Valio Ltd

Patent Trials and Appeals BoardAug 4, 2020

14353718 - (D) (P.T.A.B. Aug. 4, 2020)

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. 14/353,718 04/23/2014 Kirsi Rajakari Q211565 5656 23373 7590 08/04/2020 SUGHRUE MION, PLLC 2000 PENNSYLVANIA AVENUE, N.W. SUITE 900 WASHINGTON, DC 20006 EXAMINER TURNER, FELICIA C ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 08/04/2020 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): PPROCESSING@SUGHRUE.COM USPTO@sughrue.com sughrue@sughrue.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KIRSI RAJAKARI, KAI HOTAKAINEN and PAIVI MYLLARINEN Appeal 2019-004870 Application 14/353,718 Technology Center 1700 ____________ Before KAREN M. HASTINGS, MICHAEL G. McMANUS, and JANE E. INGLESE, Administrative Patent Judges. McMANUS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 seeks review of the Examiner’s decision to reject claims 1–4, 6–14, and 16–20. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Valio Ltd. Appeal Brief dated Feb. 19, 2019 (“Appeal Br.”) 2. Appeal 2019-004870 Application 14/353,718 2 CLAIMED SUBJECT MATTER The present application generally relates to a stable liquid enzyme formulation comprising a milk protein crosslinking enzyme and/or a milk protein modifying enzyme. Specification filed April 23, 2014 (“Spec.”) ¶ 1. The Specification teaches that milk protein crosslinking and/or modifying enzymes are useful in the manufacture of “processed fish, meat and egg products, pastes and [pâté]s, fruits, berries and vegetables, soy products, cereal products, bread and bakery products.” Id. ¶ 12. The Specification further teaches that a problem associated with milk protein crosslinking and modifying enzyme formulations is the lack of stability of the formulation. Id. ¶ 4. The Specification additionally provides that The invention is based on the finding that when a transglutaminase, tyrosinase or protein glutaminase is stored in a suspension of a polyol, such as glycerol or sorbitol, and water in the pH range from 4.4 to 5.1, its activity is remained moderately during storage at room temperature and excellently during storage in the temperatures of a refrigerator and/or a freezer. Id. ¶ 23. Claim 1 is illustrative of the subject matter on appeal and is reproduced below with certain limitations bolded for emphasis: Appeal 2019-004870 Application 14/353,718 3 1. A liquid enzyme formulation comprising at least one milk protein crosslinking and/or modifying enzyme selected from transglutaminase, protein glutaminase and tyrosinase in polyol-water suspension comprising from 25% to 100% (w/w) polyol and having pH value within the range from 4.4 to 5.1, wherein the at least one milk protein crosslinking and/or modifying enzyme selected from transglutaminase, tyrosinase and protein glutaminase maintains its activity in the formulation. Appeal Br. 22 (Claims App.) (emphasis added). REFERENCES The Examiner relies upon the following prior art: Name Reference Date Schooneveld-Bergmans US 2003/0190399 Al Oct. 9, 2003 Chou US 2003/0219853 Al Nov. 27, 2003 Parkhideh US 2005/0008581 A1 Jan. 13, 2005 Miwa US 2011/0064847 A1 Mar. 17, 2011 Bodo US 2011/0189344 Al Aug. 4, 2011 REJECTIONS The Examiner maintains the following rejections: 1. Claims 1–4, 6, 8–10, 12–14, 16, and 18 are rejected under pre- AIA 35 U.S.C. § 103(a) as being unpatentable over Schooneveld-Bergmans in view of Miwa. Final Action dated May 15, 2018 (“Final Act.”) 2–5. 2. Claims 7 and 17 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Schooneveld-Bergmans in view of Miwa and further in view of Chou. Id. at 5–6. 3. Claim 11 is rejected under pre-AIA 35 U.S.C. § 103(a) as Appeal 2019-004870 Application 14/353,718 4 being unpatentable over Schooneveld-Bergmans in view of Miwa and further in view of Bodo. Id. at 6. 4. Claims 19 and 20 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Schooneveld-Bergmans in view of Miwa and further in view of Parkhideh. Id. at 6–7. DISCUSSION Rejection 1. The Examiner rejects claims 1–4, 6, 8–10, 12–14, 16 and 18 as obvious over Schooneveld-Bergmans in view of Miwa. Id. at 2–5. In support of the rejection, the Examiner finds that Schooneveld-Bergmans teaches a liquid enzyme formulation including polyol and having a pH from 4 to 5. Id. at 2. The Examiner further finds that Schooneveld-Bergmans discloses utilizing protein modifying enzymes in its liquid enzyme formulation. Id. at 8. The Examiner finds, however, that Schooneveld- Bergmans does not explicitly teach that the enzyme is a milk protein modifying enzyme. Id. at 2. The Examiner finds that Miwa teaches the use of protein glutaminase and transglutaminase as protein modifying enzymes that can modify milk proteins. Id. (citing Miwa ¶ 51). The Examiner determines that one of ordinary skill in the art would have had reason to modify the formulation of Schooneveld-Bergmans to include protein glutaminase and transglutaminase (as taught by Miwa) in order to store such enzymes. Id. at 2–3, 8. Appellant alleges error on several bases. First, Appellant argues that “the presently claimed invention is different from Schooneveld-Bergmans and Miwa.” Appeal Br. 8; see id. 8–11. Appeal 2019-004870 Application 14/353,718 5 Appellant argues that Schooneveld-Bergmans does not teach or suggest a stable liquid protein modifying enzyme composition. Id. at 9. Appellant contends that the focus of Schooneveld-Bergmans is carbohydrase enzymes. Id. Appellant directs us to differences in the reported stability of various carbohydrases as showing that “the activity of different enzymes differ considerably even under the same storage conditions.” Id. Appellant asserts that Schooneveld-Bergmans does not teach that the pH of the formulation is adjusted to a range of 4 to 5. Id. at 10. In this regard, Appellant states that one of skill in the art would recognize that Schooneveld-Bergmans teaches the use of ascorbic acid in high quantities such that “ascorbic acid is not used to adjust the pH of the composition, but rather, is used in order to improve the flour and dough.” Id. Appellant further asserts that ascorbic acid would be unstable in the claimed formulation. Id. Appellant additionally asserts that the activity (after a period of storage) of the enzymes of Schooneveld-Bergmans was measured at a pH outside the claimed range. Last, Appellant cites to a treatise indicating that “[o]ptimal conditions for storage are distinctive to each protein.” Id. at 11 (underscoring omitted) (citing Pierce Biotechnology, Protein Stability and Storage, TR0043.1, hereafter “Pierce”). In the Reply, Appellant argues that Pierce indicates that “persons of ordinary skill in the art would have understood that stability properties of the protein modifying enzyme can be significantly different from those of carbohydrases.” Reply Brief dated June 5, 2019 (“Reply Br.”) 6. The foregoing is not persuasive. Appellant may be correct that the primary thrust of Schooneveld-Bergmans concerns carbohydrase enzymes. Precedent, however, requires that “all disclosures of the prior art, including Appeal 2019-004870 Application 14/353,718 6 unpreferred embodiments, must be considered.” See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Accordingly, the Examiner may rely on Schooneveld-Bergmans’ teaching that “[l]iquid compositions according to the invention comprise one or more enzymes that may be selected from the group consisting of . . . a protein modifying enzyme.” Schooneveld-Bergmans ¶ 13. Appellant asserts that Schooneveld-Bergmans does not teach the claimed pH range. Appeal Br. 10–11; Reply Br. 5–6. Appellant, however, does not squarely address Schooneveld-Bergmans’ teaching that “an aqueous solution of ascorbic acid with a pH preferably from 4 to 5 (obtainable by adding buffer salts)” may be used in making the formulation. Schooneveld-Bergmans. The Examiner finds that this teaches a formulation having a pH within the claimed range. Final Act. 2. Appellant does not specifically rebut such finding. Appellant’s factual assertion that “ascorbic acid is not used to adjust the pH of the composition” is not supported by evidence of record nor directly contrary to the Examiner’s finding. Similarly, Appellant’s assertion regarding the stability of ascorbic acid is not supported by citation to evidence of record. Appellant further asserts that the examples of Schooneveld-Bergmans were measured at a pH outside the claimed range. In this regard, the Examiner finds that the “tests were conducted after the enzymes were stabilized for different periods of up to 26 weeks.” Answer 11 (emphasis in original). The tests were conducted at the optimal pH for enzyme activity, not the optimal pH for storage. Id. There is some ambiguity as to whether Appellant relies on Pierce to indicate 1) that the formulation of the Examiner’s hypothetical combination Appeal 2019-004870 Application 14/353,718 7 would not have the claimed stability or 2) that a person of ordinary skill would not have had a reasonable expectation of success in preserving protein modifying enzymes according to Schooneveld-Bergmans. Appeal Br. 10– 11. Neither point is persuasive. Pierce is insufficient to overcome the plain teaching of Schooneveld-Bergman that it is applicable to “a protein modifying enzyme.” Schooneveld-Bergmans ¶ 13. Further, the portion of Pierce quoted by Appellant (“[o]ptimal conditions for storage are distinctive to each protein”) is immediately followed by “nevertheless, it is possible to suggest some general guidelines for protein storage and stability.” Pierce 1. There is some lack of congruence between the omitted portion and the quoted portion. In view of the foregoing, we determine Appellant has failed to show error in the Examiner’s findings regarding the content of the prior art. Second, Appellant argues that a person of ordinary skill in the art would not have had a reasonable expectation of success that the formulation of Schooneveld-Bergmans could be used to preserve a milk protein modifying enzyme. Appeal Br. 11–14. Appellant argues that each enzyme has “its own unique structure and conditions for stability” thus, one of skill in the art would not regard the conditions of Schooneveld-Bergmans as broadly applicable to the storage of other enzymes. Id. at 11. An invention is obvious if “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Proctor & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). “[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so Appeal 2019-004870 Application 14/353,718 8 long as there was a reasonable probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Similarly, “[o]bviousness does not require absolute predictability of success. . . . For obviousness under § 103, all that is required is a reasonable expectation of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) Appellant has not shown evidence sufficient to rebut the plain meaning of Schooneveld-Bergmans. As above, Schooneveld-Bergmans teaches that “[l]iquid compositions according to the invention comprise one or more enzymes that may be selected from the group consisting of . . . a protein modifying enzyme.” Schooneveld-Bergmans ¶ 13 (emphasis added). Pierce teaches that “it is possible to suggest some general guidelines for protein storage and stability.” Pierce 1. Given such teachings, the Examiner’s finding that one of skill in the art would have had a reasonable probability of success that the formulation of Schooneveld-Bergmans could be used to preserve a milk protein modifying enzyme is supported and has not been shown to be in error. Third, Appellant argues that the formulation of the claims exhibits unexpected benefits. Appeal Br. 14–16. Appellant asserts that its formulation “unexpectedly retains its enzyme activity to a significant extent during storage at room temperature; and unexpectedly retains its enzyme activity excellently during storage at lower temperatures (e.g., when refrigerated or frozen[)].” Appeal Br. 14. Appellant argues that, “[i]n contrast, Schooneveld-Bergmans emphasizes the need to refrigerate the carbohydrases (4 °C) - and not to store them at room temperature (25 °C).” Id. at 14–15. Appeal 2019-004870 Application 14/353,718 9 An applicant may overcome a prima facie case of obviousness by establishing that the claimed composition is “critical,” generally by showing that the claimed composition “achieves unexpected results relative to the prior art.” In re Geisler, 116 F.3d 1465, 1469–70 (Fed. Cir. 1997) (citation omitted). Appellant may show that the claimed invention has an unexpected property over the prior art “with evidence that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would find surprising or unexpected.” In re Mayne, 104 F.3d 1339, 1343 (Fed. Cir. 1997); see also Forest Labs., LLC v. Sigmapharm Labs., LLC, 918 F.3d 928, 937 (Fed. Cir. 2019). An examination for unexpected results is a factual, evidentiary inquiry. Id. Here, the Examiner finds that Appellant errs in asserting that Schooneveld-Bergmans emphasizes the need to refrigerate enzymes. The Examiner cites to Schooneveld-Bergmans’ Table 1 which gives results for enzymes “stored at 25° C.” The results found in Schooneveld-Bergmans’ Table 1 are generally consistent with those provided in the examples described in the Specification. In both the Appeal Brief and the Reply Brief, Appellant refers to its Example 13. Appeal Br. 15; Reply Br. 11. Example 13 describes the activity of a transglutaminase enzyme refrigerated at 4° C for 26 weeks. The Specification states that “[a]fter 26 weeks storage, 89% of the activity of the enzyme was left.” Spec. ¶ 84. This is comparable to Schooneveld- Bergmans’ reported results at 26 weeks. See Schooneveld-Bergmans, Table 1. It is not apparent why one of ordinary skill in the art would see this result as surprising. Appeal 2019-004870 Application 14/353,718 10 Appellant correctly asserts that the unexpected benefit need not be specifically claimed to show criticality. Appeal Br. 15–16. Nonetheless, Appellant has not carried its burden of showing that the claimed benefit (stability of milk protein crosslinking and/or modifying enzyme formulations) is “surprising or unexpected” when compared to the closest prior art. Accordingly, Appellant has not shown error in the rejection of claims 1–4, 6, 8–10, 12–14, 16, and 18 as obvious over Schooneveld- Bergmans in view of Miwa. Rejections 2–4. The Examiner rejects claims 7, 11, 17, 19, and 20 over Schooneveld-Bergmans in view of Miwa and certain tertiary references. Final Act. 5–7. On appeal, Appellant relies on the arguments discussed above in asserting that the claims are rejected in error. As we have not found such arguments to be persuasive, we determine that Appellant has not shown error in the rejections of these claims. Appeal 2019-004870 Application 14/353,718 11 CONCLUSION For the reasons set forth in the Final Action, the Examiner’s Answer, and above, the Examiner’s rejections are affirmed. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 6, 8– 10, 12–14, 16, 18 103(a) Schooneveld- Bergmans, Miwa 1–4, 6, 8– 10, 12–14, 16, 18 7, 17 103(a) Schooneveld- Bergmans, Miwa, Chou 7, 17 11 103(a) Schooneveld- Bergmans, Miwa, Bodo 11 19, 20 103(a) Schooneveld- Bergmans, Miwa, Parkhideh 19, 20 Overall Outcome 1–4, 6–14, 16–20 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