MAGER, JENNIFER et al.

Patent Trials and Appeals Board

Dec 6, 2019

15349336 - (D) (P.T.A.B. Dec. 6, 2019)

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.
15/349,336 11/11/2016 JENNIFER MAGER 3712036-02763 1069
29157 7590 12/06/2019
K&L Gates LLP-Chicago
P.O. Box 1135
Chicago, IL 60690
EXAMINER
STEELE, AMBER D
ART UNIT PAPER NUMBER
1658
NOTIFICATION DATE DELIVERY MODE
12/06/2019 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JENNIFER MAGER, ZAMZAM FARIBA ROUGHEAD,
HEIDI STORM, and JAMES SCOTT TERESI1
Appeal 2019-005062
Application 15/349,336
Technology Center 1600

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and DAVID COTTA,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a tube
feed formulation, which have been rejected for obviousness, lack of adequate
description in the Specification, and, provisionally, for obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
“[T]he present disclosure provides a nutritional composition (e.g., oral
nutritional supplements, tube feed formulations, etc.) including at least five

1 Appellant identifies the real party in interest as Nestec S.A. Appeal Br. 2.
We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a).
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different processed whole food components; a source of protein, a source of
fat, a source of carbohydrate, and a source of vitamins and minerals.” Spec.
¶ 2. “In [one] embodiment, the present nutritional compositions have an
osmolality that is less than or equal to 400 mOsm/kg water.” Id. ¶ 175.
“Osmolality is . . . a measure of the osmoles of solute per kilogram of
solvent (osmol/kg tube feeding or Osm/kg tube feeding).” Id.
Claims 1–5, 7, 8, and 23–31 are on appeal. Claim 1, reproduced
below, is illustrative:
Claim 1: A tube feed formulation comprising at least
five different whole food components; the tube feed
formulation further comprising a source of vitamins and/or
minerals; the tube feed formulation further comprising a source
of protein; the tube feed formulation further comprising a
source of carbohydrate; the tube feed formulation further
comprising a source of fat; and the tube feed formulation has an
osmolality up to 400 mOsm/kg water.

The claims stand rejected as follows:
Claims 1–5, 7, 8, 23–26, and 28–31 under 35 U.S.C. § 103(a) as
obvious based on Klein,2 McEwen,3 and Molenaar4 (Ans. 4);
Claims 1–5, 7, 8, and 23–31 under 35 U.S.C. § 103(a) as obvious
based on Klein, McEwen, Molenaar, Anthony,5 and Ernest6 (Ans. 7);

2 Marsha Dunn Klein & Suzanne Evans Morris, Homemade Blended
Formula Handbook; Mealtime Notions, LLC; Tucson, AZ; pp. 1–199
(2007).
3 McEwen et al., US 2001/0043958 A1 (publ. Nov. 22, 2001).
4 Molenaar, US 2007/0202153 A1 (publ. Aug. 30, 2007).
5 Anthony et al., US 2006/0229256 A1 (publ. Oct. 12, 2006).
6 Ernest, US 2005/0070498 A1 (publ. Mar. 31, 2005).
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Claims 23 and 28 under 35 U.S.C. § 112, first paragraph, for lack of
adequate written description (new matter) (Ans. 3); and
Claims 1–5, 7, 8, and 23–31, provisionally, for obviousness-type
double patenting based on claims 1, 4–15, 18, and 20 of application
13/805,932 (Ans. 13).
OPINION
Obviousness
The Examiner has rejected all of the claims except claim 27 as
obvious based on Klein, McEwen, and Molenaar. The Examiner has also
rejected all of the claims as obvious based on Klein, McEwen, Molenaar,
Anthony, and Ernest. Appellant presents the same arguments with respect to
both rejections. See Appeal Br. 5–11. We will therefore address them
together.
The Examiner finds that Klein teaches “tube feeding formulas
comprising ‘real’ foods including processed fruits, processed vegetables,
processed meat, and/or processed grains.” Ans. 4. The Examiner finds that
Klein also “teaches the importance of individuals receiving homemade
blended formulas receiving enough hydration.” Id.
The Examiner finds that Klein “do[es] not specifically teach an
osmolality up to 400 mOsm/kg water,” but McEwen teaches “a liquid
nutritional product with osmolality below 700 mOsm/kg H2O and more
preferably below 600 mOsm/kg H2O.” Id. at 5. The Examiner also notes that
McEwen teaches that “products with high osmolality increase the possibility
of causing diarrhea.” Id. at 18.
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The Examiner finds that Molenaar discloses ranges of energy content
distribution between fat, protein, and carbohydrates that overlap the
distribution ranges recited in claim 7. Id. at 6. The Examiner also finds that
“Molenaar teaches liquid complete nutritional compositions comprising a
relatively low osmolality, avoiding excessive osmolality, and osmolality
between 360 and 480 mOsm.” Id. at 18.
The Examiner concludes that the cited references show that all of the
elements of the claimed composition were known in the prior art and that it
would have been obvious to combine them for the predictable result of
providing nutrition using “a particular known technique (blenderization and
tube feeding formulations) . . . as part of the ordinary capabilities of one
skilled in the art.” Id. at 7.
We agree with the Examiner that the composition of claim 1 would
have been obvious based on the cited references. Klein teaches homemade
blended formulas for tube feeding, including “a complete diet of homemade
blended foods.” Klein 1. As one example, Klein describes a tube feeding
formulation consisting of “a nice home cooked meal with vegetables, protein
and carbohydrates for dinner.” Id. at 30. Klein discusses the protein, fat, and
carbohydrate content of different whole food components. Id. at 63–66.
Klein therefore discloses a tube feeding formulation with the components
and nutritional sources recited in claim 1.
Klein does not disclose or suggest an osmolality of less than 400
mOsm/kg water for its compositions. However, McEwen discloses “an
elemental nutritional product useful for providing nutritional support to
patients suffering from malabsorption conditions.” McEwen ¶ 1. McEwen
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states that “[p]roducts with a high osmolality increase the possibility of the
product causing diarrhea. . . . The osmolality of these product[s] should be
maintained at a level below 700 mosm/kg H2O, more preferably below 600
mosm/kg H2O.” Id. ¶ 74.
Molenaar discloses “concentrated liquid nutritional products . . . for
the treatment of cachexia.” Molenaar ¶ 1. Molenaar states that its
composition should have “a relatively low osmolarity, so as to allow quick
passage through the stomach.” Id. ¶ 22.7 More specifically, “[t]he osmolarity
of the composition is preferably between 360 and 480 mOsm, preferably
between 390 and 430 mOsm.” Id. ¶ 42. Molenaar describes its composition
as “a thin liquid.” Id. ¶ 43.
Based on McEwen and Molenaar, it would have been obvious to a
person of ordinary skill in the art to formulate Klein’s tube feed formulation
so that it had an osmolality of 400 mOsm/kg water or less, because McEwen
discloses that high osmolality increases the possibility of causing diarrhea,
and suggests a preferred osmolality of no more than 600 mOsm/kg water.
Molenaar suggests a low osmolarity, preferably 390–430 mOsm, to allow
quick passage through the stomach. Thus, a skilled artisan would have
recognized that an osmolality of, for example, 390–400 mOsm/kg water
would allow for quick passage through the stomach without increasing the
possibility of diarrhea.

7 Molenaar refers to “osmolarity” and claim 1 refers to “osmolality,” but
Appellant does not argue that the claimed composition is distinguished on
the basis of the different terminology. See Reply Br. 5.
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Appellant argues that “the skilled artisan would understand that th[e]
formula of Klein would intrinsically have a very high osmolality--above 400
mOs/Kg--due to the high water content and osmolality of the ingredients
used.” Appeal Br. 6. Appellant, however, does not point to any evidence to
support this assertion, and “[a]ttorney’s argument in a brief cannot take the
place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). In
any event, the rejection is based on modifying Klein’s composition to have
the recited osmolality.
Appellant also argues that the Examiner has not explained why one of
ordinary skill in the art “would have sought to optimize the osmolality of the
formula of Klein alone or in combination with the liquid nutritional product
of McEwen. Moreover, there is no reason or motivation for the skilled
artisan to combine Klein and McEwen.” Appeal Br. 6.
This argument is not persuasive, because McEwen discloses that
liquid nutrition products with a high osmolality increase the possibility of
causing diarrhea, and therefore teaches that an osmolality below 600
mOsm/kg water is preferred. McEwen ¶ 74. The Examiner also (Ans. 18)
pointed to Molenaar’s disclosure of a product having a relatively low
osmolarity, preferably 390–430 mOsm, to allow quick passage through the
stomach. Molenaar ¶¶ 22, 42. These teachings would have provided those
skilled in the art with a reason to modify Klein’s tube feed composition to
have an osmolality within the claimed range.
Appellant argues that “the cited references do not provide any
teachings on how to adjust the osmolality of formulations to which blended
whole food ingredients with intrinsically high osmolality (such as that in
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Klein) have been added.” Appeal Br. 6. “Molenaar does not provide any
teachings on how to adjust the osmolality of the formula of Klein.” Id. at 7.
This argument is also unpersuasive, because both Molenaar and
McEwen describe preferred osmolality (or osmolarity) ranges for their
products, which is an indication that those skilled in the art were aware of
how to modify a particular liquid formulation to adjust its osmolality to a
desired level. We note that Appellant’s Specification describes desired
osmolality ranges for the claimed composition (Spec. ¶ 175), but provides
no guidance on how to achieve them, a further indication that those skilled
in the art were aware of how to adjust osmolality. See also id. (defining
osmolality as simply the amount of solute per kilogram of solvent).
Appellant has not provided evidence that adjusting osmolality would not
have been a routine procedure to those of ordinary skill in the art.
Regarding claim 7,8 Appellant argues that “the cited references do not
provide any teachings on how to adjust the energy contents of the formula of
Klein alone or in combination with the liquid nutritional composition of
Molenaar.” Appeal Br. 8. Appellant also argues that “there is no reason or
motivation for the skilled artisan to combine Klein and Molenaar.” Id. at 9.
These arguments are unpersuasive. Molenaar itself provides a reason
to adjust the energy contents of Klein’s composition to values within the
ranges recited in claim 7, because Molenaar teaches that its composition

8 Claim 7 is directed to “[t]he tube feed formulation of Claim 1, wherein the
source of fat provides 25% to 35% of the total energy of the tube
formulation, the source of protein provides 25% to 30% of the total energy
of the tube formulation, and the source of carbohydrates provides 45% to
65% of the total energy of the tube formulation.”
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“provides a balanced, liquid concentrated food product.” Molenaar ¶ 27
(emphasis added). Thus, a skilled artisan would recognize that the claimed
levels of energy content are suitable for providing a balanced food product.
With regard to Appellant’s argument that the references do not teach
how to adjust the energy contents of Klein’s composition, we note that Klein
discloses numerous sources of protein, fat, and carbohydrates that can be
included in its composition. Klein 63–66. Klein also discloses recommended
amounts of protein for children of different ages (id. at 63), as well as the
protein content of different foods (id. at 63–64); states that 25–40% of the
energy in a child’s diet should come from fats (id. at 65); and states that
“[a]bout half of the calories in a healthy diet come from carbohydrates” (id.
at 66). Appellant has not persuasively explained why the guidance provided
by Klein would not be sufficient to allow a skilled artisan to adjust the
energy contents of its composition to meet the values recommended by
Molenaar.
In summary, we affirm the rejection of claims 1 and 7 under 35
U.S.C. § 103(a) based on Klein, McEwen, and Molenaar. Claims 2–5, 8, 23–
26, and 28–31 fall with claim 1 because they were not argued separately.
37 C.F.R. § 41.37(c)(1)(iv) (2018).
For the same reasons, we affirm the rejection of claims 1 and 7 under
35 U.S.C. § 103(a) based on Klein, McEwen, Molenaar, Anthony, and
Ernest. Claims 2–5, 8, and 23–31 fall with claim 1 because they were not
argued separately. 37 C.F.R. § 41.37(c)(1)(iv).
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New Matter
The Examiner has rejected claims 23 and 28 on the basis that the
Specification does not provide support for “a polypeptide comprising
arginine, citrulline, or glutamine,” as recited in claim 23, or for “a protein
hydrolysate,” as recited in claim 28. Ans. 3–4.
Appellant does not present any arguments addressing the new matter
rejection in the Appeal Brief or Reply Brief. We therefore affirm the
rejection. See 37 C.F.R. § 41.37(c)(1)(iv) (The Appeal Brief must contain
“[t]he arguments of appellant with respect to each ground of rejection.”);
MPEP § 1205.02 (9th Ed., Rev. 08.2017 (Jan. 2018)) (“If a ground of
rejection stated by the examiner is not addressed in the appellant’s brief,
appellant has waived any challenge to that ground of rejection and the Board
may summarily sustain it.”).
Provisional Obviousness-type Double Patenting
The Examiner has provisionally rejected all of the claims for
obviousness-type double patenting based on the claims of application
13/805,932. Ans. 13.
Appellant does not present any arguments addressing the provisional
rejection in the Appeal Brief or Reply Brief. We therefore affirm it. See 37
C.F.R. § 41.37(c)(1)(iv); MPEP § 1205.02.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
1–5, 7, 8,
23–26, 28–
31
103(a) Klein, McEwen,
Molenaar
1–5, 7, 8,
23–26, 28–
31

1–5, 7, 8,
23–31
103(a) Klein, McEwen,
Molenaar, Anthony,
Ernest
1–5, 7, 8,
23–31

23, 28 112, first
paragraph
Written Description 23, 28
1–5, 7, 8,
23–31
Provisional
Obviousness-type
Double Patenting
1–5, 7, 8,
23–31

Overall
Outcome
1–5, 7, 8,
23–31

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