Ex Parte Darouiche

Board of Patent Appeals and Interferences

Jul 25, 2002

08555198 (B.P.A.I. Jul. 25, 2002)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 25

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RABIH O. DAROUICHE
__________

Appeal No. 2001-0599
Application No. 08/555,198
__________

ON BRIEF
__________

Before WINTERS, WILLIAM F. SMITH, and GRIMES, Administrative Patent
Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 23-27, 30, and 35-41, all of the claims remaining. Claim
23 is representative and reads as follows:
23. An implantable medical device comprising:

a medical device having one or more surfaces; and

an antiseptic composition layer coating said one or more surfaces
of the medical device, the antiseptic composition including a
combination of antiseptics in an effective concentration to inhibit the
growth of bacterial and fungal organisms.

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Application No. 08/555,198

The examiner relies on the following references:
Kitrilakis et al. (Kitrilakis) 3,699,956 Oct. 24, 1972
Sakamoto et al. (Sakamoto) 4,539,234 Sep. 03, 1985
Lee 4,723,950 Feb. 09, 1988
Goldberg et al. (Goldberg) 5,100,689 Mar. 31, 1992
Dangman et al. (Dangman) 5,335,373 Aug. 09, 1994

Claims 23-26, 30, and 35-37 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Sakamoto.
Claims 23-26, 30, 35, and 36 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Lee.
Claims 23-27, 30, and 35-41 stand rejected under 35 U.S.C. § 103 as
obvious in view of Kitrilakis, Dangman, and Goldberg.
We affirm in part and reverse in part.
Background
The specification discloses that implanted medical devices are a common
source of bacterial and fungal infections, and that various methods have been
tried to prevent such infections, including coating the implanted devices with
antibiotics. See pages 3-5. “However, although antibiotic-coated medical
devices, such as those coated with minocycline and rifampicin, are very effective
against Staphylococci, their efficacy against gram-negative bacteria and
[C]andida is limited.” Id., page 5.
The specification discloses that coating medical devices with antiseptics,
rather than antibiotics, provides broader protection against infectious agents.
The coated medical device may be, e.g., a urinary catheter or vascular catheter.
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See page 6. The specification states that “‘antiseptics’ as used in the present
invention means any of a category of antimicrobial substances that inhibits the
action of microorganisms, including but not limited to chlorhexidine,
methylisothiazolone, thymol, α-terpineol, cetylpyridinium chloride, and
chloroxylenol.” Page 8.
Discussion
The examiner rejected some of the claims as anticipated by either
Sakamoto or Lee, and rejected all of the claims as obvious in view of Kitrilakis,
Dangman and Goldberg. Appellants have stated that all of the claims subject to
each rejection stand or fall together. Appeal Brief, page 5. Since claim 23 is the
broadest claim subject to each rejection, all of the claims in each rejection stand
or fall with claim 23. Claim 23 is directed to an implantable medical device which
is coated on one or more surface(s) with a combination of antiseptics in a
concentration effective to inhibit growth of bacteria and fungi.
1. Anticipation
The examiner rejected claims 23-26, 30, and 35-37 under 35 U.S.C.
§ 102(b) as anticipated by Sakamoto. Sakamoto discloses a
urethral catheter capable of preventing urinary tract infection which
[is] . . . comprised of a material selected from the group consisting
of an olefin polymer, a diene polymer or a silicone polymer as the
base material, and an antimicrobial substance being chemically
bonded with the inside and/or outside walls of the urethral catheter.

Column 3, lines 14-24. Sakamoto states that “antimicrobial substance . . . means
antibiotics, antiseptics and disinfectants.” Column 3, lines 59-61. Sakamoto
provides a list of exemplary antibiotics, and states that “[a]s the antiseptics and
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Application No. 08/555,198

disinfectants, it is preferred to use dyestuff medical preparations such as acrinol
or acriflavine, etc., furan medical preparations such as nitrofurzone, etc., cationic
soap medical preparations such as benzalkonium chloride or benzethonium
chloride, etc., cyclohexidine and povidone-iodine.” Column 4, lines 60-66.
Finally, Sakamoto teaches that “[t]hese antimicrobial substances can be used
alone or as a combination of two or more of them.” Column 4, lines 67-68.
“It is well settled that a claim is anticipated if each and every limitation is
found either expressly or inherently in a single prior art reference.” Celeritas
Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522
(Fed. Cir. 1998). “[T]he description of a single embodiment of broadly described
subject matter constitutes a description of the invention for anticipation
purposes.” In re Lukach, 442 F.2d 967, 970, 169 USPQ 795, 797 (CCPA 1971).
Sakamoto discloses a urethral catheter (an implantable medical device),
having inside and outside walls (i.e., surfaces) to which are bonded antimicrobial
substances, including antiseptics, which can be used in combinations of two or
more. Thus, Sakamoto identically discloses all of the limitations of the instant
claims. We agree with the examiner that Sakamoto anticipates instant claim 23.
Appellant does not dispute that Sakamoto discloses a urethral catheter
coated with a combination of antiseptics. Rather, Appellant argues that
Sakamoto’s invention is limited to urethral catheters because of its “requirement
for an ionic bonding step that limits the base materials to olefin polymers, diene
polymers or silicone polymers.” Appeal Brief, page 7. In contrast, Appellant
argues, the instantly claimed invention can be applied to a wider variety of base
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Application No. 08/555,198

materials and is therefore applicable to a wider variety of implantable medical
devices. Id. Appellant concludes that “the requirement for ionic bonding is a key
structural difference between Sakamoto et al. and the current invention. This is
all that is required to negate a § 102(b) reference.” Id.
This argument is not persuasive. Whether the prior art disclosure is more
limited than the instant claims does not make the claims patentable over the prior
art. “It is well settled that a generic claim cannot be allowed to an applicant if the
prior art discloses a species falling within the claimed genus.” In re Slayter, 276
F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960). The instantly claimed
invention—that is, the invention defined by the claims—does not exclude
products coated with antiseptics bound via ionic bonding. Therefore, the claims
contain no limitation that distinguishes them from prior art. The claims read on,
and are anticipated by, the antiseptic-coated urethral catheters disclosed by
Sakamoto. See Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 772, 218 USPQ
781, 789 (Fed. Cir. 1983) (“The law of anticipation does not require that the
reference ‘teach’ what the subject [application] teaches. Assuming that a
reference is properly ‘prior art,’ it is only necessary that the claims under attack
. . . ‘read on’ something disclosed in the reference, i.e., all limitations of the claim
are found in the reference.”).
The examiner also rejected claims 23-26, 30, 35, and 36 under 35 U.S.C.
§ 102(b) as anticipated by Lee. Since we have concluded that all of these claims
are anticipated by Sakamoto, we have no need to address whether these claims
are also anticipated by Lee.
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2. Obviousness
The examiner rejected claims 23-27, 30, and 35-41 under 35 U.S.C. § 103
as obvious in view of the combined teachings of Kitrilakis, Dangman, and
Goldberg. The examiner characterized Kitrilakis as “rais[ing] the problems of
indwelling catheters, but disclos[ing] little in terms of inhibition of bacterial
infection absent a steady supply of antibacterial agent, as opposed to
incorporation into the catheter itself.” Examiner’s Answer, page 5.1 The
examiner found the deficiencies of Kitrilakis to be remedied by Dangman and
Goldberg who, “also addressing the problems of medical devices in contact with
bacterial sources of infection, are shown to have presented the means to simplify
such bacterial inhibition; incorporation of an antibacterial coating composition
with the device itself.” Id. The examiner concluded that
it would be obvious to one of ordinary skill in the art of medical
devices at the time the invention was made to use one of
Kitri[lak]is, modified with the further developments in order to
optimize ease of use and antiseptic character Dangman and to
provide acceptable protection and duration of effect, minimization of
tissue damage as GOLDBERG teaches. . . . One having ordinary
skill in the art would be motivated to perform these modifications in
order to provide less bulky means of infection control when utilizing
medical devices.

Id., page 6.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the

1 The examiner also characterized Kitrilakis as “show[ing] the instantly claimed implanted long
term urinary devices and peritoneal dialysis catheters . . . coated with an antibacterial
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Application No. 08/555,198

applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993). Prima facie obviousness requires, among other things, evidence of “a
reason, suggestion, or motivation to lead an inventor to combine [the cited]
references.” Pro-Mold and Tool Co. v. Great Lakes Plastics Inc., 75 F.3d 1568,
1573, 37 USPQ2d 1626, 1629 (Fed. Cir. 1996). An adequate showing of
motivation to combine requires “evidence that ‘a skilled artisan, confronted with
the same problems as the inventor and with no knowledge of the claimed
invention, would select the elements from the cited prior art references for
combination in the manner claimed.’” Ecolochem, Inc. v. Southern Calif. Edison
Co., 227 F.3d 1361, 1375, 56 USPQ2d 1065, 1075 (Fed. Cir. 2000) (quoting
In re Rouffet, 149 F.3d 1350, 1357, 47 USPQ2d 1453, 1456 (Fed. Cir. 1998)).
We agree with Appellant that the examiner has not made out a prima facie
case of obviousness. We find ourselves in agreement with the following
argument succinctly stated in the Appeal Brief:
The prior art cited by Examiner consists of: (1) an antimicrobial
“coating” that is in reality a diffusion layer covering porous cloth or
fibrous mat soaked with antimicrobials; (2) a multi-ply glove with
suspended liquid antimicrobials between the plies; and (3) a
method for treating surfaces to make them hydrophilic. These
references do not show the “antiseptic composition layer” that is the
crux of the present invention. Nor can the cited references be
combined to teach the present invention. Kitrilakis et al. and
Dangmann [sic] et al. are inapposite in that one slowly dispenses
antimicrobial agents through a diffusion layer while the other
contains its antimicrobial agents between impenetrable plies of a
glove until a ply is punctured. Applying the hydrophilic surface
treatment taught by Goldberg et al. to the “coating” taught by
Kitrilakis et al. would result in a nonfunctional device. Combining

composition.” Examiner’s Answer, page 5. For the reasons discussed infra, we consider this
characterization to overstate the relevance of Kitrilakis to the instant claims.
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Application No. 08/555,198

Goldberg et al. and Dangmann [sic] et al. would likely yield a
functional glove but would certainly not teach the present invention.
In short, the cited references do not render the present invention
obvious.

Appeal Brief, pages 9-10. In a nutshell, the references cited by the examiner do
not disclose or suggest all the limitations of the instant claims, nor do they
provide a motivation to combine those limitations that are disclosed. The
references therefore do not support a prima facie case of obviousness.
Summary
We affirm the rejection under 35 U.S.C. § 102(b) based on Sakamoto
because the prior art reference discloses all of the limitations of the claimed
invention. However, we reverse the rejection under 35 U.S.C. § 103 because the
examiner has not shown that the cited references would have suggested the
claimed invention to a person of ordinary skill in the art. Thus, claims 27 and
38-41 are free of any pending rejection.

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Application No. 08/555,198

No time period for taking any subsequent action in connection with this
appeal may be extended under 37 CFR § 103.

AFFIRMED IN PART

Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
William F. Smith )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Eric Grimes )
Administrative Patent Judge )

EG/dym

Appeal No. 2001-0599 Page 10
Application No. 08/555,198

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