Ex Parte Leaman

Board of Patent Appeals and Interferences

Jul 28, 2011

11162320 (B.P.A.I. Jul. 28, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DONALD H. LEAMAN, JR.
____________

Appeal 2010-005024
Application 11/162,320
Technology Center 1700
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Before JEFFREY T. SMITH, BEVERLY A. FRANKLIN and
MARK NAGUMO, Administrative Patent Judges.

SMITH, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2010-005024
Application 11/162,320

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STATEMENT OF THE CASE
This is an appeal under 35 U.S.C. § 134 from a final rejection of
claims 1, 3, 5 through 13, 15, 17 through 23, 25 through 33, 35 through 38,
and 40 through 46. We have jurisdiction under 35 U.S.C. § 6.
Appellant’s invention relates “to a method and apparatus for
preserving urine specimens at room temperature.” App. Br. 2. Claim 1 is
illustrative:
1. A device for maintaining stabilization of a urine
specimen at room temperature for urine transport which
comprises a plastic molded container that is simultaneously
injection molded with both a plastic and a hydrophobic
antimicrobial wherein the plastic molded container is
configured such that a ratio of interior volume to interior
surface of the container is approximately one and wherein the
antimicrobial comprises triclosan within a range of about 0.01
to 0.80% by weight.
The Examiner relied on the following references in rejecting the
appealed subject matter:
Griffith US 4,042,337 August 16, 1977
Lee US 4,723,950 February 9, 1988
Bracken et al. US 2003/0139730 A1 July 24, 2003

Appellant requests review of the following rejections from the
Examiner’s final office action:
1. Claims 1, 3, 5, 7-13, 15, 17, 19-22, 32-33, 36-38, 40-43 and 45-46
stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Bracken
in view of Lee.
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2. Claims 6, 18, 23, 25-31, 35 and 44 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Bracken and Lee and further in view of
Griffith.

OPINION
The prior art rejections 1
The dispositive issue on appeal is: Did the Examiner err in
determining that a person of ordinary skill in the art would have recognized
that the triclosan disclosed by Lee would have been a suitable anti-microbial
agent for the article of Bracken?2
We answer this question in the negative and, therefore, we affirm.
The Examiner found that Bracken discloses a urine collection bag
made from an extruded film of polymer compounded with an antimicrobial
agent. Ans. 3. The Examiner also found that the antimicrobial agent of
Bracken “serves to prevent the migration of bacteria to the patient from
whom the urine is collected, but also does not kill the intrinsic bacteria in the
urine collected, so that it can be tested at a later time to provide important
medical data.” Id. at 4; Bracken, ¶ [0021]. In addition, the Examiner found
that Bracken teaches using the polymer/antimicrobial agent compound to
make a variety of medical products via injection molding. Id. The
Examiner further found that Bracken discloses “that one or more different

1 Appellant has not argued dependent claims separately. Accordingly, the
dependent claims stand or fall together with the respective independent
claims. We will limit our discussion to independent claim 1.
2 The same issue would also apply to the rejection over Bracken, Lee and
Griffith (i.e., the issue is substantially the same). Appellant’s arguments for
this rejection focus on the issues raised above related to the combination of
Bracken and Lee. App. Br. 7.
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antimicrobial agents can be incorporated into the polymer at different and
varying levels, thus allowing a collection system to be tailor made that has
optimized antimicrobial properties.” Ans. 3-4; Bracken, ¶ [00 22]. The
Examiner recognized that Bracken does not teach triclosan as the
antimicrobial agent (Ans. 6). 3
With respect to the antimicrobial agent triclosan, the Examiner relies
on Lee to teach forming a medical device by coextruding a polymer with
triclosan, which is identified as an antimicrobial material. Id.; Lee, col 3, ll.
58-61, col 4, l. 10, Example 2. The Examiner properly concluded that it
would have been obvious to one of ordinary skill in the art at the time of the
instant invention to use triclosan as the antimicrobial material in the product
of Bracken since both Bracken and Lee use antimicrobial agents that can be
molded at high temperatures. Ans. 6.
Appellant argues that his “amended claims specifically require a
hydrophobic antimicrobial that is simultaneously injection molded with a
plastic so that leaching of the antimicrobial material does not occur.” App.
Br. 7. According to Appellant, “[i]ncorporating the teachings of Lee into
Bracken would require that an antimicrobial be combined or coated with a
hydrophilic polymer which is not required” by Appellant’s claims. Id.
Appellant argues that “Lee specifically combines the antimicrobial triclosan,
which is hydrophobic, with a hydrophilic polymer so that leaching of the
triclosan can occur.” Id. Appellant additionally argues that Bracken teaches

3 The Examiner identified other characteristics not specifically described in
Bracken such as the concentration of the polymer and the volume of the
interior surface of the container. Ans. 4-5. However, Appellant does not
dispute the Examiner’s finding of obviousness as to these characteristics.
(See App. Br. generally).
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away from using triclosan because it uses “a preferred antimicrobial material
for use in the urine collection system of the present invention is organic acid
metal salts, such as salts comprising phosphoric acid esters and zinc metal,
particularly materials that can provide a stabilizing effect to polymers.” Id.
at 8.
We are unpersuaded by Appellant’s line of argument and agree with
the Examiner’s reasoning (Ans. 7-8) that it would have been obvious to a
person of ordinary skill in the art to substitute the triclosan (a known
antimicrobial agent) of Lee in the product of Bracken. Appellant has not
adequately refuted the Examiner’s position. Further, we note that all of
Appellant’s independent claims are written in open language that does not
exclude additional, unrecited elements or method steps such as the addition
of a hydrophilic polymer.Appellant has failed to adequately explain why a
person of ordinary skill in the art would have expected that triclosan, an
antimicrobial agent known to be molded into a medical article to control and
prevent the retrograde migration of pathogenin microorganism, would have
been unsuitable for use in the product of Bracken (See Lee, col 1, ll. 13-15;
Bracken, ¶ [0021]).
With respect to the container configuration, Appellant argues that the
claimed limitation of “a ratio of interior volume to interior surface of the
container be approximately equal to one” addresses the problem of creating
“a urine transport and storage container capable of preserving a urine
specimen at room temperature for later testing.” App. Br. 9. We are
unpersuaded by Appellant’s argument for the reasons set forth by the
Examiner. Ans. 10. Moreover, Bracken discloses that the medical device is
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designed so as to not kill the bacteria in the urine bag so that it can be tested
to provide important medical data. Bracken, ¶ [0021].
For the foregoing reasons and those presented by the Examiner, we
affirm the rejection of claims 1, 3, 5, 7-13, 15, 17, 19-22, 32-33, 36-38, 40-
43 and 45-46 under 35 U.S.C. § 103(a) as being unpatentable over Bracken
and Lee.
Appellant relies on the same line of arguments to address the
Examiner’s rejection of claims 6, 18, 23, 25-31, 35 and 44 under 35 U.S.C.
§ 103(a) as being unpatentable over Bracken, Lee and Griffith. App. Br. 9-
11. Accordingly, we affirm this rejection as well for the reasons stated
above.

ORDER
The rejection of claims 1, 3, 5, 7-13, 15, 17, 19-22, 32-33, 36-38, 40-
43 and 45-46 under 35 USC § 103(a) as unpatentable over Bracken and Lee
is affirmed.
The rejection of claims 6, 18, 23, 25-31, 35 and 44 under 35 USC
§ 103(a) as unpatentable over Bracken, Lee and Griffith is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(v).

AFFIRMED

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