Ex Parte Kleyne

Board of Patent Appeals and Interferences

Feb 26, 2008

09614790 (B.P.A.I. Feb. 26, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SHARON F. KLEYNE
__________

Appeal 2007-0945
Application 09/614,790
Technology Center 1600
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Decided: February 26, 2008
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Before, DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. 1 The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse the obviousness rejection and enter two new grounds of rejection.
Claim 90 is representative.

1 Oral Hearing held February 12, 2008.
Appeal 2007-0945
Application 09/614,790

90. A method for moisturizing the eye comprising spraying a mist
consisting essentially of droplets of water having an average diameter
between 5 and 150 microns on the surface of the eye of a subject in need
thereof, wherein the amount of water that is sprayed on the eye is sufficient
to hydrate the aqueous layer of the tear film on the eye of the subject but is
below that which will wash away the tear film, and wherein the mist is
sprayed from a device comprising a sealed container, water within said
container, and an actuator for spraying a mist of water from said container,
and wherein the water is sprayed on the surface of the eye within a period of
10 seconds.

Cited References
Hutson US 5,588,564 Dec. 31, 1996
Junkel US 5,620,633 Apr. 15, 1997
Hahn US 5,893,515 Apr. 13, 1999
Embleton WO 97/23177 Jul. 3, 1997

Grounds of Rejection
Claims 90-93 and 97-101 stand rejected under 35 U.S.C. § 103 as
obvious over Junkel in view of Hahn, Hutson and Embleton.

DISCUSSION
Background
The present invention relates to application of therapeutic and other
fluids for moisturizing and treating the surface of the eye. (Specification 1.)
The surface of the eye is kept moist by the presence of tear film.
(Specification 1.) The tear film has a trilaminar structure including an inner
mucous layer, a middle aqueous layer and an outer lipid layer.
(Specification 1-2.)

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Application 09/614,790

Among other features, Appellant claims a method of moisturizing the
eye with an amount of water sufficient to hydrate the aqueous layer of the
eye but below that which will wash away the tear film.
Obviousness
Claims 90-93 and 97-101 stand rejected under 35 U.S.C. § 103 as
obvious over Junkel in view of Hahn, Hutson and Embleton.
While we find the Examiner has cited references pertinent to
the claimed subject matter we disagree with the Examiner’s reasoning
and analysis for combining the cited references. For this reason we
reverse the obviousness rejection before us and enter the following
two new grounds of rejection under 37 C.F.R. § 41.50(b).

New Grounds of Rejection
Claims 90-93 and 97-101 are newly rejected under 35 U.S.C. § 102(b)
as obvious over Junkel.
As to claim 90, Junkel describes a portable misting device with a fan
for atomizing a liquid mist, such as water, which may be used by sunbathers
and athletes as a cooling device. (Junkel, col. 1, ll. 5-19.) As is customary
such devices are used to fan and cool the body, including the face. The mist
is sprayed from a sealed container, such as a container sealed with a screw
cap. (Junkel, col. 3, ll. 29-37.) On this record there is no evidence that a
person of ordinary skill in the art using the device of Junkel’s misting device
would not administer a mist to the face, including the eyes for a period of
time within 10 seconds.

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Appeal 2007-0945
Application 09/614,790

Appellant’s burden under the circumstances presented herein was
described in In re Best, 562 F.2d 1252, 1255 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
. . . Whether the rejection is based on ‘inherency’ under 35
U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. §
103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO's inability to
manufacture products or to obtain and compare prior art
products [footnote omitted].

Thus, because both the device of Junkel and the claimed device are
the same or substantially the same in that they provide a method of
delivering a mist to the face, including the eyes, Appellant has the burden of
proving that the method and mist provided by the device of Junkel produces
a droplet size different from that claimed and that the mist droplets of Junkel
which will wash away the tear film as opposed to hydrating the aqueous
layer of the eye.
Appellant argues that Junkel does not disclose moisturizing the
surface of the eye but rather pertains to cooling the body. (Br. 10.)
However, on this record there is no evidence that a person of ordinary skill
in the art using Junkel’s misting device would not inherently administer a
mist to the face, including the eyes for a period of time within 10 seconds.
Appellant argues that there is no disclosure in Junkel to administer an
amount of fluid to the eye less than that which would flood the eye and wash
away the tear film. (Reply Br. 3.) In response, there is no disclosure in

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Appeal 2007-0945
Application 09/614,790

Junkel that the amount of fluid in the mist would necessarily wash away the
tear film. Thus it remains the burden of Appellant under the principles set
forth in In re Best to show that the misting device of Junkel necessarily
provides an amount of fluid which would flood the eye. Therefore we are
not persuaded by Appellant’s arguments with respect to Junkel.
Therefore, we enter the above new ground of rejection of the claims
for anticipation.

Claims 90-93 and 97-101 are newly rejected under 35 U.S.C. § 103(a)
as obvious over Embleton in view of Hahn and Hutson.
Embleton discloses an ophthalmic treatment liquid in the form
of a jet or stream. (Embleton abstract.) Embleton discloses that one
of the ophthalmic treatment therapies which may be administered is
water. (Embleton 13: 6-12.) Embleton further discloses that the total
volume of treatment fluid is preferably no greater than 10 µl and most
preferably in the range of 3 to 8 µl. (Embleton 3: 35-37.) Embleton
does not specifically disclose administering water in the form of a
mist.
Hutson discloses that administration of an ophthalmic liquid in
a fluid mist to the surface of the eye. (Hutson, col. 2, ll. 5-7.) The
spray mist includes an atomizer, a micromizer or an aerosol dispenser.
(Hutson, col. 3, ll. 49-56.) The fluid mist dispenser of Hutson may
include an eye wash solution reservoir (Huston, col. 6, ll. 41-43) and
is useful for the treatment of dry eye syndrome which requires
frequent eye hydration. (Hutson, col. 6, ll. 65-67.)

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Application 09/614,790

Similarly, Hahn discloses a device for generating a spray mist
or fine droplets to the eye. (Hahn, abstract and col. 2, ll. 41-45.)
Hahn discloses that it is known to use saline solution, eye wash or eye
moistening liquids in the eye. (Hahn col. 1, ll. 25-30, 50-54.) The
mist generator of Hahn can adjust the volume of the fluid pumped
with each depression. (Hahn, col. 17, ll. 47-50.)
In making an obviousness determination over a combination of prior
art references, it is important to identify a reason why persons of ordinary
skill in the art would have attempted to make the claimed subject matter.
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). If a technique
has been used to improve one device, and a person of ordinary skill would
recognize that it would be used in similar devices in the same way, using the
technique is obvious unless its application is beyond that person's skill. KSR
Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1731 (2007). “[W]hen the
question is whether a patent claiming the combination of elements of prior
art is obvious” the relevant question is “whether the improvement is more
than the predictable use of prior art elements according to their established
functions.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007).
We find that it would have been obvious to one of ordinary skill
in the art to substitute water administered in a dose of 3 to 8 µl in the
form of a jet or stream described by Embleton with administration of
water in the form of a mist using a misting device for administration
to the eye, as disclosed by Hutson and Hahn as they are both
techniques for administration of fluids to the eye to moisturize the
eye.

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Appeal 2007-0945
Application 09/614,790

Appellant puts forth several Declarations from persons of
ordinary skill in the art arguing unexpected results and that a long
standing unresolved problem was solved by the claimed method.
(Reply Br. 7-8.)
Appellant puts forth the Declaration of Dr. Philip Paden who
testified that the misting device of the invention is a departure from
previous accepted doctrine in ophthalmology. (Br. 16; Paden
Declaration ¶ 4.)
Appellant argues the Declaration of Dr. William Mathers
evidences unexpected advantages of the claimed invention which
overcomes the difficulty in administering eye drops and the lack of
patient compliance in administering eye drops. (Br. 16; Mathers
Declaration ¶ ¶ 6-7.)
The Declaration of Dr. Darwin Liao indicates outstanding
results with a product according to the claimed invention in the
treatment of dry eye, particularly in treating patients with motor
difficulties. (Br. 16; Liao Declaration ¶ ¶ 5-6.)
Appellant puts forth the Declaration of Dr. Rachel Garrett (Dec.
18, 2001) as evidence that a person of ordinary skill in the art would
not construe Embleton as administering water to the eye but
administering a treatment fluid based on water. (Br. 14-15; Garrett
Declaration ¶ ¶ 4-5.) A second Declaration of Dr. Garrett (also dated
Dec. 18, 2001) argues that eye irrigation fluids such as disclosed in
Embleton require more than 3 microliters of fluid. (Garrett
Declaration ¶ ¶ 3-4.)

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Appeal 2007-0945
Application 09/614,790

We are not persuaded by the Declarations before us. In response to
the Paden and Garrett Declarations, Embleton discloses that one of the
ophthalmic treatment therapies which may be administered is water.
(Embleton 13: 6-12.) Embleton further discloses that the total volume of
treatment fluid is preferably no greater than 10 µl and most preferably in the
range of 3 to 8 µl (Embleton 3: 35-37) within the range of the second Garrett
Declaration. Furthermore, the preponderance of evidence on this record
supports a finding that a person of ordinary skill in this art would have
reasonably expected that the substitution of Embleton’s jet or spray with a
mist, as taught by Hutson and Hahn, would moisturize the eye. With respect
to the Mathers and Liao Declarations, we find one of ordinary skill in the art
would have expected that substituting a jet spray with a mist would provide
advantages over administration of eye drops, particularly for those with
motor difficulties. It is particularly noted that Hutson provides that a mist is
easier to administer than eye drops for people with neuromuscular problems
(Hutson, col. 1, ll. 33-41). Therefore, we do not find the assertions made in
the Paden, Mathers, Liao, or either Garrett Declarations persuasive.
“Expected beneficial results are evidence of obviousness of a claimed
invention, just as unexpected results are evidence of unobviousness thereof.”
In re Gershon, 372 F.2d 535, 538 (CCPA 1967).
Therefore, we enter the above new ground of rejection of the
claims for obviousness.

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Appeal 2007-0945
Application 09/614,790

SUMMARY
The obviousness rejection presented in the Answer is reversed. We
enter two new grounds of rejection of the claims for anticipation and
obviousness.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides "[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner. . . .

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Application 09/614,790

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
REVERSED and 41.50(b)

Ssc:
HOWARD EISENBERG, ESQ.
1220 LIMBERLOST LANE
GLADWYNE, PA 19035

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