Ex Parte Holahan

Board of Patent Appeals and Interferences

Mar 18, 2009

10485879 (B.P.A.I. Mar. 18, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JOHN L. HOLAHAN
____________

Appeal 2009-0546
Application 10/485,8791
Technology Center 1700
____________

Decided:2 March 18, 2009
____________

Before CHUNG K. PAK, CHARLES F. WARREN, and
CATHERINE Q. TIMM, Administrative Patent Judges.

PAK, Administrative Patent Judge.

DECISION ON APPEAL

Appellant seeks our review under 35 U.S.C. § 134 of the
Examiner’s final rejection of claims 24 through 27, 29 through 34, 84, and
85. Claims 1 through 5, 7 through 23, 42 through 48, 56 through 62, 77
through 83, 86 through 90, 92 through 103, and 105 through 111, the

1 An oral hearing was held on February 11, 2009.
2 The two-month time period for filing an appeal or commencing a civil action, as
recited in 37 C.F.R. § 1.304, begins to run from the decided date shown on this
page of the decision. The time period does not run from the Mail Date (paper
delivery) or Notification Date (electronic delivery).

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other claims pending in the above-identified application, stand withdrawn
from consideration by the Examiner. We have jurisdiction under 35
U.S.C. § 6 (2002).
We REVERSE.
STATEMENT OF THE CASE
The subject matter on appeal is directed to “[a] treatment of
dysphagia” (Claim 24). According to page 1, paragraph [0003], of the
Specification:
Swallowing problems in humans include difficulty in
swallowing, inability to swallow, and discomfort in
swallowing. These problems are collectively termed
dysphagia. Dysphagia is a common unfortunate secondary
condition that accompanies many primary human disease
states such as stroke, multiple sclerosis, asperger syndrome,
esophageal cancer, laryngeal cancer, chagus disease cystic
fibrosis, Huntington’s chorea, …. and Alzheimer’s disease.

Details of the appealed subject matter are recited in representative
claim 24 reproduced below:
24. A treatment for dysphagia which comprises admixing a packaged
aqueous concentrate thickener composition with a liquid food that is suitable for
consumption by a person without dysphagia, and then feeding the thickened
liquid food to a patient having the condition of dysphagia, to facilitate
consumption of the liquid food by the patient, said packaged aqueous
concentrate thickener composition consisting essentially of a fully hydrated
thickener and water.
As evidence of unpatentability of the claimed subject matter, the
Examiner has proffered the following prior art references:
Ninomiya US 5,932,235 Aug. 3, 1999
Zablocki US 6,139,895 Oct. 31, 2000
Uzuhashi US 6,455,090 B1 Sep. 24, 2002
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The Examiner has rejected claims 24 through 27, 29 through 34, 84,
and 85 under 35 U.S.C. § 103(a) as unpatentable over the combined
disclosures of Ninomiya, Uzuhashi, and Zablocki.
Appellant appeals from the Examiner’s decision rejecting claims 24
through 27, 29 through 34, 84, and 85 under 35 U.S.C. § 103(a) as
unpatentable over the combined disclosures of Ninomiya, Uzuhashi, and
Zablocki .

ISSUE
The dispositive question raised by the Examiner and Appellant is:
Has the Examiner demonstrated that the combined disclosures of
Niomiya, Uzuhashi, and Zablocki would have led one of ordinary skill in
the art to mix a packaged aqueous concentrate thickener composition
consisting essentially of a fully hydrated thickener and water with a liquid
food and feed the resulting thickened food to a patient suffering from
dysphagia within the meaning of 35 U.S.C. § 103(a)?

FINDINGS OF FACT
1. Ninomiya teaches a jellied medical composition comprising a base
containing a thickening agent (e.g., carrageenan and locust bean gum) for
oral administration which is easily taken by patients of advanced age or
patients with dysphagia (col. 1, ll. 5-20, col. 4, ll. 10-13, and abstract).
2. Ninomiya teaches that its jellied medical composition packed in a
disposable container has “solidity appropriate for swallowing and with
good texture, which is suitable for improvement of compliance” and
“which does not easily cause syneresis” (col. 1, ll. 9-20 and col. 7, ll. 5-9).
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3. Ninomiya teaches that its jellied medical composition comprises a
liquid dispersion medium containing a pharmaceutically effective
component retained in the pit of the skeleton of the solid phase composed
of the base (jelly base) (col. 4, l. 64 to col. 5, 1.12 and col. c6, ll. 57-61).
4. Ninomiya teaches that this jellied composition “can be applied to
the jellied compositions other than the jellied medical composition for
oral administration of the present invention, such as food….” (col. 6, l. 65
to col. 7, l. 2).
5. Consistent with the disclosure of Ninomiya, a Rule 1.132 affidavit
executed by John L. Holahan on October 18, 2005, states that “gel is a
solid that has a three-dimensional framework of a gelling agent that
encloses pockets of water that may separate from the structure….that
separation, known as syneresis…” (para. 13).
6. Ninomiya teaches or suggests forming a jellied food composition
packed in a disposable container for patients with dysphagia and does not
teach or suggest “admixing a packaged aqueous concentrate thickener
composition [consisting essentially of a fully hydrated thickener and
water] with a liquid food… (emphasis added)” as recited in claim 24.
7. Uzuhashi teaches thickening a liquid food with a liquid additive
thickener for the purpose of feeding “patients who have mastification and
deglutition difficulties caused by an eating disorder” (col. 1, ll. 5-40)
8. Uzuhashi teaches including crystallizing substances, such as
isopropyl alcohol, certain polysaccharides, and reactive ions, in its liquid
additive thickener to render the thickener partially hydrophobic (partially
crystallized) (col. 3, l. 340 to col. 54).
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9. The Examiner acknowledges that the thickener taught by Uzuhashi
is not fully hydrated as required by claim 24 (Ans. 6).
10. In fact, Uzuhashi teaches (col. 2, ll. 17-24) that:
[W]here the liquid thickening agent is simply produced by the
conventional method so as to obtain a desired viscosity and
coagulation force without greatly diluting the object, it has a high
initial viscosity and thus loses its fluidity. This kind of liquid
thickening agent is not easy to use. In addition, even where it is
added to food, a desired viscosity and formation for gels (gelation)
cannot be obtained by dispersing it over the whole food.

11. Zablocki teaches forming an acidic edible composition having
perceived maximum sweetness and overall flavor by adding to an edible
liquid food, such as beverages, salad dressings, or syrups, a low acetylated
xanthan gum corresponding to the claimed thickening agent “in an
amount effective to substantially maintain the initial viscosity of the
composition for at least about four months under typical storage
conditions” (abstract, col. 1, ll. 7-20, col. 1, l. 61- col. 2, l. 7, and col. 4, ll.
35-37).
12. Zablocki teaches (col. 5, ll. 27-32) that:
Those of skill in the art will recognize that it may be
necessary or expedient to alter the process as illustrated
herein to obtain the maximum amount of hydration of low
acetylated xanthan gum. This is generally brought about by
increased mixing time of the xantahn gum with water and/or
increased shearing.

13. Zablocki does not produce an edible composition useful for patients
suffering from dysphagia or patients who have mastification and
deglutition difficulties caused by an eating disorder.

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PRINCIPLES OF LAW
Under 35 U.S.C. § 103, the factual inquiry into obviousness
requires a determination of: (1) the scope and content of the prior art; (2)
the differences between the claimed subject matter and the prior art; (3)
the level of ordinary skill in the art; and (4) secondary considerations if
necessary. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). As
explained by the Supreme Court in KSR Int’l Co. v. Teleflex, Inc., 127 S.
Ct. 1727, 1740-41 (2007):
[A]nalysis [of whether the subject matter of a claim would
have been obvious] 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….

Nevertheless, "rejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion
of obviousness." KSR at 1741-42, quoting In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006). In assessing obviousness, prior art teachings that
negate or support patentability must be fairly considered. See In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).

ANALYSIS AND CONCLUSION OF LAW
As indicated supra, Ninomiya teaches a packaged jellied medical or
food composition useful for patients suffering from dysphagia. Ninomiya
teaches that the thickening agent in the packaged jellied medical or food
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composition is in the form of solid (gel) which is structured to contain a
liquid dispersion medium having absorbed or dispersed pharmaceutical
ingredients. Nowhere does Ninomiya teach making a packaged aqueous
concentrate thickener composition consisting essentially of a fully
hydrated thickener and water, much less mixing the packaged aqueous
concentrate thickener composition with a liquid food prior to feeding the
resulting thickened food to a patient suffering from dysphagia.
To remedy this deficiency, the Examiner relies on the disclosure of
Uzuhashi and Zablocki. However, Uzuhashi teaches mixing a liquid
additive thickener containing a partially crystallized thickening agent (a
not fully hydrated thickening agent as acknowledged by the Examiner),
water and a crystallizing agent with a liquid food for the purpose of
making an edible food for a patient suffering from the same or similar
problem taught by Ninomiya. Zablocki teaches employing a low
acetylated xanthan gum, as opposed to a natural thickening agent, such as
xanthan gum, in forming an edible liquid food for a person without
dysphagia or a similar problem. According to Zablocki, the low
acetylated xanthan gum, if used in an appropriate amount, can help
maintain the initial viscosity of the edible liquid food for at least about
four months under typical storage conditions. Nowhere does Zablocki
teach forming a packaged aqueous concentrate thickener composition
consisting essentially of a fully hydrated thickener and water for the
purpose of making a food useful for patients suffering from dysphagia.
From these collective teachings of Ninomiya, Uzuhashi and
Zablocki, one of ordinary skill in the art may have been led to make
Ninomiya’s packaged jellied medical or food composition useful for
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patients suffering from dysphagia via employing the liquid additive
thickener containing a partially crystallized low acetylated xanthan gum
thickening agent (not fully hydrated), water and a crystallizing agent
suggested by Uzuhashi and Zablocki. However, they would not have led
one of ordinary skill in the art to mix a packaged aqueous concentrate
thickener composition consisting essentially of a fully hydrated thickener
and water with a liquid food and then feed the resulting thickened food to
a patient suffering from dysphagia within the meaning of 35 U.S.C. §
103(a).
For the reasons set forth above and in the Appeal Brief and the
Reply Brief, we determine that the Examiner has failed to carry the
burden of establishing a prima facie case of obviousness within the
meaning of 35 U.S.C. § 103(a).
ORDER
The decision of the Examiner is reversed.

REVERSED

PL Initail:
sld

POLSTER, LIEDER, WOODRUFF & LUCCHESI
12412 POWERSCOURT DRIVE SUITE 200
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ST. LOUIS, MO 63131-3615