Ex Parte Kanie

Board of Patent Appeals and Interferences

Dec 16, 2010

10826165 (B.P.A.I. Dec. 16, 2010)

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.
10/826,165 04/16/2004 Jiro Kanie 889_001 8549
25191 7590 12/16/2010
BURR & BROWN
PO BOX 7068
SYRACUSE, NY 13261-7068
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
12/16/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JIRO KANIE
__________

Appeal 2010-009442
Application 10/826,165
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. MCCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
enteral nutrition product, a method for preparing the product, and a device
for administering the product. The Patent Examiner rejected the claims as

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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Application 10/826,165

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anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

STATEMENT OF THE CASE
Claims 8-13, which are all the pending claims, are on appeal. Claim 1
is representative and reads as follows:
1. An enteral nutrition product for enteral administration, not orally, but
directly to a stomach or intestines of a dysphagic patient from an external
container connected to an external portion of a feeding tube provided
through a through-hole of a stoma formed through a portion of the
abdominal and stomach walls of the patient upon the application of pressure
to said external container, said enteral nutrition product comprising:
a semi-solid material having a substantially self-supporting
consistency that deforms to flow under an externally applied load without
liquefying and that is capable of containing a higher concentration of a
nutrient component than a liquid,
wherein said semi-solid material comprises a mixture of a liquid
nutrient solution and a semi-solidifying agent comprising agar that is added
to said liquid nutrient solution; and
wherein said mixture comprises said semi-solidifying agent and said
liquid nutrient solution in a predetermined ratio sufficient to ensure that said
self-supporting consistency of said semi-solid enteral nutrition product
remains substantially unchanged before, during, and after enteral
administration of said semi-solid enteral nutrition product into the patient,
and said self-supporting consistency of said semisolid enteral nutrition
product is further maintained within the stomach or the intestines of the
patient such that said semi-solid enteral nutrition product does not liquefy
due to the body temperature of the patient, to thereby prevent the patient
from experiencing gastro-esophageal reflux.

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The Examiner rejected the claims as follows:
• claims 8, 10, 11 and 13 under 35 U.S.C. §102(b) as anticipated by
Resmer;2 and
• claims 8-13 under 35 U.S.C. § 103(a) as unpatentable over Resmer
and Kabushiki.3

ANTICIPATION
The Issue
The Examiner’s position is that Resmer taught a semi-solid enteral
formulation comprising a nutrient liquid and an emulsifying agent. (Ans. 3.)
The Examiner found that Resmer disclosed that its nutrient liquid included
milk products along with semi-solidifying agents such as agar-agar. (Id.)
The Examiner also found that Resmer’s product is semi-solid with a
disclosed viscosity of 70 cp and is used in feeding tube devices, delivered to
a patient under pressure from an exterior device. (Id.) Additionally, the
Examiner found that Resmer disclosed forming the product by mixing the
nutrient liquid with the agar-agar components along with other nutritional
components at an elevated temperature, then cooled and stored. (Id.)
According to the Examiner, the instant claim recitation regarding
application site, location of tube placement, and operating procedures of the
feeding tube are directed toward a future intended use for the enteral
product. (Id.) The Examiner found that the Resmer’s enteral product is
structurally, i.e., compositionally, identical to that of the instant claims, as

2 US Patent No. 5,232,733 issued to Paul Resmer, Aug. 3, 1993.
3 Kabushiki et al., Total Parenteral Nutritional and Enteral Nutrition,
59 NIPPON RINSHO, no. 782, 283-307 (2001).
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both comprise a nutrient liquid and a semi-solidifying component. (Id.)
Additionally, the Examiner’s position is that because Resmer’s product
comprises the compositional limitations of the claims, the product would
inherently meet the instant claim limitations regarding the product
maintaining its self-supporting consistency within the stomach or intestines
of the patient. (Id. at 4.)
Appellant contends that Resmer disclosed a solution and emulsion
that a skilled artisan would have “understood to exhibit liquid characteristics
… and would not be sufficiently solid to exhibit the claimed semi-solid
consistency characteristics or prevent the possibility of reflux.” (App. Br.
11.) According to Appellant, “for an enteral nutrition product to be
considered a ‘semi-solid material,’ in the context of claim 8, the enteral
nutrition product is required to exhibit self-supporting consistency
characteristics.” (Id. at 12.) Appellant asserts that Resmer did not expressly
or inherently disclose or suggest this limitation. (Id.) Appellant also asserts
that Resmer’s product is administered through a nasogastric tube rather than
directly to a stomach or intestines, as instantly claimed. (Id. at 11.)
The issue with respect to this rejection is whether the Resmer
disclosed an enteral nutrition product comprising a semi-solid material
having a substantially self-supporting consistency, as claimed.

Findings of Fact
1. We agree with the Examiner’s explicit findings regarding Resmer’s
disclosure, except for the finding that Resmer taught a semi-solid enteral
formulation. (See Ans. 3-6.)
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2. Resmer described its tube food as a “stable emulsion structure.”
(Resmer col. 4, l. 34.)

Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).

Analysis
We agree with the Examiner that the preamble recitation of
administering the claimed enteral nutrition product “directly to a stomach or
intestines of a dysphagic patient” refers to a future intended use for the
claimed composition. As the Examiner explained, the claim body describes
a structurally complete invention such that the preamble statement of
purposed or intended use is not a claim limitation. (See Ans. 3-4, citing
Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)).
However, we agree with Appellant that Resmer did not disclose that
its tube food comprised a semi-solid material, as claimed. While Resmer
disclosed that its product comprised a liquid nutrient and agar, the reference
described the resulting composition as an emulsion (FF-2) having a viscosity
of 70 cp (Ans. 3). The Examiner has not provided an adequate explanation
why a skilled artisan would have understood that this product would
inherently have a self-supporting consistency, as recited in instant claim 8.
The Examiner’s explanation that the viscosity of Resmer’s product “is
approximately as viscous as olive oil” (Ans. 9) is insufficient, as a skilled
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artisan would not consider olive oil to be a semi-solid material having a
substantially self-supporting consistency.
Accordingly, we find the rejection did not establish that Resmer
disclosed each and every element of the claimed invention and we reverse it.

OBVIOUSNESS
The Issue
For the obviousness rejection, the Examiner’s position is that Resmer
anticipated the elements of claim 8, including the limitation “a semi-solid
material having a substantially self-supporting consistency....” (Ans. 5.)
The Examiner combines Kabushiki solely to address elements of dependent
claims 9 and 12. (Id. at 5-6.)
Appellant contends that because Resmer did not disclose the invention
of claim 8, the rejected claims would not have been obvious over the
combined prior art. (App. 14-15.) Further, Appellant asserts there are
secondary considerations that rebut a prima facie case of obviousness. (See
id. at 15-17.)
The issues with respect to this rejection are: whether the record
supports the Examiner’s conclusion that the cited references would have
made the claimed inventions prima facie obvious, and if so, whether
Appellant has provided evidence of unexpected results such that the totality
of evidence weighs in favor of nonobviousness.

Principles of Law
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention – including all its
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limitations – with the teaching of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995).

Analysis
We found that the Examiner did not establish that Resmer disclosed
every limitation of claim 8, and we reversed the anticipation rejection over
Resmer. Kabushiki does not cure Resmer’s deficiency. We agree with
Appellant that by relying upon Resmer as disclosing the invention of claim
8, the Examiner has not accounted for all of the limitations claims 8-13.
Accordingly, we reverse the obviousness rejection.

CONCLUSIONS OF LAW
Resmer did not disclose an enteral nutrition product comprising a
semi-solid material having a substantially self-supporting consistency.
The record does not support the Examiner’s conclusion that the cited
references would have made the claimed inventions prima facie obvious.

SUMMARY
We reverse the rejection of claims 8, 10, 11 and 13 under 35 U.S.C.
§102(b) as anticipated by Resmer; and we reverse the rejection of claims 8-
13 under 35 U.S.C. § 103(a) as unpatentable over Resmer and Kabushiki.

REVERSED

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Application 10/826,165

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dm

BURR & BROWN
PO BOX 7068
SYRACUSE NY 13261-7068