Burbidge, Adam et al.

Patent Trials and Appeals Board

Sep 19, 2019

14365731 - (D) (P.T.A.B. Sep. 19, 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.
14/365,731 06/16/2014 Adam Burbidge 3712036-02224 2586
29157 7590 09/19/2019
K&L Gates LLP-Chicago
P.O. Box 1135
Chicago, IL 60690
EXAMINER
CORDAS, EMILY ANN
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
09/19/2019 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 ADAM BURBIDGE, JAN ENGMANN, and
SIMINA POPA NITA1
__________

Appeal 2019-004051
Application 14/365,731
Technology Center 1600
__________

Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, 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
method for promoting safe swallowing of nutritional products, which have
been rejected for obviousness and provisionally rejected for obviousness-
type double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM the provisional double patenting rejection.

1 Appellant identifies the Real Party in Interest as Nestec S.A. Appeal Br. 2.
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STATEMENT OF THE CASE
“Dysphagia is the medical term for the symptom of difficulty in
swallowing.” Spec. ¶ 2. The inability to properly swallow food or liquids
can lead to aspiration and infection. Id. ¶ 7. “Mild to moderate oral
pharyngeal dysphagia may require the texture of foods to be modified in
order to minimize the likelihood of choking or aspiration.” Id. ¶ 103.
“A know[n] treatment for beverages and liquid foods is to increase the
viscosity of the food/beverage by adding starch or gum thickeners. . . . It is,
however, often disliked by patients because of the extra swallowing effort
and may also leave residues at high levels of viscosity.” Id. ¶ 111.
The Specification discloses that
providing inventive nutritional products to dysphagic patients
having increased bolus cohesion due to its extensional
viscosity, without dramatically modifying other physical
properties of the material such as, for example, its shear
viscosity, dramatically reduces the amount of swallowing effort
for the patient, as well as the risk of residue build-up in the
oropharyngeal and/or esophageal tracts.
Id. ¶ 116.
“Shear viscosity, often referred to as simply viscosity, describes the
reaction of a material to applied shear stress.” Id. ¶ 107. “Another
rheological property of a material is its extensional viscosity.” Id. ¶ 108.
“Extensional viscosity is generally only relevant in flows where a fluid is
‘stretched’/extended (e.g., when a flowing through a constriction such as an
esophageal sphincter), or when compressed (e.g., between . . . the tongue
and pharynx).” Id. ¶ 112.
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A “Capillary Breakup Extensional Rheometer (CaBER) is an example
for a rheometer applying extensional stress.” Id. ¶ 109.
During the CaBER experiment as performed herein for
measuring the relaxation time of the nutritional product, a drop
of said product is placed between two vertically aligned and
parallel circular metal surfaces. . . . The metal surfaces are then
rapidly separated linearly. . . . The filament formed by this
stretching action subsequently thins under the action of
interfacial tension.
Id. “The relaxation time in a CaBER experiment is determined” based on a
plot of the filament thickness versus time during the thinning process. Id.
“[T]he nutritional products of the present disclosure aim to improve
the cohesion of food boluses to prevent a food bolus from being broken up
into smaller fragments, which may enter the airway.” Id. ¶ 113. “[T]he
incorporation of food grade polymers . . . increas[es] the cohesiveness of the
food bolus.” Id.
Claims 26, 51–57, and 59–65 are on appeal. Claim 26 is the only
independent claim and reads as follows:
Claim 26: A method for promoting safe swallowing of nutritional
products in a patient in need of same, the method comprising administering
to the patient a liquid nutritional product comprising an aqueous solution of
a food grade biopolymer comprising at least one of okra gum or cactus
mucilage, the food grade biopolymer providing to the liquid nutritional
product:
a shear viscosity less than about 100 mPas when measured at a shear
rate of 50s–1; and
a relaxation time, determined by a Capillary Breakup Extensional
Rheometry (CaBER) experiment, of more than 10 ms (milliseconds) at a
temperature of 20° C,
wherein the liquid nutritional product comprising the food grade
polymer has an increased cohesiveness.
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The claims stand rejected as follows:
Claims 26, 51–55, 57,2 59, 60, and 63–65 under 35 U.S.C. § 103(a) as
obvious based on Holahan,3 Ghadimi,4 Grönlund,5 De Block,6 Stillman,7
Ramsden,8 and Guil-Guerrero9 (Ans. 3–4);
Claims 26, 56, and 59–6110 under 35 U.S.C. § 103(a) as obvious
based on Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-
Guerrero, and Ramsden11 (Ans. 10);

2 The statement of the rejection does not include claim 57, but claim 57 is
addressed in the body of the opinion. Ans. 4. Thus, we assume that the
omission of claim 57 from the statement of the rejection was a typographical
error.
3 Holahan, WO 03/011051 A1, published February 13, 2003.
4 Ghadimi, Free Amino Acids of Different Kinds of Milk, 13 AMER. J. CLIN.
NUTR. 75–81 (1963).
5 Grönlund et al., Maternal breast-milk and intestinal bifidobacteria guide
the compositional development of the Bifidobacterium microbiota in infants
at risk of allergic disease, 37 CLIN. EXP. ALLERGY 1764–72 (2007).
6 De Block et al., Evaluation of Two Methods for the Determination of
Lactulose in Milk, 6 INT. DAIRY JOURNAL 217–222 (1996).
7 Stillman, US 7,115,297 B2, issued Oct. 3, 2006.
8 Lawrence Ramsden, “Plant and Algal Gums and Mucilages,” in CHEMICAL
AND FUNCTIONAL PROPERTIES OF FOOD SACCHARIDES, CRC Press LLC, Piotr
Tomasik (ed.) (2003). The copy of record does not include page numbers, so
our citations are to the relevant subsection of the reference.
9 Guil-Guerrero, Nutritional composition of Plantago species (P-major L.,
P-lanceolata, L., and P-media L.), ECOL. FOOD NUTR. 1–17 (Aug. 2010).
10 The Examiner states that some of the rejections include claim 58. See Ans.
10, 17, 21. However, claim 58 has been cancelled. See Adv. Action mailed
Oct. 11, 2018, at 2.
11 This rejection is based on the same evidence as the first rejection (with
Ramsden being cited twice) but because the rejections are based on different
rationales, we address them as separate rejections.
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Claims 26 and 60 under 35 U.S.C. § 103(a) as obvious based on
Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-Guerrero,
and Cárdenas12 (Ans. 16);
Claim 56 under 35 U.S.C. § 103(a) as obvious based on Holahan,
Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-Guerrero, and
Fukui13 (Ans. 12);
Claims 26 and 60–62 under 35 U.S.C. § 103(a) as obvious based on
Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-Guerrero,
Clarke14 and Redgwell15 (Ans. 14);
Claims 26, 60, and 61 under 35 U.S.C. § 103(a) as obvious based on
Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-Guerrero,
and Hussein16 (Ans. 17);
Claims 26, 55, 59, and 60 under 35 U.S.C. § 103(a) as obvious based
on Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-
Guerrero, and Hyldon17 (Ans. 18); and

12 Cárdenas, Rheology and Aggregation of Cactus (Opuntia ficus-indica)
Mucilage in Solution, J PACD 152–159 (1997).
13 Fukui, US 6,277,395 B1, issued Aug. 21, 2001.
14 Clarke, US 6,271,001 B1, issued Aug. 7, 2001.
15 Redgwell, Structural Features of the Mucilage from the Stem Pith of
Kiwifruit (Actinidia deliciosa): Part I, Structure of the Inner Core, 153
CARBOHYDRATE RES. 97–106 (1986).
16 Hussein, Utilization of some plant polysaccharides for improving yoghurt
consistency, 56(2) ANNALS OF AGRIC. SCI. 97–103 (2011).
17 Hyldon, US 3,664,847, issued May 23, 1972.
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Claims 26, 51, 52, 59, 60, and 65, provisionally, for obviousness-type
double patenting based on claims 43, 47, and 49–52 of application
14/002,052 (Ans. 21).
I
The Examiner has rejected claims 26, 51–55, 57, 59, 60, and 63–65 as
obvious based on Holahan, Ghadimi, Grönlund, De Block, Stillman,
Ramsden, and Guil-Guerrero. The Examiner finds that “Holahan teaches a
method of promoting effective swallowing by a person with dysphagia
comprising of feeding an aqueous concentrated xanthan gum thickener
composition (a food grade polymer) with a liquid food.” Ans. 4. The
Examiner finds that “Stillman teaches a similar method of promoting safe
swallowing of nutritional products by administering a nutritional product
comprising an aqueous solution of a food grade biopolymer” such as
psyllium gum. Id. at 5–6.
The Examiner cites Ghadimi, Grönlund, and De Block as evidence of
components (which do not include okra gum or cactus mucilage) inherently
found in milk or breast milk. Id. at 4–5. The Examiner cites Ramsden and
Guil-Guerrero as evidence that “psyllium gum comes from plants of the
genus Plantago which includes ribwort.” Id. at 6.
The Examiner finds that “Holahan teaches the method where the
nutritional product containing a thickener and lists many examples of
thickeners.” Id. The Examiner concludes that it would have been obvious “to
modify the teachings of Holahan in such a way that the food grade polymer
is psyllium mucilage or ribwort mucilage as recited in claims 26 and 60 for
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the purpose being able thicken a nutritional composition for the promotion
of safe swallowing.” Id. (emphasis added).
Claim 26, however, is limited to a method of administering a product
that comprises okra gum or cactus mucilage, not psyllium mucilage or
ribwort mucilage. The Examiner has not pointed to any disclosure in any of
the cited references that would have led a skilled artisan to modify
Holahan’s method to include a composition comprising either okra gum or
cactus mucilage, and therefore has not shown that the cited references would
have made obvious a method meeting the limitations of claim 26. We
reverse the rejection of claims 26, 51–55, 57, 59, 60, and 63–65 under 35
U.S.C. § 103(a) based on Holahan, Ghadimi, Grönlund, De Block, Stillman,
Ramsden, and Guil-Guerrero.
II
The Examiner has rejected claims 26, 56, and 59–61 as obvious based
on Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-
Guerrero, and Ramsden. The Examiner has rejected claims 26 and 60 as
obvious based on Holahan, Ghadimi, Grönlund, De Block, Stillman,
Ramsden, Guil-Guerrero, and Cárdenas. The same issue is dispositive for
both rejections.
The Examiner finds that “neither Holahan or Stillman teach . . . okra
gum” but Ramsden teaches that okra gum was a well-known source of food
grade polymers used in food and pharmaceuticals as a thickening and gelling
agent. Ans. 11. Similarly, the Examiner finds that “Holahan does not teach
the method wherein the food grade biopolymer is . . . cactus mucilage.
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However, cactus mucilage was a known source of food grade polymers in
food as taught by Cárdenas.” Id. at 16.
The Examiner concludes that it would have been obvious “to modify
the teachings of Holahan and Stillman in such a way that the food grade
polymer was okra gum . . . for the purpose [of] being able [to] thicken a
nutritional composition for a patient with a swallowing disorder” because
okra gum was known for use as a thickening agent. Id. at 11–12. Similarly,
the Examiner concludes that it would have been obvious “to modify the
teachings of Holahan in such a way that the food grade polymer is cactus
mucilage for the purpose [of] being able [to] thicken a nutritional
composition for a patient with a swallowing disorder” because “food was
known to contain such polymers for it[s] rheological properties as taught by
Cárdenas.” Id. at 16–17.
The Examiner acknowledges that Holahan and Stillman are silent with
regard to the shear viscosity, relaxation time, and cohesiveness of the
nutritional composition as recited in claim 26. Id. at 7. The Examiner
reasons, however, that “the dilution or thickness of the nutritional product is
a result effective variable and that the amount of diluting or thickness of the
nutritional product would be [a] matter of routine optimization.” Id. at 10.18
Appellant argues that “Holahan does not present a selection of
specific biopolymers that are able to confer a high extensional viscosity

18 The Examiner also finds that the recited properties are “inherent to the
composition as taught by Holahan and Stillman.” Ans. 8. This finding is not
supported by the evidence because the compositions of Holahan and
Stillman do not comprise either okra gum or cactus mucilage, which are
required by all of the claims.
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(cohesiveness) to a liquid product while maintaining a ‘thin liquid’ texture
with the shear viscosity as recited in independent claim 26.” Appeal Br. 7.
“In contrast, Holahan only describes the ‘thickening’ of liquid foods.” Id.
Appellant argues that “Declaration II, [19] Annex 3 . . . presents data
with regard to the shear viscosity and relaxation time of ‘Resource
ThickenUp clear’ solutions . . . contain[ing] the biopolymers xanthan and
hydrolysed starch.” Id. at 6. Appellant argues that the results of the
experiments in the declaration show that, in contrast to okra gum or cactus
mucilage, “the use of xanthan/starch can merely serve to ‘thicken’ a liquid,
i.e. to increase its shear viscosity. However, it cannot provide any significant
level of cohesiveness, i.e. extensional viscosity, to the product.” Id. at 6–7.
Appellant argues that, “[a]s demonstrated by the experimental data
submitted in Declaration II, okra and cactus mucilages are not functionally
equivalent and actually have superior cohesiveness to other biopolymers
disclosed in Holahan, such as xanthan.” Id. at 8–9. That is, okra gum and
cactus mucilage “actually had superior cohesiveness to the preferred
thickener of Holahan and Stillman, i.e., xanthan.” Id. at 7.
We agree with Appellant that the rejection is not supported by a
preponderance of the evidence of record. Holahan teaches a “treatment for
dysphagia . . . which comprises feeding a concentrate thickener composition
contained within a food to a patient having the condition of dysphagia.”
Holahan ¶ 13. Holahan discloses a variety of thickeners, but does not

19 Declaration under 37 C.F.R. § 1.132 of Jan Engmann, dated May 18,
2018.
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disclose okra gum or cactus mucilage. Id. ¶ 20. “In a preferred aspect, the
thickener selected comprises xanthan gum.” Id. ¶ 21.
Stillman discloses modified “fiber-water”: “an invention composed
specifically of water and soluble fiber (that’s simple enough) that is
tasteless, odorless and colorless, much like water itself,” containing one or
more additional elements. Stillman 7:15–23. Stillman discloses that its fiber-
water can include “[v]iscosity changing additives . . . for those with
swallowing difficulties.” Id. at 31:27–30. Stillman discloses that viscosity
changing additives include gums. Id. at 31:34–37. Stillman lists numerous
gums, but does not include okra gum or cactus mucilage. See id. at 31:55 to
33:39.
Ramsden discusses “the structure and functional properties of the
gums and their value in food applications.” Ramsden § 15.1. Ramsden
teaches that “[o]kra gum is only a weak emulsifiant but can act as a
thickener.” Id. § 15.5.1.5.
Cárdenas states that cactus mucilage in solution forms “large
aggregates [that] may underlie some of the special functional properties
already identified for the use of cactus mucilage in food and other products.”
Cárdenas 152, abstract. “[L]ittle is known about the molecular and
rheological characteristics underlying specialized functional properties as an
additive for food.” Id. at 153. “Cactus mucilage may find applications in the
food, cosmetics, pharmaceutical and other industries.” Id. at 155–156.
The Examiner concludes that the disclosures of Ramsden and
Cárdenas would have led a skilled artisan to use okra gum or cactus
mucilage in Holahan’s composition, as a “substitution of one known type of
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food grade plant-based polymer for another for the purpose of thickening
food for administration to a patient with a swallowing disorder.” Ans. 12,
17. Regarding the properties recited in claim 26, the Examiner concludes
that
one of ordinary skill in the art would recognize that the dilution
or thickness of the nutritional product is a result effective
variable and that the amount of diluting or thickness of the
nutritional product would be matter of routine optimization
depending on the properties of the aqueous solution and the
subject being administered the nutritional product.
Id. at 10.
The Examiner finds that Stillman discloses a “nutritional product
[that] is diluted prior to administering,” Ans. 9–10, but does not cite any
evidence showing that the degree of dilution or thickness of a nutritional
product was a result-effective variable. However, even if the degree of
thickness of a liquid nutritional product was recognized as a result-effective
variable, and therefore obvious to optimize, Appellant has provided evidence
to show that the thickness of a composition relates only to its shear viscosity
and not to relaxation time as claimed.
Appellant’s Declaration II describes biopolymer solutions comprising
cactus, okra, or flax seed extracts as follows: “[T]hese liquid foods have a
low shear viscosity and thus, they still have the texture of a ‘thin liquid.’”
Declaration II ¶ 6. See also id. ¶ 9 (discussing shear viscosity ranges that
progressively increase for nectar-like, honey-like, and pudding-like foods).
Declaration II supports the position that shear viscosity and relaxation
time, as recited in claim 26, can vary independently. The declaration
“presents data with regard to the shear viscosity and relaxation time of
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‘Resource ThickenUp clear’ solutions in mineral water (6 g/l and 12 g/l).”
Id. ¶ 11. “‘ThickenUp Clear’ . . . contains the biopolymers xanthan and
hydrolysed starch.” Id. The data show that the shear viscosity of the
solutions increased from 40 mPas at 6 g/l to 180 mPas at 12 g/l, but the
“relaxation time (CaBER, ms)” was “not measurable” for either solution. Id.
The declaration also states that the data show that xanthan/starch can
merely thicken a liquid—i.e., increase its shear viscosity—but it “cannot
provide any significant level of cohesiveness . . . to the product.” Id. ¶ 12.
Claim 26 requires a “liquid nutritional product comprising [a] food grade
polymer” and having “an increased cohesiveness.”
In short, while the evidence supports the Examiner’s position that
“Holahan, Ramsden and Cárdenas are directed to thickening food” (Ans.
23), the evidence also shows that the parameters recited in claim 26 require
more than simply thickening—increasing the shear viscosity—of a food.
Rather, claim 26 requires increasing the cohesiveness of the composition, as
reflected by the low shear viscosity and the relaxation time (as measured by
a CaBER experiment) recited in the claim. The Examiner has not shown that
a method comprising administering a product with the properties recited in
claim 26 would have been obvious based on the cited references.
III
The Examiner has rejected claims 26, 55, 56, and 59–62 as obvious
based on Holahan, Ghadimi, Grönlund, De Block, Stillman, Ramsden, Guil-
Guerrero, and (a) Fukui, (b) Hussein, (c) Hyldon, or (d) the combination of
Clarke and Redgwell. The Examiner concludes that claim 26 would have
been obvious based on Holahan, Ghadimi, Grönlund, De Block, Stillman,
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Ramsden, and Guil-Guerrero, for the reasons discussed in the first rejection,
and cites Fukui, Hussein, Hyldon, or the combination of Clarke and
Redgwell for their disclosures of additional food grade polymers recited in
claims 55, 56, and 59–62.
As discussed above, however, the Examiner’s first rejection did not
set out a prima facie case of obviousness for a method meeting all of the
limitations of claim 26. The Examiner does not point to any disclosure of
okra gum or cactus mucilage in Fukui, Hyldon, or the combination of Clarke
and Redgwell, and does not provide any reason why these references would
have led a person of ordinary skill in the art to modify Holahan’s
composition to include okra gum or cactus mucilage. Therefore, the
Examiner has not shown that Fukui, Hyldon, or the combination of Clarke
and Redgwell make up for the deficiency discussed above.
The Examiner finds that Hussein does disclose okra gum: “Hussein
teaches okra and Jew’s mallow contain polysaccharides useful for thickening
yogurt.” Ans. 17. The Examiner concludes that it would have been obvious
“to modify the teachings of Holahan in such a way that the food grade
polymer is okra gum or mallow mucilage for the purpose [of] being able [to]
thicken a nutritional composition for a patient with a swallowing disorder”
because the modification is “the substitution of one known type of food
grade plant-based polymer for another for the purpose of thickening food for
administration to a patient with a swallowing disorder.” Id. at 18.
The Examiner’s reliance on Hussein, however, suffers from the same
deficiency discussed above with regard to Ramsden and Cárdenas; i.e., claim
26 requires increasing the cohesiveness of a composition, not simply
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thickening it. The Examiner has not pointed to any disclosure in Hussein that
would have made obvious a composition with the properties recited in claim
26.
IV
The Examiner has provisionally rejected claims 26, 51, 52, 59, 60, and
65 for obviousness-type double patenting based on claims 43, 47, and 49–52
of application 14/002,052. Ans. 21.
Appellant presents no argument in the Appeal Brief disputing the
merits of the provisional rejection. We therefore affirm it. See 37 C.F.R.
§ 41.37(c)(1)(iv) (The Appeal Brief must include “[t]he arguments of
appellant with respect to each ground of rejection.”); Hyatt v. Dudas, 551
F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a
ground of rejection to the Board, . . . the Board may treat any argument with
respect to that ground of rejection as waived.”).

CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
26, 51–55, 57, 59,
60, 63–65
§ 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
Ramsden, Guil-
Guerrero
26, 51–55, 57,
59, 60, 63–65
26, 56, 59–61 § 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
26, 56, 59–61
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Claims
Rejected
Basis Affirmed Reversed
Ramsden, Guil-
Guerrero, Ramsden
26, 60 § 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
Ramsden, Guil-
Guerrero, Cárdenas
26, 60
56 § 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
Ramsden, Guil-
Guerrero, Fukui
56
26, 60–62 § 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
Ramsden, Guil-
Guerrero, Clarke,
Redgwell
26, 60–62
26, 60, 61 § 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
Ramsden, Guil-
Guerrero, Hussein
26, 60, 61
26, 55, 59, 60 § 103(a) Holahan,
Ghadimi, Grönlund,
De Block, Stillman,
Ramsden, Guil-
Guerrero, Hyldon
26, 55, 59, 60
26, 51, 52, 59, 60,
65
obviousness-type
double patenting
(provisional)
14/002,052
26, 51, 52, 59,
60, 65

Overall Outcome 26, 51, 52, 59,
60, 65
53–57, 61–64
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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).

AFFIRMED-IN-PART