NUTRIQUEST, LLC

Patent Trials and Appeals Board

Mar 9, 2022

2021003329 (P.T.A.B. Mar. 9, 2022)

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. 15/266,570 09/15/2016 Chad Hagen 081192-550333 1275 27148 7590 03/09/2022 POLSINELLI PC PO Box 140310 KANSAS CITY, MO 64114-0310 EXAMINER SULLIVAN, DANIELLE D ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 03/09/2022 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): patentdocketing@polsinelli.com uspt@polsinelli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHAD HAGEN, ROBERT MUSSER, RYAN COONEY, KIM FRIESEN, RAN SONG, and CHESTER WIERNUSZ Appeal 2021-003329 Application 15/266,570 Technology Center 1600 BEFORE RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-3, 6, 10-15, 17, 19-31, 40, 41, and 62-66.2 We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as NUTRIQUEST, LLC. Appeal Br. 1. 2 Claims 33-39 and 42-61 are pending in the application but have been withdrawn from consideration. Final Act. 2. Appeal 2021-003329 Application 15/266,570 2 We affirm. CLAIMED SUBJECT MATTER The claims are directed to antimicrobial clay compositions and methods for using the compositions. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for controlling microbes without disrupting resident gut microflora, the method comprising orally administering an antimicrobial effective amount of an antimicrobial clay to an animal, wherein the clay is mined clay comprising about 3% to about 10% pyrite, about 1 % to about 5% Fe3+, and about 1 % to about 15% aluminum. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Hill et al. US 3,950,546 Apr. 13, 1976 Rowe US 6,468,964 B1 Oct. 22, 2002 Darlington, et al. US 2010/0272769 A1 Oct. 28, 2010 Metge, et al. WO 2010/141070 A1 Dec. 9, 2010 REJECTIONS The Examiner has rejected the pending claims as follows: Claims 40, 41, 62, and 64 have been rejected under 35 U.S.C. § 103 as unpatentable over Metge in view of Hill. Claims 1-3, 6, 10-13, 17, 19, 25, 27-29, 31, 63, 65, and 66 have been rejected under 35 U.S.C. § 103 as unpatentable over Metge in view of Hill and Rowe. Claims 14, 15, 20-24, 26, and 30 have been rejected under 35 U.S.C. § 103 as unpatentable over Metge in view of Hill, Rowe, and Darlington. Appeal 2021-003329 Application 15/266,570 3 OPINION All of the rejections rely on the combination of Metge and Hill. Appellant has argued the rejections together. See Appeal Br. 3. We shall address the rejections together as well. The Examiner finds Metge teaches a clay containing from 3 to 20% pyrite is effective against the growth of E. coli. Final Act. 3. The Examiner finds Metge does not teach using the clay to treat pigs nor does Metge teach an aluminum content of the clay to range from 1 to 15% and the iron content to range from 1 to 5 % of the clay. Id. at 4. The Examiner finds Hill teaches a dietary supplement fed to baby pigs that comprises clays having an aluminum content of 15 to 50%. The Examiner finds the dietary supplement of Hill protects the pigs from scouring. Id. The Examiner finds: “Although not specifically taught, the formulations will additionally aid in other properties such as the control of influenza and growth since the supplements improve cleanliness and aid in protecting baby pigs so they are able to flourish.” Id. The Examiner concludes: Metge and Hill are both drawn to the use of antimicrobial clays to control microbes. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Metge and Hill et al. to include the treatment of pigs with a reasonable expectation of success. One would have been motivated at the time of the invention to combine the teachings because clays were taught by Hill et al. as dietary supplements that aid in protecting pigs from scouring. It would have been prima facie obvious to one of ordinary skill to combine the teachings of Metge and Hill et al. to include iron in a range of 3.5-8% and aluminum at a range of 15% with a reasonable expectation of success. One would have been motivated at the time of the invention to combine the Appeal 2021-003329 Application 15/266,570 4 teachings because clays were taught by Hill et al. to preferably comprise aluminum silicate and minerals, such as iron. Id. at 4-5. Appellant contends Hill does not teach or suggest the use of an antimicrobial clay. Appeal Br. 6. Appellant contends Hill is directed to the use of clay to prevent knee abrasions in pigs and does not contain any teaching that the clay has an antimicrobial effect. Id. at 7. Appellant contends the Examiner erred in finding that the clays used by Hill could prevent scouring and influenza. Id. at 8. Appellant argues that Hill contains no such teaching and the Examiner has failed to properly support the finding. Id. at 8-9. Appellant contends Hill does not teach or suggest a feed composition. Id. at 10. Appellant contends the clay composition of Hill is designed to be scattered on the floor of the farrowing house to prevent damage to the pigs’ knees. Id. Appellant argues that Hill does not teach administering the clay orally. Id. Appellant contends one skilled in the art would not have been motivated to combined the teachings of Hill and Metge as there is not suggestion to administer clay orally to control microbes. Id. at 11. Appellant contends Rowe does not teach the administration of clays to control microbes without disrupting gut microflora. Appeal Br. 12. Appellant contends Rowe teaches the use of clay to reduce the adverse effects of rapid fermentation of starch in the gut. Id. Appellant contends Rowe and Hill are not analogous art as they do not relate to the problem facing the inventor, oral administration of clay to control microbes in an animal. Id. at 12-13. Appellant contends that the rejection is based on the impermissible use of hindsight. Id. at 13. Appeal 2021-003329 Application 15/266,570 5 Appellant contends that one skilled in the art would not have had a reasonable expectation of success in using clays to control microbes. Id. at 15. Appellant contends that the file of pharmacology is unpredictable and that substituting the clay of Metge for the clay of Hill could produce drastically different outcomes. Id. Appellant also contends that changing the route of administration can produce different outcomes. Id. Appellant contends it would not have been obvious for an individual of skill in the art to simply modify the teaching of antimicrobial clay for topical administration by Metge with administration of a clay not described as antimicrobial, as taught by Hill or the combination of Hill and Rowe, and have a reasonable expectation of success in treating or controlling microbes in an animal. Neither Hill nor Rowe teach or suggest an antimicrobial clay, or administering an antimicrobial clay to an animal to control microbes in the animal. Id. We have considered the arguments advanced by the Examiner and Appellant and find the Examiner’s position is supported by a preponderance of the evidence in the record before us. While Hill discusses the use of clay to protect the knees of young pigs, Hill specifically teaches that the clay, fortified with minerals, provides a food supplement for the pigs. See, e.g., Hill, Abst., col. 1, ll. 37-57. Hill teaches that the iron is preferably in the form of iron carbonate and iron sulfate and that the iron sulfate is present in an amount of from 1 to 2.5 %. Id. col. 2, ll. 23-28. Hill also teaches clay mixtures which comprise 15 to 50 % aluminum silicate. Id. col. 1, ll. 1-10. Appeal 2021-003329 Application 15/266,570 6 Metge teaches clay which naturally comprise 3 to 10 % pyrite (iron sulfate). Metge, 10. Metge teaches that clays with significant levels of pyrite exbibit antimicrobial properties. Id. Rowe teaches that clays can be taken orally without any adverse effects. See Rowe col. 3, ll. 54-66. We agree with the Examiner that one skilled in the art would have been motivated to combine the teachings of Metge, Hill, and Rowe to produce the claimed method. Ans. 10. One skilled in the art would have been motivated to orally administer the clay of Metge because both Hill and Rowe teach that clays can be administered orally. One skilled in the art would have adminstered the clays of Metge in an oral composition to provide iron sulfate as a nutritional supplement as taught by Hill as a well as to control bacteria as taught by Metge. Appellant contends that Hill does not teach or suggest that the clays used in Hill have an antimicrobial effect. Appeal Br. 7-9. While we agree with Appellant that Hill is silent about the clay having an antimicrobial effect, Appellant’s argument is an attack on the teachings of the individual reference and not the teachings of the combined references because Metge provides such a teaching. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Metge teaches that clays having a significant amount of pyrite (iron sulfate) have such an antimicrobial effect. Metge, 10. This includes clays where the iron sulfate is added to the base clay as taught in Hill. Id. Thus, Appeal 2021-003329 Application 15/266,570 7 one skilled in the art reading Hill and Metge would understand that the clays of Hill would exhibit the antimicrobial properties taught in Metge. Appellant next contends that Hill does not teach a dietary composition. Appeal Br. 10. We are not persuaded by this argument. Hill teaches that the clay in combination with minerals including iron provides a food supplement. Hill, Abst. Appellant contends Rowe does not teach or suggest administering clay to control microbes without disrupting gut microflora. Appeal Br. 12. While we agree with Appellant that Rowe does not teach controlling microbes, we agree with the Examiner that Rowe teaches oral administration of clay without disrupting the microflora in the gut. Ans. 14-15. Metge is cited for teaching the antimicrobial effect of clays. Metge, 10. Appellant next contends that Hill and Rowe are not analogous art because they do not relate to the oral administration of clays to control microbes. Appeal Br. 12-13. Again, we are not persuaded by this argument. Both Hill and Rowe teach that clay can be administered orally to provide a beneficial nutritional effect. Thus, they both relate to oral administration of clay to an animal, the same route of administration and administered product recited in claim 1. While the administration of the clay in Hill and Rowe is for nutritional purposes, the administration itself is reasonably pertinent to the problem addressed by the claim of providing clay to an animal. . “In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). Appeal 2021-003329 Application 15/266,570 8 Appellant argues that the rejection is based on the improper use of hindsight. This argument is unpersuasive. “Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here Appellant has not pointed to nor do we discern any basis on the rejection that was gleaned only from Appellant’s disclosure. See Appeal Br. 13-14. Appellant contends that one skilled in the art would not have had a reasonable expectation of success in orally administering the clays of Metge to control microbes in the gut of an animal. Appeal Br. 14-15. Appellant argues that Metge only teaches topical application of the clays and that owing to the unpredictability of the art one skilled in the area would not expect the oral administration of the clays to have the same result. Id. We have considered Appellant’s argument and are not persuaded that the rejection is in error. Metge teaches that the recited clays are effective against E. coli, which is known to cause food poisoning. See, e.g., Metge ¶ 22; Darlington ¶ 116. Given the teachings of Hill and Rowe that clays can be adminstered orally and the teachings of Metge that the disclosed clays are effective against E.coli, we find that one skilled in the art would have had a reasonable expectation of success that such clay, when administered orally, would be effective in treating microbes, such as E. coli. “Obviousness does not require absolute predictability of success. . . . For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). Appeal 2021-003329 Application 15/266,570 9 Based on the forgoing we find that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1-3, 6, 10-15, 17, 19-31, 40, 41, and 62-66 would have been obvious to one of ordinary skill in the art at the time the invention was made over Metge combined with Hill, Rowe, and/or Darlington. CONCLUSION The Examiner’s rejections are affirmed. More specifically: The rejection of claims 40, 41, 62, and 64 under 35 U.S.C. § 103 as unpatentable over Metge in view of Hill is affirmed. The rejection of claims 1-3, 6, 10-13, 17, 19, 25, 27-29, 31, 63, 65, and 66 under 35 U.S.C. § 103 as unpatentable over Metge in view of Hill and Rowe is affirmed. The rejection of claims 14, 15, 20-24, 26, and 30 under 35 U.S.C. § 103 as unpatentable over Metge in view of Hill, Rowe, and Darlington is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 40, 41, 62, 64 103 Metge, Hill 40, 41, 62, 64 1-3, 6, 10- 13, 17, 19, 25, 27-29, 31, 63, 65, 66 103 Metge, Hill, Rowe 1-3, 6, 10- 13, 17, 19, 25, 27-29, 31, 63, 65, 66 14, 15, 20- 24, 26, 30 103 Metge, Hill, Rowe, Darlington 14, 15, 20- 24, 26, 30 Appeal 2021-003329 Application 15/266,570 10 Overall Outcome 1-3, 6, 10- 15, 17, 19- 31, 40, 41, 62-66 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED