Ex Parte FORSGREN BRUSK et alDownload PDFPatent Trials and Appeals BoardMay 20, 201914225929 - (D) (P.T.A.B. May. 20, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/225,929 03/26/2014 105718 7590 05/22/2019 SCA Hygiene Products AB c/o Buchanan Ingersoll & Rooney, PC 1737 King Street, Suite 500 Alexandria, VA 22314 FIRST NAMED INVENTOR Ulla FORSGREN BRUSK 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. 1018798-000762 1190 EXAMINER KISHORE, GOLLAMUDI S ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 05/22/2019 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): ADIPDOC 1@BIPC.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ULLA FORSGREN BRUSK, BO RUNEMAN, and EV A GRAN HAKANSSON Appeal 2017-011306 Application 14/225,929 1 Technology Center 1600 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a hygiene tissue, which have been rejected as obvious. Oral argument was held on May 1, 2019. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Lactic acid producing bacteria "are important for retaining a healthy microbial flora" in the urogenital areas. (Spec. ,r 5.) When the normal microbial flora are disturbed in those areas, one is "susceptible to microbial 1 Appellant, who is SCA HYGIENE PRODUCTS AB, identifies itself as the real party in interest. (Appeal Br. 2.) Appeal 2017-011306 Application 14/225,929 infections that cause vaginitis, urinary tract infections and ordinary skin infections." (Id.) "[T]he skin is colonized by an array of organisms, which forms its normal flora." (Id. ,r 6.) "This normal flora plays an important role in preventing 'foreign' organisms from colonizing the skin, but it to needs to be kept in check, in order to avoid skin infections." (Id.) "[ A ]dministration of lactic acid producing bacteria to the urogenital area and the skin in order to out compete pathogenic species and facilitating establishment and maintenance of a beneficial microbial flora in these areas, have been found to be a successful means to treat and prevent microbial infections." (Id. ,r 13.) The prior art suggests "that lactic acid producing bacteria can be delivered via absorbent articles." (Id. ,r 14.) The invention relates to the use of hygiene tissues, rather than absorbent articles, "that are convenient to use, result in efficient transfer of the bacteria to the area where they are applied and can be stored for long time periods without loss of viability of the bacterial cells." (Id. ,r 17.) Claims 2-18 are on appeal. Claim 2 is representative and reads as follows: 2. A hygiene tissue comprising a matrix impregnated by a composition, the composition including a probiotic bacterial preparation of one or more lactic acid producing bacterial strains, the lactic acid producing bacterial strains encapsulated in a lipid phase comprising one or more lipids which are all of a non-animal origin, wherein the matrix of the hygiene tissue has a water content of 5% or less by weight, wherein the probiotic bacterial preparation has a water activity of about 0.30 or less, 2 Appeal 2017-011306 Application 14/225,929 wherein the hygiene tissue is a device for wiping skin of a user, the hygiene tissue being selected from the group consisting of a washcloth, towelette and wetwipe. ( Appeal Br. Claims Appendix 1.) The following grounds of rejection by the Examiner are before us for review: a. Claims 2-18 under 35 U.S.C. § 103 as unpatentable over WO 92/135772 and Farmer, 3 with or without WO 00/41576. 4 b. Claim 11 under 35 U.S.C. § 103 as unpatentable over WO 92/13577, Farmer, and Green, 5 with or without WO 00/41576. c. Claims 2-18 under 35 U.S.C. § 103 as unpatentable over WO 99/45099, 6 Farmer, and WO 92/13577. d. Claims 2-18 under 35 U.S.C. § 103 as unpatentable over WO 00/35502,7 Farmer, and WO 92/13577. DISCUSSION Re} ection a and b The Examiner finds that K vanta teaches tampons and sanitary napkins impregnated with lactic acid producing bacteria suspended in vegetable oil, coco fat, wax, or glycerides. (Final Action 2.) The Examiner finds that K vanta teaches that the bacterial preparation may be added as a powder "or 2 E. Kvanta, WO 92/13577, published Aug. 20, 1992. ("Kvanta") 3 Farmer et al., US 6,716,435 Bl, issued Apr. 6, 2004. 4 Conway et al., WO 00/41576, published July 20, 2000. ("Conway") 5 Green et al., US 6,365,656 Bl, issued Apr. 2, 2002. 6 Hakansson et al., WO 99/45099, published Sept. 10, 1999. ("Hakansson") 7 Forsgren-Brusk et al., WO 00/35502, published June 22, 2000. ("Forsgren-Brusk") 3 Appeal 2017-011306 Application 14/225,929 the entire composition is freeze dried." (Id.) The Examiner recognizes that K vanta does not state the water activity of the bacterial preparation, but the Examiner contends that in light of the fact that the bacterial preparation is a powder or freeze-dried and is combined with an oil, "it would have less than [the] claimed water activity." (Id. at 3 . ) The Examiner notes that K van ta does not specifically teach a towelette. (Id.) The Examiner finds, however, that Farmer discloses probiotic compositions that can be used in sanitary napkins, as well as feminine towelettes and wash cloths. (Id.) Consequently, the Examiner concludes that it would have been obvious to provide the probiotic composition of Kvanta in a towelette. (Id. at 4.) The Examiner relies on Conway for teaching that it was known that at least some lactic acid producing bacteria are resistant to water activity at varying levels, which implies that there are some lactic acid producing bacteria that are not resistant to water activity. (Id.) The Examiner contends that, "assuming that the water activity [ofKvanta's preparation] is higher" than 0.3, it would have been obvious from Conway's implicit teaching concerning the lack of water resistance of lactic acid producing bacteria to have subjected the Kvanta bacteria preparation to additional freeze-drying to ensure the water activity of the preparation is at a level that is compatible with the viability of that bacterial preparation. (Id. at 3--4.) The Examiner further states that "[i]f the lactic acid producing bacteria are susceptible to moisture, it would have been obvious ... that they would be susceptible irrespective of the place they are in, ... [so] it would have [also] been obvious to keep the water content of the matrix to be less than the claimed amount[, i.e., below 5%]." (Ans. 7.) 4 Appeal 2017-011306 Application 14/225,929 "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We conclude that the Examiner has not established a prima facie case of obviousness from the evidence on this record. In particular, the Examiner has not established that the K vanta lactic acid producing bacterial preparation is susceptible to moisture at any particular level, which is the premise the Examiner relies upon to conclude that it would have been obvious to keep the water content of the matrix to be below 5% as claimed. We note that in the prior appeal to the Board of the parent application, the following claim was rejected by the Examiner as being obvious over Kvanta and Farmer, optionally combined with Conway: 1. A hygiene tissue comprising: a matrix impregnated by a composition including a probiotic bacterial preparation of one or more lactic acid producing bacterial strains, encapsulated in a lipid phase comprising one or more lipids which are all of a non-animal origin, wherein the probiotic bacterial preparation has a water activity of about 0.30 or less, and the lipid phase has a water content of about 1 % or less by weight, wherein the hygiene tissue is a device for wiping skin of a user, the hygiene tissue being selected from the group consisting of a washcloth, towelette and wetwipe. Appeal No. 2012-006890, 2-3. 8 The Board affirmed the obviousness rejection of this claim noting that the evidence was sufficient to reasonably 8 The '6890 Appeal involved Application 10/318,165. The Examiner points to this decision in arriving at his conclusion that the prior art renders obvious this matrix water content limitation. (Ans. 7.) We note that the claim at 5 Appeal 2017-011306 Application 14/225,929 conclude that K vanta' s freeze dried bacterial preparation "would inherently have a water activity of 0.30 or less." Id. at 9--10. That conclusion was made irrespective of whether the preparation was believed to be susceptible to moisture. In the present appeal, the Examiner has provided no further evidence on whether or not the K vanta lactic acid producing bacteria was known to be susceptible to moisture at any particular level. Thus, we do not find any basis for concluding that the K vanta preparation would have been known to be susceptible to water. Without this factual foundation, we cannot conclude the Examiner has established a reason that one of ordinary skill in the art would have been motivated to keep the water content of the matrix in which the bacterial preparation is placed below 5% as claimed. "[R ]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,418 (2007) (quoting In re Kahn, 441 F.3d 977,988 (Fed. Cir. 2006)). For the foregoing reasons, we do not sustain the Examiner's rejection of claims 2-18 under 35 U.S.C. § 103 as unpatentable over Kvanta and Farmer, with or without Conway. The Examiner's rejection of claim 11 as being obvious over Kvanta, Farmer, and Green, with or without Conway suffers from the same lack of evidence as the rejection just discussed. That is, the Examiner relied on issue in the parent application appeal to the Board did not have a matrix water content limitation. 6 Appeal 2017-011306 Application 14/225,929 Green only for addressing the specific oils into which the bacterial preparation is required to be encapsulated. (Final Action 5.) For the reasons discussed above, we also do not sustain the Examiner's rejection of claim 11 under 35 U.S.C. § 103 as unpatentable over Kvanta, Farmer, and Green, with or without Conway. Re} ections c and d The Examiner finds that both Hakansson and Forsgren-Brusk disclose absorbent articles containing lactic acid producing bacteria. (Final Action 5.) The Examiner notes that both references teach that "[t]he bacteria are freeze dried in skim milkjust as in [the] instant invention." (Id. at 5---6.) The Examiner notes, however, that neither reference teaches the product to which the lactic acid producing bacteria are added is a towelette or washcloth, nor do they teach encapsulating the bacteria in oil. (Id. at 6.) The Examiner relies on K vanta for teaching absorbent articles that have lactic acid producing bacteria suspended in oil, where the oil helps retain the bacteria in the absorbent material, and relies on Farmer for teaching that lactic acid producing bacterial may be applied to sanitary articles such as sanitary napkins, towelettes, and washcloths. (Id. at 6-7.) The Examiner's position regarding the water content of the matrix is the same as it was with respect to the rejection as discussed above. (See, e.g., id. at 7.) Here again, we find the Examiner has failed to establish a prima facie case. The Examiner does not point to factual evidence to support a conclusion that the lactic acid producing bacterial preparation is susceptible to moisture at any particular level, which is the premise the Examiner relies upon to conclude that it would have been obvious to keep 7 Appeal 2017-011306 Application 14/225,929 the water content of the matrix to be below 5% as claimed. We cannot conclude, therefore, that the Examiner has established a reason that one of ordinary skill in the art would have been motivated to keep the water content of the matrix in which the bacterial preparation is placed below 5% as claimed. SUMMARY We reverse the rejection of claims 2-18 under 35 U.S.C. § 103 as unpatentable over Kvanta and Farmer, with or without Conway. We reverse the rejection of claim 11 under 35 U.S.C. § 103 as unpatentable over Kvanta, Farmer, and Green, with or without Conway. We reverse the rejection of claims 2-18 under 35 U.S.C. § 103 as unpatentable over Hakansson, Farmer, and Kvanta. We reverse the rejection of claims 2-18 under 35 U.S.C. § 103 as unpatentable over Forsgren-Brusk, Farmer, and Kvanta. REVERSED 8 Copy with citationCopy as parenthetical citation