Ex Parte Blaser et alDownload PDFPatent Trials and Appeals BoardJun 28, 201914399790 - (D) (P.T.A.B. Jun. 28, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/399,790 11/07/2014 David Blaser 25885 7590 07/02/2019 ELI LILLY & COMPANY PATENT DIVISION P.O. BOX 6288 INDIANAPOLIS, IN 46206-6288 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. X20573 2280 EXAMINER NGUYEN, JOHN P ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 07/02/2019 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): patents© lilly .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID BLASER, JACQUES BOUVIER, MARTIN FINK, JOHN GERARD MCHENERY, and STEVE NANCHEN1 Appeal2018-009173 Application 14/399,790 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and DAVID COTTA, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of controlling sea lice in fish, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm but designate the affirmance a new ground of rejection. STATEMENT OF THE CASE "The basis of sea louse control in commercial salmonid farming is largely still a treatment with chemicals such as organophosphates, synthetic 1 Appellants identify the Real Party in Interest as Blanco Tiergesundheit AG, a wholly owned subsidiary of Eli Lilly and Company. Appeal Br. 1. Appeal2018-009173 Application 14/399,790 pyrethroids, chitin synthesis inhibitors," etc. Spec. 1. The "invention relates to the control of sea lice ... [with] the known chitin synthesis inhibitor lufenuron in form of a particular formulation and according to a particular treatment schedule." Id. The Specification states that, "[ s ]urprisingly, a very long-lasting and convenient control of sea lice infesting fish, and in particular salmon, may be obtained by an in-feed treatment of the fish with lufenuron before transfer to sea or whilst at sea." Id. Claims 1, 3-8, 10, 11, and 15-24 are on appeal. Claim 1 is representative and reads as follows: 1. A method for controlling sea lice in a fish population, said method comprising oral administration of lufenuron or a veterinary acceptable salt thereof to said fish population, wherein the oral administration comprises administering a daily dose of 1 to 30 mg lufenuron/kg of fish biomass for a time period of 3 to 14 days. DISCUSSION The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103 (a) as obvious based on Martinsen 2 and Leadbeater. 3 Final Action 4 3. The Examiner finds that Martinsen teaches "a method to control parasitic infestations including sea lice infestation in farmed fish that comprises administration of a chitin synthesis inhibitor in the form of ... bath treatment, orally or injections." Final Action 3. The Examiner also finds that 2 Alexandersen et al., CA 2 616 765 Al, Open to Public Insp. Dec. 16, 1999. The Examiner and Appellants refer to this reference as "Martinsen," so we do as well. 3 Barratt et al., WO 92/06599, published April 30, 1992. The Examiner and Appellants refer to this reference as "Leadbeater," so we do as well. 4 Office Action mailed March 2, 2018. 2 Appeal2018-009173 Application 14/399,790 "Martinsen discloses use of lufenuron for the control of parasitic infestations in fish" and "discloses administration of chitin synthesis inhibitors orally for [] 7 days." Id. at 4. The Examiner finds that "Martinsen does not specifically teach oral administration of lufenuron to fish and at a daily dose of 1 to 30 mg," but concludes that this limitation, and therefore the method of claim 1 as a whole, would have been obvious when Martinsen's teachings were combined with those of Leadbeater. Id. at 4---6. We agree with the Examiner that the method of claim 1 would have been obvious based on Martinsen. We do not find that Leadbeater' s disclosure is needed to support a prima facie case of obviousness. We therefore base our affirmance on the teachings of Martinsen alone. Because the basic thrust of our reasoning differs from that of the Examiner, we designate the affirmance a new ground of rejection. See In re Kronig, 539 F.2d 1300, 1302---03 (CCPA 1976). Martinsen states that parasitic infestations are a problem in the fish farming industry. Martinsen 1: 15-16. "Infestation with sea lice ... is considered to be one of the most important disease problems in the farming of salmonids, especially in Atlantic salmon ... and rainbow trout." Id. at 1:18-20. "Substances such as chitin synthesis inhibitors, diflubenzuron and teflubenzuron, ... if administered orally, can be effective against parasitic diseases in fish." Id. at 2:12-14. "[O]ral treatments ... [using the] chitin synthesis inhibitors, diflubenzuron and teflubenzuron, have been documented for use against sea lice in salmon." Id. at 3:21-23. "Diflubenzuron and teflubenzuron, which belong to the same substance 3 Appeal2018-009173 Application 14/399,790 group as hexaflmnuron, act by inhibiting the production of chitin." Id. at 3 :26-27. "Diflubenzuron and teflubenzuron are administered to the fish via the feed, absorbed and distributed to skin and mucus, where the concentration will be high enough to inhibit the development of the parasite." Id. at 3 :33 to 4: 1. Martinsen states that its "invention pertains in a first aspect to hexaflumuron for controlling parasitic infestations in fish." Id. at 5:7-8. The "hexaflumuron can be administered to the fish orally, by adding it to the habitat of the fish or by injection." Id. at 5: 16-17. "Hexaflumuron can be added to pre-manufactured fish feed or pellets." Id. at 7:2. "[T]he fish will absorb the active substance, and therapeutic concentration of the substance will be maintained for a certain time." Id. at 7:14--16. Martinsen discloses "a method of controlling infestations in fish with parasites ... comprising administering an antiparasitically active substance to the fish by injection. In this context, useful active substances are chitin synthesis inhibitors including ... hexaflumuron, ... lufenuron," etc. Id. at 9: 1-5. "The method is e.g. useful in the control of infestations with sea lice." Id. at 9:7. Martinsen's Example 2 describes treating salmon infested with sea lice with hexaflumuron, orally administered at a dosage of either 3 .0 mg/kg/day or 9.0 mg/kg/day, 5 for 7 days. Id. at 11 :29 to 12:7. Martinsen 5 Martinsen actually states that the "Dose per day" was either 9.0 mg or 3.0 mg. Martinsen 12, Table 1. However, in describing the results of Example 2, Martinsen states that "[t]he treatment dosage varied between 3 - 9 mg hexaflumuron ... per kg fish per day for 7 days." Id. at 9:25-26 ( emphasis added). We therefore understand Martinsen's Table 1 to describe the dosage in mg/kg. 4 Appeal2018-009173 Application 14/399,790 states that "the hexaflmnuron treatment reduced the number of lice ... more than 70% as compared to the control treatment in all the groups treated with hexaflumuron .... For the groups given the highest dosage, the reduction was> 99%." Id. at 12:10-12. Martinsen's Example 6 describes treating salmon with hexaflumuron, orally administered at a dosage of 5.6 mg/kg/day, for 7 days. Id. at 15:25- 27. Another group of salmon "was given oral treatment with a daily dosage of 10 mg teflubenzuron per kg fish for 7 days, while the last group remained untreated." Id. at 15:29-30. "The fish were then exposed to natural sea lice infestation." Id. at 15:33. Martinsen reports that the results of the experiment in Example 6 were that "fish treated with hexaflumuron had a significantly lower number of lice larger than Chalimus II at 5, 8 and 11 weeks." Id. at 16:5-6.6 "The group treated with teflubenzuron had the same number of lice as the untreated control group at each assessment, which demonstrates that teflubenzuron does not have the same protective effect as hexaflumuron." Id. at 16:6-9. After 11 weeks, all the fish not treated with hexaflumuron were bathed with deltamethrin, "which ma[ de] it difficult to determine the exact protection period. The fish were, however, protected for at least 11 weeks." Id. at 17- 18. Martinsen's Example 8 describes testing "9 different active substances ... for protective effect against sea lice." Id. at 18: 15. The substances tested included the following chitin synthesis inhibitors: "hexaflumuron, buprofezin, diflubenzuron, fluazuron, [and] lufenuron," all of which were 6 Chalimus II is an early developmental stage of a sea louse. Martinsen 11: 1. 5 Appeal2018-009173 Application 14/399,790 injected "at a dosage of about 50 mg/kg." Id. at 18:27-31. Martinsen reports that "[ fJish injected with lufenuron showed good protection against lice until ... 128 days after injection. Hexaflumuron ... conferred significant protection against sea lice until ... 9 months after injection." Id. at 19:20- 22. Martinsen does not report results for any of the other chitin synthesis inhibitors tested (i.e., buprofezin, diflubenzuron, and fluazuron). Martinsen states that [i]t is very surprising that hexaflumuron, in addition to having a therapeutic effect, also protects fish from new attacks by juvenile parasites for an extended period of time after completing the treatment. ... This is in great contrast to the closely related substances, diflubenzuron and teflubenzuron, which do not protect against new establishments by sea lice (see Examples 6 and 8). Id. at 8:12-18. Notably, while Martinsen's specification seems to focus on hexaflumuron, its claims are all directed to using lufenuron to treat parasitic infestations in fish. See id. at 22-23. We conclude that a person of ordinary skill in the art would have found it obvious, based on Martinsen's disclosure, to control sea lice in fish by orally administering lufenuron at a daily dose of 1-30 mg/kg of fish biomass for a period of 3-14 days. A skilled artisan would have found this method obvious based on a combination of Martinsen's disclosures. First, Martinsen's claimed invention is directed to using lufenuron to treat parasitic, including sea lice, infestations in fish. Martinsen's claim 2 does not specify the route of administration; claim 3 depends from claim 2 and specifies injection, which implies that claim 2 encompasses other routes 6 Appeal2018-009173 Application 14/399,790 of administration. See Martinsen 22. The other routes of administration described by Martinsen are oral administration and by bath. Id. at 5: 16-1 7. Second, Martinsen teaches that three other chitin synthesis inhibitors ( diflubenzuron, teflubenzuron, and hexaflumuron) are effective in treating sea lice infestations in fish when orally administered. Id. at 3:21-23, 16:5-6. Third, Martinsen teaches that lufenuron, like hexaflumuron, provides long-term protection when administered by injection. Id. at 19:10-15. Martinsen reports that the same experiment showed that diflubenzuron does not provide long-term protection. Id. at 19: 12-13 ("only the groups injected with hexaflumuron, lufenuron or moxidectin showed protection," emphasis added). Similarly, Martinsen teaches that hexaflumuron also provides long- term protection against sea lice when administered orally at 5.6 mg/kg/day for seven days (id. at 15:26-27, 16:5---6), and "teflubenzuron does not have the same protective effect as hexaflumuron" (id. at 16:8-9). In summary, because both lufenuron and hexaflumuron provided long-term protection against sea lice when injected, and hexaflumuron was shown to provide long-term protection when administered orally at 5.6 mg/kg/day for seven days, it would have been obvious to administer lufenuron orally at 5.6 mg/kg/day for seven days with a reasonable expectation that doing so would provide effective protection against sea lice infestation. The evidence is equivocal about whether orally administering lufenuron in the same dosage, for the same time period, as the administration ofhexaflumuron in Martinsen's Example 6 would have been expected to provide the same long-term protection as Martinsen found for hexaflumuron. However, Appellants' claim 1 does not require long-term protection. And 7 Appeal2018-009173 Application 14/399,790 Martinsen discloses that oral administration of diflubenzuron or teflubenzuron were known treatments for sea lice infestation (Martinsen 3:21-23), even though those compounds did not provide long-term protection (id. at 16:8-9, 19: 12-13). Thus, the evidence shows that those skilled in the art recognized treatments for sea lice infestation as effective even if they did not provide long-term protection. The method made obvious by Martinsen therefore meets the limitations of Appellants' claim 1. Appellants argue that Martinsen's disclosure is focused on administration of active agents by injection. Appeal Br. 3. This argument is unpersuasive because Martinsen expressly describes administration orally, by bath, or by injection (Martinsen 5: 16-17) and provides a working example of administration orally and by bath (id. at 15:26-28). Martinsen's disclosure therefore is not limited to administration by injection. Appellants also argue that "Martinsen does not provide a basis to select lufenuron for further development as a lead compound." Appeal Br. 3. This argument is also unpersuasive. A "lead compound" analysis applies "[i]n cases involving the patentability of a new chemical compound." Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir. 2012) (emphasis added). See also id. ("[W]hether a new chemical compound would have been prima facie obvious over particular prior art compounds ordinarily follows a two-part inquiry. First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts."); id. at 1292 ("The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or 8 Appeal2018-009173 Application 14/399,790 motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success."). Here, claim 1 requires no modification of a prior art compound to make a claimed compound; lufenuron was known in the art. The difference between the prior art and the claimed invention is not in the compound that is administered, but in the manner of administering the known compound recited in the claimed method. For the reasons discussed above, we conclude that the administration of lufenuron that is recited in claim 1 would have been obvious to a skilled artisan based on Martinsen. Appellants argue that Leadbeater relates to "a very different problem from oral delivery of an active ingredient," Appeal Br. 4, and "[t]here is no reason for a skilled person to combine Martinsen and Leadbeater," id. at 5. However, as noted above, we conclude that the method of claim 1 would have been prima facie obvious over Martinsen alone. Finally, Appellants argue that the "data in present specification, indeed, shows surprisingly long-lasting and convenient control of sea lice." Appeal Br. 6. Specifically, Appellants argue that Id. Example 2, Table 4 shows oral treatment with a dose as low as 1 mg/kg of lufenuron for 7 days (meaning an overall amount of 7 mg/kg lufenuron) showed about the same prophylactic efficacy as the 50 mg/kg injectable treatment disclosed in Martinsen. Example 1, Table 1, shows long lasting protection at a dose of 3 mg/kg/ day ( an overall amount of 21 mg/kg of fish biomass) of lufenuron, and Table 2 shows about 9 months of protection at 5 mg/kg for 7 days ( an overall amount of 3 5 mg/kg of fish biomass, Table 2). When compared to Martinsen's disclosure of 50 mg/kg lufenuron by injection, see Figure 8, T7 ( about 6 months), the data in the Specification shows an unexpected effect. 9 Appeal2018-009173 Application 14/399,790 This argument is unpersuasive because it is based on a comparison of the results shown in the Specification's working examples with the results shown in Martinsen's working examples. Thus, the data relied on do not represent a side-by-side comparison of fish treated with lufenuron administered orally or by injection, but a comparison of the results from an experiment, conducted under certain conditions, in which lufenuron was administered orally, with results from a different experiment, conducted under different conditions, in which lufenuron was administered by injection. It is therefore unclear what probative weight the evidence should be given with respect to nonobviousness. In addition, the record lacks a persuasive explanation, based on evidence, of why the results shown in the Specification would have been considered unexpected to a person of ordinary skill in the art. Martinsen states that [i]t is very surprising that hexaflumuron, in addition to having a therapeutic effect, also protects fish from new attacks by juvenile parasites for an extended period of time after completing the treatment. Salmon species are protected from new establishments of sea lice for a period of at least 8 weeks such as at least 12 weeks including at least 6 months and even up to 10 months after transfer to sea water. Martinsen 8:12-16. Specifically, Martinsen's experiments show that orally administered hexaflumuron protected fish from sea lice for at least 11 weeks (id. at 16: 18) and injected hexaflumuron protected fish from sea lice for 9 months (id. at 19:21-22). Given that it was known from Martinsen that hexaflumuron-a chitin synthesis inhibitor, like lufenuron-gave long-term protection against sea lice when orally administered, it is unclear why a skilled artisan would 10 Appeal2018-009173 Application 14/399,790 have been surprised to see similar results from orally administered lufenuron. Although the Specification uses the word "[ s ]urprisingly" (Spec. 1 ), and Appellants argue that the results were unexpected (Appeal Br. 6), "[i]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice." In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) based on Martinsen. "All of the claims stand or fall together." Appeal Br. 3. Claims 3-8, 10, 11, and 15-24 therefore fall with claim 1. Our basic reasoning differs from that of the Examiner, and we therefore designate the affirmance as a new ground of rejection. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." Section 4I.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: ( 1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection 11 Appeal2018-009173 Application 14/399,790 designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under§ 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure§ 1214.01. AFFIRMED 37 C.F.R. § 4I.50(b) 12 Copy with citationCopy as parenthetical citation