Ex Parte Holahan

Patent Trial and Appeal Board

Feb 17, 2017

13025882 (P.T.A.B. Feb. 17, 2017)

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.
SITH 9317W3 3634
EXAMINER
JONES, DAMERON LEVEST
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
13/025,882 02/11/2011
1688 7590 02/17/2017
Polster, Lieder, Woodruff & Lucchesi, L.C.
12412 Powerscourt Dr. Suite 200
St. Louis, MO 63131-3615
John L. HOLAHAN
02/17/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN L. HOLAHAN1
Appeal 2016-001113
Application 13/025,882
Technology Center 1600
Before ULRIKE W. JENKS, ELIZABETH A. LaVIER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of treating dysphagia, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
“[Difficulty in swallowing, inability to swallow, and discomfort in
swallowing ... are collectively termed dysphagia.” (Spec. 12.) “People
with dysphagia generally lack proper muscle control and coordination to
properly seal the windpipe or they lack the ability to properly propel the
1 Appellant identifies the Real Party in Interest as Simply Thick LLC.
(Appeal Br. 1.)
Appeal 2016-001113
Application 13/025,882
entire bolus of food and/or beverage to the stomach.” (Id. at 13.)
Thickening beverages, such as by the addition of starch, “is a common
method of managing dysphagia.” (Id. at || 4, 5.) The thickening agent can
be added “at or near the point and time of [use]” or it can be added to a
beverage at the “supplier’s manufacturing facility” to provide a “pre­
thickened beverage.” (Id. at | 5.) Appellant’s invention is directed to
thickened beverage compositions comprising xanthan gum.
Claims 9 and 13 are on appeal. Claim 9 is representative and reads as
follows:
9. A method of treating dysphagia comprising feeding a
dysphagic person a pre-mixed, pre-packaged, pre-thickened,
ready-to-consume water-based liquid food composition
thickened with about 0.01% to about 5% by weight of xanthan
gum only, such that it is suitably thick for swallowing by a
dysphagic patient.
(Appeal Br. 10.)
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Application 13/025,882
The following ground of rejection by the Examiner is before us on
review:
Claims 9 and 13 under 35 U.S.C. § 103 as unpatentable over Nimura2
and Kamarei.3
DISCUSSION
The Examiner finds that Nimura teaches liquid foods useful with
patients who have dysphagia, where those liquid foods are thickened with
xanthan gum in a weight percent of from about 0.05 to 5.0% of the liquid to
achieve a viscosity such that a patient with dysphagia may orally take the
liquid. (Final Action 3; Ans. 2-4.) The Examiner recognizes that Nimura
2 Nimura et al., JP 11-318356, published Nov. 24, 1999. We note that the
Examiner initially relied on a machine translation for understanding the
disclosure of Nimura. (See Final Action 3.) The machine translation was
poor, as it included much content that did not appear to make much sense,
though it sufficiently indicated that the reference disclosed the use of
xanthan gum to thicken a composition to be ingested by those with difficulty
swallowing. (See, e.g., Nimura machine translation || 4, 14.) The
Examiner provided a “human translation” with the Examiner’s Answer.
Appellant refers to this translation in the Reply Brief (Reply Br. 5), as do
we. Appellant appears to take issue with the prior art status of the
translations. (Reply Br. 5, n. 2.) We do not find any error with the
Examiner’s reliance on these translations. “[A] proper examination under 37
C.F.R. § 1.104 should be based on the underlying documents and
translations, where needed.” Ex parte Jones, 62 USPQ2d 1206, 1208 (BPAI
2001). Furthermore, “extrinsic evidence may be considered when it is used
to explain, but not to expand, the meaning of a reference.” In re Baxter
TravenolLabs., 952 F.2d 388, 390 (Fed. Cir. 1991). Translations, such as
those relied upon by the Examiner here, provide evidence as to what one of
ordinary skill in the art would have understood the foreign language
reference to disclose. It does not expand the meaning of the reference.
3 A. Reza Kamarei, US 5,985,339, issued Nov. 16, 1999.
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does not teach that the liquid composition with the xanthan gum is a pre­
mixed, pre-packaged, pre-thickened, and ready-to-use product. (Final
Action 3; Ans. 4.) However, the Examiner finds that providing the product
in such a manner would have been obvious in light of the teachings of
Kamarei. (Id.)
The Examiner finds that Kamarei discloses that sterilized, non­
refrigerated, shelf-stable nutritional foods for special dietary use and medical
foods were known in the art. (Final Action 3^4; Ans. 5.) The Examiner
further finds that Kamarei teaches these foods may be taken orally, including
by persons with dysphagia, and that those compositions may include a fiber,
such as guar gum or carboxymethylcellulose. (Final Action 3; Ans. 4—5.)
The Examiner finds that these fibers, like xanthan gum, also behave as
thickeners. (Ans. 11—12.) According to the Examiner, in light of Kamarei’s
teachings, it would have been obvious to formulate the Nimura compositions
into a pre-mixed, pre-packaged, ready-to-consume formulation that could be
provided to dysphagia patients. (Final Action 4; Ans. 7—8, 14.)
We agree with the Examiner’s factual findings and conclusion that it
would have been obvious to formulate the Nimura liquid product thickened
with xanthan gum as a pre-packaged, pre-thickened, and ready-to-consume
liquid composition in light of Kamarei. “The combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398,416 (2007).
While Appellant asserts that the combination of elements would not
have been predictable (Appeal Br. 6), Appellant does not provide a sufficient
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Application 13/025,882
evidentiary basis for such assertion. We do not discern anything
unpredictable about formulating a thickened liquid for oral consumption by
a dysphagic patient as a pre-mixed, pre-packaged, pre-thickened, ready-to-
consume liquid food composition in light of Kamarei’s teachings. In
particular, Kamarei teaches that ready-to-consume shelf-stable liquid food
compositions were known in both non-refrigerated (see, e.g., Kamarei col.
17—24 (Table 2)) and refrigerated form (Kamarei abstract). Thus, Kamarei
evinces that ready-to-consume nutritional beverages are desired by
consumers, rather than mixing ingredients prior to their use. Moreover,
Kamarei teaches that such compositions can be prepared for use with those
who suffer from dysphagia. (Kamarei 14:61—64.) As such, and contrary to
Appellant’s argument (Appeal Br. 8; Reply Br. 8), there would have been a
reason to combine the teaching of Nimura’s formulation to be used with
dysphagic patients in a ready-to-drink formulation, as taught by Kamarei.
Appellant contends that Nimura teaches away from the claimed
invention because it “suggests the high viscosity [xanthan gum taught
therein] is different from conventional xanthan gum.” (Reply Br. 5—6.) We
do not find this argument persuasive. Appellant’s claims on appeal do not
exclude high viscosity xanthan gum.
Moreover, while it is true that the drinking ease by the patients with a
swallowing dysfunction was rated as inferior (Reply Br. 6) when the green
tea included a conventional xanthan gum compared to when it contained the
high viscosity xanthan gum (Nimura H 25, 28—29), such inferiority does not
teach away from the claimed invention. That is because, whether or not the
conventional xanthan gum thickened formulation was inferior, the product
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Application 13/025,882
was suitably thick such that it could be swallowed. The inferiority measure
was based on time until the tea was drunk and expression during drinking,
etc. (Nimura 125.) Appellant’s claims merely require that the liquid food is
“suitably thick for swallowing by a dysphagic patient.” (See, e.g., Claim 9.)
“[J]ust because better alternatives exist in the prior art does not mean that an
inferior combination is inapt for obviousness purposes.” In re Mouttet, 686
F.3d 1322, 1334 (Fed. Cir. 2012).
Appellant’s argument that Nimura “does not even suggest Applicant’s
claimed concentrations” (Reply Br. 6) is equally unavailing. Nimura
specifically identifies the use of xanthan gum preferably in an amount of
from 0.05—5.0 weight %, and more preferably 0.1—3 weight %. (Nimura
114.) The preferable range overlaps almost entirely with the range recited
in Appellant’s claim 9, and the more preferred range disclosed in Nimura is
precisely the range recited in Appellant’s claim 13.
Appellant’s arguments that one of skill in the art would not look to
Kamarei to combine with Nimura because Kamarei does not teach or
suggest using xanthan gum as required by the claims, that Kamarei suggests
the use of a fiber in an amount to normalize bowel function, that
“‘thickening’ is a negative in the context of liquid food products,” and that
Kamarei is directed to tube feeding in which it would be undesirable to use a
thickened product (Reply Br. 7) are also unpersuasive. As the Examiner
explained (see, e.g., Final Action 5—6; Ans. 10-11), Kamarei is not solely
directed to compositions for tube feeding, but is also concerned with
compositions that are shelf-stable and self-contained to be ingested orally
(see, e.g., Kamarei 15—16 (Examples 1—28 direct to “ready to drink”
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compositions). That Kamarei does not recognize that the inclusion of fibers
would result in thickening is not decisive, nor does it matter that Kamarei
does not disclose xanthan gum as one of the potential soluble fibers. That is
because the rejection is based on obviousness, not anticipation, and Nimura
teaches these elements. Kamarei is relied upon for teaching that it was
known to make liquid foods in ready-to-drink formulations.
Nor does it matter that Kamarei teaches thickening caused by the
presence of heat-stable enzymes in ultra-high temperature (“UHT”)
pasteurized non-refrigerated, shelf-stable products is problematic because it
can lead to off flavors. (Kamarei 10:20-33.) Indeed, Kamarei’s discussion
of thickening by heat stable enzymes that remain in formulations after UHT
is beside the point. Kamarei teaches inclusion of soluble fibers, such as guar
gum and carboxymethylcellulose (Kamarei 12:56—62), which Appellant’s
Specification teaches are equivalent thickeners to xanthan gum. (Spec. 130.)
Thus, Kamarei does not teach away from compositions that would be
thickened by inclusion of fibers, such as xanthan gum, that are shelf-stable
and provided in ready-to-use formulations.
Moreover, as noted above, Kamarei teaches that its liquid food
products can be formulated to provide to those having dysphagia (14:61—64),
and Nimura teaches that thickened products are beneficial for such patients
so that they can “orally take meals” (Nimura abstract). That Kamarei
“suggests a refrigeration-shelf stable product” (Appeal Br. 7) is also not
decisive. While the pending claims on appeal do not require a refrigeration-
shelf stable product, they also do not exclude such a product, and Nimura
does not exclude such a possibility.
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Application 13/025,882
For the foregoing reasons, we disagree with Appellant that the
combination of Nimura and Kamarei does not teach or suggest the method
of claims 9 and 13 (Appeal Br. 8—9; Reply Br. 8).
SUMMARY
We affirm the rejection of claims 9 and 13 under 35 U.S.C. § 103 as
unpatentable over Nimura and Kamarei.
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
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