Ex Parte Kleyne

Patent Trials and Appeals Board

Nov 14, 2014

11599496 - (D) (P.T.A.B. Nov. 14, 2014)

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.
11/599,496 11/13/2006 Willam Kleyne 798.0012 2779
29085 7590 11/14/2014
HOWARD EISENBERG, ESQ.
1220 LIMBERLOST LANE
GLADWYNE, PA 19035
EXAMINER
SHEARER, DANIEL R
ART UNIT PAPER NUMBER
3754
MAIL DATE DELIVERY MODE
11/14/2014 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte WILLAM KLEYNE1
________________

Appeal 2012-008575
Application 11/599,496
Technology Center 3700
________________

Before JASON V. MORGAN, ROBERT A. POLLOCK, and
ROBERT L. KINDER, Administrative Patent Judges.

KINDER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Willam Kleyne (Appellant) appeals under 35 U.S.C. § 134(a) from the
Examiner’s decision rejecting claims 12–15 and 17–23. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 According to Appellant, the real party in interest is Bio-Logic
Aquatechnologies, Inc. App. Br. 3.
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Application 11/599,496

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References
The Examiner relies upon the following prior art references:
Carlsson et al. US 6,547,770 B2 Apr. 15, 2003
Mehta US 6,688,497 Feb. 10, 2004

Rejection on Appeal
Claims 12–15 and 17–23 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Carlsson and Mehta.

Claimed Subject Matter
Claim 22, the only independent claim, is illustrative of the claimed
subject matter on appeal. Claim 22 is a method for washing the eyes or skin
with a device containing water with a concentration of inorganic solutes of
less than 10% that of isotonic saline and then spraying this fluid on a person
to remove chemical, biological, or physical contaminants. App. Br. 27,
claim 22. Appellant argues for the separate patentability of several
dependent claims, we therefore consider each argument in turn.

OPINION
We have reviewed the Examiner’s rejection in light of Appellant’s
arguments that the Examiner erred. We disagree with Appellant’s
conclusions as to all rejections. We adopt as our own the findings and the
reasons set forth by the Examiner at pages 5 to 13 in the Answer to
Appellant’s Brief. We further highlight and address specific findings and
arguments for emphasis as follows.
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Claim 22, reproduced below, essentially claims using ordinary water
with small amounts of naturally occurring minerals (such as salt) to cleanse
wounds or debris from a person’s skin or eyes.2
22. A method for washing the eyes or skin of an
individual in need thereof comprising holding away from the
body a device containing a fluid consisting essentially of water,
which fluid is essentially free of organic solutes and has a level
of inorganic solutes less than 10% that of isotonic saline, and
topically spraying the fluid onto the eyes or skin of the
individual in an amount and for a time sufficient to remove
chemical, biological, and/or physical contaminants from on or
in the eyes or skin of the individual.
App. Br. 26; see also id., claims 17–19 (less than 5%, 1% and 1/140 that of
isotonic saline, respectively). While not discussed in the Specification,
Appellant submitted evidence suggesting the tonicity of isotonic saline is
about 300 mOsm, which is similar to human blood. See id. at 15, 7
(“Typically, such bodily fluids have an osmolarity about 300 to 330
mOsm.”). Appellant explains, “[o]smolarity is a measurement of the
amounts of dissolved solutes in a fluid. Osmolarity of a fluid is often stated
in units of osmoles (Osm), or more typically in units of milli-osmoles
(mOsm), which is 1/1000 of an osmole.” Id. at 7. Thus, a water solution
according to claim 22 with a level of inorganic solutes less than 10% that of

2 Appellant submitted the Declaration of Michael Saraceno, which states
that the commercial embodiment of the invention is BioMed Wash, and
“until the introduction of BioMed Wash, all eye rinses utilized for safety
compliance purposes in the United States were of saline, a water-based
mixture of salts. BioMed Wash, in contrast, is essentially pure water, with
essentially no salts.” Sarceno Decl. ¶ 6.

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isotonic saline would be a solution of with a tonicity of about 30 mOsm or
less.
Appellant argues, without identifying persuasive support in the
Specification, that use of “an extremely hypotonic” solution as a topical
cleanser achieves superior cleansing results compared to normal saline
solutions. App. Br. 7–8.3 Appellant also contends that isolated pancreatic
cells or “externally situated cells such as corneal cells,” placed in extremely
hypotonic fluid are known to become “swollen to such an extent that the
cells will burst and will die.” Id. Accordingly, Appellant argues, this may
explain why extremely hypotonic fluids have not been used in the prior art
for flushing the eyes or wounds in skin. Id.
The Specification, however, does not indicate that the claimed range
provides any advantage or medical benefit. See, e.g., Spec. 5 (providing a
brief description of the contents of the spray). The Specification also fails to
indicate how such a solution would differ from naturally occurring fresh
water in terms of mineral or salt content—or note that naturally occurring
fresh water falls within the scope of the “fluid consisting essentially of
water,” as set forth in independent claim 22. And though the claimed range
encompasses naturally occurring tap water, Appellant alleges that traditional
wisdom dictates that one of skill in the art would be dissuaded from using

3 Appellant submitted evidence related to these contentions in the form of a
frequently asked questions page entitled “BIO MED WASH FIRST AID” as
part of the Declaration of William Kleyne, the named inventor and
Appellant. This page suggests “[s]aline (salt) decreases shelf life, makes
water heavy and dehydrating, and can sting.” The page continues by
claiming Bio Med Wash is “proven to absorb more deeply and beneficially
than other waters, including saline solution.”
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“extremely hypotonic” fluids having a mean level of tonicity below about
140 mOsm for cleaning skin or flushing eyes because tissue damage would
result from using such fluids. App. Br. 13–20, 15 (140 mOsm “which is
roughly one half the tonicity of tear fluid”); Reply Br. 2–4. We disagree
with Appellant’s contentions.
In attempting to demonstrate that one of skill in the art would be
dissuaded from using a hypotonic or “extremely hypotonic” solution as a
topic rinse to cleanse skin wounds or remove contaminate from the eyes,
Appellant relies on studies and evidence suggesting “when cells are placed
in a medium containing such [extremely hypotonic] fluids” damage may
result to cells including “swelling and bursting.” App. Br. 14–18.
Appellant’s evidence, however, involves either exposing isolated internal
body cells to hypotonic fluids (see App. Br. 18 (After “20 to 30 seconds,
almost all pancreatic islet cells were killed.”)) or immersing the eye in
hypotonic fluids for up to 25 minutes to measure temporary changes in
corneal thickness. See Ronald Stevenson et al., Corneal Transparency
Changes Resulting from Osmotic Stress, Opththal. Physiol. Opt. Vol. 3, No.
1, 33–39, 34 (1983) (“bathe the eye [in hypotonic fluid] by means of adapted
swimming goggles” to determine halo effect on the eye) (see Figure 5,
corneal thickness as measured by halo effect at or near baseline at seven
minutes post treatment.) We do not find Appellant’s evidence convincing.
Appellant provides no persuasive evidence suggesting that less
extensive exposure to hypotonic, or extremely hypotonic, fluids would cause
eye damage, and presents no evidence regarding adverse effect of such
fluids on the skin. Moreover, because the claims only require “spraying the
fluid onto the eyes or skin” with exposure “for a time sufficient to remove
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chemical, biological, and/or physical contaminants,” as set forth in claim 22,
we further find Appellant’s argument unpersuasive. Indeed, using distilled
water with an osmolarity near 0 mOsm (App. Br. 7) to flush contaminates
from the eyes or skin would fall within the scope of the claims and such a
use of distilled water appears unlikely to cause harm to the eyes or skin if
used only for a quick rinse.
The Examiner finds that Mehta teaches the claimed range and we
agree. Mehta teaches preparing water based hypotonic solutions by mixing
varying amounts of minerals with water for use in rinsing skin. “A
hypotonic solution can be prepared either mixing less than one packet of the
NaCl/NaHCO3 mixture into approximately 8 ounces of water, or mixing one
packet with more than 8 ounces of water.” Mehta, col. 7, ll. 25–28. Mehta
likewise discloses “[h]ypotonic . . . saline solutions can be used for rinsing
and lavaging, with varying levels of comfort for the user depending on the
saline content of the solution.” Id., col. 7, ll. 30–32. Thus, Mehta teaches
one of ordinary skill in the art how to make a hypotonic solution comprising
a NaCl/NaHCO3 mixture with “a level of inorganic solutes less than 10%
that of isotonic saline” (claim 22), with a “level of inorganic solutes in the
fluid is less than 5% that of isotonic saline” (claim 17), with a “level of
inorganic solutes in the fluid is less than 1% that of isotonic saline” (claim
18), and with a “level of inorganic solutes in the fluid is 1/140 that of
isotonic saline” (claim 19) with no more than routine experimentation. See
In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.”).
Further, because Appellant: (i) offers no evidence concerning the importance
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of the claimed ranges, (ii) fails to explain how changing the range impacts
the purpose of the claimed invention, and (iii) fails to identify the range
where optimal results may be achieved, we find the differences in ranges
identified in claims 22 and 17–19 to be arbitrarily selected and lack
criticality to support nonobviousness. See In re Woodruff, 919 F.2d 1575,
1578 (Fed. Cir. 1990) (“The law is replete with cases in which the difference
between the claimed invention and the prior art is some range or other
variable within the claims. . . . [I]n such a situation, the applicant must show
that the particular range is critical, generally by showing that the claimed
range achieves unexpected results relative to the prior art range.”) (citation
omitted).
Appellant argues dependent claim 14 should be separately allowable
because claim 14 further distinguishes the prior art by calling “for cleansing
a wound.” App. Br. 20. For the reasons discussed above, we disagree that
the use of a hypotonic solution for washing a wound is contrary to the
teaching of the prior art and Appellant has not presented any reliable
evidence that one of skill in the art would have concluded treating external
skin with such a solution would be harmful or cause cells to “burst and die.”
Id.
Similarly, Appellant argues dependent claim 20 should be separately
allowable because it requires “spraying the fluid onto the eye.” See App. Br.
26, 21. Appellant contends that “extremely hypotonic fluids are known in
the prior art to cause swelling and damage to corneal cells.” Id. Again,
while Appellant’s evidence may suggest that swelling or discomfort may
result from extended exposure to “extremely hypotonic fluids,” such
evidence does not suggest that one of skill in the art would have been
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dissuaded from adopting the rinse as taught by Mehta. Further, Mehta
specifically teaches use of its solution on eye tissue. Mehta, Abstract; col. 3,
ll. 48–50 (“Implementations of the invention may include one or more of the
following. The tissue can be a mucus membrane, eye tissue, skin, or tissue
inside an oral cavity.”).
Appellant presents evidence of secondary considerations, including
commercial success of the product embodying the invention. App. Br. 22–
23, 28 (Evidence Appendix). We have considered this evidence, and for the
reasons set forth by the Examiner (Ans. 11–12), we find it unpersuasive.
Appellant makes no new arguments for the patentability of claims 12,
13, 15, 21, and 23, thus, we affirm the Examiner’s rejection of these claims
for the reasons set forth for claim 22. We, therefore, conclude that
Appellant’s arguments are not persuasive of Examiner’s error and we sustain
the Examiner’s rejection of claims 12–15 and 17–23 pursuant to 35 U.S.C.
§ 103(a).

CONCLUSION
The rejection of claims 12–15 and 17–23 under 35 U.S.C. § 103(a) as
unpatentable over Carlsson and Mehta is affirmed.
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DECISION
We AFFIRM the Examiner’s decision rejecting claims 12–15
and 17–23.

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)(iv).
AFFIRMED

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