Ex Parte Albrecht et alDownload PDFPatent Trial and Appeal BoardMay 5, 201612951125 (P.T.A.B. May. 5, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/951,125 11/22/2010 106587 7590 05/09/2016 Abbott Laboratories Department 108140, Bldg. RP3-2 3300 Stelzer Road Columbus, OH 43219-3034 FIRST NAMED INVENTOR Daniel S. Albrecht 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 10242US01 (35226/05572) 9157 EXAMINER GWARTNEY, ELIZABETH A ART UNIT PAPER NUMBER 1791 NOTIFICATION DATE DELIVERY MODE 05/09/2016 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): ipdocket@calfee.com AN_Patent_Docketing@abbott.com wfrick@calfee.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DANIEL S. ALBRECHT and JOHN B. LASEKAN Appeal2014-009745 Application 12/951,125 Technology Center 1700 Before ROMULO H. DELMENDO, JULIA HEANEY, and BRIAND. RANGE, Administrative Patent Judges. RANGE, Administrative Patent Judge. DECISION ON APPEAL SUMMARY Appellants appeal 1 under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1-23 and 25-29. Non-Final Act. 2; Appeal Br. 4. We have jurisdiction. 35 U.S.C. § 6(b ). We AFFIRM. 1 According to Appellants, the real party in interest is Abbott Laboratories. Appeal Br. 2. Appeal2014-009745 Application 12/951, 125 STATEMENT OF CASE Appellants describe the present invention as relating to soy protein- based powdered nutritional formulas for infants or toddlers that contain lutein and fructooligosaccharide (FOS). Spec. i-f 1. Lutein is a carotenoid, and carotenoids have been reported to have health benefits. Id. i-fi-1 3--4. Appellants explain that FOS adds stability to lutein in a soy based formula while also providing "an infant stool pattern, frequency, and color more closely resembling that of breastfed infants." Id. i-f 6. For purposes of appeal, Appellants group the claims in three groups. Appeal Br. 10. Group I consists of claims 1-12 and 19-21. Appeal Br. 10. Claim 1, reproduced below with emphasis added, is illustrative of Group I: 1. A powdered nutritional formula comprising, per 100 g of formula: from about 15 µg to about 17 5 µg of lutein; from about 1.1 g to about 3 g of a fructooligosaccharide; and soy protein. Id. at 19 (Claims Appendix). Group II consists of claims 13, 14, and 25-27. Id. at 10. Claim 25, reproduced below, is illustrative of Group II. 25. A method of increasing the stability oflutein present in a soy protein-based powdered nutritional formula comprising per 100 g of formula, from about 15 µg to about 175 µg of lutein, the method comprising the step of adding from about 1.1 g to about 3 g of a fructooligosaccharide to the composition. Id. at 22 (Claims Appendix). Group III consists of claims 15-18, 22, 23, 28, and29. Id. at 10. Claim 15, reproduced below, is illustrative of Group III. 2 Appeal2014-009745 Application 12/951, 125 15. A method for improving the stool pattern of a formula-fed infant, the method comprising: reconstituting a powdered infant formula comprising, per 100 g of formula, from about 15 µg to about 175 µg of lutein; from about 1.1 g to about 3 g of a fructooligosaccharide; and soy protein; and administering the reconstituted infant formula to the infant at least until the infant's stool frequency and stool softness is increased. Id. at 20-21 (Claims Appendix). REFERENCES The Examiner relied upon the prior art below in rejecting the claims on appeal: Dohnalek et al. (hereinafter, "Dohnalek") Barrett-Reis US 5,827,526 Oct. 27, 1998 US 2007/0166354 Al July 19, 2007 REJECTIONS The Examiner rejected claims 1-23 and 25-29 under 35 U.S.C. § 103 as unpatentable over the combination of Barrett-Reis and Dohnalek. Non- Final Act. 3. ANALYSIS We review the appealed rejections for error based upon the issues identified by Appellants and in light of the arguments and evidence produced thereon. Cf 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) ("it has long been the Board's practice to require an applicant to identify the alleged error in the examiner's rejections")). Appellants' 3 Appeal2014-009745 Application 12/951, 125 arguments with respect to each of the three claim groupings are discussed below. Group I. Appellants argue claims 1-12 and 19-21 collectively. Appeal Br. 10. We therefore limit our discussion to claim 1. Claims 2-12 and 19-21 stand or fall with that claim. 37 C.F.R. § 41.37(c)(l)(iv) (2013). Appellants argue that the Examiner fails to establish a prima facie case for obviousness because claim 1 requires between about 15 and about 17 5 micrograms of lutein per 100 grams of dry formula and the Examiner "[lacks] evidence or rationale" to establish lutein amounts recited in the prior art meet these amounts. Appeal Br. 11-12. We disagree. Barrett-Reis explains that its formula could take the form of a reconstitutable powder. Barrett-Reis i-f 62. Barrett-Reis does not discuss the amount of lutein per weight in its dry form embodiments, but it discloses 50 to 1150 micrograms2 lutein per liter in liquid form (i.e., as fed). Non-Final Act. 3--4; see also e.g., Barrett-Reis i-f 28. This liquid form lutein density range overlaps with the Specification's disclosure of 53 micrograms of lutein per liter as fed. Non-Final Act. 4; Spec. i-f 81, Table 6. Barrett-Reis also teaches formula caloric density ranges from about 609 kcal/liter ranging up to 810 kcal/liter (or up to 1015 kcal/liter for pre-term infants of low birth weight). Ans. 9; Barrett-Reis i-f 63. This overlaps with the Specification's caloric density ranges from about 609 kal/liter to 845 kcal/liter. Ans. 9; Specification i-f 55. We further note that diluting the formula with water will not contribute to calories; calories come from the dry formula. 2 We note that the claim uses the abbreviation µg but Barrett-Reis uses the abbreviation mcg. Both abbreviations refer to micrograms. 4 Appeal2014-009745 Application 12/951, 125 Because Barrett-Reis teaches the same density of lutein in liquid formula and the same caloric densities as the Specification, a preponderance of the evidence supports that a person of ordinary skill in the art making dry formula based on the teachings of Barrett-Reis would have arrived at a dry formula including the claimed lutein content. Ans. 9. Cf KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ("a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ"). Appellants provide no factual argument to the contrary and make no allegation of criticality in the range of lutein recited in claim 1. Accordingly, we sustain the Examiner's rejection of claims 1-12 and 19-21. Group II. Appellants argue claims 13, 14, and 25-27 collectively. Appeal Br. 10, 15. We therefore limit our discussion to independent claim 25. Claims 13, 14, 26, and 27 stand or fall with that claim. 37 C.F.R. § 41.37(c)(l)(iv) (2013). Appellants first raise the same arguments raised for Group I. Appeal Br. 15. We do not find those arguments persuasive for the reasons explained above. Appellants also implicitly argue that claim 15 requires lutein stability and explicitly argue that the Examiner fails to establish that the prior art references teach lutein stability. Appeal Br. 15-16. We again disagree. Claim 25 only refers to lutein stability in its preamble: "A method of increasing the stability of lutein present in a soy protein-based powdered nutritional formula comprising .... " The recitation following comprising provides a complete method, and the preamble recitation "of increasing the stability of lutein present" merely states the purpose or intended use of the invention. Thus, the "of increasing the stability of lutein present" language 5 Appeal2014-009745 Application 12/951, 125 is not a limitation. Cf Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1292 (Fed. Cir. 2015) ("[p]reamble language that merely states the purpose or intended use of an invention is generally not treated as limiting the scope of the claim.") (internal quotes and citation omitted). Because claim 25 does not require lutein stability, the prior art references need not teach lutein stability, and we sustain the Examiner's rejection of claim 25 on this basis. In the alternative, we discern no reversible error even if the "of increasing the stability of lutein present" language limits the scope of claim 25. The prior art combination includes the FOS taught by Dohnalek. Non- Final Act. 8; Dohnalek Abstract. According to the Specification, the FOS will necessarily add stability to the formula's lutein. Spec. i-f 6. The fact that Appellants have recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See In re Kubin, 561F.3d1351, 1357 (Fed. Cir. 2009) ("[T]he Kubin-Goodwin application itself instructs that CD48 binding is not an additional requirement imposed by the claims on the NAIL protein, but rather a property necessarily present in NAIL."); cf Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) ("[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer."). Moreover, Appellants present no persuasive argument or evidence that the prior art combination of Dohnalek and Barrett-Reis does not necessarily increase lutein stability (because of Dohnalek's FOS). Cf In re Best, 562 F.2d 1252, 1255 (CCPA 6 Appeal2014-009745 Application 12/951, 125 1977) ("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.") (citation omitted). We therefore sustain the Examiner's rejection of claims 13, 14, and 25-27. Group III. Appellants argue claims 15-18, 22, 23, 28, and 29 collectively. Appeal Br. 10, 13. We therefore limit our discussion to claim 15. Claims 16-18, 22, 23, 28, and 29 stand or fall with that claim. 37 C.F.R. § 41.37(c)(l)(iv) (2013). Appellants again raise the same arguments raised for Group I. Appeal Br. 13. We do not find those arguments persuasive for the reasons explained above. Appellants also argue that claim 15 is drawn to a method to loosen stool, but the Examiner cites only stool hardening techniques. Appeal Br. 13-14. Appellants further argue that the Examiner fails to establish predictability or reasonable expectation of success. Appeal Br. 14--15. To the extent Appellants argue that the combination of the Dohnalek and Barrett-Reis references is improper, we disagree. To assess the proposed combination of references, we must "take account of the inferences and creative steps that a person of ordinary skill in the art would employ" when seeking to improve formula. KSR, 550 U.S. at 418. In doing so, we must recognize that "the problem motivating the patentee may be only one of many addressed by the patent's subject matter." Id. at 420. "Under the correct analysis, any need or problem known in the field of endeavor at the 7 Appeal2014-009745 Application 12/951, 125 time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." Id. Here, the Examiner explains that a person of skill in the art would have incorporated the FOS taught by Dohnalek in the formula ofBarrett- Reis for the purpose of reducing diarrhea in children consuming the formula. Non-Final Act. 4. This position is well supported as Dohnalek focuses on adding FOS to formula to regulate stool. See, e.g., Dohnalek Abstract; 11: 19--21 ("The results from the clinical study demonstrate that the method of this invention is effective in reducing the duration and recurrence of diarrhea"). A preponderance of the evidence establishes that addition of FOS to the Barrett-Reis formula would predictably improve that formula in the same manner FOS improved the Dohnalek formula. Improvement of Barrett-Reis in this fashion is no more than predictable use of prior art elements according to established functions. Cf KSR, 550 U.S. at 417. Thus, the Examiner did not err in combining these references. To the extent Appellants argue that the combination of Barrett-Reis and Dohnalek fails to teach some element of claim 15, Appellants' argument fails because Appellants do not identify what element the prior art fails to teach. Moreover, as explained below, it does not appear that any element of claim 15 is missing from these references. Claim 15 's preamble recites that it is a method "for improving the stool pattern of a formula-fed infant." The quoted preamble language is not limiting because the claim body defines a structurally complete invention and this language states only a purpose or intended use. Cf Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Moreover, even if this language were limiting, the combination would be expected to improve stool pattern 8 Appeal2014-009745 Application 12/951, 125 because Dohnalek teaches that the FOS reduces diarrhea. Non-Final Act. 7; Dohnalek Abstract; 11: 19-21. Thus, the preamble recitation does not distinguish claim 15 from the recited art. Claim 15 also recites "administering the reconstituted infant formula to the infant at least until the infant's stool frequency and stool softness is increased." Both Barrett-Reis and Dohnalek disclose that the formula is to be administered for an extended period of time. Non-Final Act. 7; Barrett- Reis i-fi-132 ("formula may be prepared and administered as a sole source ... of nutrition"), 114--115 (explaining study where infants received formula for 56 days); Dohnalek 8:21-55 (explaining study where children received formula as sole source of milk beverages for 16 weeks). Because a child's stool frequency and softness will periodically increase and decrease over any extended period of time, this claim element is met. Non-Final Act. 7. Because Appellants identify no reversible error with respect to claim 15, we sustain the Examiner's rejection of claims 15-18, 22, 23, 28, and 29. DECISION For the above reasons, we affirm the Examiner's rejection of claims 1-23 and 25-29. 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 9 Copy with citationCopy as parenthetical citation