ABBOTT LABORATORIESDownload PDFPatent Trials and Appeals BoardDec 31, 20202020000480 (P.T.A.B. Dec. 31, 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. 14/979,717 12/28/2015 TIMOTHY CHAPMAN 12462USO1 (206856) 2322 139559 7590 12/31/2020 Porter Wright Morris & Arthur LLP 41 South High Street Columbus, OH 45215 EXAMINER GEORGE, PATRICIA ANN ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 12/31/2020 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): AN_Patent_Docketing@abbott.com ipdocket@porterwright.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TIMOTHY CHAPMAN, KELLEY LOWE, and NORMANELLA DEWILLE Appeal 2020-000480 Application 14/979,717 Technology Center 1700 Before JAMES C. HOUSEL, N. WHITNEY WILSON, and DEBRA L. DENNETT, Administrative Patent Judges. HOUSEL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–15, 17–22, 24–29, and 31–39.2 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 Abbott Laboratories as the real party in interest. Appeal Brief (“Appeal Br.”) filed July 10, 2019, 1. 2 Although the Final Office Action, page 1, indicates that claims 37 and 38 have been withdrawn from consideration, this Office Action includes two separate rejections of these claims, one of which is before us on appeal. See Final Act. 2, 13–15. Appeal 2020-000480 Application 14/979,717 2 CLAIMED SUBJECT MATTER The invention relates to substantially clear nutritional liquids having improved sensory characteristics, particularly to acidic nutritional compositions. Specification (“Spec.”) filed December 28, 2015, Title and ¶ 2.3 Appellant discloses that individuals prefer clear nutritional supplements because they provide a thin, good-tasting, and refreshing means of supplementing energy, protein, vitamins, and minerals. Id. ¶ 3. However, Appellant notes that conventional clear supplements often have undesirable sensory characteristics, including off-notes in aroma and flavor, e.g., metallic aftertaste, due to the combination of vitamins and minerals, and sour taste, mouth irritation, and throat catch due to acidulants. Id. ¶ 4. Appellant discloses a clear acidic liquid supplement that exhibits improved sensory characteristics, wherein the supplement includes malic acid, but is substantially free of vitamin C. Id. ¶ 6. Claim 1, reproduced below from the Claims Appendix to the Appeal Brief, is illustrative of the claimed subject matter: 1. A liquid nutritional composition comprising: at least one source of protein; at least one vitamin; at least one mineral; malic acid; and folic acid; wherein a total protein content is 1 wt% to 10 wt%, by weight of said liquid nutritional composition; wherein said liquid nutritional composition: is substantially free of fat, is free of vitamin C, has a pH of less than or equal to 4.6, and 3 This Decision also cites to the Examiner’s Answer (“Ans.”) dated August 22, 2019, and the Reply Brief (“Reply Br.”) filed October 22, 2019. Appeal 2020-000480 Application 14/979,717 3 is substantially clear; and wherein a concentration of the malic acid exceeds a concentration of the folic acid in the liquid nutritional composition. Claim 29, the remaining independent claim, recites a similar liquid nutritional composition as claim 1, and further including a hydrocolloid. REFERENCES The Examiner relies on the following prior art: Name Reference Date Liebrecht et al. (“Liebrecht”) US 5,641,531 June 24, 1997 Yang US 2003/0099753 A1 May 29, 2003 Parente et al. (“Parente”) US 2005/0123650 A1 June 9, 2005 Taormina et al. (“Taormina”) US 2007/0264401 A1 Nov. 15, 2007 Mellema et al. (“Mellema”) US 2008/0268102 A1 Oct. 30, 2008 Ragnarsson et al. (“Ragnarsson”) US 2012/0114819 A1 May 10, 2012 (“FAO”) Chapter 4. Folate and Folic Acid, Human Vitamin and Mineral Requirements: Report of a Joint FAO/WHO Consultation, Bangkok, Thailand, https://web.archive.org/web/20031126 110224/http://www.fao.org/docrep/00 4/Y2809E/y2809e0a.htm. Nov. 26, 2003 Appeal 2020-000480 Application 14/979,717 4 REJECTIONS The Examiner maintains, and Appellant requests our review of, the following rejections under 35 U.S.C. § 103:4 1. Claims 1–6, 8–15, 17–21, 24, 25, 27–29, 31, and 33–36 as unpatentable over Yang as evidenced by FAO; 2. Claims 7, 26, and 32 as unpatentable over Yang as evidenced by FAO, and further in view of Taormina; 3. Claims 22 and 39 as unpatentable over Yang as evidenced by FAO, and further in view of Taormina and Liebrecht; and 4. Claims 37 and 38 as unpatentable over Yang as evidenced by FAO, and further in view of Mellema, Parente, and Ragnarsson. OPINION We review the appealed rejections for error based upon the issues Appellant identifies, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”). After considering the argued claims and each of Appellant’s arguments, we are not persuaded of reversible error in the Examiner’s obviousness rejections. Therefore, we affirm the stated rejections for substantially the fact findings, reasoning, and conclusion of obviousness set forth in the Examiner’s Answer, which we adopt as our own. We offer the following for emphasis only. 4 The Examiner has withdrawn a rejection of claims 37 and 38 under 35 U.S.C. § 112(b). Ans. 3. As such, this rejection is not before us on appeal. Appeal 2020-000480 Application 14/979,717 5 For purposes of this appeal, to the extent that the claims on appeal are separately argued, we will address them separately consistent with 37 C.F.R. § 41.37(c)(1)(iv) (2018). Rejection 1: Obviousness of claims 1–6, 8–15, 17–21, 24, 25, 27–29, 31, and 33–36 Claims 1–6, 8–15, 17–21, 24, 25, 27, 29, and 33–36 Appellant argues claims 1 and 29 together. We, therefore, select claim 1 as representative; claims 2–6, 8–15, 17–21, 24, 25, 27, 29, and 33–36 stand or fall with claim 1. The Examiner finds that Yang teaches a clear liquid nutritional composition as recited in claim 1 having a pH less than 4.0 and including up to 10 wt% protein, at least one vitamin, at least one mineral, and malic acid. Ans. 4–5. The Examiner finds that Yang lists folic acid as one of the vitamins that may be included in the composition and teaches an amount of 80 mg, as an example. Id. at 5–6. In addition, the Examiner finds that Yang provides that the amount of edible acids is from about 0.10–3 wt%, of which up to 50 wt% may be malic acid. Id. at 6. Therefore, the Examiner finds that the concentration of malic acid exceeds that of folic acid in the composition. Id. Because Yang does not teach the use of fats or lipids in the composition, and does not include such in any of the example compositions, the Examiner finds that Yang’s composition is fat-free. Id. Further, the Examiner finds that Yang teaches that the use of vitamin C is optional and, therefore, concludes that it would have been obvious to omit vitamin C from Yang’s composition. Id. Appellant argues that Yang fails to teach liquid nutritional compositions that contain malic and folic acids, but does not contain vitamin C. Appeal Br. 9. Appellant asserts that because Yang teaches use of vitamin Appeal 2020-000480 Application 14/979,717 6 premixes containing both vitamin C and folic acid, Yang fails to teach or suggest specifically omitting vitamin C in a composition with malic and folic acids. Id. Appellant also asserts that Yang teaches that malic acid can lead to undesirable viscosity in the composition. Id. Therefore, Appellant contends that, in the absence of hindsight, an ordinary artisan would have no apparent reason to modify Yang to arrive at the liquid nutritional composition of claim 1, containing malic and folic acids, but lacking vitamin C. Id. at 11. Appellant’s arguments are not persuasive of reversible error because they fail to account for the entirety of Yang’s teaching which, as the Examiner finds, encompasses the claimed invention. In re Shuman, 361 F.2d 1008, 1012 (1966) (references must be evaluated by ascertaining the facts fairly disclosed therein as a whole). Prior art references are available for all they fairly teach or suggest. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); accord Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1336-37 (Fed. Cir. 2004). In addition, although Appellant focuses on Yang’s use of vitamin premixes in the examples, Yang is not limited to its examples. See Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“[A]ll disclosures of the prior art, including unpreferred embodiments, must be considered.” (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976))); In re Fracalossi, 681 F.2d 792, 794 n.1 (CCPA 1982) (explaining that a prior art reference’s disclosure is not limited to its examples). As the Examiner correctly finds, Yang teaches that the liquid nutritional composition may include, among other things, one or more vitamins. Yang ¶ 13. Appeal 2020-000480 Application 14/979,717 7 Given Yang’s teaching, the Examiner’s conclusion that it would have been obvious to one of ordinary skill in the art to include one vitamin, or any combination of vitamins in the composition, such as folic acid and another vitamin other than vitamin C, is supported and reasonable, absent a persuasive showing of unexpected results. Upsher-Smith Labs., Inc. v. Pamlab, LLC, 412 F.3d 1319 (Fed. Cir. 2005) (optional inclusion of a component includes compositions that do and do not contain the component). Moreover, notwithstanding Yang’s teaching that amounts of malic acid greater than 50 wt% of the edible acids may be undesirable (Yang ¶¶ 30, 80), the Examiner finds, without dispute, that Yang teaches compositions including concentrations of malic acid greater than that of folic acid. Appellant further contends that compositions of claim 1 “surprisingly have better sensory characteristics than those that contain malic acid, folic acid, and vitamin C.” Appeal Br. 9, 11. Appellant directs attention to Specification Examples 2–7 and paragraphs 69 and 70 in this regard. Id. at 11–12. To the extent that Appellant is asserting unexpected results, this argument is unpersuasive. In order for a showing of unexpected results to be probative evidence of non-obviousness, it falls upon Appellant to at least establish: (1) that there actually is a difference between the results obtained through the claimed invention and those of the prior art, In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (noting that the burden of analyzing and explaining data to support nonobviousness rests with the appellants); and (2) that the difference actually obtained would not have been expected by one Appeal 2020-000480 Application 14/979,717 8 skilled in the art at the time of invention, id.; In re D’Ancicco, 439 F.2d 1244 (CCPA 1971). See also In re Freeman, 474 F.2d 1319, 1324 (CCPA 1973). Other than directing attention to Examples 2–7 and two paragraphs from the Specification, Appellant fails to analyze and explain how or why this information supports nonobviousness. Further, although Appellant discloses that the removal of only vitamin C from a clear liquid beverage surprisingly had a significant impact on reduction or elimination of metallic off-notes in the beverage (Spec. ¶ 69), Appellant previously disclosed that it was known that the combination of vitamins and minerals may contribute to such off-notes (id. ¶ 4). Also, only Examples 4 and 6 indicate any reduction of metallic off-notes (id. at Tables 2A and 2B), and then only “slightly less metallic.” Such evidence is inconsistent with the statement that removal of only vitamin C had a significant impact on reduction or elimination of such metallic off-notes. Finally, we note that claim 1 is very broad in scope, encompassing compositions with 1–10 wt% protein, at least one vitamin and mineral, and any amount of malic and folic acids (as long as malic > folic). Appellant’s disclosed sensory data compares five substantially similar compositions lacking vitamin C to a single similar composition including vitamin C. Such data does not permit an assessment as to whether omitting vitamin C in other compositions within the scope of claim 1, such as including a single vitamin and mineral, or a significant amount of malic acid, would likewise produce a “slightly less metallic” result. Accordingly, we sustain the Examiner’s obviousness rejection of claims 1–6, 8–15, 17–21, 24, 25, 27, 29, and 33–36. Appeal 2020-000480 Application 14/979,717 9 Claims 28 and 31 Claim 28 depends from claim 1, and further requires that the concentration of the malic acid exceeds the concentration of the other acidulants in the composition. Claim 31, depending from claim 29, recites the same requirement. The Examiner finds that Yang provides for the use of multiple edible acids, including malic acid, citrus acid, and phosphoric acid, wherein the amount of malic acid is up to 50 wt% of the combination of acids, Yang encompasses compositions whose concentration of malic acid exceeds that of the other acids. Ans. 9. Appellant argues that Yang teaches that when a combination of malic acid or citrus acid is used with phosphoric acid, the concentration of malic acid should not exceed 50 % of the combination. Appeal Br. 13. Appellant urges that the claimed invention shows the surprising benefits of malic acid exceeding the concentration of all other acidulants in the composition. Id. This argument is not persuasive of reversible error because Appellant fails to address the Examiner’s finding, which is based on a combination of three acids, i.e., malic, citrus, and phosphoric acids, in which the concentration is up to 50 wt% of the combination of these three acids. In addition, Appellant fails to direct our attention to any evidentiary support or persuasive technical reasoning showing any benefits, much less surprising benefits, of the malic acid concentration exceeding that of all other acidulants. Accordingly, we sustain the Examiner’s obviousness rejection of claims 28 and 31. Appeal 2020-000480 Application 14/979,717 10 Rejection 2: Obviousness of claims 7, 26, and 32 Claim 7 depends from claim 1, and further requires that the at least one source of protein comprises casein. Claim 26 (depending from claim 1) and claim 32 (depending from claim 29) each further requires acetic acid, fumaric acid, lactic acid, or tartaric acid. The Examiner acknowledges that Yang fails to teach that the protein includes casein and that the composition includes one of the recited acids in claims 26 and 32. Ans. 11. The Examiner finds that Taormina teaches protein fortified nutritional beverages wherein the composition includes casein and lactic acid. Id. The Examiner concludes that it would have been obvious to have included casein and lactic acid in Yang’s composition because Taormina teaches casein is a suitable source of protein for nutritional compositions. Id. Appellant argues Taormina fails to teach or suggest a liquid nutritional composition containing malic and folic acids, but omitting vitamin C, and which also contains acetic acid, fumaric acid, lactic acid, or tartaric acid. Appeal Br. 14. In addition, Appellant argues that Taormina only mentions casein in a list of many possible proteins and fails to teach or suggest its use in a liquid nutritional composition containing malic and folic acids, but omitting vitamin C. Id. Appellant’s arguments are not persuasive of reversible error because the rejection does not rely on Taormina to teach or suggest the omission of vitamin C from a liquid nutritional composition containing malic and folic acids. Instead, the Examiner finds, without dispute, that Taormina teaches Appeal 2020-000480 Application 14/979,717 11 the use of casein as one known source of protein and the use of lactic acid5 as one of the acidulants in a liquid nutritional composition. Thus, absent evidence of unexpected (or unpredictable) results, a preponderance of the evidence supports the Examiner’s conclusion that it would have been obvious to have included casein and lactic acid in Yang’s liquid nutritional composition. Accordingly, we sustain the Examiner’s obviousness rejection of claims 7, 26, and 32. Rejection 3: Obviousness of claims 22 and 39 Claim 22 depends from claim 1, and claim 39 depends from claim 29, and each further requires at least one high intensity sweetener selected from sucralose, stevia, monk fruit, and acesulfame potassium, and the composition comprises a caloric density from about 178 kcal to about 346 kcal per 8 ounce serving. The Examiner acknowledges that Yang fails to teach use of a high intensity sweetener or the caloric density of 178–346 kcal/8 ounces. Ans. 12. The Examiner finds that Taormina teaches that a high intensity sweetener, such as stevia, may be used for a liquid nutritional composition. Id. The Examiner concludes that it would have been obvious to have included a high intensity sweetener, such as stevia, in Yang’s liquid nutritional composition because Taormina suggests its use for similar purposes in liquid nutritional compositions. Id. The Examiner further finds, without dispute, that Liebrecht teaches clear liquid nutritional compositions including protein with malic, 5 Indeed, Taormina teaches that any combination of listed acidulants may be used including malic acid, acetic acid, fumaric acid, lactic acid, and tartaric acid. Taormina ¶ 59. Appeal 2020-000480 Application 14/979,717 12 citric, and phosphoric acids, wherein the caloric density is at least 1 kcal/ml (about 240 kcal/8 ounces). Id. at 13. Thus, the Examiner concludes, without dispute, that it would have been obvious to provide that Yang’s liquid nutritional composition has a caloric density of at least about 240 kcal/8 ounces because Liebrecht teaches that it was known to have provided such a caloric density for similar compositions for a similar purpose. Id. Appellant argues that an ordinary artisan would not look to Taormina to modify Yang because Yang is directed to beverage compositions without additives, stabilizers, or specially processed ingredients. Appeal Br. 16. Appellant also contends that Yang only teaches “sweetness” in relation to carbohydrates, and that carbohydrates with a high sweetness factor can lead to undesirable product characteristics. Id. These arguments are not persuasive of reversible error. Initially, we note that the Examiner finds that although Yang teaches additives, stabilizers, or specially processed ingredients are not desired, Yang is not clear what these ingredients cover. Ans. 22. The Examiner notes that Yang includes an antifoam emulsion agent which functions as a stabilizer, as well as other components as additives. Id. Appellant does not dispute or otherwise address these findings. Further, Taormina teaches the same sweeteners as Yang, e.g., sucrose, fructose, and corn syrup, but also discloses that a liquid nutritional composition may also include non-nutritive sweeteners including sucralose, stevia, and acesulfame potassium. Taormina ¶ 88. Yang’s discussion regarding undesirable product characteristics is focused on nutritive sweeteners, rather than non-nutritive sweeteners. Therefore, a preponderance of the evidence supports the Examiner’s Appeal 2020-000480 Application 14/979,717 13 conclusion that it would have been obvious to have included one or more non-nutritive sweeteners in Yang’s liquid nutritional composition. Accordingly, we sustain the Examiner’s obviousness rejection of claims 22 and 39. Rejection 4: Obviousness of claims 37 and 38 Claims 37 and 38, which respectively depend from claim 1 and claim 29, each further requires that the composition includes a combination of malic, citric, and phosphoric acids, wherein the concentration of malic acid exceeds that of both citric and phosphoric acids, and the composition has a viscosity less than 25 cps. The Examiner finds that Yang teaches that the liquid nutritional composition may include a combination of malic, citric, and phosphoric acids, wherein the amount of malic acid may be up to 50 wt% of the combination. Ans. 9. As such, the Examiner finds that Yang encompasses compositions whose concentration of malic acid exceeds that of the other acids. Id.6 The Examiner further finds that Yang teaches that the composition may have a viscosity less than 40 cps and Ragnarsson teaches a liquid nutritional composition may have a viscosity from about 1–25 cps, both of which encompass viscosities less than 25 cps. Id. at 16. Appellant argues that one skilled in the art would not modify Yang to have a malic acid concentration greater than that of citric and phosphoric 6 The Examiner relies on Mellema and Parente in support of these prior findings. See Ans. 14–16. However, as discussed above with regard to claims 28 and 31, because we find no error in the Examiner’s findings regarding Yang’s teaching of a combination of malic, citric, and phosphoric acids, the rejection need not rely on Mellema and Parente. We, therefore, need not further address Mellema and Parente. Appeal 2020-000480 Application 14/979,717 14 acids because Yang teaches excessive amounts of malic acid can lead to undesirable viscosity. Appeal Br. 17. This argument is unpersuasive for the same reasons given above with regard to the substantially same argument raised against the rejection of claims 28 and 31. Appellant further argues that Ragnarsson teaches a composition can have a viscosity from 1–20,000 cps, and does not suggest modifying Yang to have a viscosity less than 25 cps. Appeal Br. 18. This argument is unpersuasive. Yang teaches liquid nutritional compositions having viscosities less than 40 cps, preferably less than 20 cps, and specifically teaches example compositions having viscosities less than 25 cps. Yang, Abstract and ¶¶ 14, 22, 83, 84. Thus, Yang alone supports the Examiner’s rejection as to the viscosity as recited in claims 37 and 38. Moreover, Ragnarsson not only discloses that the composition may have a viscosity from 1–20,000 cps, Ragnarsson further discloses that the viscosity may be a narrower range of 1–25 cps, consistent with the Examiner’s finding. See Ragnarsson ¶ 10. Appellant fails to address this teaching of the narrower range. Accordingly, we sustain the Examiner’s obviousness rejection of claims 37 and 38. CONCLUSION Upon consideration of the record and for the reasons set forth above and in the Examiner’s Answer, the Examiner’s decision to reject claims 1– 15, 17–22, 24–29, and 31–39 under 35 U.S.C. § 103 is affirmed. Appeal 2020-000480 Application 14/979,717 15 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–6, 8–15, 17–21, 24, 25, 27–29, 31, 33–36 103 Yang, FAO 1–6, 8–15, 17–21, 24, 25, 27–29, 31, 33–36 7, 26, 32 103 Yang, FAO, Taormina 7, 26, 32 22, 39 103 Yang, FAO, Taormina, Liebrecht 22, 39 37, 38 103 Yang, FAO, Mellema, Parente, Ragnarsson 37, 38 Overall Outcome 1–15, 17– 22, 24–29, 31–39 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation