Ex Parte Knorr et alDownload PDFPatent Trial and Appeal BoardMay 27, 201611544120 (P.T.A.B. May. 27, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111544,120 10/06/2006 26691 7590 05/31/2016 POTTER ANDERSON & CORROON LLP ATTN: JANETE. REED, PH.D. P.O. BOX 951 WILMINGTON, DE 19899-0951 FIRST NAMED INVENTOR Ruth Knorr 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. 34102-020 [7991/US/NP] 8321 EXAMINER NICKOL, GARY B ART UNIT PAPER NUMBER 1645 MAILDATE DELIVERY MODE 05/31/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RUTH KNORR, CHRISTOPH CA V ADINI, JALIL BENY ACOUB, and EBENEZER SATY ARAJ1 Appeal2013-005274 Application 11/544,120 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TA WEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to compositions and methods relating to the modulation of immunity or enhancement of vaccine efficacy in a feline, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse and enter a new ground of rejection. 1 Appellants identify the Real Party in Interest as Nestec, S.A. (Appeal Br. 3.) Appeal2013-005274 Application 11/544,120 STATEMENT OF THE CASE "Probiotics have been defined as live microorganisms that, when administered in adequate amounts, confer a health effect on the host." (Spec. ,-i 4.) Appellants' inventions relate to "composition[ s] comprising one or more probiotic organisms in an amount effective for the modulation of immunity or the enhancement of vaccine efficacy in an animal" and methods for modulating immunity or enhancing vaccine efficacy by administering such compositions. Claims 1--4, 6-9, 25, 27, 29-30, and 32-33 are on appeal. Claim 1 is illustrative and is reproduced below, with emphasis on the dispositive limi ta ti on: 1. A composition formulated for administration to a young feline, comprising one or more probiotic Enterococcus bacteria in an amount effective for the modulation of immunity or enhancement of vaccine efficacy in the feline, further comprising 7-oxo- dehydroepiandrosterone and one or more of alpha=carotene, beta= carotene, astragalus, or echinacea, wherein if the composition is a dry food composition, the dry food composition includes a coating, the coating comprising the one or more probiotic Enterococcus bacteria. The claims stand rejected as follows: Claims 1--4, 6-9, 25, 27, 29, 30, 32, and 33 are rejected under 35 U.S.C. § 103(a) as obvious over Zink,2 Bishop,3 Ahlem,4 and Netke. 5 2 Zink et al., WO 01/90311 Al, published Nov. 29, 2001. 3 Bishop et al., U.S. 5,972,917, issued Oct. 26, 1999. 4 Ahlem et al., US 2006/0079492 Al, published Apr. 13, 2006. 5 Netke et al., US 2007/0122399 Al, published May 31, 2007. 2 Appeal2013-005274 Application 11/544,120 Claims 1--4, 6-9, 25, 27, 29, 30, 32, and 33 are rejected under 35 U.S.C. § 103(a) as obvious over Zink, Jira, 6 Ahlem, and Netke. I. Issue The Examiner has rejected claims 1--4, 6-9, 25, 27, 29, 30, 32, and 33 under 35 U.S.C. § 103(a) as obvious over the combination of Zink, Ahlem, Netke, and either Bishop or Jira. (Ans. 3.) Because our decision on these rejections tum on the same issue, we address them together. The Examiner finds that Zink teaches "a [cat] food composition comprising ... Enterococcusfaecium SF68 (NCIMB 10415)." (Ans. 4 (citations omitted).) The Examiner finds that Zink also teaches using legumes in its composition, which according to the Examiner is well-known to contain beta-carotene. (Id.) The Examiner finds that Zink does not teach a composition further comprising 7-oxo-dehyroepiandrosterone ("7-oxo-DHEA"). (Id. at 5.) However, the Examiner finds that Bishop teaches administering 7-oxo- DHEA to augment immune response as well as to ameliorate bone diseases. (Id.) Likewise, the Examiner finds that Jira teaches a pharmaceutical composition comprising 7-oxo-DHEA for the treatment of certain diseases in pets. (Id. at 8.) The Examiner further cites Ahlem and Netke as teaching, respectively, "compositions including [7-oxo-DHEA] known for their ability to enhance the activity of thermogeic enzymes [and] thus induc[ e] an immune response" and "a pharmaceutical composition formulated in food 6 Jira et al., US 2003/0092145 Al, published May 15, 2003. 3 Appeal2013-005274 Application 11/544,120 [and suitable for cats,] further comprising vitamin A (i.e., beta-carotene) ... to facilitate bone healing." (Id. at 5 (citations omitted).) The Examiner concludes that it would have been obvious to incorporate 7-oxo-DHEA such as taught by Bishop or Jira into the compositions taught by Zink in order to take advantage of the properties of 7-oxo-DHEA in augmenting immune response and in bone healing. (Id. at 5-6, 8-9.) The issue with respect to this rejection is whether the evidence of record supports the Examiner's conclusion that the cited prior art renders obvious a composition comprising one or more of alpha-carotene, beta- carotene, astragalus, or echinacea, as required by the claims. Findings of Fact FF 1. Zink teaches that the pet food composition according to its invention "may include any one or more of a starch source, a protein source and lipid source." (Zink 10: 15-1 7.) FF2. Zink teaches that "[ s Jui table starch sources are, for example, grains and legumes such as com, rice, wheat, barley, oats, soy, and mixtures of these." (Id. at 10:19-20.) FF3. Netke teaches a nutritional composition effective in facilitating bone healing comprising vitamin A. (Netke Abstract.) Analysis The Examiner bears the burden of establishing a prima face case of obviousness, In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992), and such a 4 Appeal2013-005274 Application 11/544,120 prima facie case "requires a suggestion of all limitations in a claim." CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). Here, the Examiner does not maintain that the cited references explicitly disclose a composition containing one or more of alpha-carotene, beta-carotene, astragalus, or echinacea. Rather, the Examiner asserts that Zink teaches pet foods containing legumes, which "necessarily teach[ es] beta-carotene" because beta-carotene is a well-known component of legumes. (Ans. 4, 12-13.) The Examiner further asserts that Netke teaches compositions comprising beta-carotene because it teaches vitamin A as an ingredient. (Id. at 5, 12-13.) Appellants contend that the combination of Zink, Ahlem, Netke, and either Bishop or Jira does not teach, suggest, or otherwise render obvious a composition comprising beta-carotene. (Appeal Br. at 13.) Appellants argue that the disclosure in Zink only suggests using legume as a starch source in pet food compositions, and further argue that the starch-containing portions of legumes (e.g., seeds) do not necessarily contain beta-carotene. (Reply Br. 8-10.) Appellants also argue that, while beta-carotene may be converted to vitamin A and vice versa, the presence of vitamin A does not necessarily indicate the presence of beta-carotene because vitamin A supplements may be in the form of other compounds such as retinol or retinoic acid. (Id. at 10-11.) On balance, we find that Appellants have the better position. While the Examiner finds that it is well-known that legumes contain beta-carotene, the Examiner cites to no evidence and provides no articulated reasoning why all legumes or parts of legumes used in pet food compositions necessarily 5 Appeal2013-005274 Application 11/544,120 contain beta-carotene. Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI 1990) ("In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art."). Likewise, while we agree that beta- carotene is a precursor of vitamin A, the Examiner provides no evidence or articulated reasoning why the presence of vitamin A necessarily indicates the presence of such a precursor. In the absence of such evidence and articulated reasoning, the Examiner has not set forth a prima facie case of obviousness because the rejection fails to evidence a required element of the claims. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ("[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."). Accordingly, we reverse the rejection of claims 1--4, 6-9, 25, 27, 29, 30, 32, and 33 under 35 U.S.C. § 103(a) as obvious over the combination of Zink, Bishop, Ahlem, and Netke. We likewise reverse the rejection of these claims under 35 U.S.C. § 103(a) as obvious over the combination of Zink, Jira, Ahlem, and Netke. 6 Appeal2013-005274 Application 11/544,120 II. Under the provisions of 3 7 C.F .R. § 41. 50(b ), we enter the following new ground of rejection: Claims 1, 10, 16, 25, and 32 are rejected under 35 U.S.C. § 103(a) as obvious over Zink, Bishop, and Hayek. 7 Findings of Fact FF4. Zink teaches using probiotics, including microorganisms of the genus Streptococcus (Enterococcus), in pet food compositions such as cat food. (Zink 1:3-10, 3:1-8, 5:24-25, 9:1-3, 9:30-32, 10:1-9, Example 14.) Zink further teaches dried pet food containing a coating comprising Enterococcusfaecium SF68. (Id. at 40:28-31, 41:18-38.) FF5. Zink teaches that its probiotics "have a particular beneficial impact on pets in their gastrointestinal tract, on their skin and/or coat, on their immune system, and on the effects of aging." (Id. at 4: 19-21; see also id. at 4:30-33, 9:34-36, 12:25-30.) Zink specifically discloses the use of its probiotics for regulating the immune response of pets. (Id. at 3 :23-26, 4: 10- 12, 5:7-11.) FF6. Zink teaches that the bacterial strain of its invention "may be used in any amount from about l.OE+04 to about I.OE+ 12 cfu/animal and day and preferably from l.OE+05 to about I.OE+ 11 cfu/animal and day, most preferably from l.OE+07 to LOE+ 10 cfu/animal and day." (Id. at 3:10-13.) 7 Hayek, U.S. Patent 6, 133,323, issued Oct. 17, 2000. 7 Appeal2013-005274 Application 11/544,120 FF7. Bishop relates to the use of certain vitamin D compounds in the modulation of immune and inflammatory responses. (Bishop Abstract, 3: 13-18.) FF8. Bishop teaches that its compounds are useful in treating certain veterinary as well as human disorders. (Id. at 12:38--40, 12:38--40.) FF9. Bishop teaches the co-administration of the compounds of its invention with known immune response augmenting agents including 7-oxo- DHEA. (Id. at 14:6-12.) Bishop teaches that combining compounds of its invention with such immune response augmenting agents "can give rise to a significantly enhanced immunomodulating activity, thus providing an increased therapeutic effect." (Id. at 14: 12-16.) FF 10. Hayek teaches "a process for feeding a companion animal such as a dog or cat a diet containing an effective amount of f3-carotene to enhance immune response and improve the overall health of the animal." (Hayek Abstract.) FF 11. The Specification teaches that the daily dose of the pro biotic organisms of the invention can be measured in terms of colony forming units (CPU) administered per animal, per day. The Specification states: The daily dose of pro biotic organisms can range from about 105 to about 1012 CPU/day. More preferably, the daily dose of probiotic organisms is about 107 to about 109 CPU/day. More preferably, the daily dose of pro biotic organisms is about 108 to about 109 CPU/day. Most preferably, the daily dose of pro biotic organisms is about 108 CPU/day. 8 Appeal2013-005274 Application 11/544,120 Analysis Claims 1, 10, 25, 32 Claim 32 is directed toward a composition comprising (1) one or more probiotic Enterococcus bacteria in an amount effective for the modulation of immunity or enhancement of vaccine efficacy in a feline, (2) 7-oxo-DHEA, and (3) one or more of alpha-carotene, beta-carotene, astrogalus, or echinacea. Zink teaches using probiotics, including microorganisms of the genus Enterococcus, in cat food. (FF4.) Zink specifically discloses the use of its probiotics for regulating the immune response of pets. (FF5.) Bishop relates to other compounds also useful in the modulation of immune responses, and further teaches that its compounds are useful in treating certain veterinary as well as human disorders. (FF7, FF8.) Bishop teaches that 7-oxo-DHEA is an immune response augmenting agent and teaches that co-administration of such augmenting agent with the compounds of its invention "can give rise to a significantly enhanced immunomodulating activity, thus providing an increased therapeutic effect." (FF9.) Finally, Hayek teaches "a process for feeding a companion animal such as a dog or cat a diet containing an effective amount of B-carotene to enhance immune response and improve the overall health of the animal." (FFlO.) Applying the KSR standard of obviousness to the findings of fact, we conclude that a skilled artisan of ordinary creativity would have predictably modified Zink's composition to add 7-oxo-DHEA and beta-carotene in order to further enhance immunomodulating activity and provide increased therapeutic effect. In particular, Zink teaches a cat food composition for 9 Appeal2013-005274 Application 11/544,120 immunomodulation. Bishop and Hayek discloses 7-oxo-DHEA and beta- carotene, respectively, as immune response augmenting agents. Bishop further teaches that co-administering immune response augmenting agents with immunomodulatory compounds can give rise to increased therapeutic effect. Thus, adding 7-oxo-DHEA and beta-carotene to Zink's composition is merely a "predictable use of prior art elements according to their established functions." KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007). Accordingly, claim 32 is rendered obvious by the combination of Zink, Bishop, and Hayek8. Claim 1 is directed toward the composition of claim 32 formulated for administration to a young feline, wherein if the composition is a dry food composition, the composition includes a coating comprising the Enterococcus bacteria. Claim 10 relates to a method for modulating immunity in a young feline, comprising administering to the feline on a regular basis the composition with the ingredients described in claim 1. 8 In the Appeal Brief, Appellants argue that Bishop is not analogous art and thus should not be relied on for purposes of an obviousness rejection. (Appeal Br. 26-27.) We disagree. "Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved." In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992). In this case, Bishop, like the instant application, deal with compositions and methods for immunomodulation. (FF7.) Thus, it is at least reasonably pertinent to the particular problem involved in the application. 10 Appeal2013-005274 Application 11/544,120 Claim 25 relates to a composition with the ingredients described in claim 1 formulated as a kitten food or treat. We find that any differences between these other independent claims and claim 32 do not obviate the obviousness rejection based on Zink, Bishop and Hayek. With respect to the wherein clause of claim 1, Zink teaches dried pet food containing a coating comprising Enterococcus bacteria. (FF4.) Similarly, Zink teaches administering its probiotic composition to pets on a regular basis. (FF6.) Finally, contrary to Appellants' argument in the Appeal Brief (Appeal Br. 26, 28), the limitations in claims 1, 10, and 25 relating to "young felines" do not render these claims non-obvious. Zink discloses formulating its invention as cat food. (FF4.) Even if we were to consider "young felines" a species within a broader genus of cats, this would be a situation where the disclosure of a small genus anticipates the species. In re Petering, 301F.2d676, 682 (CCPA 1962). Accordingly, the combination of Zink, Bishop, and Hayek also renders claims 1, 10, and 25 obvious for the reasons already discussed. Claim 16 Claim 16 relates to a method for enhancing vaccine efficacy in a young feline, comprising administering to the feline on a regular basis a composition with the ingredients described in claim 1, where the probiotic Enterococcus bacteria is in "an amount effective to enhance vaccine efficacy in the feline." The preamble of claim 16 merely states the purpose or the intended use of the invention and is thus non-limiting. Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). With respect to the limitation regarding the 11 Appeal2013-005274 Application 11/544,120 amount of Enterococcus to be administered, Zink teaches using the bacterial strain of its invention in amounts that substantially overlap those disclosed in the Specification. (FF6, FF 11.) Accordingly, the combination of Zink, Bishop, and Hayek renders claim 16 obvious as well for the reasons already discussed. In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977) ("[W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.") (quotation marks omitted). SUMMARY In summary, we reverse the rejection of claims 1--4, 6-9, 25, 27, 29, 30, 32, and 33 under 35 U.S.C. § 103(a) as obvious over Zink, Bishop, Ahlem, and Netke. We reverse the rejection of claims 1--4, 6-9, 25, 27, 29, 30, 32, and 33 under 35 U.S.C. § 103(a) as obvious over Zink, Jira, Ahlem, and Netke. New grounds of rejection of claims 1, 10, 16, 25, and 32 under 35 U.S.C. § 103(a) as obvious over Zink, Bishop, and Hayek are set forth. We have not addressed Appellants' dependent claims, but in the event of further prosecution we leave it to the Examiner to consider whether any of the dependent claims should also be rejected over the prior art. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 12 Appeal2013-005274 Application 11/544,120 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 C.F.R. § 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 C.F.R. § 41.50(b) also provides that 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 proceeding will be remanded to the Examiner .... (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record .... REVERSED; 37 C.F.R. § 41.50(b) 13 Copy with citationCopy as parenthetical citation