Ex Parte Mercenier et alDownload PDFPatent Trial and Appeal BoardMar 16, 201713319477 (P.T.A.B. Mar. 16, 2017) Copy Citation 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. 13/319,477 01/12/2012 Annick Mercenier 3712036-01428 4966 29157 7590 03/20/2017 K&T Oates T T .P-Phiraan EXAMINER P.O. Box 1135 CHICAGO, IL 60690 VISONE, THOMAS J ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 03/20/2017 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): USpatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANNICK MERCENIER, SOPHIE NUTTEN, and GUENOLEE PRIOULT1 Appeal 2015-001440 Application 13/319,477 Technology Center 1600 Before JOHN G. NEW, JOHN E. SCHNEIDER, and TIMOTHY G. MAJORS, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a milk composition that contains probiotics, which have been rejected as obvious and for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Nestec, S.A. (Appeal Br. 2.) Appeal 2015-001440 Application 13/319,477 STATEMENT OF THE CASE The Specification describes a milk product containing probiotics to be fed to infants and children over ten months old. Spec 1,11. 3—6. The probiotics may be non-replicating probiotic micro-organisms that have been heat treated. Spec. 1,11. 6—8. Claims 1—8, 10, 12, 13 and 15 are on appeal. Claim 1 is the sole independent claim and reads as follows: 1. Growing-up-milk composition comprising probiotic micro organisms to be administered to infants or young children starting at the age of 10 months, the probiotic micro-organisms have been rendered non-replicating by a heat treatment having conditions selected from the group consisting of 1) a temperature exceeding 135 °C for 1-10 seconds and 2) a temperature from 71.5 °C to 74 °C for 15-30 seconds, and the probiotic micro-organisms are selected from the group consisting of Bifidobacterium longum NCC 3001 (deposit number ATCC BAA-999), Bifidobacterium longum NCC 2705 (deposit number CNCM 1-2618), Bifidobacterium breve NCC 2950 (deposit number CNCM 1-386), Bifidobacterium lactis NCC 2818 (deposit number CNCM 1-3446), Lactobacillus johnsonii Lai (deposit number CNCM 1- 1225), Lactobacillus paracasei NCC 2461 (deposit number CNCM 1-2116), Lactobacillus rhamnosus NCC 4007 (deposit number CGMCC 1.3724), Lactobacillus reuteri DSM 17938, Lactobacillus reuteri ATCC55730, Streptococcus thermophilus NCC 2019 (deposit number CNCM 1-1422), Streptococcus thermophilus NCC 2059 (deposit number CNCM 1-4153), Lactobacillus casei NCC 4006 (deposit number CNCM 1-1518), Lactobacillus acidophilus NCC 3009 (deposit number ATCC 700396), Lactobacillus casei ACA-DC 6002 (NCC 1825 deposit number ACA-DC 6002), Escherichia coli Nissle (deposit number DSM 6601), Lactobacillus bulgaricus NCC 15 (deposit number CNCM 1-1198), Lactococcus lactis NCC 2287 (deposit number CNCM 1-4154), and combinations thereof. 2 Appeal 2015-001440 Application 13/319,477 The claims stand rejected as follows: Claims 1—3, 5, 6, 8, 12, 13, and 15 have been rejected under 35 U.S.C. § 103(a) as unpatenable over McMahon2 in view of Kamarel3 and in further view of Arigoni4 and Donnet-Hughes5 as evidenced by Sprenger.6 Claim 4 has been rejected under 35 U.S.C. § 103(a) as unpatenable over McMahon in view of Kamarel, Arigoni, Donnet-Hughes and Sprenger in further view of Secretin.7 Claims 7 and 10 have been rejected under 35 U.S.C. § 103(a) as unpatenable over McMahon in view of Kamarel, Arigoni, Donnet-Hughes and Sprenger in further view of Kohk.8 Claims 1—8, 10, 12, 13, and 15 have been provisionally rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1—3, 5—8, and 10-16 of copending Application No. 13/319,964; claims 10-11 of copending Application No. 13/319,963 (now abandoned); claims 1—8, 10, and 12—17 of copending Application No. 13/319,959 (now US 8,691,214 B2); claims 1—8, 10, 12—15, and 17 of 2 McMahon et al., US 2008/0206212 Al, published Aug. 28, 2008 (“McMahon”). 3 Kamarel, US 6,194,009 Bl, issued Feb. 27, 2001 (“Kamarel”). 4 Arigoni et al., US 2004/0126870 Al, published July 1, 2004 (“Arigoni”). 5 Donnet-Hughes et al., WO 2006/108824 Al, published Oct 19, 2006 (“Donnet-Hughes”). 6 Sprenger et al., US 2009/0041736 Al, published Feb. 12, 2009 (“Sprenger”). 7 Secretin, WO 2004/112507 Al, published Dec. 29, 2004 (“Secretin”) 8 Kohk et al., Comparative physio-chemical changes in some constituents of special milks and dahi obtained from them, 33 Indian J. Dairy Sci. 219 (1980) (Abstract only) (“Kohk”). 3 Appeal 2015-001440 Application 13/319,477 copending Application No. 13/319,947 (now abandoned); claims 1—8, 10, and 12—16 of copending Application No. 13/319,943 (now abandoned); claims 1—8 and 10—15, of copending Application No. 13/319,941 (now abandoned); claims, 1—8, 10, and 12—15 of copending Application No. 13/319,653 (now abandoned); claims 1—8, 10, and 12—15 of copending Application No. 13/319,651 (now US 8,196,374); claim 15 of copending Application No. 13/319,649 (now US 8,784,798 B2); claims 1—8, 10, and 12—15 of copending Application No. 13/319,638 (now abandoned); claims 13 and 15 of copending Application No. 13/319,632; claims 1-4, 6, 12—15, 24—27 of copending Application No. 13/319,627 (now US 9.375,454 B2); claims 1-9, and 16 of copending Application No. 13/319,625; and claims 22—26, and 30—36 of copending Application No. 13/283,778 (now abandoned). Claims 1—8, 10, 12, 13, and 15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 and 10-17 of US 7,179,460 B2. THE OBVIOUSNESS REJECTIONS Claims 1—3, 5, 6, 8, 12, 13, and 15 The issue with respect to this rejection is whether the evidence of record supports the Examiner’s conclusion that claims 1—3, 5, 6, 8, 12, 13, and 15 would have been obvious over McMahon combined with Kamarel, Arigoni, Donnet-Hughes and Sprenger. The Examiner finds that McMahon discloses an infant formula comprising inactivated probiotic bacteria from the genera Lactobacillus, Bifidobacterium, Lactococcus, and Escherichia. Final Act. 2. The Examiner finds that McMahon teaches that the probiotics can be inactivated 4 Appeal 2015-001440 Application 13/319,477 by heat treatment, lyophilization, UV light, gamma radiation, pressure, or chemical or mechanical disruption. Id. The Examiner finds that while McMahon does not teach inactivation using the temperatures and times recited in the instant claims, Kamarel discloses Ultra High Temperature (“UHT”) treatment of infant formula at 135° to 150° C from 2 to 5 seconds. Final Act. 3. With respect to the specific strains of probiotics recited in the instant claims, the Examiner finds that Arigoni and Donnet-Hughes teach at least two of the strains recited in the claims. Final Act. 3^4. The Examiner concludes that “one of ordinary skill in the art would be motivated to inactivate the probiotics taught by McMahon using the art recognized UHT parameters taught by Kamarek [sic] in order to ensure proper inactivation.” Final Act. 3. The Examiner also reasons that “it would have been a matter of routine optimization using standard techniques available at the time of invention to ensure at least 90% inactivation of the bacteria and to determine the optimal nutrient concentrations in the composition taught by McMahon and Kamarel.” Id. Appellants contend that one skilled in the art would not be motivated to combine the teachings of McMahon with those of Kamarel. Appeal Br. 8—9. Appellants also contend that none of the references teach or suggest that heat treatment of the specific strains recited in the claims would result in inactive strains that retained the same biological reactive attributes as live strains. Appeal Br. 9. Appellants argue that there is sufficient evidence of unexpected results to overcome a prima facie case of obviousness. Appeal Br. 10-14. The evidence of record supports the Examiner’s position. McMahon teaches an infant formula comprising probiotic bacteria that have been 5 Appeal 2015-001440 Application 13/319,477 inactivated. McMahon 13. The inactivation can be achieved through heat treatment. Id. fl\. Kamarel discloses UHT as a method to kill or inactivate bacteria in infant formulas. Kamarel col. 3,11. 54—61. Similarly Kohk teaches pasteurization at 71.5° C for 15 seconds. Kohk Abstract. We agree with the Examiner that “one of ordinary skill in the art would find it advantageous, since McMahon broadly teaches the use of heat treatment, to utilize a well-established heat treatment method, such as pasteurization by UHT or HTST, to inactivate the probiotics.” Ans. 9. Appellants contend that the properties of probiotics are strain specific and that one skilled in the art would not expect the teaching of McMahon to be applicable to the strains taught in Arigoni and Donnet-Hughes. Appeal Br. 9. We are unpersuaded. As the Examiner points out, McMahon teaches the use of inactivated bacteria from the genus Lactobacillus. Ans. 11. Donnet-Hughes teaches a specific strain of Lactobacillus is especially useful for promoting immune function. Id. We thus agree with the Examiner that the references provide a motivation to combine the teachings of the references. Id. With respect to Appellants’ arguments regarding unexpected results, we agree with the Examiner that the data in the Specification is insufficient to overcome the Examiner’s rejection. [T]he short time/high temperature heat treatments constitute well known pasteurization techniques such as UHT and HTST. Thus, any unexpected result offered by Appellant must also be inherently present in the prior art. It is well established that “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). 6 Appeal 2015-001440 Application 13/319,477 Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Ans. 12. Appellants argue that at the time of the invention, probiotics were added after pasteurization and that this distinguished the present product from the prior art. Appeal Br. 13—14. We agree with the Examiner that this argument is not consistent with the scope of the claims. Ans. 14. Nothing in the claims dictates when the probiotics are rendered inactive. Appellants argue that, with respect to claim 5, the references do not teach or suggest a heat treatment exceeding 135° C for 1—10 seconds. Appeal Br. 14—15. We agree with the Examiner that the references contain such a teaching. Kamarel teaches UHT treatment of the composition at from 135 to 150° C for 2 to 5 seconds. This falls within the range cited in claim 5. With respect to claim 8, Appellants argue that none of the cited references “[sjuggest that heat treatment by UHT-like treatment can generate anti-inflammatory profiles from non anti-inflammatory live strains.” Appeal Br. 15—16. Here again, Appellants are arguing limitations that are not in the claims. Moreover, as the Examiner explains “Donnet- Hughes teaches that Lactobacillus rhamnosus NCC 4007 is a well-known probiotic that advantageously promotes immune function and McMahon teaches use of inactivated probiotic bacteria from the genera Lactobacillus. It is also noted that, as discussed above, the heat inactivation methods (e.g., UHT and HTST) taught by the prior art would inherently impart the anti-inflammatory profiles of the claimed invention.” Ans. 16. 7 Appeal 2015-001440 Application 13/319,477 Claim 4 Claim 4 adds the limitation that the composition of claim 1 comprises 1.5 —2.5 mg nucleotides per 100 mL of formula. Appeal Br. 22 (Claims App.) The Examiner finds that Secretin teaches an infant formula containing 2-5 mg nucleotides per 100 mL of formula. Final Act. 4—5. The Examiner concludes that one skilled in the art would modify the composition taught by McMahon, Kamarel, Arigoni, Donnet-Hughes and Sprenger to incorporate the teachings of Secretin to ensure the nutritional needs of the recipient are met. Id. Appellants’ sole argument with respect to this rejection is that Secretin does not remedy the deficiencies of the other references with respect to heat treatment. As discussed above, we do not find the references to be deficient in their teachings. Thus Appellants’ argument is unpersuasive. Claims 7 and 10 With respect to claims 7 and 10, the Examiner finds that, in addition to the teachings of McMahon, Kamarel, Arigoni, Donnet-Hughes and Sprenger, Kohk teaches pasteurization at 71.5° C for 15 seconds which falls within the range cited in the claims. Final Act. 5—6. The Examiner finds that it would have been obvious to use the heat treatment in Kohk to inactivate probiotic bacteria as taught by McMahon. Id. Appellants essentially reiterate the arguments made above. For the reasons stated above, we find the arguments unpersuasive. Conclusion of Law We conclude that the evidence of record supports the Examiner’s rejections under 35 U.S.C. § 103(a). 8 Appeal 2015-001440 Application 13/319,477 THE OBVIOUSNESS-TYPE DOUBLE PATENTING REJECTIONS Analysis Appellants have offered no arguments with respect these rejections and have therefore waived their appeal of the rejections. We therefore affirm the rejections. SUMMARY We affirm the rejections under 35 U.S.C. § 103(a). We affirm the rejections under non-statutory obviousness-type double patenting. 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). AFFIRMED 9 Copy with citationCopy as parenthetical citation