Mead Johnson Nutrition Company

Patent Trials and Appeals BoardOct 25, 2021

2021003312 (P.T.A.B. Oct. 25, 2021)

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. 15/293,437 10/14/2016 Maciej Chichlowski 254750.000066 (MJN15285) 1568 6980 7590 10/25/2021 TROUTMAN PEPPER HAMILTON SANDERS LLP 600 PEACHTREE ST NE STE 3000 ATLANTA, GA 30308 EXAMINER GEORGE, PATRICIA ANN ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 10/25/2021 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): jim.schutz@troutman.com patents@troutman.com ryan.schneider@troutman.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MACIEJ CHICHLOWSKI and BRIAN BERG Appeal 2021-003312 Application 15/293,437 Technology Center 1700 ____________ Before JEFFREY T. SMITH, LILAN REN, and MERRELL C. CASHION, JR., Administrative Patent Judges. REN, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–4, 6–8, 15, 16, 18, 20, 21, and 49–72. We have jurisdiction under 35 U.S.C. § 6(b). A hearing was held on September 28, 2021. We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as “Mead Johnson Nutrition Company.” Appeal Br. 3. Appeal 2021-003312 Application 15/293,437 2 CLAIMED SUBJECT MATTER Claim 1, reproduced below, are illustrative of the claimed subject matter: 1. A nutritional composition comprising: human milk oligosaccharides (HMOs), wherein the HMOs consist of about 60-80% sialylated HMOs, about 0-20% fucosylated HMOs, and about 10-30% of HMOs that are neither sialylated or fucosylated, wherein the HMOs that are neither sialylated or fucosylated comprise lacto-N-biose (LNB), lacto-N-neotetraose (LnNT) and/or lacto-N-tetraose. Claims Appendix (Appeal Br. 14). REFERENCES The prior art relied upon by the Examiner are: Name Reference Date Martinez US 5,405,637 Apr. 11, 1995 Garcia-Rodenas (“GR”) US 2007/0104700 A1 May 10, 2007 Wittke US 2012/0172288 A1 July 5, 2012 Kuang US 2014/0107193 A1 Apr. 17, 2014 Prieto (as translated) WO 1998/043494 A1 Oct. 8, 1998 Sprenger WO 2012/069415 A1 May 31, 2012 Martin WO 2014/154494 A1 Oct. 2, 2014 Lori S. Brizee, Increasing Caloric Concentration of Infant Formula 1–5 Gaining and Growing: Assuring Nutritional Care of Preterm Infants (Feb. 19, 2012) (Children's Hosp. & Regional Med. Ctr., Seattle, WA) (“UW”) REJECTIONS2 Claims Rejected 35 U.S.C. § Reference(s)/Basis 1–4, 6, 16 103 GR, Martin, Sprenger, Prieto 7 103 GR, Martin, Sprenger, Prieto, UW 8, 18 103 GR, Martin, Sprenger, Prieto, Wittke 2 The indefiniteness rejection has been withdrawn. Ans. 3–4. Appeal 2021-003312 Application 15/293,437 3 15 103 GR, Martin, Sprenger, Prieto, Kuang 20 103 GR, Martin, Sprenger, Prieto, Martinez, UW 21 103 GR, Martin, Sprenger, Prieto, Martinez, UW, Wittke, Kuang 49–53, 57, 61–65, 69 103 GR, Sprenger, Prieto 54, 66 103 GR, Sprenger, Prieto, UW 55, 58, 67, 70 103 GR, Sprenger, Prieto, Wittke 56, 68 103 GR, Sprenger, Prieto, Kuang 59, 71 103 GR, Sprenger, Prieto, Martinez, UW 60, 72 103 GR, Sprenger, Prieto, Martinez, UW, Wittke, Kuang OPINION We review the appealed rejection for error based upon the issues identified by Appellant 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) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”)). After having considered the evidence presented in this Appeal and each of Appellant’s contentions, we are not persuaded that reversible error has been identified, and we affirm the Examiner’s § 103 rejections for the reasons expressed in the Final Office Action and the Answer. We add the following primarily for emphasis. Claim 13 Appellant acknowledges “GR teaches compositions that improve gut barrier maturation in infants that can optionally include ‘human milk 3 Appellant argues independent claims 1, 49, and 61 together and does not present separate arguments for the appealed rejections of any of their Appeal 2021-003312 Application 15/293,437 4 oligosaccharides, such as sialyllactose’” but argues that “GR does not provide any motivation to combine its teachings with any of the other cited references.” Appeal Br. 8 (citing GR ¶ 20). Appellant argues that a skilled artisan, “on reading GR, would not have any teaching, suggestion, motivation, or guidance to modify the compositions taught in GR such that sialyllactose is a necessary ingredient.” Id. Appellant’s arguments are unpersuasive, first and foremost, because they are unsupported by evidence. “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Appellant’s arguments are unpersuasive also because they do not address the Examiner’s rationale to combine the references. Compare Appeal Br. 8, with Final Act. 5, 6–7, 8; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). We emphasize that “evidence of a motivation to combine need not be found in the prior art references themselves, but rather may be found in the knowledge of one of ordinary skill in the art or, in some cases, from the nature of the problem to be solved.” Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006) (internal quotation omitted). respective dependent claims. See Appeal Br. 7–13. We select independent claim 1 as representative of the subject matter claimed and limit our discussion to this claim. Accordingly, claims 2–4, 6–8, 15, 16, 18, 20, 21, and 49–72 stand or fall with claim 1. See id.; see also 37 C.F.R. § 41.37(c)(1)(iv) (2020). Appeal 2021-003312 Application 15/293,437 5 Moreover, it is well settled that it is a matter of obviousness for one of ordinary skill in the art to associate components of a composition in a known manner in the absence of any new or unexpected co-action between the components. In re Castner, 518 F.2d 1234, 1238-1239 (CCPA 1975); In re Lindner, 457 F.2d 506, 508 (CCPA 1972). Likewise, it is a matter of obviousness for one of ordinary skill in the food art to formulate new recipes by the addition or elimination of common ingredients in the absence of an unexpected co-action or cooperation between the ingredients. In re Levin, 178 F.2d 945, 948 (CCPA 1949). In the present case, Appellant does not explain adequately why such a proposed combination is in error or beyond an ordinary artisan’s skill. See KSR, 550 at 417 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”). Nor does Appellants direct us to objective evidence that establishes the nutritional composition comprising sialylated HMOs, fucosylated HMOs and HMOs that are neither sialylated or fucosylated co- act with one another in an unexpected way. Thus, Appellant does not identify reversible error in the Examiner’s determination of obviousness. Appellant next argues that Martin describes bovine milk oligosaccharides which, according to Appellant, “are patentably distinct from the claimed HMOs.” Appeal Br. 9. Appellant, however, does not address the Examiner’s findings that bovine oligosaccharides are sufficiently similar in structure to human milk oligosaccharides that a skilled artisan would have combined the prior art teachings. Compare id., with Final Act. 32. The Examiner’s finding is supported by the Specification which provides Appeal 2021-003312 Application 15/293,437 6 that “the HMO disclosed herein may be derived from cow milk. . . .” Spec. ¶ 56.4 Appellant’s argument that the claim term “the HMOs consist of” excludes bovine milk oligosaccharides (Appeal Br. 9) is unpersuasive because it is inconsistent with the Specification as we note above. Appellant’s argument that Martin does not teach or suggest the amount of “about 60-80% sialylated HMOs” recited in claim 1 (Appeal Br. 9, 11) is unpersuasive. The Examiner finds that Martin teaches or suggests a composition having up to 100 wt% of sialylated oligosaccharides. Final Act. 4 (citing various portions of Martin, including 13:11–19). The Examiner finds that, and Appellant acknowledges, one embodiment in Martin describes “at least 0.04 wt% of a sialylated oligosaccharide.” Martin 14:5–6 (cited in Final Act. 5); see also Appeal Br. 9 (quoting Martin 13:16–14:7). The Examiner’s finding that Martin teaches or suggests a range of the 4 The Specification states that the recited HMOs may be those “present in or that would be present in the pediatric subject’s mother’s breast milk.” Spec. ¶ 61; see also id. ¶ 1 (“The present disclosure . . . provid[es] to the pediatric subject a nutritional composition comprising an HMO profile that . . . would have been found in the mother's breast milk[.]”), ¶ 7 (“The present disclosure addresses this need by providing nutritional compositions to a pediatric subject wherein the HMO composition of the nutritional composition mimics the HMOs present (or that would be present) in a pediatric subject's mother's breast milk.”). Such “HMOs may be isolated or enriched from milk” or it “may be derived from cow milk” and other animal milk. Id. ¶ 56.To the extent that the claim language may be interpreted to encompass a natural phenomenon in the form of naturally produced human milk (id.), the Examiner may consider whether the claims are patent ineligible under section 101. See ChargePoint, Inc. v. SemaConnect, Inc., 920 F.3d 759, 765 (Fed. Cir. 2019) (citing Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014)) (holding that section 101 “contains longstanding judicial exceptions, which provide that laws of nature, natural phenomena, and abstract ideas are not eligible for patenting.”). Appeal 2021-003312 Application 15/293,437 7 sialylated oligosaccharide encompassing the recited range in claim 1 is therefore supported by evidence in the record. Appellant’s argument that not all embodiments in Martin specifically disclose the recited amount of sialylated oligosaccharide does not identify reversible error in the Examiner’s fact-finding. Appellant next argues that the claim term “the HMOs consist of” excludes N-acetylated oligosaccharide which is required in Sprenger’s teaching. Appeal Br. 10. We are unpersuaded because claim 1 is drafted using the open transitional language “comprising” in the preamble, which recites “a nutritional composition comprising of . . .” Therefore, the claim does not exclude components in addition to those specifically recited. In re Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004) (explaining that the “reasonable interpretation of the claims containing both of the terms ‘comprising’ and ‘consists’ is that the term ‘consists’ limits the ‘said portion’ language to the subsequently recited numbered nucleotides, but the earlier term ‘comprising’ means that the claim can include that portion plus other nucleotides.”). In addition, the claim language “HMOs that are neither sialylated or fucosylated” “comprise lacto-N-biose (LNB), lacto-N-neotetraose (LnNT) and/or lacto-N-tetraose” does not exclude additional components. Moreover, as the Examiner points out, N-acetylated oligosaccharide is neither an oligosaccharide that is “sialylated or fucosylated” as recited in claim 1. To the extent that Appellant argues “HMOs that are neither sialylated or fucosylated” are structurally distinguishable from the prior art, Appellant does not present evidence in support of this argument. See Appeal Br. 10; see also Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) (“[T]he patentability of apparatus or composition Appeal 2021-003312 Application 15/293,437 8 claims depends on the claimed structure, not on the use or purpose of that structure.”); In re Schaumann, 572 F.2d 312, 317 (CCPA 1978) (holding that the prior art teaching need not be in ipsissimis verbis). Appellant acknowledges that Sprenger discloses a mixture that “is structurally closer to human breast milk oligosaccharides than commercially available prebiotic ingredients” which may include “neutral (fucosylated or N-acetyl-lactosamine or other) oligosaccharides.” Sprenger 4:30–34; see also Appeal Br. 10 (citing Sprenger 4:33–34). Appellant, however, argues that a skilled artisan would not “have any reasonable expectation of success in modifying the compositions taught in Sprenger to omit the N-acetylated oligosaccharide . . . .” Id. Appellant’s argument is unpersuasive because it is incommensurate in scope with claim 1 which does not exclude N-acetylated oligosaccharide. The argument is unpersuasive also because it is unsupported by evidence. Johnston, 885 F.2d at 1581 (“Attorneys’ argument is no substitute for evidence.”). The Examiner’s finding that Sprenger teaches or suggests the recited “HMOs that are neither sialylated or fucosylated” is supported by evidence in the record and no reversible error has been identified. With regard to Appellant’s argument that “Sprenger is silent on including the specific non-sialylated and non-fucosylated HMOs lacto-N- biose (LNB), lacto-N-neotetraose (LnNT) and/or lacto-N-tetraose in its compositions” (Appeal Br. 10, 11), we note that the Examiner cites Prieto — rather than Sprenger — for this particular claim element. See Final Act. 7. Appellant’s argument with regard to Sprenger is therefore unpersuasive. Appellant’s argument that Prieto “is completely silent on the relative amounts of different types of oligosaccharides (e.g., fucosylated Appeal 2021-003312 Application 15/293,437 9 oligosaccharides)” and that it is “further completely silent on including any sialylated oligosaccharides in its compositions, and necessarily therefore cannot disclose compositions with the recited relative amounts of the three types of HMOs” (Appeal Br. 11) is likewise unpersuasive because it does not address the Examiner’s findings with regard to Prieto. See Final Act. 7, 35. Appellant’s arguments with regard to Prieto (Appeal Br. 11) are unpersuasive also because they are unsupported by evidence. Johnston, 885 F.2d at 1581 (“Attorneys’ argument is no substitute for evidence.”). CONCLUSION The Examiner’s rejections are affirmed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 6, 16 103 GR, Martin, Sprenger, Prieto 1–4, 6, 16 7 103 GR, Martin, Sprenger, Prieto, UW 7 8, 18 103 GR, Martin, Sprenger, Prieto. Wittke 8, 18 15 103 GR, Martin, Sprenger, Prieto, Kuang 15 20 103 GR, Martin, Sprenger, Prieto, Martinez, UW 20 21 103 GR, Martin, Sprenger, Prieto, 21 Appeal 2021-003312 Application 15/293,437 10 Martinez, UW, Wittke, Kuang 49–53, 57, 61–65, 69 103 GR, Sprenger, Prieto 49–53, 57, 61–65, 69 54, 66 103 GR, Sprenger, Prieto, UW 54, 66 55, 58, 67, 70 103 GR, Sprenger, Prieto, Wittke 55, 58, 67, 70 56, 68 103 GR, Sprenger, Prieto, Kuang 56, 68 59, 71 103 GR, Sprenger, Prieto, Martinez, UW 59, 71 60, 72 103 GR, Sprenger, Prieto, Martinez, UW, Wittke, Kuang 60, 72 Overall Outcome 1–4, 6–8, 15, 16, 18, 20, 21, 49– 72 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