Ex Parte Kite et al

Board of Patent Appeals and Interferences

May 1, 2009

10659413 (B.P.A.I. May. 1, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PETER KITE and DAVID HATTON
__________

Appeal1 2008-6032
Application 10/659,413
Technology Center 1600
__________

Decided: 2 May 1, 2009
__________

Before, DEMETRA J. MILLS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

STATEMENT OF CASE
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

1 Oral hearing held April 21, 2009.
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
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The following claims are representative.
32. An antiseptic composition comprising at least one salt of ethylene
diamine tetraacetic acid (EDTA) in solution, wherein the at least one EDTA
salt comprises at least one of tri-sodium and tetra-sodium EDTA at a
concentration of at least 2.0% (w/v) and less than 15% (w/v), wherein the
antiseptic composition has a bactericidal effect over a broad spectrum of
microbes, wherein the antiseptic composition has a pH of at least 9.5, and
wherein the antiseptic composition is packaged in a sterile, non-pyrogenic
form.

37. A composition of any of claims 32, 56 or 57, wherein the solution
comprises less than 10% (v/v) ethanol and water.

46. A composition of any of claims 32, 56 or 57 in a pre-filled syringe.

47. A composition of any of claims 32, 56 or 57 in a single-dosage vial.

56. A lock flush composition comprising at least one salt of ethylene
diamine tetraacetic acid (EDTA) in solution, wherein the at least one EDTA
salt comprises at least one of tri-sodium and tetra-sodium EDTA at a
concentration of at least 2.0% (w/v) and less that 15% (w/v), wherein the
lock flush composition has a pH of at least 9.5, wherein the lock flush
composition is packaged in a sterile, non-pyrogenic form, and wherein the
lock flush composition is biocompatible for use in in-dwelling access
catheters, urinary catheters, nasal tubes and throat tubes.

58. A composition of any of claims 32, 55 or 56, wherein the EDTA salt
provides at least 50% of a total antimicrobial activity of the composition.

References
Wider US 6,500,861 B1 Dec. 31, 2002
Fahim WO 00/13656 A1 Mar. 16, 2000
Kurginski GB 1,279,148 June 29, 1972

Remington’s Pharmaceutical Sciences, 835 and 1836-1837 (7th ed., 1985).

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Root et al., Inhibitory Effect of Disodium EDTA upon the Growth of
Staphylococcus epidermidis In Vitro: Relation to Infection Prophylaxis of
Hickman Catheters, 32 ANTIMICROBIAL AGENTS AND
CHEMOTHERAPY no. 11, 1627-1631 (1998).

Grounds of Rejection
1. Claims 32, 34, 39, 41, 42, 45, and 55-60 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Fahim in view of Wider.
2. Claim 46 is rejected under 35 U.S.C. § 103(a) as being unpatentable over
Fahim in view of Wider and further in view Remington’s Pharmaceutical
Sciences.
3. Claim 47 is rejected under.35 U.S.C. § 103(a) as being unpatentable over
Fahim in view of Wider and further in view of Root.
4. Claims 32, 34, 37, 41, 42, 45, 55-60 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Kurginski in view of Fahim and Wilder.

ISSUE
The Examiner argues that it would have been obvious to a person of
ordinary skill in the art to employ the antimicrobial composition of Fahim in
a sterile pyrogen free condition because Wider teaches antimicrobial
compositions packaged in a sterile and pyrogen free form.
Appellants contend that they do not perceive any suggestion to
combine the references in the manner proposed by the Examiner, or any
motivation for doing so.
The issue is: Have Appellants shown error in the Examiner’s reason
to combine the cited references?
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FINDINGS OF FACT
1. Fahim discloses antimicrobial compositions comprising about 0.025 to
about 8.0 % by weight EDTA or its sodium salts such as tetra sodium
EDTA, and the composition has a pH from about 5.0 to about 11.0. (See pg.
10, 11. 10-25; and pg. 11, ll. 6- 10.) (Ans. 3.)
2. Fahim teaches that the viscosity of the composition can be adjusted by
adding sodium chloride. (See p. 14, ll. 10-11; page 18, ll. 15-16.) The
antimicrobial properties of the compositions were also reported. Fahim
further teaches that by increasing the EDTA-Na4 concentration from 2 to 3.0
% by weight provided a substantial increase in bacteria reduction. (Fahim,
page 23, Table 8, prototype 10, wherein the composition comprises 3% by
weight of tetra sodium EDTA, NaCl, water and a pH of 9.5.) (Ans. 4.)
3. The antimicrobial compositions comprising tetra-sodium EDTA taught
by Fahim are used for topical application such as for cleaning skin. (See pg.
41, claims 35-37.) (Ans. 4.)
4. Fahim does not expressly teach that the composition is packaged in a
sterile, pyrogen free form. (Ans. 4.)
5. Wider teaches antimicrobial compositions for eliminating infections from
various surfaces and materials, including the surface of the body. It is also
taught that the antimicrobial compositions can be administered as a liquid
either orally or through a suitable delivery system, such as a catheter. (See
col. 1, ll. 8-20; col. 2, ll. 30-34; and col. 4, ll. 10-14. It is further taught that
the antimicrobial compositions are packaged in a sterile and pyrogen free
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form, and can be introduced into the abdominal cavity through a catheter.
(See col. 6, ll. 9-10; col. 7, ll. 51-55.)
6. Wider teaches the compositions therein to be used for eliminating an
infection on the epidermis of the body of the user where infection is
encountered. (See abstract; col. 5, ll. 63-64.) Wider further teaches the
spray application of the antimicrobial compositions therein to be used to
eliminate all superficial microorganisms on the surface of the skin. (See col.
6, ll. 53-56.) Wider teaches that the compositions in concentrate form are
diluted with pyrogen free water to form an effective use solution. See
abstract.
7. The Examiner finds that it would have been obvious to a person of
ordinary skill in the art to employ the antimicrobial composition of Fahim in
a sterile pyrogen free condition because Wider teaches antimicrobial
compositions as packaged in a sterile and pyrogen free form. (Ans. 4.)
8. The Examiner finds that one of ordinary skill in the art at the time of
invention would have been motivated to employ the claimed antiseptic
compositions in a sterile pyrogen free form as conventional with
antimicrobial compositions with the expectation of using the composition in
catheters. (Ans. 4-5.)
9. The Examiner finds that, while the references do not explicitly state that
“composition has an osmolarity of from 240-500 mOsM/Kg”, since Fahim
discloses the same sodium salts of EDTA as that recited in the instant
invention, the composition should possess [the] claimed properties. Since
Fahim discloses the same tetrasodium EDTA as that recited in the instant
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invention, the composition should possess [the] claimed properties. (Ans.
5.)
10. The Examiner finds that, while the references do not explicitly state that
“the EDTA salt provides at least 50 % of a total antimicrobial activity of the
composition” as in claims 58-60, since Fahim discloses the same sodium
salts of EDTA as that recited in the instant invention, the composition should
possess the claimed properties. Since Fahim discloses the same salts of
EDTA as that recited in the instant invention, the composition should
possess the claimed properties. (Ans. 5.)
11. In claim 56, the Examiner finds that the intended use of a product or
composition “wherein the lock flush composition is biocompatible for use in
in-dwelling access catheters, urinary catheters, nasal tubes and throat tubes,”
do not further limit the claim because the recitation of the intended use of
the claimed invention must result in a structural difference between the
claimed invention and the prior art in order to patentably distinguish the
claimed invention from the prior art. The Examiner finds that if the prior art
structure is capable of performing the intended use, then it meets the claim.
(Ans. 5-6.)
12. Fahim does not specifically teach the antimicrobial composition in a
single dosage vial. (Ans. 6.)
13. Root teaches a method for disinfecting a catheter by contacting
(flushing) with an antimicrobial composition of aqueous EDTA solution
having a concentration of 20 mg/ml. (Ans. 6.)
14. The EDTA used by Root is in the form of the disodium salt. Root also
teaches that the EDTA is used as a topical antiseptic in gram-negative
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infections. (See pg. 1627, paras. 3 and 6.) Root further teaches a sterile
polystyrene test tubes (vials) containing the antimicrobial composition of
disodium EDTA at a concentration of 20 mg/ml (2%). (See pg. 1628, ll. 18-
21) (Ans. 6.)
15. The Examiner finds that it would have been obvious to a person of
ordinary skill in the art to employ the antimicrobial composition of Fahim in
a sterile condition in a single-dosage vial from the teachings of Root’s
polystyrene vials. (Ans. 6.)
16. Fahim fails to recite the employment of the composition in a prefilled
syringe. (Ans. 6.)
17. Remington’s Pharmaceutical Sciences teaches sterile, pyrogen free
solutions of sodium chloride as ideal for injection. It also discloses that
hypodermic syringes are used for injection of liquids. (See pg. 1837.)
Remington also warns against injection of solutions containing pyrogens
(See pg. 835, col. 2, para. 1), and to maintain conventional sterile
methodology for injected medicaments. (Ans. 7.)
18. The Examiner finds that, possessing this teaching by Remington
Pharmaceutical Sciences, the skilled artisan would have been motivated to
provide a syringe filled with an EDTA solution with the expectation of using
such sterile, pyrogen free solution for injection. (Ans. 7.)
19. The Specification teaches a sanitizing composition having antimicrobial
and/or antifungal activity that is at least 50% of the anti-microbial and/or
antifungal activity of a tri and tetra-sodium EDTA sale composition in an
aqueous solution at a concentration of 4% (w/v) and at a pH of 10.5.
(Original claim 22.)
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PRINCIPLES OF LAW
As the Supreme Court pointed out, “it can be important to identify a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does . . .
because inventions in most, if not all, instances rely upon building blocks
long since uncovered, and claimed discoveries almost of necessity will be
combinations of what, in some sense, is already known.” KSR Int’l v.
Teleflex Inc., 550 U.S. 398, 418 (2007). Thus, “[i]n determining whether
obviousness is established by combining the teachings of the prior art, the
test is what the combined teachings of the references would have suggested
to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581
(Fed. Cir. 1995).
“When a work is available in one field of endeavor, design incentives
and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 401, 127 S.Ct. 1727, 1731 (2007). For the same reason, “if a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill. …[A] court must ask whether the improvement is
more than the predictable use of prior art elements according to their
established functions.” Id.

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ANALYSIS
Appellants argue that the exemplary compositions, formulation
methodologies and animal testing protocols described in Fahim do not
disclose or suggest any sterility precautions or post formulation sterilizing
procedures. (Br. 4-5.) Appellants find no uses or proposed uses of the
Fahim antimicrobial handwash compositions that would suggest providing
the compositions of Fahim in a sterile, non-pyrogenic form would be
necessary or advisable. (Br. 5.) Applicants do not perceive any suggestion
to combine the references in the manner proposed by the Examiner, or any
motivation for doing so. (Br. 5.)
The Examiner argues that it would have been obvious to a person of
ordinary skill in the art to employ the antimicrobial composition of Fahim in
a sterile pyrogen free condition because Wider teaches antimicrobial
compositions as packaged in a sterile and pyrogen free form. (Ans. 4.)
We find no error with the Examiner’s indicated motivational
statement to combine the cited references. Fahim teaches antimicrobial
compositions for cleaning skin comprising about 0.025 to about 8.0 % by
weight EDTA or its sodium salts such as tetra sodium EDTA, and the
composition has a pH from about 5.0 to about 11.0. Wider teaches
antimicrobial compositions used for eliminating infections from various
surfaces, including the surface of the body are packaged in a sterile and
pyrogen free form. See the Wider abstract, wherein it is disclosed that the
compositions therein are useful for eliminating infection on the epidermis of
the body; see column 6, lines 53- 55, wherein it is taught that the
antimicrobial composition therein is sprayed onto skin.
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We agree with the Examiner that one of ordinary skill in the art would
have been motivated to prepare the antimicrobial composition of Fahim in a
sterile and pyrogen free form with the expectation of success of employing
the composition for eliminating infections from epidermis of the body
because 1) Wider teaches antimicrobial compositions for eliminating
infection on the epidermis of the body are effective when packaged in a
sterile and pyrogen free form, and 2) both Fahim and Wilder teach that
antimicrobial compositions therein are useful for eliminating an infection on
the epidermis of the body. (Ans. 10.) “When a work is available in one
field of endeavor, design incentives and other market forces can prompt
variations of it, either in the same field or a different one. If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1731 (2007).
In the present case, one of ordinary skill in the art aware of the use of
antimicrobials in pyrogen free form as in Wider, would have been motivated
to use other antimicrobials, such as EDTA, in pyrogen free form.
Applicants argue that “the applications of Wider are contemplated for
contact with skin that is not normally exposed (i.e., broken, cut skin).” (See
pages 6-7 of the Brief.)
This argument is not persuasive. Wider teaches compositions to be
used for eliminating an infection on the epidermis of the body of the user
where infection is encountered. (See abstract; col. 5, ll. 63-64.) Wider
further teaches application of the antimicrobial compositions therein to be
used to eliminate all superficial microorganisms on the surface of the skin.
(See col. 6, ll. 53-56.)
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Appellants argue that “[o]ne skilled in the art would understand that
Wider is not suggesting that a composition be placed in a sterile and pyrogen
free form for other (non “internal spaces”) purposes. Thus, Wilder does not
teach or suggest the use of a composition in a “sterile and pyrogen free”
form for anything but the treatment of internal spaces.” (Br. 7-8.)
Again we do not find this argument persuasive. Wider teaches
antimicrobial compositions for eliminating an infection on the epidermis of
the body, and also teaches that the compositions therein are in sterile,
pyrogen free form. (FF6.) Wider teaches that the compositions in
concentrate form are diluted with pyrogen free water to form an effective
use solution. (FF6.) Thus, Wilder teaches that the pyrogen free water
provides the compositions therein to be effective for eliminating infection in
general including the epidermis of the body.
Applicants argue that “[t]here is no reason for one skilled in the art to
package a handwash in a sterile, non-pyrogenic form because, for example, a
handwash does not typically come into contact with the user in a manner
where packaging in a sterile, nonpyrogenic form would be beneficial.” (Br.
8.)
In response, the Examiner argues that a composition for cleaning skin
such as that taught by Wilder wherein the composition is sprayed onto skin
for eliminating an infection on the epidermis of the body prior to surgical
incision is known to be in sterile, non-pyrogenic form. (FF6.)
We find that the Examiner has established with appropriate evidence
that it would have been obvious to a person of ordinary skill in the art at the
time of invention to package an antimicrobial composition for cleaning skin
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in a sterile, non-pyrogenic form with the expectation of employing for
removing superficial microorganism from skin.

Claim 56
Appellants argue that the combination of Fahim and Wider would not
result in Appellants’ claimed lock flush composition. (Br. 10.) Appellants
argue that there is no suggestion that any composition of Fahim would be
biocompatible for use in in-dwelling catheters. (Br. 10.)
We agree with the Examiner that the intended use of the claimed
composition, “wherein the lock flush composition is biocompatible for use
in in-dwelling access catheters…” does not further limit the claims and has
no bearing on patentability. “[T]erms [that] merely set forth the intended
use for, or a property inherent in, an otherwise old composition . . . do not
differentiate the claimed composition from those known in the prior art.” In
re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). “The discovery of a new
property or use of a previously known composition, even when that property
and use are unobvious from the prior art, can not impart patentability to
claims to the known composition.” In re Spada, 911 F.2d 705, 708 (Fed.
Cir. 1990). See also Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)
(“where a patentee defines a structurally complete invention in the claim
body and uses the preamble only to state a purpose or intended use for the
invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d
150, 152 81 (CCPA 1951) (preamble is not a limitation where claim is
directed to a product and the preamble merely recites a property inherent in
an old product defined by the remainder of the claim).
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We do not find that the intended use of claim 56 recites a structural
limitation in the claim. We find that the one of ordinary skill in the art
would have found the antimicrobial compositions of Fahim and Wider to be
compatible for use in indwelling catheters. (FF5.) The obviousness
rejection is affirmed.

Claims 58-59
Appellants argue that it is apparent that the EDTA salt of Fahim
wound not provide at least 50% of the total antimicrobial activity of the
Fahim composition. (Br. 12.)
Fahim discloses antimicrobial compositions comprising about 0.025
to about 8.0 % by weight tetra sodium EDTA. (See pgs. 37-38, claims 15-17;
FF1.) Fahim teaches antimicrobial compositions for cleaning skin have a
pH from about 5.0 to about 11.0. (FF1.) The Fahim compositions may
comprise tetra sodium EDTA salt and can comprise other antimicrobial
agents such as triclosan, PCMX, glutaraldehyde in variable amounts,
wherein tetra sodium EDTA salt can be present in an amount from 0.05 to
about 6.0 %. Thus, the Examiner finds that the compositions taught by
Fahim broadly encompass the instantly claimed limitation wherein the
antimicrobial combination composition provides at least 50% of a total
antimicrobial activity of the composition because the ingredients are present
in variable amounts. (Ans. 13.)
The Specification teaches a sanitizing composition having
antimicrobial and/or antifungal activity that is at least 50% of the anti-
microbial and/or antifungal activity of a tri and tetra-sodium EDTA sale
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composition in an aqueous solution at a concentration of 4% (w/v) and at a
pH of 10.5. (Original claim 22; FF19.) Because the Fahim compositions
include overlapping weight ranges of EDTA at similar pH ranges, it would
reasonably appear that the compositions of Fahim would similarly provide at
least 50% of the antimicrobial activity. Appellants have not come forth with
evidence to show that such compositions of Fahim do not provide 50% of
the microbial activity. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir.
2003) (“[T]he existence of overlapping or encompassing ranges shifts the
burden to the applicant to show that his invention would not have been
obvious.”) The obviousness rejection of claim 58 is affirmed.

2. Claim 47 is rejected under.35 U.S.C. § 103(a) as being
unpatentable over Fahim in view of Wider and further in view of Root.
Appellants contend that “[i]t would be absurd, unnecessary and
prohibitively expensive to package the handwash composition of Fahim in a
sterile condition in a single-dosage vial. Appellants submit that one of
ordinary skill in the art would not be motivated by Root et al.’s use of sterile
test tubes in experimental protocols to package the antimicrobial handwash
composition of Fahim in a sterile, non-pyrogenic form in a single-dosage
vial.” (Br. 13.)
Root teaches antimicrobial composition of disodium EDTA at a
concentration of 20 mg/ml (2%) in sterile polystyrene test tubes (vials).
(FF14.) Thus, we agree with the Examiner that Root provides motivation to
package the sterile, non-pyrogenic compositions of EDTA in a single dosage
vial because both Fahim and Root teach that antimicrobial compositions
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comprising EDTA salts therein are useful for eliminating an infection. One
of ordinary skill in the art would have been motivated at the time of
invention to pack the pyrogen free, sterile antimicrobial EDTA-salt
compositions in single dosage vial with the expectation of employing the
compositions in experimental protocols. The ordinary practioner of ordinary
creativity was aware of single use packaging, as disclosed by Root, which
permits enhanced sterility and reduced risk of infection. See, e.g., Kendall
Co. v. Progressive Medical Technology, Inc., 85 F.3d 1570, 1572 (Fed. Cir.
1996) (“[I]n order to reduce the risk of contamination between successive
patients, its customers planned to replace the pressure sleeves after each use
by a single patient. Kendall did not discourage this practice and, in fact,
marked ‘FOR SINGLE PATIENT USE ONLY. DO NOT REUSE.’”)
Appellants have not provided evidence to rebut this finding. The
obviousness rejection of claim 47 is affirmed.

4. Claims 32, 34, 37, 41, 42, 45, 55-60 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Kurginski in view of Fahim, and
Wilder.
Appellants contend that the Examiner has not established a prima
facie case of obviousness (Br. 15) and that while the composition of
Kurginski may comprise tetra-sodium EDTA, it is improper to treat the
composition of Kurginski as simply a generic composition which comprises
tetrasodium EDTA. It is a toilet cleaning composition. (Br. 14.) Appellants
further contend that the Examiner concedes that Kurginski does not teach its
composition packaged in a sterile, non-pyrogenic form. (Br. 14, 17.)
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We agree with Appellants that the Examiner has not established why
one of ordinary skill in the art would have been motivated to supply a toilet
cleaning composition which is not intended for use on the skin or in any sort
of antiseptic environment, in a sterile, non-pyrogenic form. The obviousness
rejection is reversed.

CONCLUSION
We affirm the obviousness rejections of claims 32, 34, 39, 41, 42, 45,
and 55-60 under 35 U.S.C. § 103(a) as being unpatentable over Fahim in
view of Wider; of claim 46 under 35 U.S.C. 103(a) as being unpatentable
over Fahim in view of Wider and further in view Remington’s
Pharmaceutical Sciences; and of claim 47 under 35 U.S.C. § 103(a) as being
unpatentable over Fahim in view of Wider and further in view of Root. The
obviousness rejection of claims 32, 34, 37, 41, 42, 45, 55-60 over Kurginski
in view of Fahim, and Wider is reversed. In sum, claim 37 is without
rejection.
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-IN-PART
LP

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