Ex Parte YUAN et alDownload PDFPatent Trial and Appeal BoardJul 3, 201813346426 (P.T.A.B. Jul. 3, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/346,426 01109/2012 10872 7590 07/06/2018 Riverside Law LLP Glenhardie Corporate Center, Glenhardie Two 1285 Drummers Lane, Suite 202 Wayne, PA 19087 FIRST NAMED INVENTOR Joshua (Shuhua) YUAN 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. 205972-0001-00-US.601251 4309 EXAMINER VANBUREN,LAURENK ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 07/06/2018 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): dockets@riversidelaw.com dcoccia@riversidelaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSHUA SHUHUA YUAN and SHANGXIAN XIE Appeal2017-005255 Application 13/346,426 Technology Center 1600 Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to a system for the production of a biological product. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Statement of the Case Background "Algae, especially microalgae, are a group of organisms that have received a great deal of interest during the current energy and fuel crisis, due in part to their relatively low cost to large biomass ratio" (Spec. 1 ). "[T]he 1 Appellants identify the Real Party in Interest as Renewuel LLC (see App. Br. 3). Appeal2017-005255 Application 13/346,426 fatty acid of algae can be extracted and used to generate biofuel (among other natural products and bioactive compounds)" (Id.). "Algae can be grown in a variety of systems. For example, algae can be grown in both open-culture systems, such as ponds, lakes and raceways. . . . Algae can also be grown in highly controlled closed-culture systems, similar to those used in commercial fermentation processes" (Id.). "In submerged cultivations, fungi can generally grow into two different morphologies, filamentous and pellet morphology, depending on culture conditions and medium compositions. The pellet morphology, as compared to filamentous morphology, can significantly decrease viscosity and enhance mixing and mass transfer, which can in tum greatly improve fermentation performance" (Spec. 2). "Despite the various advantages, the pelletization process is difficult to effectively control ... pelletization has seldom been used for improving the fermentation performance in a co- cultivation setting, due in part to the challenges in optimizing a more complex system" (Id.). "Therefore, a need exists for the development of a culturing system and method which provides for a more simplified harvest and increased yields" (Spec. 3). The Claims Claims 1-20 are on appeal. Independent claim 1 is representative and reads as follows: 1. A system for the production of a biological product, compnsmg: at least one fungus; at least one algae; and a growth medium, 2 Appeal2017-005255 Application 13/346,426 wherein the at least one fungus and at least one algae are co-cultivated in or on the growth medium to form a pellet in or on the growth medium during co-cultivation, such that at least 50% of the co-cultivated algae is contained within the pellet, and wherein the pellet contains the biological product. The Issues 2 A. The Examiner rejected claims 1-5 and 7-20 under 35 U.S.C. § 103(a) as obvious over Bijl3 and De Laat4 (Final Act. 6-12). B. The Examiner rejected claims 1, 5, and 6 under 35 U.S.C. § 103(a) as obvious over Bijl, De Laat, and Kock5 (Final Act. 12-13). C. The Examiner rejected claims 1 and 13 under 35 U.S.C. § 103(a) as obvious over Bijl, De Laat, and Khramtsov6 (Final Act. 13-14). A. 35 USC§ 103(a) over Bijl and De Laat The Examiner finds "Bijl teaches a system for the production of a biological product, comprising: at least one fungus (Col 3, ln 55---61); at least one algae (Col 3, ln 55---61); and a growth medium (Coll, ln 34--40)" (Final Act. 6). The Examiner finds "Bijl mentions that fungus and algae can be cultured together" (Final Act. 8). The Examiner acknowledges "Bijl does not expressly mention the desirability of forming pellets during the culturing process to produce a finished product" (Id.). 2 We note that claim 3 is objected to, but claim objections are not appealable. See MPEP § 706.01 ("rejection" appealable to Board; "objection" reviewed by way of petition to PTO Director). Accordingly, we decline to reach the merits of the Examiner's objection. 3 Bijl et al., US 6,255,505 Bl, issued July 3, 2001. 4 De Laat et al., US 2002/0039758 Al, published Apr. 4, 2002. 5 Kock et al., US 5,429,942, issued July 4, 1995. 6 Khramtsov et al., US 2009/0246844 Al, published Oct. 1, 2009. 3 Appeal2017-005255 Application 13/346,426 The Examiner finds "De Laat disclosed using a fermentation broth that encourages pellet formation" (Final Act. 8). The Examiner finds that De Laat "teaches that it is desirable to use Delaat' s medium in order to cause the fungi to produce a more rigid pellet formation" (Id.). The Examiner finds the combination obvious because De Laat teaches "it would be desirable to encourage pellet formation in order to enhance product formation" (Final Act. 8) and because "when using a culture system to make pellets it would have been obvious that when culturing the fungi and algae together and encouraging rigid pellet formation and low viscosity, it would have been obvious for at least 50% of the algae to wind up in the pellets" (Final Act. 12). The issues with respect to anticipation are: (i) Does the evidence of record support the Examiner's conclusion that Bijl and De Laat render obvious a method that produces a pellet comprised of co-cultivated fungus and algae where "at least 50% of the co- cultivated algae is contained within the pellet" as required by claim 1? (ii) Does the evidence of record support the Examiner's conclusion that Bijl and De Laat render obvious a method requiring "pre-culturing at least one fungus for at least four hours" as require by claim 15? Findings of Fact 1. Bijl teaches "a polyunsaturated fatty acid-(PUFA) containing oil, especially to a pure and stable microbial oil containing at least one polyunsaturated fatty acid. This oil can be obtained from a biomass or fermentation broth" (Bijl 1 :9-13). 2. Bijl teaches the "microbial biomass from which the oil of the invention can comprise, or originate from, any type of microorganism able 4 Appeal2017-005255 Application 13/346,426 to produce a PUP A - containing oil, for example a bacterium, a, yeast, a fungus or an algae (or a mixture thereof) ... Algae include dinoflagellates (e.g. those of the genus) Crypthecodinium" (Bijl 3 :57---65). 3. Bijl teaches "10 1 of a fermentation broth of the fungus Mortierella alpina and 10 1 of a fermentation broth of Crypthecodinium cohnii were mixed together. . . . The mixed broth was filtered and the resulting cake was mechanically dewatered" (Bijl 25: 15-21 ). 4. De Laat teaches In industrial fermentation processes, filamentous microorganisms, like filamentous bacteria such as Actinomycetes or filamentous fungi such as Penicillium or Aspergillus, typically are grown having a pellet morphology. In that regard, proteins and peptides present in complex fermentation media have the tendency to produce fluffy pellets, which easily fall apart to dispersed mycelium with very long and branched hyphae as a consequence of the high growth rates which typically are obtained using complex media. Therefore, a fluffy pellet morphology generally may cause a[ n] undesirably high broth viscosity. The use of chemically defined media has a favorable influence on morphology, for instance by producing a more rigid pellet which does not easily fall apart during fermentation. In this way, a significant decrease of the viscosity of filamentous fermentation broths may be obtained using chemically defined media. Since a low viscosity of the fermentation broth is advantageous for product formation, control of viscosity is of the utmost importance in industrial scale fermentation processes. (De Laat ,-r 28). 5. De Laat teaches: "Aspergillus niger strain CBS 513.88 or a mutant thereof is inoculated at 105-106 conidiospores/ml in a germination medium ... The culture is incubated in an orbital shaker for 48-72 hours at 5 Appeal2017-005255 Application 13/346,426 33° C., 295 rpm and then used to inoculate 10-20 volumes of a production medium" (De Laat i-fi-f 118-119). 6. The Yuan Declaration 7 states attempts were made to form pellets of co-cultivated fungi and algae using the methods described by Liu (paragraph [0051 ]). In a first attempt, pellets of P. chrysosporium alone were first generated and these fungal pellets were then co-cultivated with C. vulgaris at different ratios ( 1 :2, 1: 1, 2: 1) to carry out the co- cultivation for 2-7days both at 39°C, 200rpm and 28°C, I 50 rpm. As shown in Figure A below, the two species of P. chrysosporium and C. vulgariscan did not achieve co- pelletization during co-cultivation. (Yuan Deel. i-f 10). 7 The Yuan Declaration states: In a second attempt, P. chrysosporium was first incubated in a malt agar plate to form spores. Then the P. chrysosporium spores were directly mixed with C. vulgariscan at different ratios (1 :2; 1: 1; 2: 1 ), and then cultured according to the methods described by Liu (paragraph [0051 ]). Again, the resulting culture could not effectively co-pelletize the fungus and algae. (Yuan Deel. i-f 10). 8. The Yuan Declaration states: "In our opinion, the particular interactions specifically between fungi and algae, in combination with the complexities and unpredictable nature of forming pellets, makes pelletization processing of fungus alone, such as described in Liu, inadequate for co-pelletizing fungus with algae, and this was demonstrated experimentally" (Yuan Deel. i-f 13). 7 Declaration of Dr. Yuan and Mr. Xie, dated October 28, 2012. 6 Appeal2017-005255 Application 13/346,426 9. The Specification teaches in one embodiment of the present invention, the algae species can first be pre-cultured prior to co-cultivation. In another embodiment of the present invention, the fungi species can be pre-cultured prior to co-cultivation. In still other embodiments, both the algae and fungi are pre-cultured. Of course, neither the algae nor the fungi are required to be pre-cultured, as preculturing is an optional step. (Spec. 13). Principles of Law "Inherency ... may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). "[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed." In re Zietz, 893 F.2d 319, 321 (Fed. Cir. 1989). Analysis Claim 1 Appellants contend that because of "the significant unpredictability associated with the formation of pellets from fungus, no less from co- cultivated fungus and algae, the rejection of the claims under § 103 could only have been made with hindsight bias and ex post reasoning in the face of the Appellants' success" (App. Br. 10). Appellants contend the Examiner "has not set forth any definitive basis for rejection of claim 1 with regard to the limitation that at least 50% of the co-cultivated algae is contained within the pellets" (App. Br. 13, emphasis omitted). Appellants rely upon the Yuan Declaration to evidence that "at least 50% of co-cultivated algae being 7 Appeal2017-005255 Application 13/346,426 contained within fungal pellets cannot be an inherent characteristic that necessarily results from co-cultivation of a fungus and an algae" (App. Br. 14, emphasis omitted). The Examiner responds When two organisms like algae and fungi are co-cultured together, the two organisms will not completely separate but will come into contact with one another. Applicants argue that the new limitation in which 50% of the algae are absorbed into the pellet is not argued. Examiner would like to point out that pages 11-12 of the preceding office action discuss the importance of having a fermentation broth with a low viscosity. (Ans. 14). We find that Appellants have the better position. While we agree with the Examiner that Bijl and De Laat provide some suggestion to culture fungi and algae (FF 2-3) and some reason to form pellets from fungi (FF 4), we agree with Appellants that the Examiner provides neither a reason to optimize the production to obtain "50% of the co-cultivated algae" within a desirable pellet, nor does the Examiner provide evidence that such co- cultivation along with pelleting would inherently result in a composition with 50% of the co-cultivated algae contained within the pellet. Moreover, Appellants have provided direct experimental evidence that, at least in two situations, co-cultivation of fungi and algae do not result in 50% of the co-cultivated algae being contained within the pellet (FF 6-7) as well as opinion evidence on the unpredictability of this result (FF 8). The Yuan Declaration therefore provides evidence that reinforces Appellants' position that simply co-cultivation as taught by Bijl followed by pelletization as taught by De Laat will not necessarily result in 50% of the co-cultivated algae being contained within the pellet (FF 6-8). 8 Appeal2017-005255 Application 13/346,426 We recognize the Examiner's point that the "fungi actually used in the experiment is Phanerochaete chrysosporium which is not even specifically mentioned in appellants' specification as being one of the preferred organisms used" (Ans. 16), but find it unpersuasive because the Examiner provides no evidence supporting inherency and the Declaration is, at least, some evidence rebutting an expectation of inherency. Claim 15 Appellants contend "neither Bijl nor De Laat demonstrate the step of pre-culturing the at least one fungus for at least four hours before co- cultivating the fungus with the algae at any point" (App. Br. 15). In particular, Appellants contend "De Laat only speaks to pre-culturing as it relates to growing fungus alone, and not in terms of the timing of cultures of both fungus and algae in a process of co-cultivation" (Id.). The Examiner responds "claim only mentions that the fungus/fungi is precultured which is typically done when preparing a strain for a process especially after cryopreservation. There is nothing in the claim language that clearly expresses synergizing the fungal growth curve with the algal growth curve" (Ans. 18). We find the Examiner has the better position. Unlike Claim 1, Claim 15 simply requires pre-culturing a fungus for four hours, a step expressly suggested by De Laat who pre-cultures an Aspergillus species fungus for 48 to 72 hours (FF 5), co-cultivating fungus with algae, a step suggested and exemplified by Bijl (FF 2-3), in a manner allowing pellet formation as suggested by De Laat (FF 4 ). We agree with the Examiner that the ordinary artisan, interested in obtaining the benefits of pellet formation suggested by 9 Appeal2017-005255 Application 13/346,426 De Laat (FF 4), would have modified Bijl's co-cultivation of algae and fungus to obtain such pellets (see Final Act. 11 ). To the extent that Appellants interpret the "pre-culturing" step of Claim 15 as requiring pre-culture of both the fungus and the algae, that interpretation is not supported by the plain language of Claim 15, which does not require pre-culture of the algae. The Specification also does not support Appellants' position because the Specification recognizes that pre- culture is not required, and that either the fungi or the algae may be pre- cultured separately as well as together (FF 9). Thus, Claim 15 read in light of the Specification simply requires pre-culture of the fungus, and does not require any particular synchronization of the fungus and algae growth curves as argued by Appellants (see App. Br. 15). We are not persuaded by Appellants' argument that: "Driving the co- cultivated fungi and algae to pelletize first would make the process of granulation much more difficult" (App. Br. 16) because this simply represents attorney argument without supporting evidence. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of evidence."). We also are not persuaded by Appellants' argument that "there is absolutely no benefit to Bijl in trying to form fungal pellets to contain algae and remove algae from the growth medium during co-cultivation" (App. Br. 16). De Laat expressly suggests that "a fluffy pellet morphology generally may cause a[ n] undesirably high broth viscosity" and that "[ s ]ince a low viscosity of the fermentation broth is advantageous for product formation, control of viscosity is of the utmost importance in industrial scale fermentation processes" (FF 4). Thus, the ordinary artisan interested in 10 Appeal2017-005255 Application 13/346,426 industrial scale fermentation of the oils ofBijl (FF 1) would have had reason to use De Laat's teaching to obtain rigid pellets in order to have desirable broth viscosity as suggested by De Laat (FF 4). See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996) ("[T]he motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness."). Conclusion of Law (i) The evidence of record does not support the Examiner's conclusion that Bijl and De Laat render obvious a method that produces a pellet comprised of co-cultivated fungus and algae where "at least 50% of the co- cultivated algae is contained within the pellet" as required by claim 1. (ii) The evidence of record supports the Examiner's conclusion that Bijl and De Laat render obvious a method requiring "pre-culturing at least one fungus for at least four hours" as require by claim 15. B. and C. 35 USC§ 103(a) The Examiner relies upon Bijl and De Laat for both of these rejections to teach the "at least 50% of the co-cultivated algae is contained within the pellet" of independent claim 1 (see Final Act. 12-14). Having reversed the obviousness rejection of claim 1 over Bijl and De Laat for the reasons given above, we also find that the further combinations with Kock and Khramtsov do not render the rejected claims obvious for the same reason. 11 Appeal2017-005255 Application 13/346,426 SUMMARY In summary, we reverse the rejection of claims 1-5 and 7-14 under 35 U.S.C. § 103(a) as obvious over Bijl and De Laat. We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as obvious over Bijl and De Laat. Claims 16-20 fall with claim 15. We reverse the rejection of claims 1, 5, and 6 under 35 U.S.C. § 103(a) as obvious over Bijl, De Laat, and Kock. We reverse the rejection of claims 1and13 under 35 U.S.C. § 103(a) as obvious over Bijl, De Laat, and Khramtsov. 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-IN-PART 12 Copy with citationCopy as parenthetical citation