Burbidge, Adam Stewart. et al.

Patent Trials and Appeals Board

Sep 19, 2019

14002052 - (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.
14/002,052 09/16/2013 Adam Stewart Burbidge 3712036-01959 4213
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 STEWART BURBIDGE, JAN ENGMANN, and
SIMINA POPA NITA1
__________

Appeal 2019-004040
Application 14/002,052
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 treating a patient having a swallowing disorder, 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. “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. ¶ 82.
“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. ¶ 87.
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. ¶ 90.
“Shear viscosity, often referred to as simply viscosity, describes the
reaction of a material to applied shear stress.” Id. ¶ 85. “Extensional
viscosity is the ratio of the stress required to extend a liquid in its flow
direction to the extension rate.” Id. ¶ 86.
“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. ¶ 88. “The difference between shear and
extensional viscosity is usually expressed in terms of a ‘Trouton ratio,’
which is the ratio between the extensional viscosity and the shear viscosity
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at the same rate of deformation.” Id. The Specification discloses that,
“[b]ecause of the presence of both shear and extensional forces, . . . it is
important to consider the extensional viscosity and Trouton ratio of
nutritional products for patients having difficulty swallowing.” 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. ¶ 89. “[T]he
incorporation of food grade polymers . . . increas[es] the cohesiveness of the
food bolus.” Id.
Claims 43, 44, 46, 47, 49, 50, and 52 are on appeal. Claim 43 is the
only independent claim and reads as follows:
Claim 43: A method for treating a patient having a
swallowing disorder, the method comprising:
administering to the patient having the swallowing
disorder a liquid nutritional product comprising a nutritional
composition and a food grade polymer selected from the group
consisting of okra gum, cactus mucilage, and combinations
thereof, the liquid nutritional product having a Trouton ratio
that is 6 to 15 and an extensional viscosity greater than 100
mPa s,
wherein the liquid nutritional product comprising the
food grade polymer has an increased cohesiveness relative to
the nutritional composition.

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The claims stand rejected as follows:
Claims 43, 44, 46, 47, 50, and 52 under 35 U.S.C. § 103(a) as obvious
based on Stillman,2 Ramsden,3 Guil-Guerrero,4 Chan,5 Fukui,6 and
Dufresne7 (Ans. 3);
Claims 43, 49, and 508 under 35 U.S.C. § 103(a) as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and Ramsden9
(Ans. 7–8);
Claims 43 and 50 under 35 U.S.C. § 103(a) as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and Cárdenas10
(Ans. 9);

2 US 7,115,297 B2, Oct. 3, 2006.
3 Lawrence Ramsden, “15. Plant and Algal Gums and Mucilages,” in
CHEMICAL AND FUNCTIONAL PROPERTIES OF FOOD SACCHARIDES, Piotr
Tomasik, ed. (2003). The copy of record does not include page numbers, so
our citations are to the relevant subsection of the reference.
4 J. L. Guil-Guerrero, Nutritional composition of Plantago species (P. major
L., P. lanceolata L., and P. media L.), 40(5) Ecology of Food and Nutrition
481–495 (2001).
5 Philip Shiu-Kin Chan et al., Study of the shear and extensional rheology of
casein, waxy maize starch and their mixtures, 21 Food Hydrocolloids 716–
725 (2007).
6 US 6,277,395 B1, Aug. 21, 2001.
7 US 2004/0258823 A1, Dec. 23, 2004.
8 The Examiner states that some of the rejections include claim 51. See Ans.
7, 9, 12. However, claim 51 has been cancelled. See Adv. Action mailed
Oct. 11, 2018, at 2.
9 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.
10 A. Cárdenas et al., Rheology and Aggregation of Cactus (Opuntia ficus-
indica) Mucilage in Solution, J. PACD 152–157 (1997).
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Claims 43 and 50 under 35 U.S.C. § 103(a) as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and Sliwinski11
(Ans. 10);
Claims 43, 49, and 50 under 35 U.S.C. § 103(a) as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and Hussein12
(Ans. 12);
Claims 43 and 50 under 35 U.S.C. § 103(a) as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and Hyldon13
(Ans. 13);
Claims 43 and 50 under 35 U.S.C. § 103(a) as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and Turker14
(Ans. 14); and
Claims 43, 44, 49, 50, and 52, provisionally, for obviousness-type
double patenting based on claims 25, 59, 60, 64, and 65 of application
14/365,731 (Ans. 16).
I
The Examiner has rejected claims 43, 44, 46, 47, 50, and 52 as
obvious based on Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, and

11 WO 2006/054886 A1, May 26, 2006.
12 M. M. Hussein et. al., Utilization of some plant polysaccharides for
improving yoghurt consistency, 56(2) Annals of Agricultural Science 97–
103 (2011).
13 US 3,664,847, May 23, 1972.
14 Arzu Ucar Turker & Ekrem Gurel, Common Mullein (Verbascum thapsus
L.): Recent Advances in Research, 19(9) Phytotherapy Research 733–739
(2005).
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Dufresne. The Examiner finds that “Stillman teaches administering a
nutritional composition comprising a soluble fiber with viscosity changing
characteristics to a patient with a swallowing disorder (dysphagia).” Ans. 4.
The Examiner finds that Stillman teaches soluble fiber from plant sources,
including psyllium gum. Id. The Examiner cites Ramsden and Guil-Guerrero
as evidence that “psyllium gum comes from plants of the genus Plantago
which includes ribwort.” Id.
The Examiner acknowledges that “Stillman is silent as to the
Trouton’s ratio and the extensional viscosity of the nutritional product,” and
does not disclose “increased cohesiveness.” Id. at 5. The Examiner finds,
however, that the recited properties would have been inherent in Stillman’s
product because it “is either identical or sufficiently similar to the claimed
nutritional product.” Id. at 6.
Alternatively, the Examiner finds that, as evidenced by Chan, Fukui,
and Dufresne, the Trouton’s ratio and extensional viscosity of a nutritional
product are result effective variables subject to routine optimization. Id. The
Examiner concludes that “the invention as a whole was prima facie obvious
to one of ordinary skill in the art.” Id. at 7.
Appellant argues that “the Examiner admits that Stillman does not
disclose such a specific plant mucilage as okra gum.” Appeal Br. 7.
Appellant argues that “Stillman does not present a selection of specific
biopolymers that are able to confer a high extensional viscosity
(cohesiveness) to a liquid product while maintaining a ‘thin liquid’ texture
(low shear viscosity). In contrast, Stillman only describes the ‘thickening’ of
liquid foods.” Id. Appellant argues that, “[a]s demonstrated by the
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experimental data submitted in Declaration III,[15] okra and cactus
mucilages have superior cohesiveness and therefore, are not functionally
equivalent to other biopolymers disclosed in Stillman, such as xanthan.” Id.
at 8.
We agree with Appellant that the Examiner has not established a
prima facie case of obviousness. In particular, claim 43 requires a
composition comprising either okra gum or cactus mucilage. The Examiner
does not point to any disclosure in the cited references of either okra gum or
cactus mucilage, and does not provide any reason why a person of ordinary
skill in the art would have modified Stillman’s composition to include okra
gum or cactus mucilage.
Because the Examiner has not shown that the cited references would
have made obvious a method meeting the limitations of claim 43, we reverse
the rejection of that claim, and dependent claims 44, 46, 47, 50, and 52,
under 35 U.S.C. § 103(a) based on Stillman, Ramsden, Guil-Guerrero, Chan,
Fukui, and Dufresne.
II
The Examiner has rejected claims 43, 49, and 50 as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, and Dufresne, and
Ramsden. The Examiner has rejected claims 43 and 50 as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, and Dufresne, and
Cárdenas. The same issue is dispositive for both rejections.

15 Declaration under 37 C.F.R. § 1.132 of Jan Engmann, dated May 18,
2018.
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The Examiner finds that “Stillman does not 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. 8. Similarly, the Examiner finds that “Stillman does not teach
. . . cactus mucilage. However, cactus mucilage was a known source of food
grade polymers in food as taught by Cárdenas.” Id. at 9.
The Examiner concludes that it would have been obvious “to modify
the teachings of 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 8–9. Similarly, the Examiner
concludes that it would have been obvious “to modify the teachings of
Stillman 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
10.
Appellant argues that “Stillman does not present a selection of specific
biopolymers that are able to confer a high extensional viscosity
(cohesiveness) to a liquid product while maintaining a ‘thin liquid’ texture
(low shear viscosity). In contrast, Stillman only describes the ‘thickening’ of
liquid foods.” Appeal Br. 7.
Appellant argues that “Declaration III 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.
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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 III, okra and cactus mucilages have superior
cohesiveness and therefore, are not functionally equivalent to other
biopolymers disclosed in Stillman, such as xanthan.” Id. at 8. That is, okra
gum and cactus mucilage “actually had superior cohesiveness to the
preferred thickener of 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. 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.
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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 Stillman’s composition, as a “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.” Ans. 9, 10.
Regarding the Trouton ratio and extensional viscosity recited in claim 43,
the Examiner finds that “one of ordinary skill in the art would recognize that
the Trouton’s ratio and extensional viscosity of the nutritional product are a
result effective variables” that would be routinely optimized, “as evidenced
by Chan, Fukui, and Dufresne.” Id. at 6.
Chan states that proteins and polysaccharides are commonly used in
foods as, among other things, thickening agents. Chan 716, left col. Chan
describes “the shear and uniaxial extensional flow behaviour of aqueous
casein and phosphated waxy maize starch systems.” Id., abstract. “Trouton
ratios were calculated to compare different responses of biopolymers to the
shear and extensional deformation.” Id. The Examiner does not point to any
disclosure in Chan indicating that there is an optimal range of Trouton ratios
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or extensional viscosities for nutritional compositions, especially those for
people with a swallowing disorder.
Fukui discloses “an assistive-drink to facilitate swallowing medicines
characterized in that it contains water and an adhesive paste to make viscous
liquid or gelatinoid.” Fukui 1:62–64. “Specifically, the viscosity at 20° C. is
preferably 1,000–25,000 cP if it is a viscous liquid, and the jelly strength at
20° C. is preferably 10–100 g/cm2 if it is a gelatinoid.” Id. at 3:43–46. Fukui
states:
If the jelly strength is less than 10 g/cm2 or the viscosity
is less than 1,000 cP, misswallowing is apt to occur in
swallowing medicines. On the other hand, if the jelly strength
exceeds 100 g/cm2 or the viscosity exceeds 25,000 cP,
swallowing becomes difficult for those who have difficulty in
swallowing. Thus both cases are unpreferable.
Id. at 3:47–52.
Thus, Fukui teaches a desirable range of viscosities, for viscous
liquids, for people with difficulty swallowing medicines. Fukui, however,
does not specify whether the viscosity is shear viscosity, volume viscosity,
or extensional viscosity. See Spec. ¶¶ 85–86. The Specification states that
shear viscosity is “often referred to as simply viscosity.” Id. ¶ 85.
Dufresne discloses “a method for preparing an adapted food
composition for facilitating the act of swallowing in dysphagic patients,”
comprising the step of “allowing the incorporation of at least one binding
and/or gelling and/or thickening compound capable to modulate the
rheological profile of the transformed food substance.” Dufresne ¶¶ 15–16.
“[T]he rheological profile or the serving rheological profile consists in a
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combination of rheological parameters defined as firmness, cohesiveness,
springiness, adhesiveness, gumminess, chewiness and consistency.” Id. ¶ 19.
The Examiner has not, however, pointed to any disclosure in Dufresne
of an optimal range of firmness, cohesiveness, springiness, adhesiveness,
gumminess, chewiness or consistency for patient having a swallowing
disorder, nor has the Examiner explained how those parameters relate to the
Trouton ratio or extensional viscosity recited in claim 43. The Examiner
does point to specific viscosity ranges suggested by Dufresne “to quantify
and standardize the thickened liquids used in the treatment of dysphagia.”
Dufresne ¶ 90, see also Ans. 7. As with Fukui, however, the Examiner does
not explain why a skilled artisan would read Dufresne’s disclosure to relate
to extensional viscosity rather than shear viscosity, which is “often referred
to as simply viscosity.” Spec. ¶ 85.
Appellant’s Declaration III supports the position that shear viscosity
and extensional viscosity can vary independently. The declaration “presents
data with regard to the shear viscosity and relaxation time of ‘Resource
ThickenUp clear’ solutions in mineral water (6 g/l and 12 g/l).” Declaration
III, ¶ 10. “‘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.
“CaBER experiments are useful to assess whether biopolymers can confer a
high extensional viscosity to a nutritional product, such as a liquid.” Id. ¶ 6.
The declaration also states that the data show that xanthan/starch can
thicken a liquid—i.e., increase its shear viscosity—but it “cannot provide
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any significant level of cohesiveness to the product.” Id. ¶ 11. Claim 43
requires a “liquid nutritional product comprising [a] food grade polymer”
and having “an increased cohesiveness relative to the nutritional
composition.”
In short, while the evidence supports the Examiner’s position that
“Stillman, Ramsden and Cárdenas are directed to thickening food” (Ans.
19), the evidence also shows that the parameters recited in claim 43 require
more than simply thickening—increasing the shear viscosity—of a food.
Rather, claim 43 requires increasing the cohesiveness of the composition, as
reflected by the extensional viscosity and Trouton ratio (extensional
viscosity/shear viscosity; Spec. ¶ 88). The Examiner has not shown that a
method comprising administering a product with the properties recited in
claim 43 would have been obvious based on the cited references.
III
The Examiner has rejected claims 43, 49, and 50 as obvious based on
Stillman, Ramsden, Guil-Guerrero, Chan, Fukui, Dufresne, and one of
Sliwinski, Hussein, Hyldon, or Turker. The Examiner concludes that claim
43 would have been obvious based on Stillman, Ramsden, Guil-Guerrero,
Chan, Fukui, and Dufresne, for the reasons discussed in the first rejection,
and cites Sliwinski, Hussein, Hyldon, and Turker for their disclosures of
additional food grade polymers recited in claims 49 and 50.
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 43. The Examiner does not point to any disclosure of
okra gum or cactus mucilage in any of Sliwinski, Hyldon, or Turker, and
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does not provide any reason why these references would have led a person
of ordinary skill in the art to modify Stillman’s composition to include okra
gum or cactus mucilage. Therefore, the Examiner has not shown that
Sliwinski, Hyldon, or Turker make up for the deficiencies 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. 12. The Examiner concludes that it would have been obvious
“to modify the teachings of Stillman 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 12–13.
The Examiner’s reliance on Hussein, however, suffers from the same
deficiency discussed above with regard to Ramsden and Cárdenas; i.e., claim
43 requires increasing the cohesiveness of a composition, not simply
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
43.
IV
The Examiner has provisionally rejected claims 43, 44, 49, 50, and 52
for obviousness-type double patenting based on claims 25, 59, 60, 64, and
65 of application 14/365,731. Ans. 16.
Appellant presents no argument in the Appeal Brief disputing the
merits of the provisional rejection. We therefore affirm it. See 37 C.F.R.
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§ 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
43, 44, 46, 47, 50,
52
§ 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne
43, 44, 46, 47,
50, 52
43, 49, 50 § 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne,
Ramsden
43, 49, 50
43, 50 § 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne,
Cárdenas
43, 50
43, 50 § 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne,
Sliwinski
43, 50
43, 49, 50 § 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne,
Hussein
43, 49, 50
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Claims
Rejected
Basis Affirmed Reversed
43, 50 § 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne,
Hyldon
43, 50
43, 50 § 103(a) Stillman,
Ramsden, Guil-
Guerrero, Chan,
Fukui, Dufresne,
Turker
43, 50
43, 44, 49, 50, 52 obviousness-type
double patenting
(provisional)
14/365,731
43, 44, 49, 50,
52

Overall Outcome 43, 44, 49, 50,
52
46, 47
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