when it was included in animals' feed. Id. at 8-10. The Levine Declaration presents data from three experiments. In Example 1, chickens were fed a feed preparation containing no beta glucan ( control), or containing Euglena beta glucan at either 0.009 wt% or 0.026 wt%. Id. ,r 6.1.1. "Body weight and feed conversion ratios were calculated at days 14, 28, and 42." Id. ,r 6.1.2. The results showed that "[b ]roilers fed beta glucan at an inclusion ration of 90 g/ton [0.009 wt%] showed a significant decrease (p<0.05) in mortality corrected feed conversion ratio in the starter diet as compared to the control diet, whereas broilers fed 260 g/ton [0.026 wt%] beta glucan did not show significant improvement." Id. ,r 6.1.6. Dr. Levine concludes from these data that 9 Declaration under 37 C.F.R. § 1.132 of Robert Levine, filed Oct. 30, 2014. 8 Appeal2017-002781 Application 13/773,971 the dose-response relationship for beta glucan from Euglena is not a simple linear function where more is better-rather, there is a very narrow window in which the beta glucan has an optimal effect and above this window there is no positive effect or there can be a negative effect. The present invention in related to using beta glucan from Euglena within this narrow window. Id. In the same experiment, the chickens were given Newcastle/Bronchitis vaccine and "[b ]irds fed diets containing 90 g/ton beta glucan showed a significantly higher level of antibody titers than the control diet at day 25, whereas broilers fed 260 g/ton beta glucan did not show significant improvement in antibody levels compared to the control." Id. ,r,r 6.1.3, 6.1.8. Dr. Levine concludes that "low doses of B-1,3-glucan from Euglena unexpectedly improves animal health. Id. ,r 6.2. The Levine Declaration also describes a second experiment, in which chickens were fed different amounts ofbeta-(1,3)-glucan from Euglena. Id. ,r,r 7.1-7.8. Dr. Levine testified that "[t]reatment 2, which received 45 g/MT [0.0045 wt%] beta glucan for the full 49 days, demonstrated the largest improvement in performance relative to the control group (treatment 1 ): the growth rate was 3.4% faster and the mortality-adjusted feed conversion ratio was 1.9% lower." Id. ,r 7.3. Dr. Levine states that, "[fJor a commercial producer, this is a tremendous improvement that is highly sought after in a competitive marketplace." Id. In the same experiment, treatment 6, [using] 180 g/MT [0.018 wt%] beta glucan in the starter diet and no subsequent exposure resulted in an overall 3.4% improvement in growth rate with a 0.5% mortality adjusted improvement in the FCR [ feed conversion ratio]. For treatment 7, when 90 g/MT [0.009 wt%] beta glucan was used 9 Appeal2017-002781 Application 13/773,971 in the starter, 45 g/MT [0.0045 wt%] in the grower, and none in the finisher feed, overall growth rates were increased 2.0% and mortality adjusted FCR was improved 0.2% relative to the control. Dr. Levine testified that "the use of beta glucan at only low doses (i.e., 45 g/MT) or at moderately higher doses for just a brief time (i.e., 180 g/MT for the first two weeks of life) has surprisingly been found to improve feed efficiency and increase growth rates in animals." Id. ,r 7 .8. Finally, the Levine Declaration reports an experiment in which pigs were "vaccinated with Porcine circovirus type 2 (PCV2) and M hyopneumoniae vaccines" and then fed one of five diets: "(1) a negative control diet; (2), (3), (4) and (5) were the [same] diet with 45, 90, 180, 260 g/MT beta glucan added." Id. ,r 8.1. Antibody titers were later measured. Id. ,r 8.2. The results showed that "[t]he treatment group receiving 45 g/MT beta glucan showed the greatest numerical increase in antibody titers compared to the control group." Id. Dr. Levine testified that Id. [t]his result was unexpected, since with the increasing inclusion of beta glucan was thought to increase specific immune response. These data show again that at low doses of beta glucan from Euglena, immunomodulation that conferred a positive benefit on the animal was unexpectedly achieved. In contrast, at higher doses of beta glucan (in this case, above 180 g/MT) there was actually a negative effect. Thus, Appellants' evidence shows that feeding animals a diet containing beta-(1,3)-glucan from Euglena at doses within those recited in claim 17-specifically 0.0045 wt%, 0.009 wt%, and 0.018 wto/o-resulted in higher feed conversion ratios and higher antibody titers when compared to 10 Appeal2017-002781 Application 13/773,971 animals fed a diet containing either no beta-(1,3)-glucan or a diet containing beta-(1,3)-glucan at a dose higher than what is recited in claim 17. Dr. Levine testified that these results were unexpected and commercially significant. The Examiner responded to Appellants' unexpected results argument and evidence as follows: [A] 260 g/ton beta glucan is 0.026% ... which is significantly or substantially close to (especially within experimental error) the claimed range of 0.001 % to 0.02% recited in Appellant[s'] claims. That is, Appellant's arguments or declaration which are presented to show unexpected or unforeseen results is not commensurate with the scope of the claims or convincing. It should be noted that if appellant intends to rely on unexpected or unforeseen results, attention is invited to M.P .E.P. § 716. Absent clear, convincing, side-by-side data demonstrating unobviousness vis-a-vis the prior art commensurate with the scope of protection sought, the claims are considered prima facie obvious. Thus, the [Levine] Declaration ... is insufficient to overcome the ... 103(a) rejections. Ans. 24. We agree with Appellants that the rejections on appeal are not supported by a preponderance of the evidence of record. As discussed above, the Levine Declaration presents evidence that animals fed a diet containing beta-(1,3)-glucan from Euglena at doses ranging from 0.0045 wt% to 0.018 wt% showed higher feed conversion ratios and higher antibody titers, compared to animals fed a diet without beta-(1,3)-glucan or a diet containing higher levels ofbeta-(1,3)-glucan than required by the claims. See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) ("If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling 11 Appeal2017-002781 Application 13/773,971 within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims."). The Examiner's reasoning does not show that Appellants' evidence is not commensurate in scope with the claims. If anything, the fact that Appellants' comparison was to an amount ofbeta-(1,3)-glucan that is close to--but not within-the claimed range shows the criticality of including beta-(1,3)-glucan from Euglena within the dosage range recited in the claims in order to increase feed conversion ratios and antibody titers. Thus, we conclude that the § 103 rejections on appeal are not supported by a preponderance of the evidence of record. SUMMARY We reverse all of the rejections on appeal. REVERSED 12 Copy with citationCopy as parenthetical citation