Ex Parte RAAD

Patent Trial and Appeal Board

Jan 26, 2017

11560300 (P.T.A.B. Jan. 26, 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.
11/560,300 11/15/2006 ISSAM RAAD UTSC:950US 5538
108197 7590 01/30/2017
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
BOWMAN, ANDREW J
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
01/30/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket @ phiplaw .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IS SAM RAAD
Appeal 2015-001317
Application 11/560,300
Technology Center 1700
Before TERRY J. OWENS, MARK NAGUMO, and BRIAN D. RANGE,
Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’
rejection of claims 2—6, 16, 33—36, 38, 39, 41, 42, 46-49, 51, 52, 58—61
and 68—74. We have jurisdiction under 35 U.S.C. § 6(b).
The Invention
The Appellant claims a method for coating or impregnating a
non-organic surface1 with an antimicrobial agent. Claim 16 is illustrative:
16. A method for coating or impregnating a non-organic
surface with an antimicrobial agent, comprising:
1 The Appellant defines “non-organic surface” as “a superficial or external
aspect of any object other than a living organism” (Spec. 100012).
Appeal 2015-001317
Application 11/560,300
a) contacting the surface with an [sic] composition
comprising an antimicrobial agent, comprising chlorhexidine,
gentian violet and a solvent; and
b) heating the surface at a temperature that is at least
50°C for at least 8 hours, wherein at least some of the solvent
that was contacted with the surface is removed, and wherein the
antimicrobial agent coats or impregnates the surface.
The References
Darouiche US 5,624,704 Apr. 29, 1997
Fox EP 0 328 421 A2 Aug. 16, 1989
Raad WO 02/082907 A1 Oct. 24,2002
The Rejections
Claims 2-6, 16, 33-36, 38, 39, 41, 42, 46-49, 51, 52, 58-61 and 68-
74 stand rejected under 35 U.S.C. § 103 over Raad in view of Darouiche and
Fox.2
OPINION
We affirm the rejection.
The Appellant argues the claims in two groups: 1) claims 2—6, 16, 33—
36, 41, 42, 46-49, 51, 52, 58—61 and 68—74, and 2) claims 38 and 39
(App. Br. 3—7). We therefore limit our discussion to one claim in each
group, i.e., claims 16 and 38.3 The other claim or claims in each group stand
or fall with the claim we address. See 37 C.F.R. § 41.37(c)(l)(iv) (2012).
2 Claims 38 and 39 depend from canceled dependent claim 37, and
claims 71—74 depend from canceled dependent claim 65.
3 On April 4, 2011 the Appellant changed claim 37’s dependency from
claim 36 to claim 16 then, on August 15, 2013, canceled claim 37 but,
apparently inadvertently, did not amend its dependent claim 3 8 to depend
from claim 16. For purposes of this appeal we consider claim 38 to depend
from claim 16.
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Application 11/560,300
Claim 16
Raad coats and impregnates a non-organic surface, which can be the
surface of a medical implant, by contacting the surface with an antimicrobial
agent composition comprising chlorhexidine, gentian violet and a solvent,
and drying the composition to remove the solvent (abstract; p. 1,11. 12—19;
p. 3,11. 14—15, 31-33; p. 4,11. 9-14, 2A-30; p. 5,11. 22-24; p. 8,11. 19-20,
28-31; p. 13,11. 1-17).
Darouiche impregnates a non-metallic medical implant with an
antimicrobial agent (which can be chlorhexidine) by dissolving the
antimicrobial agent in an organic solvent to form an antimicrobial solution,
adding a penetrating agent to the solution, preferably adding to the solution
an alkalizing agent to enhance the reactivity of the material of the implant,
heating the solution to about 30 to 70 -C to increase the antimicrobial
agent’s adherence to the implant material, applying the solution to at least a
portion of the implant such that the antimicrobial agent permeates the
material of the implant, removing the impregnated implant from the
solution, and allowing the solution to dry (col. 3,11. 24-48, 61—65; col. 4,
11. 53—58; col. 5,11. 16—17).4 In an example, catheters are dipped in an
antimicrobial solution for 1 hour at 45 -C, removed from the solution, and
dried for at least 8 hours, preferably overnight (col. 8,11. 28-32).
Fox coats a medical device with a combination of a silver salt and
chlorhexidine or its salts (abstract) to “impart antimicrobial activity to the
medical device through a sustained and controlled activity rate over an
4 Darouiche is incorporated by reference into the Appellant’s Specification
(100035).
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Application 11/560,300
appreciable period of time, without hampering the biocompatibility of the
surface and other intended functions of the device” (p. 2,11. 37—39). “The
coated medical device can be dried at room temperature to remove solvent
or with the aid of a slightly elevated temperature over an appropriate time
period” (p. 12,11. 22—23). The elevated temperature must be “below that
which inactivates the antimicrobial agent” (p. 12,11. 5—6). In Example 6 a
silver sulfadiazine/chlorhexidine acetate coating is air dried for about one
minute and then dried in an oven at 40 °C for 24 hours (p. 17,11. 29-30).
Establishing a prima facie case of obviousness requires showing that
one of ordinary skill in the art would have had both an apparent reason or
suggestion to modify the prior art and predictability or a reasonable
expectation of success in doing so. See KSR, 550 U.S. at 418; In re Vaeck,
947 F.2d 488, 493 (Fed. Cir. 1991).
Darouiche would have motivated one of ordinary skill in the art to dry
Raad’s chlorhexidine/gentian violet/solvent antimicrobial agent composition
by heating it preferably overnight at about 30-70 -C to enhance the adhesion
of the chlorhexidine/gentian violet to the medical device. One of ordinary
skill in the art would have had a reasonable expectation of success in doing
so because Darouiche’s disclosure that the heating to about 30—70 -C
enhances the adherence of chlorhexidine to the medical device (abstract;
col. 5,11. 16—17) would have indicated to such a person that Raad’s gentian
violet, due to being ionically or covalently chemically bonded to the
chlorhexidine (p. 3,11. 14—17, 31—33; p. 4,11. 9-14), would undergo
enhanced adherence to the medical device surface along with the
chlorhexidine. Darouiche’s temperature range of about 30—70 -C which
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Application 11/560,300
overlaps the Appellant’s range of at least 50 -C would have rendered prima
facie obvious, to one of ordinary skill in the art, temperatures within the
overlap. See In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997); In re
Boesch, 617 F.2d 272, 276 (CCPA 1980); In re Malagari, 499 F.2d 1297,
1303 (CCPA 1974). That conclusion of prima facie obviousness is
supported by Fox’s disclosure that drying can be carried out at any
temperature “below that which inactivates the antimicrobial agent” (p. 12,
11. 5—6) and Fox’s indication that overnight (24 hours) heating at an elevated
temperature (40 -C) within Darouiche’s temperature range (about 30 to
70 -C) is effective for treating a substrate which has been impregnated with
an infection-resistant agent/organic solvent solution (Example 6).
The Appellant asserts that “the longest time of treatment that is taught
by Darouiche is 120 minutes” (App. Br. 4).
That is the length of time the implant is dipped in the antimicrobial
composition, not the antimicrobial composition-impregnated implant’s
drying time, which preferably is overnight (col. 3,11. 48—52; col. 8,11. 33-
35).
The Appellant asserts that “the highest temperature taught in the
Darouiche examples is 45- C” (App. Br. 4).
Darouiche is not limited to its examples. See In re Fracalossi, 681
F.2d 792, 794 n.l (CCPA 1982); In re Mills, 470 F.2d 649, 651 (CCPA
1972). Instead, all disclosures therein must be evaluated for what they
would have fairly suggested to one of ordinary skill in the art. See In re Boe,
355 F.2d 961, 965 (CCPA 1966). Darouiche’s disclosed heating
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Application 11/560,300
temperature range wherein the adherence of the antimicrobial agent to the
implant material is enhanced is about 30 to 70 -C (col. 3,11. 38^44).
The Appellant asserts that the Appellant’s Example 2 shows that
overnight heating of catheters at 60 -C has a dramatic effect on the catheter’s
antimicrobial efficacy (App. Br. 5), and the Appellant “direct[s] the
Examiner’s attention to Figures 5—8 and the accompanying text in
Example 1, which demonstrates convincingly that the heat treatment of
claim 16 provides a substantially improved coated catheter in terms of
bacterial adherence (Fig. 5) and zones of inhibition (Figs. 6-7)” (App. Br. 6).
Those assertions do not establish that those benefits would not be
achieved by carrying out Darouiche’s overnight heating within the disclosed
30 to 70 °C range at which the adherence of the antimicrobial agent to the
implant material is enhanced (col. 3,11. 38-44; col. 8,11. 33—35).
Claim 38
Claim 38 requires that “the surface is heated for about 12 hours to
about 96 hours.”
The Appellant asserts that “even greater antimicrobial action is seen
when heated for longer periods of time (claims 38 and 39)” (Reply Br. 3).
Darouiche’s overnight heating (col. 8,11. 33—35) is within the
Appellant’s claim 38’s required heating period.
The Appellant asserts that heating for 1 day or 3 days shows a
dramatic microbial killing ability improvement compared to no heating
(App. Br. 6—7).
That assertion does not establish that carrying out Darouiche’s
overnight drying (col. 8,11. 33—35) within the temperature range of about 30
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Application 11/560,300
to 70 °C at which adherence of the antimicrobial agent to the implant
material is enhanced (col. 3,11. 48—52) would not have been prima facie
obvious to one of ordinary skill in the art.
For the above reasons we are not persuaded of reversible error in the
rejection.
DECISION/ORDER
The rejection of claims 2—6, 16, 33—36, 38, 39, 41, 42, 46-49, 51, 52,
58—61 and 68—74 under 35 U.S.C. § 103 over Raad in view of Darouiche
and Fox 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).
AFFIRMED
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