Robert den HoedDownload PDFPatent Trials and Appeals BoardFeb 2, 20212020002805 (P.T.A.B. Feb. 2, 2021) 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. 15/591,301 05/10/2017 Robert den Hoed P08126US0 2629 34082 7590 02/02/2021 ZARLEY LAW FIRM P.L.C. CAPITAL SQUARE 400 LOCUST, SUITE 200 DES MOINES, IA 50309-2350 EXAMINER HANLEY, SUSAN MARIE ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 02/02/2021 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 2020-002805 Application 15/591,301 Technology Center 1600 Before DEBORAH KATZ, JON M. JURGOVAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL1 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the Examiner’s decision to reject claims 1, and 3–21. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant has not identified the real party in interest. See Appeal Br. 1. A search of the assignment records for this application reveals no recorded assignment for the application. We shall therefore treat the inventor as the “applicant.” Appeal 2020-002805 Application 15/591,301 2 CLAIMED SUBJECT MATTER The claims are directed to a method of producing jellyfish collagen extract. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of producing jellyfish collagen extract, comprising the steps of: obtaining a quantity of frozen jellyfish; adding the frozen jellyfish to a tank containing water; adding protease enzymes and sodium bisulfate to the tank to form a mixture; heating the tank to 60° C for a period of time that permits a reaction in the mixture; filtering the mixture to remove sediment concentrate from the mixture to form a solid; and drying the solid to form a jellyfish collagen extract. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Jackson US 3,875,138 Apr. 1, 1975 Sjolander US 5,411,887 May 2, 1995 Zukor US 2011/0068106 A1 Mar. 24, 2011 Trowell US 2015/0094219 A1 Apr. 2, 2015 Suzuki US 2016/0010890 A1 Jan. 14, 2016 Gueta US 2016/0120955 A1 May 5, 2016 Ikeda JP 2001-1078492 Jul. 3, 2001 Yoshinaka2 JP 2007-051191 A Mar. 1, 2007 2 Citations are to the English translation of records. Appeal 2020-002805 Application 15/591,301 3 REJECTIONS Claims 1, 3–19, and 21 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. Final Act. 2. Claim 20 is rejected under 35 U.S.C. § 103 as being unpatentable over Sjolander in view of Yoshinaka, Ikeda, Jackson, and Gueta, as evidenced by Suzuki , Zukor, and Trowell. Final Act. 10. OPINION Enablement The Examiner finds that the claims are not enabled as the Specification does not teach one skilled in the art how to practice the claimed method without undue experimentation. Final Act. 2. Applying the factors recited in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), the Examiner finds that because of the unpredictable nature of the art and limited amount of guidance in the specification, and undue amount of experimentation would be required to practice the claimed method, particularly the heating of a mixture containing the jellyfish to 60°C. Final Act. 3–6. In support of this finding, the Examiner point to the teaching of Sjolander and Yoshinaka were it teaches that the temperature should not exceed 42°C or 34°C. Id. at 4. Appellant contends that the claims are fully enabled. Appeal Br. 5. Appellant contends that the art is not unpredictable and that the Specification provides ample guidance as to how to practice the invention particularly the steps required and the order in which the steps are performed. Id. at 3–4. Appellant also contends that the Examiner fails to give proper weight to the Declaration of Dr. Den Hoed which show that the claimed method does in Appeal 2020-002805 Application 15/591,301 4 fact work as described in the Specification.3 Id. at 4. Appellant contends that no undue experimentation is required to practice the invention as one skilled in the art would understand how to heat the mixture to the desired temperature. Id. Appellant contends that the teachings of the references are irrelevant to the issue of enablement as Sjolander relates to a different starting material and the method of Yoshinaka is different from the method of the claims. Legal Principles [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). [A] [S]pecification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971). 3 37 C.F.R. § 1.132, Declaration of Robert den Hoed, filed May 24, 2019 (hereinafter “den Hoed Decl.”). Appeal 2020-002805 Application 15/591,301 5 Analysis We have considered the arguments presented by the Examiner and Appellant as well as the evidence of records and conclude that Appellant has the better position. The Specification and den Hoed Declaration both establish that the claimed method is enabled. The example reported in the Specification reports that conducting the recited method at 60°C resulted in the production of collagen having the composition reported in the Specification. Spec. 2–4. Dr. den Heod’s declaration confirms that the work reported in the Specification was actually performed and resulted in the production of collagen. See den Heod Decl. ¶¶ 3–6. The Examiner contends that the den Heod Declaration should be given little weight as it merely restates the claimed method and that the method was enabled. Ans. 21. The Examiner contends that the declaration does not present any data or reasoning to support the conclusions given the teachings of Sjolander and Yoshinaka. Id. We are unpersuaded by the Examiner’s arguments. Dr. den Heod’s declaration confirms that the work reported in the Specification was actually performed and achieved the results reported in the Specification. See den Heod Decl. ¶¶ 3–4. The Examiner has not provided any persuasive argument or evidence, other than the Sjolander and Yoshinaka references, to show why Dr. den Heod’s testimony should be ignored. And Dr. den Heod’s declaration provides a plausible explanation for why the production of collagen in the claimed method is effective at 60°C: the claimed method involves cleaved sulphur reacting with protease enzymes, which is different than the reactions of Sjolander and Yoshinaka for salting out collagen. Id. Appeal 2020-002805 Application 15/591,301 6 ¶¶ 7–14. Dr. den Heod’s declaration is corroborated by what the Specification and prior art references teach. We find the Examiner’s reliance of Sjolander and Yoshinaka to be misplaced. The method taught in Sjolander uses a different starting materials and different method steps. See Sjolander, Abstract. Most notably, Sjolander does not teach the addition of sodium bisulfate prior to heating the mixture. Id. Yoshinaka teaches the use of jellyfish as the starting material but does not teach the addition of a protease and sodium bisulfate prior to heating. See Yoshinaka ¶ 12. Given the significant differences in the claimed method and those described in the prior art, we do not agree with the Examiner that the teachings of the references support a finding on non-enablement. Nor does the record support any reason to doubt the objective truth of the statements of Dr. den Hoed’s declaration which was relied on for enabling support. Conclusion Based on the forgoing we do not sustain the Examiner’s rejection of claims 1, 3–19, and 21 s under 35 U.S.C. § 112(a) for lack of enablement. Obviousness The Examiner has rejected claim 20 under 35 U.S.C. § 103 as unpatentable over Sjolander combine with Yoshinaka, Ikeda, Jackson, and Gueta, as evidenced by Suzuki, Zukor, and Trowell. Claim 20 is similar to claim 1 recited above with the exception that claim 20 does not specify that the heating step is performed at 60°C. Appeal Br. 10 (Claims App.). The Examiner finds that Sjolander teaches a method for extracting collagen from animal tissue by placing the tissue in ice water at a given pH and the heating the mixture to about 42 to 44°C. Final Act. 10. The Appeal 2020-002805 Application 15/591,301 7 Examiner finds that Sjolander teaches that a proteolytic enzyme is then added to the mixture and permitted to react for from 1.75 to 3.5 hours. Id. The Examiner finds that Sjolander teaches that the collagen is then collected. Id. The Examiner finds that Sjolander does not teach or suggest the addition of sodium bisulfate. Id. at 11. The Examiner finds that Yoshinaka teaches a method for extracting collagen from jellyfish and that the method include the addition of salt to aid in recovering the collagen. Id. The Examiner finds that Jackson discloses the use of sodium bisulfate to initiate fibril formation and that Gueta teaches that collagen precipitate is in the form of fibrils. Id. at 12–13. The Examiner concludes It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to collect the collagen freed by hydrolysis of jellyfish in the method of modified Sjolander by salting out with sodium bisulfate and freeze-drying the resultant solid. The ordinary artisan would have been motivated to do so because, Jackson teaches that inorganic salts including sodium chloride, sodium sulfate and sodium bisulfate precipitate polypeptides by fibril formation and collagen is precipitated in the form of fibrils. Yoshinaka teaches freeze-drying of the resultant solid. The ordinary artisan would have had a reasonable expectation that one could precipitate the freed collagen in the method of modified Sjolander by the addition of sodium bisulfate because collagen is precipitated in the form of fibrils and sodium bisulfate is known to precipitate polypeptides via the initiation of fibril formation. Id. at 13 Appeal 2020-002805 Application 15/591,301 8 Appellant contends that the cited references do not teach or suggest the limitation of adding the protease enzyme and sodium bisulfate together to form a mixture. Appeal Br. 6. Appellant contends that the cited references teach the use of salts to salt out the collagen and not to provide sulfur to the enzymatic reaction. Id. Appellant also contends that Jackson is not relevant to the claimed process as it is directed to recovering glucagon which is significantly different from collagen. Id. Analysis We have considered the arguments advanced by the Examiner and Appellant as well as the evidence of record and find that Appellant has the better position. None of the cited references, either alone or in combination, teach or suggest the claimed method. We begin by construing claim 20. “[N]ot unlike a determination of infringement, a determination of anticipation, as well as obviousness, involves two steps. First is construing the claim, followed by, in the case of anticipation or obviousness, a comparison of the construed claim to the prior art.” Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998). Claim 20 recites the steps of “adding protease enzymes and sodium bisulfate to the tank to form a mixture” and “heating the tank for a period of time that permits a reaction in the mixture.” Appeal Br. 10 (Claims App.). Given that the claim calls for forming a mixture followed by permitting a reaction in the mixture we construe the claims to call for mixing the protease enzyme and sodium bisulfate before the heating step. This is consistent with the teachings of the Specification as reflected in Figure 2 below which shows addition of sodium bisulfate before the heating step. Appeal 2020-002805 Application 15/591,301 9 Figure 2 of the present application showing a flowchart of the claimed method. In addition, the Specification teaches A mixture of protease enzymes 18 and sodium bisulfate 20 are then added to the tank 14. . . . Appeal 2020-002805 Application 15/591,301 10 The contents of the tank 14 is then heated to 60 ° C which is maintained for between 2 and 20 hours to permit the contents of the tank to react with one another. Spec. 2. Thus the Specification supports our interpretation of claim 20 to require that the sodium bisulfate is added to the mixture before the heating step. Toro Co. v. White Consolidated Inds., 199 F.3d 1295, 1301 (Fed. Cir. 1999) (claim terms construed in light of Specification and drawings). As Appellant points out, the references cited by the Examiner all teach the addition of salt after the heating step as part of the extracting the collagen from the reaction mixture. Appeal Br. 6. For example, Yoshinaka teaches the use of a salting out step as part of the collecting step. Yoshinaka, claim 7. Similarly, Jackson, which purports to teach the use of sodium bisulfate, teaches the addition of salt to initiate fibril formation. See Jackson, col. 5, ll. 49–51. Fibril formation occurs after the glucagon is separated from the other materials. See Jackson, Fig. 1. We agree with Appellant that none of the references teach or suggest the present method that calls for mixing the protease enzymes with sodium bisulfate prior to heating. The Examiner contends that the order of the steps is irrelevant. Final Act. 13–14. While this is generally true, as discussed above, the claims in this case are properly construed to require the steps be performed in order. See Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322, (Fed.Cir.1999) (The language of the claim, the Specification and prosecution history can support a construction in which the steps are performed in the order written.). Thus it is incumbent on the Examiner to show a teaching or Appeal 2020-002805 Application 15/591,301 11 suggestion in the art that the addition of sodium bisulfate occurs before the heating step. The Examiner has not pointed to any such a teaching in the references nor do we discern one. See Ans. 23–26. Conclusion Based on the forgoing we conclude that a preponderance of the evidence does not support the Examiner’s finding that the subject matter of claim 20 would have been obvious to one of ordinary skill in the art at the time the invention was made over Sjolander combined with Yoshinaka, Ikeda, Jackson, and Gueta, as evidenced by Suzuki, Zukor, and Trowell. DECISION The Examiner’s rejections are reversed. More specifically: The rejection of claims 1, 3–19, and 21 under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement is reversed. The rejection of claims 20 under 35 U.S.C. § 103 as being unpatentable over Sjolander in view of Yoshinaka, Ikeda, Jackson, and Gueta, as evidenced by Suzuki , Zukor, and Trowell is reversed. Appeal 2020-002805 Application 15/591,301 12 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–19, 21 112(a) Enablement 1, 3–19, 21 20 103 Sjolander, Yoshinaka, Ikeda, Jackson, Gueta, Suzuki, Zukor, Trowell 20 Overall Outcome 1, 3–21 REVERSED Copy with citationCopy as parenthetical citation