Ex Parte Kleyne

Patent Trial and Appeal Board

Nov 14, 2014

11599496 (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 01/27/2015
HOWARD EISENBERG, ESQ.
1220 LIMBERLOST LANE
GLADWYNE, PA 19035
EXAMINER
SHEARER, DANIEL R
ART UNIT PAPER NUMBER
3754
MAIL DATE DELIVERY MODE
01/27/2015 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 KLEYNE
________________

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 REQUEST FOR REHEARING

A panel of this Board entered a decision on appeal on November 14,
2014 (hereinafter “Decision”). The panel affirmed the rejections made by
the Examiner in the Final Rejection of September 9, 2011.
Appellant filed a Request for Rehearing (hereinafter “Req. Reh’g”)
pursuant to 37 C.F.R. § 41.52 on January 5, 2015. We have jurisdiction
under 35 U.S.C. § 6(b).
A request for rehearing “must state with particularity the points [of
law or fact] believed to have been misapprehended or overlooked by the
Board,” and must comply with 37 C.F.R. § 41.52(a)(1).
As the Request fails to establish that the Board misapprehended or
overlooked a point of fact or law, the Request for Rehearing is denied.
Appeal 2012-008575
Application 11/599,496

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DISCUSSION
A person of ordinary skill in the art would recognize Appellant’s
claims capture naturally occurring fresh water sprayed from a device onto
the eyes or skin to remove contaminants. Appellant asks us to reconsider
our decision affirming the Examiner’s determination that this claim scope is
unpatentable. The obviousness analysis was conducted with an
understanding of the knowledge base and basic understanding of a person of
ordinary skill in the field of topical administration of liquids for healthcare
in light of the evidence of record. See Spec. 1 (“Field of Invention”).
Independent claim 22 requires “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.” We concluded the claimed
range captures water solutions with a tonicity of about 30 mOsm or less. See
Decision 3–4. Appellant does not dispute this interpretation.
“An osmole (Osm) is a unit of osmotic pressure equivalent to the
amount of solute that dissociates in solution to form one mole (Avogadro’s
number) of particles (molecules and ions). A milliosmole (mOsm) is one
thousandth of an osmole (1 Osm × 10-3).” App. Br. 7, n. 1. A person of
ordinary skill in the art would recognize that pure water (H2O without
osmotically active solutes) has, by definition, an osmolality of zero. App.
Br. 7 (“Absolute pure water . . . has an osmolarity of 0 mOsm”). Further, a
person of ordinary skill in the art would also recognize that fresh water in
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Application 11/599,496

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the United States may have a tonicity from about 1 to 10 mOsm,1 and,
therefore, may also have levels of inorganic solutes less than 10% that of
isotonic saline. Thus, as we explained in our Decision, a person having
ordinary skill in the art would recognize the range of claim 22 captures fresh
water. See Decision 3–4. Appellant does not dispute this fact. Req. Reh’g
2, 3 (differentiating the claimed invention because naturally occurring tap
water is “often irritating due to the mechanical effect of the stream”).
Indeed, as we noted, Appellant submitted evidence stating that the
commercial embodiment of the invention, BioMed Wash, “is essentially
pure water, with essentially no salts.” Decision 3, n. 2 (quoting Sarceno
Decl. ¶ 6).
Appellant’s claims 18 and 19 narrow the range to “the level of
inorganic solutes in the [essentially water] fluid is less than 1% that of
isotonic saline” and “1/140 that of isotonic saline.” A person of ordinary
skill in the art would also recognize these levels also capture both pure water
and certain fresh water sources with only minor amounts of inorganic
solutes.
Appellant contends the Board applied improper hindsight in affirming
the Examiner’s rejection because a person of ordinary skill in the art would
not have known to apply Mehta’s teaching of how to prepare a hypotonic
solution (col. 7, ll. 22–33) to arrive at the claimed ranges. Req. Reh’g 4–7.
Appellant reiterates:

1 See, e.g., Peter Russell, Paul Hertz, Beverly McMillan, Biology: The
Dynamic Science 3d Ed., 1070, 1084 (2014) (“Freshwater (1–10
mOsm/L)”). See attached.
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The present invention is based, in part, on the discovery
that flushing the eyes or a wound can be effectively achieved by
utilizing an extremely hypotonic fluid . . . the flushing
performed by holding a device containing a fluid consisting
essentially of water and having an extremely low tonicity and
spraying the fluid from the device onto the eyes or a wound is
performed safely and comfortably.
Id. at 5.
Appellant’s (unclaimed) classification of the fluid as “extremely
hypotonic” distorts the fact that Appellant’s claims capture purified and
naturally occurring fresh water. Appellant contends a person of ordinary
skill in the art would not recognize that the claim scope captures fresh water
and would not know that such water has long been used to clean both the
eyes and skin of contaminants. Based on the evidence of record, we agreed
with the Examiner that Mehta’s disclosure of preparing a water solution by
adding a 2.16 gram packet, or less, of NaCl/NaHCO3 (inorganic solute) to 8
ounces (i.e., more than 236.59 grams) of water or more independently
teaches or suggests preparing a hypotonic solution to achieve any desired
osmolality, including those ranges and amounts claimed by Appellant.
Mehta, col. 7, ll. 25–29; see also Decision 6–7. We find no
misapprehension of fact or law in this conclusion.
Appellant also contends that “the accepted wisdom in the art prior to
the present application is to not flush the eyes or a wound with fluids that are
extremely hypotonic.” Id. at 6. Appellant’s contentions are contradicted by
common logic and the evidence of record, which our Decision addresses.
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Decision 5. See also Siegel,2 US 7,186,417 B1, col. 4, ll. 39–48 (“When
formulating the aqueous suspensions, ophthalmic compositions, their
osmotic pressure ([Π]) may be adjusted to from about 10 milliosmolar
(mOsM) to about 400 mOsM, using appropriate amounts of physiologically
and ophthalmologically acceptable salts.”). The evidence does not suggest a
person of ordinary skill in the art would be dissuaded from using fluids
within the claimed ranges to spray onto the eyes or skin to remove
contaminants as Appellant contends. Likewise, the evidence of record does
not support Appellant’s contentions that using fresh water or purified water
to flush the eyes or a wound was contrary to conventional wisdom. We thus
find Appellant’s arguments fail to persuasively identify any
misapprehension of fact or law. See Decision 5–6.
Accordingly, the Appellant has not persuaded us that the panel
overlooked or misapprehended any facts or law in reaching the Decision.
Based on our consideration of the totality of the record before us, we find no
error in the Examiner’s conclusion that the claimed invention encompassed
by claims 12–15, and 17–23 is unpatentable over Carlsson and Mehta under
35 U.S.C. § 103(a).

2 Siegel was cited and addressed by Appellant at App. Br. 15 and addressed
by the Examiner at Ans. 10.
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Application 11/599,496

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DECISION
We have granted Appellant’s request to the extent that we have
reconsidered our decision entered November 14, 2014, but we deny the
request with respect to making any changes therein.
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)(v)(2009).

DENIED

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