Berseth, Carol Lynn. et al.

Patent Trials and Appeals Board

May 27, 2020

13595296 - (D) (P.T.A.B. May. 27, 2020)

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.
13/595,296 08/27/2012 Carol Lynn Berseth 254750.000026
(MJN15220)
2283
6980 7590 05/27/2020
TROUTMAN SANDERS LLP
600 Peachtree St., NE, Suite 3000
Atlanta, GA 402214
EXAMINER
MOORE, WALTER A
ART UNIT PAPER NUMBER
3619
NOTIFICATION DATE DELIVERY MODE
05/27/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
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 CAROL LYNN BERSETH, KELLY WALSH, DEBORAH
SCHADE, and ANA CECILIA MUNOZ-ESPADA

Appeal 2019-005180
Application 13/595,296
Technology Center 1700
____________

Before LINDA M. GAUDETTE, KAREN M. HASTINGS, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 27 and 29–39. We have jurisdiction
under 35 U.S.C. § 6(b). Oral arguments were heard in this appeal on May
18, 2020.
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Mead
Johnson Nutrition Company. Appeal Br. 3.
Appeal 2019-005180
Application 13/595,296

2

Appellant’s invention is directed to premature infant formula fortifiers
that are useful in supplementing premature infant formula (Spec. ¶ 1; Claim
27).
Claim 27 is representative of the subject matter on appeal:
27. A premature infant formula fortifier comprising:
a protein component, wherein about 14 to 22% of the caloric
content of the fortifier is from protein,
a fat component, wherein about 30 to about 40% of the caloric
content of the fortifier is from fat,
a carbohydrate component, and
about 100 to about 150 international Units (IU) of vitamin D
per 7.5 kcal of the fortifier.

Appellant appeals the following rejections:
1. Claims 27 and 29–30 are rejected under 35 U.S.C. § 103 as
unpatentable over Barrett-Reis ‘632 (US 2006/0204632 A1,
published Sep. 14, 2006) in view of Agostoni (C. Agostoni et al.,
Enteral Nutrient Supply for Preterm Infants: Commentary From
the European Society for Paediatric Gastroenterology,
Hepatology, and Nutrition Committee on Nutrition, 50 JPGN
85–91 (2010), Barrett-Reis ‘206 (US 6,294,206 B1, issued Sep.
25, 2001) and Etcheverry (P. Etcheverry et al., Calcium, Zinc,
and Iron Bioavailabilities from a Commercial Human Milk
Fortifier: A Comparison Study, 87 J. Diary Sci. 3629–3637
(2004).
2. Claims 31 and 33 are rejected under 35 U.S.C. § 103 as
unpatentable over Barrett Reis ‘632 in view of Agostini, Barrett-
Appeal 2019-005180
Application 13/595,296

3
Reis ‘206, Etcheverry and Euber (US 2008/0286416 A1,
published Nov. 20, 2008).
3. Claim 32 is rejected under 35 U.S.C. § 103 as unpatentable over
Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206,
Etcheverry, Puski (US 2006/0233915 A1, published Oct. 19,
2006).
4. Claim 34 is rejected under 35 U.S.C. § 103 as unpatentable over
Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206,
Etcheverry, Puski, and Euber.
5. Claim 35 is rejected under 35 U.S.C. § 103 as unpatentable over
Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206,
Etcheverry, and Wittke (US 2010/0316619 A1, published Dec.
16, 2010).
6. Claim 36 is rejected under 35 U.S.C. § 103 as unpatentable over
Barrett Reis ‘632 in view of Agostini, Barrett-Reis ‘206,
Etcheverry, Euber, and Janda (US 5,418,010, issued May 23,
1995).
7. Claims 37 and 38 are rejected under 35 U.S.C. § 103 as
unpatentable over Barrett-Reis ‘632 in view of Agostini, Barrett-
Reis ‘206, Etcheverry, Euber, Janda, and Zimmerman (Michael
B. Zimmermann et al., Chapter 7: Encapsulation of Iron and
Other Micronutrients for Food Fortification, Michael B.
Zimmermann and Erich J. Windhab, 187-188).
8. Claim 39 is rejected under 35 U.S.C. § 103 as unpatentable over
Thompson (US 2007/0243290 A1, published Oct. 18, 2007) in
view of Sahay (Manisha Sahay et al., Rickets-vitamin D
Appeal 2019-005180
Application 13/595,296

4
deficiency and dependency, 16(2) Indian Journal of
Endocrinology and Metabolism 164–176 (Mar.-Apr. 2012),
and/or Walsh (US 2012/0135103 A1, published May 31m,
2012).
Appellant argues claims 27 and 39 separately (Appeal Br. 7–18). Any
claim not argued separately will stand or fall with our analysis of claim 27.
37 CFR § 41.39(c).

FINDINGS OF FACT & ANALYSIS
The Examiner’s findings and conclusions regarding the rejection of
claim 27 over Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206, and
Etcheverry are located on pages 3– 8 of the Non-Final Action.
Appellant argues that the applied references cannot be combined to
suggest the claimed subject matter (Appeal Br. 11). Appellant contends that
the claims relate to a premature infant formula fortifier to supplement the
nutritional value of commercially available premature infant formulas
(Appeal Br. 11). Appellant contends that none of the applied references
discloses from about 100 to about 150 international units (IU) of vitamin D
per 7.5 kcal of formula fortifier (Appeal Br. 12). Appellant argues that
Barrett-Reis ‘632 is directed to fortifiers for human milk or other baby
formulas (Appeal Br. 12). Appellant contends that Barrett-Reis ‘632 does
not teach that the concentration of vitamin D in claim 27 (Appeal Br. 12).
Appellant argues that Barrett-Reis ‘632’s vitamin D concentration is 3 IU
per 7.5 kcal which is much lower than the concentration required in claim 27
(Appeal Br. 12). Appellant contends that Barrett-Reis ‘632 does not suggest
Appeal 2019-005180
Application 13/595,296

5
increasing the amount of vitamin D to a level recited in claim 27 (Appeal Br.
13). Appellant argues that a person of ordinary skill in the art would have
understood that the commercially available fortifiers already contain
sufficient concentrations of vitamin D (Appeal Br. 13). Appellant argues
that Agostoni teaches a recommended vitamin D intake for preterm infants
of 800 to 1000 IU/day but is silent about Appellant’s identified problem that
commercially available premature infant formulas do not contain the
adequate amounts of certain nutrients such as protein and vitamin D (Appeal
Br. 13). Appellant argues that Barrett-Reis ‘206 is directed to human milk
fortifier, not premature infant formula as claimed and does not teach the
claimed amount of vitamin D (Appeal Br. 14). Appellant contends that
Etcheverry studies human milk fortifiers that are added to human milk and
does not teach adding a fortifier to a commercially available preterm infant
formula (Appeal Br. 14). Appellant argues that Etcheverry teaches the
importance of supplementing human milk in order to not have to utilize
commercially available infant formulas such that there would have been no
reason to supplement preterm infant formula based on Etcheverry’s
teachings (Appeal Br. 14).
Appellant’s arguments attack the references individually instead of
addressing what the combined teachings would have suggested to one of
ordinary skill in the art. In the present case, the Examiner finds that Barrett-
Reis ‘632 does not teach the amount of vitamin D recited in claim 27 (Non-
Final Act. 7). The Examiner finds that Agostoni discloses that the major
goal of enteral nutrition is to achieve similar foetal growth coupled with
satisfactory functional development (Non-final Act. 7). The Examiner finds
that Agostoni recommends between 800 to 1000 IU per day of vitamin D,
Appeal 2019-005180
Application 13/595,296

6
which Agostoni discloses is important for supporting a large number of
physiological processes such as neuromuscular function and bone
mineralization (Non-final Act. 7). The Examiner finds that Barrett-Reis
‘206 teaches liquid and powdered forms of milk fortifiers that are added to
human milk to meet the nutritional needs of the infant (Non-Final Act. 8).
The Examiner finds that Barrett-Reis ‘206 discloses a milk fortifier
composition containing 112.5 IU/7.5 kcal vitamin D (Non-Final Act. 8).
The Examiner finds that Etcheverry discloses a milk fortifier used to
overcome nutrient deficiencies that comprises, inter alia, 150 IU of vitamin
D per 7.5 kcal (Non-Final Act. 8). The Examiner concludes that it would
have been obvious in light of Barrett-Reis ‘632, Agostoni, Barrett-Reis ‘206
and Etcheverry to produce a composition comprising vitamin D in the
amount recited in claim 27 in order to meet the nutritional needs of the
infant as suggested by Barrett-Reis ‘632, Etcheverry, and Barrett-Reis ‘206
(Non-Final Act. 8).
The Examiner’s stated rejection is based upon what the combined
teachings would have suggested to one of ordinary skill in the art regarding
the compositional requirement of a fortifier in order to meet the nutritional
needs of the infant. See also, Ans. 31. The Examiner provides specific
findings that Barrett-Reis ‘206 discloses using amounts of vitamin D within
the claimed concentration range in conventional infant milk fortifiers (Non-
Final 8). The Examiner finds that Etcheverry and Agostoni further support
that it is desirable to use higher amounts of vitamin D to meet the nutritional
needs of an infant (Non-Final Act. 7–8; Ans. 31–32). Barrett-Reis ‘632
teaches that the fortifiers may be added to either human milk or other
premature infant formulas such that modifying Barrett-Reis ‘632 to include a
Appeal 2019-005180
Application 13/595,296

7
vitamin D concentration of 100 to 150 IU per 7.5 kcal of the fortifier would
have been obvious (¶ 28; Ans. 29). We agree with the Examiner’s analysis
(Ans. 29–31). Specifically, the Examiner finds that the addition of or
elimination of ingredients in a recipe fails to provide any patentable
distinction to the claimed subject matter because such is considered to be
merely a change in proportion that carries forward an original concept of
controlling the amount of vitamin D in a fortifier composition (Ans. 30–31;
Non-Final Act. 8). We agree that vitamin D is recognized as a result
effective variable in the applied art that would have been optimizable to
deliver the desired nutrition to a premature infant.
We disagree, however, with the Examiner’s determination that the
preamble recitation “[a] premature infant formula fortifier” is a statement of
intended use and does not patentably distinguish the claimed product from
the prior art (Non-Final Act. 3). We agree with Appellant that claim 27 is
limited to a premature infant formula fortifier as the claim refers to “the
fortifier” in the body of claim 27. Nevertheless, Barrett-Reis ‘632 teaches
that the nutritional value of a fortifier may be tailored to a premature infant
and added to human milk or other suitable infant formula (¶¶ 22, 28, 66).
Barrett-Reis ‘632 recognizes that the human milk fortifier may be added to
“other suitable infant formula” and is concerned with preterm infants (¶¶ 22,
28, 66, 68, 92).
We agree with the Examiner’s finding that Appellant has not shown
any criticality in the claimed vitamin D range (Ans. 29). The Examiner has
established that it was known to add vitamin D in concentrations to infant
formulas and fortifiers that overlap with the concentration in claim 27 (Ans.
31-32; Non-Final Act. 7–8). The Examiner has established that the claimed
Appeal 2019-005180
Application 13/595,296

8
vitamin D concentration would have been an obvious amount to use in
fortifier compositions. In other words, we determine that the Examiner has
established a prima facie case of obviousness so that the burden shifted to
Appellant to rebut the prima facie case. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). Appellant has not provided any evidence that the claimed
concentration of vitamin D is critical or otherwise yields unexpected results
(Appeal Br. generally).
Appellant argues that Euber and Puski do not teach premature infant
formula fortifier (Appeal Br. 15). Appellant contends that Euber and Puski
are directed to human milk fortifier or human milk supplement and would
not have suggested a vitamin D amount for premature infant formula
(Appeal Br. 15).
Appellant’s arguments are not persuasive with regard to the rejection
of claim 27 because the Examiner does not rely on Euber or Puski to reject
the subject matter of claim 27 (Non-Final Act. 3). Rather, Euber is used in
the § 103 rejection of claims 31, 33, 34, and 36–38 to teach the pH and use
of pectin (Non-Final Act. 11, 13, 15, 17). Puski is used in the § 103
rejection of claim 32 to teach the amount of DHA added to the fortifier
(Non-Final Act. 12). Appellant has not separately argued any of these
claims.
Appellant argues that the Examiner’s finding that the ranges of
Barrett-Reis ‘632’s fortifier overlap with the ranges recited in claim 27 is
based on unsupported assumptions and does not provide a basis to conclude
that the values are indeed taught or suggested by the prior art (Appeal Br.
16). As noted by the Examiner, Appellant’s argument is not supported by
any specific challenge to the Examiner’s calculations (Ans. 37). We agree.
Appeal 2019-005180
Application 13/595,296

9
Appellant’s argument fails to provide any specific reversible error in the
Examiner’s calculations.
Regarding claim 39 Appellant argues that neither Thompson nor
Walsh teaches or describes an infant formula fortifier, nor suggests
combining an infant formula fortifier with a premature infant formula to
provide the amount of protein, vitamin D and kilocalories per ounce of
composition as recited in claim 39 (Appeal Br. 18). Appellant argues that
claim 39 requires that the combination of the fortifier and infant formula
results in a composition having a certain level of vitamin D in addition to
other features (Reply Br. 7). Appellant contends that the cited art must
disclose an infant formula fortifier meeting the requirements of claim 27 in
addition to a combination with that fortifier and an infant formula (Reply Br.
7).
With regard to the interpretation of claim 39, the Examiner finds that
the recited fortifier of claim 27 and an infant formula are two intermediate
products that do not patentably distinguish the final product recited in claim
39 (Final Act. 18). We agree. The preamble of claim 39 recites that the
composition is formed from the fortifier of claim 27 and a premature infant
formula, but once these two compositions are mixed, the resulting
composition has the recited protein amount, vitamin D concentration and
energy density. In other words, the Examiner correctly interprets claim 39
as a final composition having protein, vitamin D and the recited energy
density, regardless of how that composition was formed (Final Act. 18).
Claim 39 may be viewed as a product-by-process claim where the final
product is formed by the process of mixing the fortifier and infant formula
together. As a product-by-process claim patentability is based on the
Appeal 2019-005180
Application 13/595,296

10
product limitations implied by the process only. See In re Thorpe, 777 F.2d
695, 698 (Fed. Cir. 1985) (“E]ven though product-by-process claims are
limited by and defined by the process, determination of patentability is based
on the product itself. The patentability of a product does not depend on its
method of production. If the product in the product-by-process claim is the
same as or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process.”). In this
case, the Examiner is correct that the end product is merely a composition
having the recited protein amount, vitamin D concentration, and energy
density.
The Examiner makes fact findings and conclusions regarding
Thompson, Sahay and Walsh which are not specifically challenged by
Appellant (Non-Final Act. 18–21). Appellant’s assertion that the prior art
does not teach the subject matter of claim 39 is not sufficient to show
reversible error with any of the Examiner’s specific fact findings and
conclusions.
On this record, we affirm the Examiner’s § 103 rejections (1) to (8).

DECISION SUMMARY
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
27, 29, 30 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry
27, 29,
30

Appeal 2019-005180
Application 13/595,296

11
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
31, 33 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry, Euber
31, 33
32 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry, Puski
32
34 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry, Puski,
Euber
34
35 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry, Wittke
35
36 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry, Euber,
Janda
36
37, 38 103 Barrett-Reis ‘632,
Agostoni, Barrett-
Reis ‘206,
Etcheverry, Euber,
Janda, Zimmerman
37, 38
39 103 Thompson, Sahay,
Walsh
39
Overall Outcome 27, 29–
39

Appeal 2019-005180
Application 13/595,296

12
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