Ex Parte Brockman et al

Patent Trial and Appeal BoardJul 12, 2016

13140139 (P.T.A.B. Jul. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/140,139 06/16/2011 23909 7590 07114/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Jeffrey A. Brockman 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. 8772-00-US-Ol-HL 6207 EXAMINER HEYER, DENNIS ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 07/14/2016 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): Patent_Mail@colpal.com uspto@thebellesgroup.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEFFREY A. BROCKMAN and STEVEN C. ZICKER1 Appeal2014-007668 Application 13/140, 139 Technology Center 1600 Before JACQUELINE W. BONILLA, TA WEN CHANG, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to a method of treating cats by feeding them a food composition that includes lipoic acid, which have been rejected as anticipated. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm. STATEMENT OF THE CASE Appellants' specification indicates that "[i]t is believed that histamine may ... be involved in feline idiopathic cystitis [("FIC")]." (Spec. i-f 2.) 1 Appellants identify the Real Party in Interest as Hill's Pet Nutrition, Inc. (Appeal Br. 1.) Appeal2014-007668 Application 13/140,139 The specification indicates that a study of cats with "urinary tract infections indicate[ d] that genes involved in histamine release and signaling pathways are increased in expression in ... cats with FIC" and notes that treating "feline cell lines" with lipoic acid "decreases the expression of key genes in the same histamine release/signaling pathways that are up regulated in FIC." (Id.) The claimed invention relates to including the antioxidant lipoic acid in feline food compositions in amounts effective to "inhibit histamine related pathways." (Spec. i-f 6.) Appellants' specification defines the term "inhibiting histamine related pathway" as "refer[ ring] to the ability of a companion animal[] to have reduced release of histamine and thereby treat or prevent disorders associated with histamine release." (Spec. i-f 30.) The specification indicates that lipoic acid in a cat food composition in at least about 25 parts per million ("ppm") when administered to a cat will result in inhibition of histamine related pathway. (Spec. i-fi-130-31, 35.) Claims 1-5 and 8-12 are on appeal. Claims 1 and 8 are representative and read as follows: 1. A method of inhibiting histamine related pathways in a companion animal comprising administering to a companion animal in need thereof a food composition comprising an effective amount of lipoic acid to inhibit histamine related pathways in the companion animal, wherein said effective amount of lipoic acid to inhibit histamine related pathways in the companion animal is at least about 25 ppm, and wherein the companion animal is a cat. 8. The method of claim 1, wherein the effective amount is effective to treat idiopathic cystitis or interstitial cystitis in the companion animal. (Appeal Br. 7.) 2 Appeal2014-007668 Application 13/140,139 The following ground of rejection by the Examiner is before us on review: Claims 1-5 and 8-12 under 35 U.S.C. Â§ 102(b) as anticipated over Zicker, 2 as evidenced by Gill 3 and Plotnick. 4 DISCUSSION The Examiner finds that Zicker teaches a method of preventing or treating kidney disease in cats "comprising administering a food composition comprising one or more food ingredients admixed with antioxidants and mitochondrial cofactors in amounts sufficient to prevent or treat kidney disease." (Final Action 3 (citing Zicker i-f 24); Ans. 2-3.) The Examiner notes that Zicker provides an embodiment of a feline food that includes at least about 25 ppm a-lipoic acid. (Ans. 7 (citing Zicker i-fi-1 41- 42, 48--49).) The Examiner explains that Zicker does not indicate whether kidney disease is a histamine-related pathway, or whether Zicker's method of providing to a cat a food composition comprising at least 25 ppm a-lipoic acid inhibits histamine pathways in the cat, as recited in the claims. The Examiner relies upon Gill and Plotnick for evidence that kidney disease involves increased histamine. (Final Action 4 (noting that Gill teaches that "plasma histamine levels are significantly increased in patients 2 Zicker et al., WO 2007 /022344 A2, published Feb. 22, 2007. 3 D.S. Gill et al, Plasma histamine in patients with chronic renal failure and nephrotic syndrome, 44 J. Clin. Pathol. 243-245 (1991). 4 Arnold Plotnick, Long-term Medical Management of Feline Chronic Renal Failure, in web.archive.org/web/20081017233921/http://www.manhattancats.com/ Articles/CRF .html 3 Appeal2014-007668 Application 13/140,139 with kidney disease and that raised histamine concentrations in said patients may contribute to the damage of glomerular arteries" and that Plotnick teaches a "need to administer histamine-2 receptor antagonists" to address the increase in gastric acidity brought about by increased gastrin levels.) The Examiner concludes that the teachings of Gill and Plotnick support a conclusion that kidney disease as disclosed in Zicker is "histamine-related" and the administration of the amounts of lipoic acid taught to be administered in Zicker "will both treat kidney disease and inhibit a histamine-related pathway." (Final Action 4--5; Ans. 3--4.) The Examiner further finds that Zicker "teaches the identical invention in as complete detail as is contained in the claim." (Ans. 7.) The Examiner further notes that the evidence relied upon "reasonably support[s] a conclusion of inherency;" and, [i]n the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed method is different from those taught by the prior art, i.e. that administering lipoic acid does not inhibit a histamine related pathway in a companion animal in need thereof, and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989) (Final Action 5---6; Ans. 4--5.) Regarding claim 8, which requires administration of an amount of lipoic acid that is effective to treat interstitial cystitis or idiopathic cystitis, the Examiner notes that Appellants' specification at i-f 18 indicates the effective amount is at least 25 ppm. (Final Action 6; Ans. 5.) The Examiner concludes that Zicker' s composition that includes lipoic acid in at least 25 ppm would necessarily treat interstitial cystitis or idiopathic cystitis. (J d.) 4 Appeal2014-007668 Application 13/140,139 Appellants' arguments do not persuade us that the Examiner's factual findings and conclusion that claim 1 would have been anticipated by Zicker are erroneous. As a threshold matter, Appellants statement of what is required under the law to establish inherent anticipation is incorrect. Appellants contend that the law for inherent anticipation requires evidence that makes clear that the missing descriptive matter from the prior art relied upon "would be so recognized [to be present] by persons of ordinary skill in the art." (Appeal Br. 4 (citing Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991)).) However, the Federal Circuit has "reject[ ed] the contention that inherent anticipation requires recognition in the prior art." Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). In Schering, the Federal Circuit explained that "Continental Can does not stand for the proposition that an inherent feature of a prior art reference must be perceived as such by a person of ordinary skill in the art before the critical date." Id. In particular, the Court explained that in Continental Can there was a disputed material fact over "whether the blow molding inherently produced hollow ribs;" thus, summary judgment of anticipation was vacated. Id. The Court noted that Continental Can makes no reference to whether the inherent feature, hollow ribs, was recognized before or after the critical date of the patent at issue ... in Continental Can, this court did not require past recognition of the inherent feature, but only allowed recourse to opinions of skilled artisans to determine the scope of the prior art reference. 5 Appeal2014-007668 Application 13/140,139 Id. Inherent anticipation is established if the prior art necessarily and inevitably functions in accordance with, or includes, the claimed limitations. Id. at 1378. As to factual matters, Appellants argue that the Examiner has failed to make out a prim a f acie case of anticipation with respect to claim 1 5 because "Appellants' patent specification nowhere mentions kidney disease" and Zicker refers to treating kidney disease "rather than what is covered by the pending claims, which is inhibiting histamine release" and "the only disclosure that connects lipoic acid with reduced histamine release is Appellants' own disclosure." (Appeal Br. 4, 6.) We do not find these arguments persuasive. The method of inhibiting histamine related pathways in a cat recited in claim 1 requires administering to a cat a food composition comprising at least 25 ppm lipoic acid to inhibit histamine related pathways in the companion animal. (Appeal Br. 7.) As discussed above, whether or not Zicker recognizes administering to a cat a food composition with at least 25 ppm lipoic acid results in reduced histamine release is not dispositive of whether it inherently anticipates. "[I]nherency is not necessarily 5 Appellants contend that because idiopathic cystitis was the species elected with respect to the Examiner's requirement to elect a species recited in claim 8, that election necessarily limits the scope of each of claims 1-5 and 8-12 under appeal to the elected species, citing Ex parte Ohsaka, 2 USPQ2d 1460, 1461(BPAI1987). (Reply Br. 2.) Appellants are incorrect as prosecution on the merits was expanded by the Examiner to Appellants' generic claim 1, as well as idiopathic cystitis. However, in light of the species election, we take no position with respect to the non-elected species "interstitial cystitis" recited in claim 8. 6 Appeal2014-007668 Application 13/140,139 coterminous with knowledge of those of ordinary skill in the art. Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art." Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed. Cir. 2005) (quoting MEHL/Biophile Int'! Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed.Cir.1999)). What matters is whether Zicker teaches "the very same method," i.e., administering to a cat a composition comprising at least 25 ppm lipoic acid; if it does "then the particular benefits must naturally flow from those methods even if not recognized as benefits at the time of [Zicker's] disclosure." Id. at 1378; see also id. at 1379--80 (noting with respect to claims that "merely require[] application of the composition to exposed skin surfaces" that "[b ]ecause Pereira discloses the very same composition and teaches its topical application, the district court correctly applied the inherency doctrine. Using the same composition claimed by Dr. Perricone in the same manner claimed by Dr. Perricone naturally results in the same claimed skin benefits."); see also MEHL/Biophile, 192 F.3d at 13 65---66 (prior art method did not perform the steps for the purpose of hair depilation, but it was determined that hair depilation would have been a necessary, albeit unrecognized and inherent, consequence of carrying out the steps). In addition to teaching cat food compositions that comprise between 25 and 200 ppm lipoic acid (Zicker i-f 42), Zicker expressly teaches an embodiment of administering cats a food composition that includes 25 ppm oflipoic acid (Zickeri-f49). (Ans. 7.) Claim 1 and Appellants' Specification indicate that 25 ppm of lipoic acid is sufficient to inhibit histamine related pathway in cats. (Appeal Br. 7 (claim 1 ); Specification 7 Appeal2014-007668 Application 13/140,139 i-fi-130-31, 35). Consequently, Zicker expressly includes the recited method steps of claim 1. Thus, absent evidence to the contrary, we are persuaded that Zicker' s method necessarily achieved the claimed function, whether or not Zicker recognized any relationship between lipoic acid's ability to reduce histamine release. Appellants have not provided sufficient evidence establishing that the claimed method is different from the prior art. We, therefore, agree with the Examiner that the evidence relied upon reasonably supports a conclusion of inherency with respect to claim 1. Appellants' argument with respect to claim 8 is equally unavailing. According to Appellants, Zicker (or some other prior art) must correlate "the amounts of lipoic acid required to treat kidney disease with the amount needed to treat idiopathic cystitis" to establish anticipation of claim 8. (Appeal Br. 4.) However, claim 8 simply requires that the effective amount administered, i.e., at least about 25 ppm, is effective to treat idiopathic cystitis (Appeal Br. 7). Appellants' Specification indicates that 25 ppm of lipoic acid is sufficient to treat idiopathic cystitis in cats. (Specification i-fi-130-31, 35). The law does not require that Zicker recognize its cat food composition that contains at least about 25 ppm lipoic acid used to treat kidney disease also results in treatment of idiopathic cystitis. Perricone, 432 F.3d at 1378. Zicker expressly includes the recited method steps of claim 8. Thus, absent evidence to the contrary, we are persuaded that Zicker' s method necessarily achieved the claimed function, whether or not Zicker recognized any relationship between lipoic acid's ability to treat idiopathic cystitis in addition to kidney disease. 8 Appeal2014-007668 Application 13/140,139 Accordingly, we affirm the Examiner's anticipation rejection of claims 1 and 8 over Zicker. Claims 2-5 and 9-12 have not been argued separately and therefore fall with claim 1. 37 C.F.R. Â§ 41.37(c)(l)(iv). SUMMARY For the reasons discussed, we affirm the Examiner's rejection of claims 1-5 and 8-12 under 35 U.S.C. Â§ 102(b) as anticipated over Zicker, as evidenced by Gill and Plotnick. 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. Â§ 1.136(a). AFFIRMED 9