den Hoed, RobertDownload PDFPatent Trials and Appeals BoardApr 10, 202015234712 - (D) (P.T.A.B. Apr. 10, 2020) 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. 15/234,712 08/11/2016 Robert den Hoed P07738US2 1647 34082 7590 04/10/2020 ZARLEY LAW FIRM P.L.C. CAPITAL SQUARE 400 LOCUST, SUITE 200 DES MOINES, IA 50309-2350 EXAMINER PYLA, EVELYN Y ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 04/10/2020 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): crasmussen@zarleylaw.com emarty@zarleylaw.com kconrad@zarleylaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ROBERT DEN HOED __________ Appeal 2019-004985 Application 15/234,7121 Technology Center 1600 __________ Before ERIC B. GRIMES, RACHEL H. TOWNSEND, and CYNTHIA M. HARDMAN, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of making hydrolyzed marine Type I collagen, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Collagen is a natural substance that has shown “positive beneficial results for treating degenerative diseases” and has been “found to block a tumor’s angiogenesis.” (Spec. 1.) Appellant’s invention is concerned with a method of making hydrolyzed Type I collagen from marine skin. (Id.) 1 We use the word “Appellant” to refer to “Applicant” as defined in 37 C.F.R. § 1.42. Appeal 2019-004985 Application 15/234,712 2 Claims 1–4 and 6–13 are on appeal. Claim 1 is representative and reads as follows: 1. A method of making hydrolyzed marine Type I collagen, comprising the steps of: combining water, marine skin, and sodium hydroxide to form a mixture in a tank; mixing the tank for approximately 40 minutes; rinsing the mixture; adding water and sulfuric acid to the tank and mixing for approximately 40 minutes; draining liquid from the tank while retaining the marine skin; adding citric acid and water to the tank and mixing for approximately 40 minutes; and draining the citric acid and water, and thereafter adding water and draining the water until the pH of the mixture is between 2.8 and 3.4. (Appeal Br. 12.) The prior art relied upon by the Examiner is: Name Reference Date Grossman US 5,093,474 Mar. 3, 1992 Summers US 2013/0035473 A1 Feb. 7, 2013 P. Kittiphattanabawon et al., Characterisation of acid-soluble collagen from skin and bone of bigeye snapper (Priacanthus tayenus), 89 Food Chemistry 363–372 (2005) (“2005 Kittiphattanabawon”) S. Brier et al., Purification and characterization of pepsins A1 and A2 from the Antarctic rock cod Trematomus bernacchii, 274 FEBS Journal, 6152–6166 (2007) T. Potaros et al., Characteristics of Collagen from Nile Tilapia (Oreochromis niloticus) Skin Isolated by Two Different Methods, 43 Kasetsart J. (Nat. Sci.), 584–593 (2009) P. Kittiphattanabawon et al., Isolation and Characterisation of collagen from the skin of brownbanded bamboo shark (Chiloscyllium Appeal 2019-004985 Application 15/234,712 3 punctatum) 119 Food Chemistry 1519–1526 (2010) (“2010 Kittiphattanabawon”) Sietz® K Series Depth Filter Sheets, Pall Food and Beverage, (2011), available at W. Feng, et al. Optimization of enzyme-assisted extraction and characterization of collagen from Chinese sturgeon (Acipenser sturio Linnaeus) skin, 9(Suppl 1) Pharmacogn Mag., S32–S37 (2013) G. Aguirre-Alvarez et al., The effect of drying temperature on mechanical properties of pig skin gelatin films, 9(3), CyTA - Journal of Food, 243–249 (2011) The following grounds of rejection by the Examiner are before us on review: Claims 1, 4, and 62 under 35 U.S.C. § 103(a) as unpatentable over Grossman, Potaros, and 2005 Kittiphattanabawon. Claims 2, 3, and 7–13 under 35 U.S.C. § 103(a) as unpatentable over Grossman, Potaros, 2005 Kittiphattanabawon, Pall, Feng, Aguirre-Alvarez, 2010 Kittiphattanabawon, Brier, and Summers. DISCUSSION Regarding independent claims 1 and 4, the Examiner finds that Grossman teaches a method of producing gelatin from fish skins that involves soaking those skins in aqueous sodium hydroxide, washing the soaked skins with water until a pH of about 7 is reached, then washing the material in aqueous sulfuric acid, washing that material in water until a pH of about 7 is reached, then soaking that processed material with aqueous 2 Appellant filed an Amendment after the final rejection, which combined claim 5 with claim 4 and canceled claim 5, which amendment was entered by the Examiner. (See Advisory Action dated Sept. 28, 2018.) Appeal 2019-004985 Application 15/234,712 4 citric acid solution, then washing that soaked material until a pH of about 7 is reached. (Final Action 4–5.) Next the material so treated is washed in distilled water to remove residual salt in overnight extraction. (Id. at 5.) Afterward the mixture is filtered, centrifuged, and then lyophilized. (Id.) The Examiner notes that Grossman does not identify what pH is reached with the washing in distilled water to remove residual salts after the citric acid treatment. (Final Action 9.) The Examiner relies on 2005 Kittiphattanabawon to conclude that the washing step with distilled water to remove residual salts, would have been obvious to carry out by one of ordinary skill in the art until an acidic pH within the claimed range was reached. (Final Action 9.) In particular, the Examiner finds that 2005 Kittiphattanabawon teaches that type I collagen from fish skins has a high solubility at pH range from 2–5. (Id.) From this, the Examiner concludes that one of ordinary skill in the art would have been motivated to modify the method of Grossman to wash the residual salts from citric-acid treated and washed material in water until a pH of from 2–5 is reached so as to “maximize the solubility of the type I collagen” of Grossman. (Id.) Furthermore, the Examiner notes that “Grossman teaches the final pH is 3.77 (col. 4, line 32), thus it is reasonable to consider the distilled water for overnight extraction was of an acidic pH.” (Ans. 18.) And, the Examiner determines that, in conjunction with the solubility teaching of 2005 Kittiphattanabawon, “one of ordinary skill, wanting to obtain a collagen product, would be motivated to employ a pH range that provides optimum solubility.” (Id.) Appeal 2019-004985 Application 15/234,712 5 The Examiner relies on Potaros for teaching that tilapia skin, the fish skin treated in Grossman, comprises type I collagen. (Final Action 4.) The Examiner concludes, therefore, that “Grossman’s method of producing gelatin (hydrolyzed collagen) from fish skins necessarily produces hydrolyzed marine Type I collagen.” (Id.) The Examiner’s rejection of independent claim 12 relies on the same teachings discussed above. (See Final Action 11.) The additional references the Examiner relies on are to address additional limitations not present in claims 1, 4, and 6. We disagree with the Examiner’s conclusion that it would have been obvious to modify the washing step of Grossman to remove salts to achieve a pH within the range claimed of independent claims 1, 4, and 12. First, we note that it appears that with respect to Grossman the Examiner improperly treats the “final wash with distilled water to remove any residual salts” as the same step as the overnight extraction in distilled water controlled at a temperature within the range of 40–50 °C. In particular, the Examiner states: The citric acid-treated skins were washed with water until the washings had pH about 7, and were then subjected to a final wash with distilled water to remove any residual salts by placing the treated skins in a vessel containing distilled water controlled at a temperature within the range of 40°– 50° C. (Final Action 5.) However, Grossman teaches washing in distilled water to remove residual salts and then placing the “thus-treated skins . . . in a vessel containing distilled water controlled at a temperature within the range of 40°–50°C” for overnight extraction. (Grossman 4:9–16.) These are two separate steps that involve the use of distilled water. Appeal 2019-004985 Application 15/234,712 6 It is true that the pH of the final product of Grossman was determined to be pH 3.77 (Ans. 18). However, that was the pH after the residual salts from the citric acid treated material were washed in distilled water and also then subjected to an overnight extraction in distilled water at a temperature within the range of 40°–50°C, then filtered, centrifuged, and lyophilized. (Grossman 4:9–33.) While it may be that the overnight extraction in distilled water contributed to the final acidic pH of the product—which product was not arrived at until after the material that was extracted in distilled water overnight, filtered, centrifuged, and then lyophilized—the final pH does not provide any information as to the pH resulting from the washing of the citric acid treated material with distilled water to remove any residual salts from the citric acid treatment, a step which occurs before extraction in distilled water and filtering of the extracted product, which could affect pH of the final product. Furthermore, we disagree with the Examiner’s conclusion that 2005 Kittiphattanabawon’s determination that its extracted collagen final product has a high solubility in a pH range from 2–5 (Final Action 9) and can be completely solubilized in 0.5 M acetic acid (Ans. 18) would suggest to one of ordinary skill in the art anything regarding at what pH one step during the treatment process to extract collagen from marine skin in the first instance should be carried out. Indeed, we agree with Appellant that the solubility of an extracted collagen at a particular pH does not speak to what pH any particular intermediate step in the method of making (extracting) collagen should be carried out or was likely carried out. (Appeal Br. 5.) Additionally, that 2005 Kittiphattanabawon “employ[s] acidic treatment of the fish skins” and that “the obtained collagen pellet was Appeal 2019-004985 Application 15/234,712 7 solubilized in 0.5 M acetic acid” (Ans. 20) does not provide a relevant teaching as to why one of ordinary skill in the art would have modified the Grossman process of washing the citric acid treated material with distilled water in a manner that this washing would be carried out to an acidic pH within the claimed range. In particular, the 2005 Kittiphattanabawon process does not teach using distilled water washing to achieve an acidic pH during its process. Rather, to the extent an acidic pH is desirable and achieved during the extraction process in 2005 Kittiphattanabawon, it is by soaking skins that were defatted in 10% butyl alcohol in an acetic acid solution for 24 hours after being washed with cold water. (2005 Kittiphattanabawon 364 (2.4. Preparation of collagen from skin and bone).) Thus, we do not find that 2005 Kittiphattanabawon would have provided any motivation to one of ordinary skill in the art regarding the pH to be achieved when washing the citric acid treated material with distilled water to remove salts during the Grossman process, prior to overnight extraction in distilled water. In light of the foregoing, we conclude that the Examiner has failed to meet the initial burden of presenting a prima facie case of obviousness. In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) (citations omitted). And we therefore, reverse the rejection of claims 1, 4, and 6 under 35 U.S.C. § 103(a) as unpatentable over Grossman, Potaros, and 2005 Kittiphattanabawon, as well as claims 2, 3, and 7–13 under 35 U.S.C. § 103(a) as unpatentable over Grossman, Potaros, 2005 Kittiphattanabawon, Pall, Feng, Aguirre-Alvarez, 2010 Kittiphattanabawon, Brier, and Summers. Appeal 2019-004985 Application 15/234,712 8 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 6 103 Grossman, Potaros, 2005 Kittiphattanabawon 1, 4, 6 2, 3, 7– 13 103 Grossman, Potaros, 2005 Kittiphattanabawon, Pall, Feng, Aguirre- Alvarez, 2010 Kittiphattanabawon, Brier, Summers 2, 3, 7–13 Overall Outcome 1–13 REVERSED Copy with citationCopy as parenthetical citation