4LIFE PATENTS, LLCDownload PDFPatent Trials and Appeals BoardMay 20, 20212020005549 (P.T.A.B. May. 20, 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. 14/698,698 04/28/2015 Christopher M. Lockwood 27047-3001USU1 6234 128128 7590 05/20/2021 Dentons Durham Jones Pinegar 3301 N. Thanksgiving Way, Suite 400 Lehi, UT 84043 EXAMINER REYNOLDS, FRED H ART UNIT PAPER NUMBER 1658 NOTIFICATION DATE DELIVERY MODE 05/20/2021 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): djp.ipmail@dentons.com stacia.boren@dentons.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTOPHER M. LOCKWOOD Appeal 2020-005549 Application 14/698,698 Technology Center 1600 Before DEBORAH KATZ, JOHN G. NEW, and ROBERT A. POLLOCK, Administrative Patent Judges. POLLOCK, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to protein supplements including an animal protein and an immune modulator. Appellant seeks our review of the Examiner’s decision to reject the claims as drawn to patent ineligible subject matter, indefinite, and obvious over the prior art. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal 2020-005549 Application 14/698,698 2 STATEMENT OF THE CASE According to the Specification, athletes and other individuals who perform intense and prolonged physical exercise often require protein supplementation. Spec. ¶ 3. The Specification discloses that, although protein supplementation is most common among individuals performing resistance training, “many people consume protein supplements in connection with endurance training and other aerobic activities.” Id. ¶ 4. The Specification also discloses “edible products that include protein supplements includ[ing], but . . . not limited to, baby formulas (because low molecular weight equates to low allergenicity), protein bars, meal replacement bars, chews, gels, ready-to-drink shakes, liquids, and other foods.” Id. ¶ 12. The Specification describes various animal-protein sources. See Spec. ¶¶ 18–21. A specific example includes whey-based protein, which is “believed to provide greater benefits (i.e., increases in muscle mass) than soy-based protein products.” Id. ¶ 5. Whey protein may be provided as a concentrate, having a protein content of greater than 80% by weight (w/w) as compared to about 30% w/w for intact whey. Id. ¶ 22. Whey-protein concentrate may also be provided as a “hydrolysate, in which the proteins have been predigested to decrease their average size and to enhance their absorption by and incorporation into an individual’s body.” Id. ¶ 23. The Specification further discloses combining immune modulators with a protein supplement. Spec. ¶ 18. “[T]he immune modulators may be obtained from animal sources, such as colostrum, eggs and other animal products.” Id. ¶ 28. The Specification describes isolating various immune Appeal 2020-005549 Application 14/698,698 3 modulators from fractions of bovine colostrum or eggs. See id. ¶¶ 27, 31–33. For example, [w]hen a source of immune modulators is subjected to filtering with a 12 KD (kiloDalton) filter, the filtrate will include transfer factor, as well as immune modulators that are larger than transfer factor (e.g., in the range of about 8 KD to about 12 KD), transfer factor (including molecules of about 4KD to about 6KD) and nanofraction immune modulators. Id. ¶ 33. Claims 1, 11, 12, 47, 56, 58, 65, 66 and 69–88 are on appeal of which claims 1, 47, and 71 are independent. Appellant directs its arguments to the elements of claims 1, 47, and 71, collectively, and sets forth no additional arguments with respect to the dependent claims. See Appeal Br. 4–8. Claim 1 is representative: 1. A protein powder for human consumption, including: a protein hydrolysate of a whey protein concentrate of bovine whey, the protein hydrolysate in powdered form; and an immune modulator in powdered form, comprising bovine colostrum or a fraction of bovine colostrum, including transfer factor. Id. at 10. The Examiner rejects claims 1, 11, 12, 47, 56, 58, 65, 66, and 69–88 as drawn to unpatentable subject matter pursuant to 35 U.S.C. § 101. Final Act. 2–4. The Examiner rejects claims 1, 11, 12, 47, 56, 65, 66, 69–71, and 74– 88 under 35 U.S.C. § 112(b) as indefinite. Id. at 4–5. Appeal 2020-005549 Application 14/698,698 4 The Examiner rejects claims 1, 11, 12, 56, 65, 66, and 70–88 under 35 U.S.C. § 103 as obvious in view of Manninen,1 Moorhead,2 Gunzer,3 and Lisonbee.4 Id. at 5–8. The Examiner rejects claims 1, 11, 12, 47, 56, 58, 65, 66, and 69–88 under 35 U.S.C. § 103 as obvious in view of Merritt,5 Kirkendoll,6 and Lisonbee. Id. at 8–10. REJECTION UNDER 35 U.S.C. § 101 Principles of Law An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. But the Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bankint'l, 573 U.S. 208, 216 (2014). 1 Manninen, A. H., “Protein hydrolysates in sports nutrition,” Nutrition & Metabolism 6(38), 1–5 (2009). 2 Moorhead, J., “How does colostrum help athletes?” The Guardian, June 24, 2012, available at: https://www.theguardian.com/lifeandstyle/ 2012/jun/24/how-colostrum-help-athletes (last accessed May 7, 2021). 3 Gunzer W., et al., “Exercise-Induced Immunodepression in Endurance Athletes and Nutritional Intervention with Carbohydrate, Protein and Fat- What Is Possible, What Is Not?” Nutrients 4, 1187–1212 (2012). 4 Lisonbee et al., US 2008/0081076 A1, publ. Apr. 3, 2008. 5 Merritt, R. J., et al., “Whey Protein Hydrolysate Formula for Infants with Gastrointestinal Intolerance to Cow Milk and Soy Protein in Infant Formulas,” J. Ped. Gastroenterology and Nutrition 11, 78–82 (1990). 6 Kirkendoll, S., “Why do infants get sick so often?” Michigan Medicine press release (August 7, 2012), originally published at (https://www.uofmhealth.org/news/infant-immunity-08-07). Appeal 2020-005549 Application 14/698,698 5 In determining whether a claim falls within an excluded category, we are guided by the Supreme Court’s two-step framework, described in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) and Alice. 573 U.S. at 217–18 (citing Mayo, 566 U.S. at 75–77). In accordance with that framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). If the claim is “directed to” a patent ineligible concept, we turn to the second step of the Alice and Mayo framework, where “we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Alice, 573 U.S. at 217 (citation omitted). The United States Patent and Trademark Office (“USPTO” or “the Office”) published revised guidance on the application of § 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”).7 Under that guidance, we first look to whether the claim recites the following: (1) any judicial exceptions, including law of natures, natural phenomena, or certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human interactions such as a fundamental economic practice, or mental processes); and 7 Available at https://www.govinfo.gov/content/pkg/FR-2019-01- 07/pdf/2018-28282.pdf. Appeal 2020-005549 Application 14/698,698 6 (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.0S(a)–(c), (e)–(h)).8 Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim: 3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Analysis The Examiner rejects all pending claims as directed to ineligible subject matter. Final Act. 2–4. The Examiner finds that the claimed invention is directed to a mixture of natural products, and the claims do not include additional elements that amount to significantly more than the judicial exception. Id. at 2–3. Particularly, the Examiner finds that both bovine colostrum and bovine whey protein hydrolysate are naturally- occurring products, and that “the mixture of naturally occurring compounds will not render an invention patent eligible absent a marked difference in the resulting invention.” Id. at 3. The Examiner finds that Appellant has not 8 We acknowledge that some of these considerations may be evaluated properly under Step 2 of Alice (Step 2B of the Office Guidance). Solely for purposes of maintaining consistent treatment within the Office, we evaluate this inquiry under Step 1 of Alice (Step 2A of the Office Guidance). Appeal 2020-005549 Application 14/698,698 7 shown a “marked difference between their invention and the individual components.” Id. Appellant argues that whey-protein hydrolysate is not available in nature. Specifically, “whey is obtained by coagulating and then straining milk,” and that “[p]rotein hydrolysate comprises proteins that have been ‘predigested to decrease their average size’ and this process results in enhanced ‘absorption by and incorporation into an individual's body.’” Appeal Br. 4–5 (citing Spec. ¶ 23). Appellant contends that “the combination of bovine transfer factor with hydrolysates of a bovine whey protein concentrate imparts the resulting product with activities that neither milk nor colostrum would possesses on its own in nature in a way that is relevant to the nature of the inventions recited by the claims.” Id. at 5. Appellant further contends that the Specification presents experimental results in paragraphs [0040]–[0071] that describe markedly different properties for the combination. See id.; see also Reply Br. 4. We find Appellant’s argument persuasive. Our reviewing court has found that similar claims reciting a combination of naturally-derived products were not directed to ineligible subject matter. Nat. Alternatives Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1348–1349 (Fed. Cir. 2019). For example, in Natural Alternatives, the claim recited a “composition comprising glycine; and a) an amino acid selected from the group consisting of a beta-alanine . . . .” Id. at 1348. Our reviewing court found that: Although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine. A claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different Appeal 2020-005549 Application 14/698,698 8 characteristics and “the potential for significant utility.” See Diamond v. Chakrabarty, 447 U.S. 303, 310, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980). . . . the Product Claims are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot. Id. Likewise, although bovine colostrum including transfer factor is a natural product, the claims are not directed to bovine colostrum. Rather the claims are directed to specific formulations that incorporate bovine colostrum and whey-protein hydrolysate that have different characteristics, and can be used in be used in a manner that the natural products, as they appear in nature, cannot. See Natural Alternatives, 918 F.3d at 1349 (“even though claim 6 contains a combination of glycine and beta-alanine, both of which are natural products, that is not necessarily sufficient to establish that the claimed combination is ‘directed to’ ineligible subject matter.’”) Because we conclude that the claims are not directed to a judicial exception to the categories of patent-eligible subject matter, our analysis ends here, and we reverse the rejection under 35 U.S.C. § 101. REJECTION UNDER 35 U.S.C. § 112(b) The Examiner rejects claims 1, 11, 12, 47, 56, 65, 66, 69–71, and 74– 88 as being indefinite for failing to particularly point out and distinctly claim the invention. Final Act. 4–5. Specifically, the Examiner finds that “neither the prior art nor applicant’s disclosure allows [for] identification of the [claimed] transfer factors as more than a component of a crude mixture.” Id. at 5. The Examiner finds that “without knowing what the identity of the compound(s) that form the transfer factor(s), there are embodiments where it Appeal 2020-005549 Application 14/698,698 9 is unclear if the claims would be infringed. This renders the claims indefinite.” Ans. 7. Appellant responds that “[b]ovine colostrum inherently contains transfer factors, and it was well-known in the art to isolate these transfer factors by taking fractions of specific molecular weights.” Appeal Br. 6 (citing Lisonbee ¶ 9; Ramaekers9 ¶ 27). Appellant contends that one of ordinary skill in the art would have understood whether a fraction of bovine colostrum would include transfer factor, because it was known that fractions of colostrum with a specific molecular weight range (from 3.5 KD to 7.5 KD) included transfer factor. Id. at 6 (citing Lisonbee ¶ 4). We find Appellant’s argument persuasive. “The test for indefiniteness does not depend on a potential infringer’s ability to ascertain the nature of its own accused product to determine infringement, but instead on whether the claim delineates to a skilled artisan the bounds of the invention.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1340–1341 (Fed. Cir. 2005). We begin with the term “transfer factor.” We find that “transfer factor” is a term of art that would have been known to a person of ordinary skill. For example, Ramaekers explains that “[t]ransfer factors which are produced by leucocytes and lymphocytes, are small water soluble polypeptides of between about 44 amino acids [sic] that stimulate or transfer cell mediated immunity from one individual to another and across species but do not create an allergic response.” Ramaekers ¶ 3. Ramaekers further explains that “[i]t is common practice to refer to preparations that contain transfer factor by the name of the active component (i.e., transfer factor or 9 Ramaekers, US 2007/0128253 A1, publ. June 7, 2007. Appeal 2020-005549 Application 14/698,698 10 TF). Transfer factor extract containing transfer factors is also herein referred to as transfer factor.” Id. ¶ 4. Lisonbee likewise refers to transfer factors as “a family of molecules having molecular weights of between 3,500 Da and 7,500 Da” that play a role in “modulating cellular, or T-cell-mediated, immunity.” Lisonbee ¶ 4. Moreover, the claims do not simply recite “transfer factor,” but “colostrum including transfer factor.” See Appeal. Br. 10–11, 13. The Specification describes this colostrum as including a fraction of molecules of about 4 KD to about 6 KD. Spec. ¶ 33. We find this definition consistent with the knowledge of one of ordinary skill in the art at the time of the invention. For example, Ramaekers describes “[s]ubstantially purified transfer factor originating from leukocytes, colostrum or ova and having a molecular weight of less than 10,000 daltons and a specific activity of at least 5000 units per adsorbance unit at 214 nanometers.” Ramaekers ¶ 27. Lisonbee describes “4,000 Da to 8,000 Da molecular weight fractions (from colostrum and egg), both of which are known to contain transfer factor.” Lisonbee ¶ 31. Additionally, a skilled artisan would have known of colostrum fractions “that do not include transfer factor,” such as fractions of 250 Da to 2 KD. Id. ¶ 33. Accordingly, the claimed “colostrum including transfer factor” and its variations, delineates any colostrum containing at least a fraction of molecules of about 4 KD to about 6 KD, as was known in the art. Because the claims delineate to a skilled artisan the bounds of the invention, we reverse the Examiner’s rejection of the claims as indefinite. Appeal 2020-005549 Application 14/698,698 11 REJECTIONS UNDER 35 U.S.C. § 103 Rejection over Manninen, Moorhead, Gunzer, and Lisonbee The Examiner rejects 1, 11, 12, 56, 65, 66, and 70–88 under 35 U.S.C. § 103 as obvious over Manninen, Moorhead, Gunzer, and Lisonbee. Final Act. 5–8. Appellant contends that “[t]he Examiner has failed to demonstrate why it would be obvious to provide Manninen with the missing elements of an ‘immune modulator’ comprising bovine colostrum or a fraction of bovine colostrum, and including transfer factor, to arrive at the claimed inventions.” Appeal Br. 7–8. For the reasons set forth below, we affirm the Examiner’s rejection of independent claims 1 and 71. Appellant does not separately contest any element of dependent claims 11, 12, 56, 65, 70, and 72–88, such that they fall with the independent claims. We adopt the Examiner’s findings of fact and reasoning regarding the content and application of Manninen, Moorhead, Gunzer, and Lisonbee. We emphasize the following findings of fact relevant to the contested elements. Findings of Fact (“FF”) 1. Manninen describes the effects of ingesting protein-hydrolysate supplements on blood amino acid levels, muscle protein anabolism, body composition, exercise performance, and muscle glycogen resynthesis. Manninen 1. For example, Manninen describes a study on whey protein ingested during a resistance training program, which found that “whey protein hydrolysate group achieved substantially greater gains in muscle strength and lean body mass (LBM) compared to the casein group.” Id. at 3. 2. Manninen describes a study of male cyclists which found that “late-exercise time-trial performance was enhanced with carbohydrate plus Appeal 2020-005549 Application 14/698,698 12 casein hydrolysate beverage ingestion compared with a traditional beverage containing only carbohydrate. In addition, carbohydrate plus casein hydrolysate ingestion prevented increases in plasma creatine kinase and muscle soreness after exercise.” Id. at 3–4. 3. Manninen describes a study in which Sprague-Dawley rats were administered carbohydrate and/or protein formulations “[i]mmediately after the glycogen-depleting exercise.” Id. at 4. Manninen discloses that “whey protein hydrolysate ingestion induced significant increases in skeletal muscle glycogen levels compared with other protein sources.” Id. Manninen concludes that “whey protein hydrolysate appears to enhance the effects of carbohydrate ingestion on post-exercise muscle glycogen resynthesis.” Id. 4. Moorhead discloses that colostrum “has become an increasingly popular dietary supplement for many athletes. It is converted into a powder, and added to other drinks and shakes.” Id. at 2. 5. Moorhead discloses that colostrum benefits athletes by alleviating gut problems caused by a combination of stress and elevated body core temperature, which increases the permeability of the gut wall. Id. Moorhead further discloses that athletes who take colostrum are as much as 20% less likely to get infections of the upper respiratory tract. Id. 6. Gunzer discloses that endurance athletes may suffer from exercise-induced immunodepression. Gunzer 1. Gunzer discloses that a well-balanced diet is important because inadequate nutrition affects almost all aspects of the immune system, and that supplementation with “a single nutrient may not be as effective as a mixture of several nutritional supplements.” Abstract. Appeal 2020-005549 Application 14/698,698 13 7. Lisonbee discloses that colostrum and egg fractions containing transfer factor (4 KD to 8 KD molecular weight fractions) up-regulate cell- mediated immunity by stimulating additional metabolic activity in CD4+ white blood cells. Lisonbee ¶¶ 31, 43. 8. Lisonbee teaches “transfer factor helps balance, and even focus, immune activity by T-cells (e.g., by helping the cells ‘remember’ their primary purpose, by reducing autoimmunity and associated disorders, while improving activity against undesirable entities, such as infection of a subject's body by microorganisms (bacteria, viruses, etc.).” Id. ¶ 32. 9. Lisonbee teaches administering transfer factor may enhance “the ability of T cells to remove undesirable pathogens . . . from the body of a subject (e.g., by activating T helper (CD4+) cells, which in turn activate natural killer (NK) cells, by increasing antigen-specific immunity by enabling T memory cells, etc.).” Id. ¶ 70. 10. Lisonbee discloses that compositions containing transfer factors may be embodied as a liquid, powder, tablet, gel, or other suitable form. Id. ¶ 48. Analysis The Examiner finds that Manninen and Moorhead teach beneficial dietary supplements for athletes. Final Act. 5–6. Specifically, Manninen teaches whey-protein hydrolysate supplements and Moorhead teaches bovine-colostrum supplements. Id. The Examiner finds that Lisonbee teaches Moorhead’s bovine-colostrum supplements contain transfer factors known for supporting cell-mediated immunity. Id. at 6. The Examiner finds that a person of ordinary skill in the art would have been motivated to combine Manninen’s and Moorhead’s supplements to support an athlete’s Appeal 2020-005549 Application 14/698,698 14 immune systems with a supplement mixture as suggested by Gunzer. Id. at 6–7. The Examiner concludes that “it would be obvious to add the transfer factors of [Lisonbee] to support the immune system of the athletes using the whey protein hydrolysate of Manninen, as Gunzer et al teach that this population is prone to immunosuppression of cellular mediated immune functions.” Id. at 7. Appellant argues that Manninen’s teachings are limited to “strength/power athletes” and Moorhead’s teachings are limited to “endurance athletes.” Appeal Br. 7. Appellant argues that “[n]one of the references cited by the Examiner teaches or suggests that strength/power athletes would benefit from transfer factor supplementation, or that endurance athletes would benefit from supplementation with hydrolyzed whey protein.” Id. Appellant further argues that “[a]t least one study has shown that hydrolyzed whey protein does not benefit endurance athletes.” Id. (citing Forbes10). Accordingly, Appellant contends that “[t]he Examiner’s unsupported allegation that endurance athletes would benefit from hydrolyzed whey protein supplementation in the same way as power/strength athletes does not amount to a convincing line of reasoning as to why one of ordinary skill in the art would have combined these types of supplementation.” Id. We do not find Appellant’s argument persuasive. Contrary to Appellant’s argument, Manninen teaches the benefits of whey-protein 10 Forbes, S.C., et al., “Whey Protein Isolate Supplementation While Endurance Training Does Not Alter Cycling Performance or Immune Responses at Rest or After Exercise,” Frontiers in Nutrition 6(19), 1–9 (2019). Appeal 2020-005549 Application 14/698,698 15 hydrolysate in cyclists, i.e., endurance athletes, and in an animal model involving glycogen-depleting exercise. See FF 2, 3.11 Forbes does not rebut the Examiner’s finding of the knowledge of one skilled in the art at the time of the invention because Forbes was not published until March 2019, more than four years after the earliest filing date of the application at issue. See Forbes 1. Rather than discouraging protein supplementation for endurance athletes, Forbes confirms that as of 2009, “[t]he American Dietetic Association, American College of Sports Medicine, and the Dietitians of Canada suggest a protein intake of 1.2–1.4 g·kg−1·d−1 is necessary for endurance athletes, which is greater than the current recommended dietary allowance.” Id. at 2 (endnotes omitted). Furthermore, “[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419– 20 (2007). The Examiner has articulate reasoning with some rational underpinning to support the conclusion of obviousness, namely that a skilled artisan would have combined known nutritional supplements used by endurance athletes to prepare a formulation that would provide the benefits of both supplements. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Appellant has not shown that the results of the combination would not have been predictable. 11 Although not necessary to our Decision, we infer that Manninen’s rat model is more reflective of endurance athletes than to strength/power athletes. Appeal 2020-005549 Application 14/698,698 16 Appellant has not shown that the Examiner erred in rejecting claims 1 and 71. Accordingly, we affirm the Examiner’s rejection of those claims. Claims 11, 12, 56, 65, 70, and 72–88, which are not separately argued, fall with claims 1 and 71. 37 C.F.R. § 41.37(c)(1)(iv). Rejection over Merritt, Kirkendoll, and Lisonbee The Examiner rejects 1, 11, 12, 47, 56, 58, 65, 66, and 69–88 under 35 U.S.C. § 103 as obvious over Merritt, Kirkendoll, and Lisonbee. Final Act. 8–10. Appellant contends that “[t]he Examiner has failed to demonstrate why it would be obvious to provide Merritt with the missing elements of an immune modulator, including transfer factor, to arrive at the claimed inventions.” Appeal Br. 8. For the reasons set forth below, we affirm the Examiner’s rejection of independent claims 1, 47, and 71. Appellant does not separately contest any element of dependent claims 11, 12, 56, 58, 65, 66, 69, 70, and 72–88, such that they fall with the independent claims. We adopt the Examiner’s findings of fact and reasoning regarding the content and application of Merritt, Kirkendoll, and Lisonbee. We emphasize the following findings of fact relevant to the contested elements. Findings of Fact 11. Merritt discloses that whey-protein hydrolysate formula may be an acceptable alternative to soy or casein hydrolysate formulas for most infants with gastrointestinal symptoms of cow milk and/or formula intolerance. Merritt 78. Merritt discloses a study in which “all patients experienced symptom resolution or improvement on the whey hydrolysate Appeal 2020-005549 Application 14/698,698 17 formula compared with the cow’s milk-based and soy protein-based infant formulas.” Id. at 80. 12. Kirkendoll discloses that newborns and infants are more prone to infection because they have an immature immune system. Kirkendoll, 1. Specifically, Kirkendoll teaches that infant sensitivity to infection is due, in part, to age-dependent suppression of natural killer (“NK”) cell production. Id. Analysis The Examiner finds that Merritt teaches whey protein hydrolysate- containing formula is a suitable alternative to soy or other formulas for infants with cow milk protein intolerance. Final Act. 8. The Examiner finds that Kirkendoll teaches infants have an impaired cellular-immune response. Id. at 9. The Examiner finds that Lisonbee teaches that immune modulator supplements containing colostrum including transfer factor stimulate cell- mediated immunity. Id. The Examiner finds that a person of ordinary skill in the art would have been motivated to add Lisonbee’s transfer factor to Merritt’s whey protein hydrolysate supplement to help counteract infant immune suppression taught by Kirkendoll. Accordingly, the Examiner concludes that the claims would have been obvious over the prior art. Appellant argues that “[a]lthough infants may benefit from treatments that accelerate maturation of NK cells (Kirkendoll), the Examiner has provided no evidence that transfer factor is a treatment that accelerates maturation of NK cells.” Appeal Br. 8. Appellant argues that “[b]ecause the Examiner has not alleged that transfer factor accelerates the maturation of an infant’s immature NK cells, there is no reason to combine the teachings of Kirkendoll and Merritt.” Id. Appeal 2020-005549 Application 14/698,698 18 We do not find Appellant’s argument persuasive. First, we do not agree that Kirkendoll’s teachings are limited solely to the function of immature NK cells. Rather, we agree with the Examiner that a person of ordinary skill in the art would have considered Kirkendoll as more broadly teaching the problem of suppressed cellular immunity in infants. See Ans. 13; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”) Second, Lisonbee teaches transfer factor has broad applicability for modulating immunity. For example, Lisonbee teaches that transfer factor up- regulates cell-mediated immunity, enhances T-cell activity in removing undesirable pathogens, activates NK cells, and increases antigen-specific immunity by enabling T memory cells. FF 7–9. We agree with the Examiner that any one of the many immune-modulating benefits taught by Lisonbee would provide a reason to add transfer factor to a whey protein hydrolysate- containing infant formula to support infants’ immature immune systems. Appellant has not shown that the Examiner erred in rejecting claims 1, 47, and 71. Accordingly, we affirm the Examiner’s rejection of those claims. Claims 11, 12, 56, 58, 65, 66, 69, 70, and 72–88, which are not separately argued, fall with claims 1, 47, and 71. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2020-005549 Application 14/698,698 19 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 11, 12, 47, 56, 58, 65, 66, 69– 88 101 Eligibility 1, 11, 12, 47, 56, 58, 65, 66, 69–88 1, 11, 12, 47, 56, 65, 66, 69–71, 74–88 112(b) Indefiniteness 1, 11, 12, 47, 56, 65, 66, 69–71, 74–88 1, 11, 12, 56, 65, 66, 70–88 103 Manninen, Moorhead, Gunzer, Lisonbee 1, 11, 12, 56, 65, 66, 70–88 1, 11, 12, 47, 56, 58, 65, 66, 69– 88 103 Merritt, Kirkendoll, Lisonbee 1, 11, 12, 47, 56, 58, 65, 66, 69– 88 Overall Outcome 1, 11, 12, 47, 56, 58, 65, 66, 69– 88 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