Ex Parte Le-Henand et alDownload PDFPatent Trial and Appeal BoardJan 6, 201612444936 (P.T.A.B. Jan. 6, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/444,936 12/09/2009 29157 7590 K&L Gates LLP-Chicago P.O. Box 1135 CHICAGO, IL 60690 01/08/2016 FIRST NAMED INVENTOR Herve Le-Henand 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. 3712036-01404 3834 EXAMINER YOO, HONG THI ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 01/08/2016 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): USpatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HERVE LE-HENAND, 1 Frarn;ois Murbach, Michael Jedwab, Claudia Roessle, Luc Cynober, and Agathe Raynaud-Simon Appeal2014-000933 Application 12/444,936 Technology Center 1700 Before TERRY J. OWENS, MARK NAGUMO, and N. WHITNEY WILSON, Administrative Patent Judges. NAGUMO, Administrative Patent Judge. DECISION ON APPEAL Herve Le-Henand, Frarn;ois Murbach, Michael Jedwab, Claudia Roessle, Luc Cynober, and Agathe Raynaud-Simon (''Nestec") timely appeal under 35 U.S.C. § 134(a) from the Final Rejection2 of claims 1, 3-5, 1 The real party in interest is listed as Nestec S.A. ("Nestec"). (Appeal Brief, filed 10 June 2013 ("Br."), 2.) 2 Office action mailed 24 January 2013 ("Final Rejection"; cited as "FR"). Appeal2014-000933 Application 12/444,936 - . - - . - - . '1 -- - - - - - - - 8-17, and 19-21.-' We have jurisdiction. 35 U.S.C. § 6. We affirm substantially for reasons well-stated by the Examiner. OPINION A. Introduction 4 The subject matter on appeal relates to a composition for "enteral feeding" ('tube-feeding') (Spec. 1 [0002]) an "elderly patient," which the '936 Specification defines as "an adult patient sixty-five years of age or older who cannot receive nutrition through a normal diet but who is normo- metabolic (i.e., not suffering from a metabolic disorder)." (Id. at 4 [0020].) The composition is to be administered at least once per day, "long-term," i.e., for a period greater than one month (30 days). (Id. at 3 [0019].) The composition is said to have been designed to optimize the glycemic response in elderly patients, i.e., to avoid repeated episodes of hyperglycemia (excessive blood glucose); which is said to be associated with vascular; cardiovascular, and kidney issues. (Id. at 4 [0021]-[0022].) This goal is said to be obtained, in part, by providing decreased carbohydrate intake, with the addition of fructose, fibers, and chromium. (Id. at 5 [0027]- 6 [0030].) 3 Remaining co-pending claims 22-30 have been withdrawn from consideration to by the Examiner. (Br., Claims App.; the Examiner's summary (FR 1, §§ 5, 5a) misstates the claims rejected, as well as those withdrawn from consideration.) 4 Application 12/444,936, Long-term feed-elderly, filed 9 December 2009, as the national stage of PCT /EP07 /61098, filed 17 October 2007, which claims the benefit of a provisional application filed 9 October 2006. We refer to the "'936 Specification," which we cite as "Spec." 2 Appeal2014-000933 Application 12/444,936 Claim 1 is representative of the dispositive issues and reads: A method for providing tube-fed nutrition to an elderly patient comprising the steps of: administering to an elderly patient at least once a day long term through a tube a nutritional product comprising: a source of protein that comprises 14 to 20% by caloric content of the product, at least 50% by weight of the protein source comprising whey protein; a source of carbohydrates that comprises 10 to 45% by caloric content of the product; a source of lipids that comprises 30 to 45% by caloric content of the product, the lipids comprising 40 to 60% by weight mono-unsaturated fats, saturated fatty acids are not more than 1.1 grams per 100 kcal of the product, and from 0.4 to 2 percent by weight of the lipids are eicosapentaenoic acid; a source of dietary fiber that provides 10 to 25 grams per liter of the product; 8.0 to 18.0 micrograms of chromium per 100 kcal of the product; at least 0.5 micrograms of vitamin D per 100 kcal of the product; and the nutritional product has an energy density of 0.8 to 1.3 kcal/ml. (Claims App., Br. 13; some indentation, paragraphing' and emphasis added.) The other independent claim, claim 13, is similar in the specifically disputed limitations. (Id. at 14.) 3 Appeal2014-000933 Application 12/444,936 The final limitations recited in claims 1 and 13, related to energy density, were incorporated from dependent claims 10 and 21, respectively, which were canceled. 5 The Examiner maintains the following grounds of rejection6 : A. Claims 1, 3-5, 8, 9, and 11-17 stand rejected under 35 U.S.C. § 103(a) in view of the combined teachings of Ammann, 7 Green, 8 Lin, 9 Antoku, 10 and Burkhardt. 11 Al. Claims 9 and 20 stand rejected under 35 U.S.C. § 103(a) in view of the combined teachings of Ammann, Green, Lin, Antoku, Burkhardt, and Ernest. 12 5 Amendment filed 8 April 2013; approved for entry by the Examiner on that day (Advisory Action, mailed 8 April 2013 ("Advisory")). 6 Examiner's Answer mailed 18 July 2013 ("Ans."). 7 Christina Ammann et al., High fibre high calorie liquid or powdered nutritional composition, WO 2005/013721 Al (2005) (assigned to Nestec, SA; present co-inventor Claudia Roessle is listed as a co-inventor on Ammann). 8 Ceiwen Jane Green et al., Nutritional composition containing fibres, U.S. Patent No. 5,792,754 (1998). 9 Paul M. Lin et al., Method for providing nutrition to elderly patients, U.S. Patent No. 5,686,429 (1997) (assigned to Nestec, SA). 10 Yasunobu Antoku et al., Fat composition/or oral or enternal [sic: enteral] administration and hexacosanoic acid depressant, U.S. Patent No. 6,867,234 B2 (2005). 11 Peter Burckhardt et al., eds., Nutritional Aspects of Osteoporosis, 2d Ed., Elsevier Academic Press (2004) (excerpts from a Google® webpage). 12 Stephen P. Ernest, Enternal [sic: enteral]formulation, U.S. Patent Application Publication 2004/0067224 Al (2004). 4 Appeal2014-000933 Application 12/444,936 B. Findings of Fact Findings of fact throughout this Opinion are supported by a preponderance of the evidence of record. The Federal Circuit has explained that on appeal, the appellant must not only show the existence of error, but also that the error was harmful because it affected the decision below. In re Chapman, 595 F.3d 1330, 1338 (Fed. Cir. 2010), quoting Shinseki v. Sanders, 556 U.S. 396, 409 (2009) ("the burden of showing that an error is harmful normally falls upon the party attacking the agency's determination."). Initially, we find that Nestec presents substantive arguments for the patentability of claims 1 and 9 only. Thus, claims 3-5, 8, 9, and 11-17 stand or fall with claim 1, and claim 20 stands or falls with claim 9. Nestec urges that the Examiner failed to establish a motivation to combine the teachings of the various references, citing, in particular, Ammann, Lin, and Antoku. In particular, Nestec argues that the Examiner found that Ammann teaches a nutritional composition having an energy density of 1.4 to 1.8 kcal/ml, above the required range of 0.8 to 1.3 kcal/ml recited in claim 1. (Br. 8, 11. 9-11.) The Examiner failed, in Nestec's view, to establish a reason to use the composition taught by Lin for total enteral nutritional support, which, the Examiner found (FR 12, 11. 10-16) has a preferred caloric density of 1.2 kcal/ml, within the range required by claim 1. The Examiner found that the value of 1.4 kcal/ml reported by Ammann was "close to the endpoint range of cited range of0.8 to 1.3 kcal/ml," and concluded that the difference was not patentably distinct because it would have been obvious to use the caloric density taught 5 Appeal2014-000933 Application 12/444,936 by Lin for a successful nutritional composition in the nutritional composition taught by Ammann. (Advisory 3, 11. 1-20.) We do not find Nestec's summary dismissal of the Examiner's detailed factual findings (which Nestec does not contest) and conclusion of law persuasive. Nestec has not directed our attention to any credible evidence of record that indicates that those of skill in the art would have disagreed with the Examiner's conclusion that energy densities of 1.4 kcal/ml and 1.2 or 1.3 kcal/ml were substantially the same for nutritional compositions disclosed as being suitable for "total enteral nutritional support" (Lin, col. 6, 11. 35-36). 13 We are not persuaded of harmful error in the Examiner's findings or conclusions regarding the obviousness of the recited energy density of the nutritional composition. In a similar conclusory manner, Nestec criticizes the Examiner's conclusion that it would have been obvious to use fatty acids in amounts of not more than 1.1 grams per 100 kcal of the product, based on the teachings of Lin. (Br. 8, para. bridging 8-9.) Again, Nestec does not contest the Examiner's detailed factual findings (FR 6, 11. 1-11 ), and merely criticizes 13 In this regard, we note that both Ammann and Lin are assigned to Nestec, and Ammann shares a common inventor with the present application. Therefore, we do not find it credible that Nestec is unaware of the teachings of these references. In particular, we are concerned that Nestec has overlooked or failed to cite Ammann's disclosure that the nutritional composition has an energy content of 1.3-1.8 kcal/ml (Ammann, Abstract, 3d line; 9, 11. 1-2; claim 1 at 16, 1. 6.) Amman's disclosure is not necessary to the Examiner's determination that the preferred range of 1.4--1.8 kcal/ml is close to the range required by claim 1; but the disclosure supports strongly the Examiner's determination. 6 Appeal2014-000933 Application 12/444,936 the conclusion of obvious as lacking motivation. The similarity of the products, as explained supra, however, would have provided a reasonable expectation of success based on the similar uses, which Nestec has not disputed. Nestec also criticizes the Examiner's conclusion that it would have been obvious to use eicosapentaenoic acid (fish oil) in amounts taught by Antoku, because the Examiner failed to establish a motivation to combine the teachings. Again, Nestec does not dispute the Examiner's factual findings regarding the amounts of eicosapentaenoic acid suggested by Antoku for use in compositions for oral or enteral administration for the benefit ofhexacosanoic acid depression "with an object of producing an aging-inhibitory effect on cell membranes" (Antoku, col. 1, 11. 13-15). N estec' s similar summary criticisms (Br. 11) of the Examiner's findings and conclusions regarding the teachings of Ernest regarding lycopene and lutein, which are required by claims 9 and 20, are similarly unpersuasive. In summary, given the detailed and specific findings of fact made by the Examiner, which Nestec has not criticized for their accuracy or pertinence, 14 we are not persuaded of harmful error in the Examiner's well- stated findings of fact and conclusions of law. 14 Nestec has not criticized the Examiner's findings or analysis of Green and the combination of those teachings with relevant teachings of Ammann. (FR 3-5.) 7 Appeal2014-000933 Application 12/444,936 C. Order It is ORDERED that the rejection of claims 1, 3-5, 8-17, and 19-21 is affirmed. 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 tc 8 Copy with citationCopy as parenthetical citation