Ex Parte Lange et alDownload PDFPatent Trial and Appeal BoardNov 3, 201412153158 (P.T.A.B. Nov. 3, 2014) 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. 12/153,158 05/14/2008 Stefan Lange 10819.0001-02000 4455 22852 7590 11/04/2014 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER WANG, SHENGJUN ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 11/04/2014 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 STEFAN LANGE, LEIF GORANSSON, and IVAR LONNROTH __________ Appeal 2012-004740 Application 12/153,158 Technology Center 1600 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method for regulating the flux of fluid and electrolytes in a human. The Examiner rejected the claims as failing to comply with the written description requirement. 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 RURAL PATENT SVENSKA AB (see App. Br. 3). Appeal 2012-004740 Application 12/153,158 2 Statement of the Case Background “The present invention relates to the use of products having enzymatic activity for the preparation of a food inducing the formation of antisecretory proteins (ASP), and to the food so prepared” (Spec. 1, ll. 1–3). The Claims Claims 10–47 are on appeal. Claim 10 is representative and reads as follows: 10. A method for regulating the flux of fluid and electrolytes in a human, comprising feeding a human in need of such regulation a foodstuff comprising a malted product, wherein the foodstuff is in the form of breakfast flakes, bread, rolls, pasta products, meat products, or a powder, and wherein the malted product has by itself sufficient enzymatic activity to hydrolyze carbohydrates and proteins in the intestinal canal to induce, when consumed, in the human a level of at least 0.5 units of antisecretory proteins (ASP) per 1 ml of blood. The issue The Examiner rejected claims 10–47 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Ans. 4–5). The Examiner finds that the claims require “the presence of living enzymes, or enzymatic activity of the food stuff, that is in the form of breakfast flakes, bread, rolls, pasta products, meat products, or a powder, that lead to the production of amino acid and sugar in intestinal canal, or to the increase of ASP” (Ans. 5). The Examiner finds that the “application as originally filed provides no written description for such subject matter” (Ans. 5). Appeal 2012-004740 Application 12/153,158 3 The Examiner further finds that: No written description indicates that these foods contain any enzymatic activity. No one should believe that there is any enzymatic activity left after the cooking (baking in particular). Therefore, there is no reason to believe that the induction of ASP in the examples is due to the enzymatic activity, and is not due to the amino acid and sugar in the malted oat or barley. (Ans. 5.) The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that claims 10–47 fail to comply with the written description requirement? Findings of Fact 1. The Specification teaches “the use of products having enzymatic activity for the preparation of a food inducing the formation of antisecretory proteins (ASP)” (Spec. 1, ll. 1–3). 2. The Specification teaches that “the formation of ASP can be controlled or governed by varying the amount and proportion of the product having enzymatic activity” (Spec. 2, ll. 24–26). 3. The Specification teaches that “Malted cereals” are healthy and fresh grain that has been subjected to malting. The malting means that the grain kernels are steeped and thereafter are allowed to germinate at a carefully controlled water content and temperature until its sprout germs have developed. The germination time is adjusted to the respective lot and variety. The germinated kernels are dried and desprouted. The drying can be driven so that the enzyme activity is changed to a more or less extent. The product then obtained is malt. The nutritive substances of the kernel has then, to a restricted extent, been Appeal 2012-004740 Application 12/153,158 4 hydrolysed and the enzymes of the sprout have been activated. (Spec. 3, ll. 10–18.) 4. The Specification teaches that bread baked with 30% malted barley-flour resulted in ASP levels of 1.0 units/ml and 0.5 units/ml in two different human individuals (see Spec. 5, ll. 14–35). Principles of Law “[I]t is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure . . . or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement.” Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Analysis The description inquiry is not concerned with the operability of the claimed invention, instead asking whether the Specification provides descriptive support and possession for the claimed invention. Id. at 1352. The Specification states that malted cereals contain enzymes (FF 3) and that the amounts of these malted products in food may impact the levels of antisecretory protein in blood (FF 1–2). The Specification provides an example of feeding humans bread made with malted barley flour which results in a level of at least 0.5 units of antisecretory protein per ml of blood (FF 4). Thus, the Specification provides literal descriptive support for the claimed invention. We therefore are constrained to reverse this written description rejection. Appeal 2012-004740 Application 12/153,158 5 We note that the Examiner’s reasoning, evidence, and arguments are not drawn to a written description rejection, but rather appear more relevant to a scope of enablement rejection. However, because no scope of enablement rejection is before us, we take no position on the applicability of any enablement rejection. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that claims 10–47 fail to comply with the written description requirement. New Ground of Rejection Under the provisions of 37 C.F.R. § 41.50(b), we enter the following new grounds of rejection. Claims 10–13, 17, 21–25, 29, and 33 are rejected under 35 U.S.C. § 102(b) as anticipated by Petrofsky.2 Findings of Fact 5. Petrofsky teaches [A] typical procedure for manufacturing bakery bagels: 1. The following ingredients are put into a mixer containing a dough hook and mixed for 8-10 minutes at room temperature (60-95 degrees F.): (a) 100 lbs. of high gluten bleached malted barley flour; (b) 48 lbs. water; (c) 6 lbs. sugar or 2 lbs. malt; (d) 2 lbs. salt; (e) 4½ lbs. vegetable oil (optional); and (f) 4 oz. to 1 lb. yeast. (Petrofsky, col. 1, ll. 50–61.) 2 Petrofsky et al., US 4,657,769, issued Apr. 14, 1987. Appeal 2012-004740 Application 12/153,158 6 6. Petrofsky teaches that the “dough pieces are next cooked in water at 212 degrees F. for 30 seconds to 2 minutes until they float on the surface of the water” (Petrofsky, col. 2, ll. 8–10). 7. Petrofsky teaches that the “bagels are dried and then baked for 20 minutes at 380 degrees F” (Petrofsky, col. 2, ll. 12–13). 8. Petrofsky teaches that “calcium peroxide which also contains soya flour, diammonium phosphate, and tricalcium phosphate acts as a dough conditioner” (Petrofsky, col. 3, ll. 43–45). Principles of Law Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Analysis Claims 10 and 22 Petrofsky teaches a method of making a foodstuff, bagels, for human consumption which comprises a malted product, malted barley flour, with the further addition of malt itself (FF 5). Because every human requires proper regulation of fluid and electrolytes, as recited in the preamble of claim 10, we broadly interpret the “human in need thereof” limitation as encompassing all bagel consumers. See In re Zletz, 893 F.2d 319, 321 (Fed. Appeal 2012-004740 Application 12/153,158 7 Cir. 1989) (“[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.”). We find that Petrofsky, in producing bagels composed of 100% malted barley flour for feeding to humans, inherently satisfies the claim 10 requirement “wherein the malted product has by itself sufficient enzymatic activity to hydrolyze carbohydrates and proteins in the intestinal canal to induce, when consumed, in the human a level of at least 0.5 units of antisecretory proteins (ASP) per 1 ml of blood.” This inherency position is directly supported by Appellants’ own Specification, which teaches that bread baked with 30% malted barley flour induced antisecretory protein levels of 0.5 units per 1 ml of blood or greater (FF 4). We have considered both the Nyrén Declaration3 and the Larsson statement.4 The Nyrén Declaration teaches that “[e]xample 2 [of Johnston] heats the malted barley mixture to 140°F for at least 30 minutes, which I expect would terminate any enzymatic activity” (Nyrén Decl. 4 ¶ 12). In contrast, the Larsson statement teaches that “enzyme activity often remains in a biological sample after a moderate external impact in the form of temperature or other unfavorable environmental parameters. In baked goods there is a temperature gradient, perpendicular to the surface. Oven conditions do not extend to the interior of the goods.” This contradicting evidence is precisely the sort of situation in which Best applies, reasonably placing an evidentiary burden upon Appellants to 3 Declaration of Dr. Pål Nyrén, filed June 25, 2009. 4 Larsson, M., Baking and Enzymatic activity, Feb. 14, 2011. Appeal 2012-004740 Application 12/153,158 8 demonstrate that the bagels of Petrofsky do not inherently satisfy the functional requirements of claim 10, while simultaneously explaining why the baked bread in Example 1 of the Specification functions to satisfy the claim 10 requirements. With regard to claims 11, 12, 23, and 24, Petrofsky teaches the use of malted barley flour as well as malt (FF 5). With regard to claims 13 and 25, Petrofsky teaches admixing soya flour into the final mixture (FF 8). With regard to claims 17 and 29, Petrofsky teaches a bread foodstuff, specifically bagels (FF 5). With regard to claims 21 and 33, the ASP levels represent an inherent property as discussed above. We have applied the new ground of rejection only to claims 10–13, 17, 21–25, 29, and 33. We leave it up to the Examiner, who has more expertise in this area, to determine whether the anticipation rejection, an enablement rejection, or obviousness rejections with additional references, should be applied to any of the other pending claims. SUMMARY In summary, we reverse the rejection of claims 10–47 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. A new ground of rejection of claims 10–13, 17, 21–25, 29, and 33 under 35 U.S.C. § 102(b) as anticipated by Petrofsky is set forth. This decision contains a new ground of rejection pursuant to Appeal 2012-004740 Application 12/153,158 9 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (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 the 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) cdc Notice of References Cited Application/Control No. 12/153,158 Applicant(s)/Patent Under Reexamination Stefan Lange et al. Examiner Shengjun Wang Art Unit 1600 Page 1 of 1 U.S. PATENT DOCUMENTS * DOCUMENT NO. DATE NAME CLASS SUBCLASS DOCUMENT SOURCE ** APS OTHER A 4,657,769 4/14/87 Petrofsky et al. B C D E F G H I J K L M FOREIGN PATENT DOCUMENTS * DOCUMENT NO. DATE COUNTRY NAME CLASS SUBCLASS DOCUMENT SOURCE ** APS OTHER N O P Q R S T NON-PATENT DOCUMENTS * DOCUMENT (Including Author, Title Date, Source, and Pertinent Pages) DOCUMENT SOURCE ** APS OTHER U V W X *A copy of this reference is not being furnished with this Office action. (See Manual of Patent Examining Procedure, Section 707.05(a).) **APS encompasses any electronic search i.e. text, image, and Commercial Databases. U.S. Patent and Trademark Office PTO-892 (Rev. 03-98Notice of References Cited Part of Paper No. 16 10/31/2014, EAST Version: 3.0.0.6 10/31/2014, EAST Version: 3.0.0.6 10/31/2014, EAST Version: 3.0.0.6 10/31/2014, EAST Version: 3.0.0.6 10/31/2014, EAST Version: 3.0.0.6 Copy with citationCopy as parenthetical citation