4LIFE PATENTS, LLC

Patent Trials and Appeals Board

May 20, 2021

2020005549 (P.T.A.B. May. 20, 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.
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.

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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
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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.
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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).
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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.
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(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).
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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
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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
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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.
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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.
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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
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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.
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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
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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).
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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.
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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
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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.
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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