Ex Parte Ward

Patent Trial and Appeal Board

Nov 28, 2012

10595033 (P.T.A.B. Nov. 28, 2012)

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.
10/595,033 01/04/2006 Warren Ward WAW0101PUSA 1595
22045 7590 11/28/2012
BROOKS KUSHMAN P.C.
1000 TOWN CENTER
TWENTY-SECOND FLOOR
SOUTHFIELD, MI 48075
EXAMINER
KASSA, TIGABU
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
11/28/2012 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 WARREN WARD
__________

Appeal 2011-010056
Application 10/595,033
Technology Center 1600
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a preparation
for use as a medicament. The Examiner entered rejections for lack of utility,
lack of enablement, and indefiniteness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 7-11, 24-28, 30-33, 36, and 37 stand rejected and appealed
(App. Br. 2). As Appellant does not argue the claims subject to the various
rejections separately, the claims stand or fall together. See 37 C.F.R. §
41.37(c)(1)(vii).
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Claim 24, the only independent claim, is representative and reads as
follows:
24. A preparation for use as a medicament, comprising a
medically efficacious substance coated with an aqueous liquid
impermeable but gas permeable layer for surrounding and preventing
release of the medically efficacious substance, wherein the layer
contains a ceramic, a clay, an inorganic non-metallic material, a
polymer, a natural wax, a perforated stainless steel, or beeswax
hardened with cornstarch and talc.

The following rejections are before us for review:
(1) Claims 7-11, 24-28, 30-33, 36, and 37,
1
under 35 U.S.C. § 101, as
lacking patentable utility (Ans. 3);
(2) Claims 7-11, 24-28, 30-33, 36, and 37, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement (Ans. 4-6);
and
(3) Claims 7-11, 24-28, 30-33, 36, and 37, under 35 U.S.C. § 112,
second paragraph, as indefinite (Ans. 6-7).
UTILITY
The Examiner found that “[t]he claimed invention lacks patentable
utility” because the Specification did not “provide adequate evidence to
support the utility of the invention” (Ans. 3).
Specifically, the Examiner contended, the Specification did not
provide sufficient evidence “to show that a compound which is not released

1
In setting out the § 101 rejection, the Examiner stated that “[t]he claimed
invention lacks patentable utility” (Ans. 3). We interpret “[t]he claimed
invention” (id.) to mean all the claims on appeal (claims 7-11, 24-28, 30-33,
36, and 37), an interpretation that is not in dispute on this record.

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on or into the body can have any medically beneficial effect. Additionally,
the agents used to form the liquid impermeable but gas permeable layer (e.g.
wax) are also used in the art to form controlled release formulations of
drugs” (id.).
Appellant contends that the Examiner advanced a 73 word conclusory
rejection which, “other than merely questioning operability,” did not
“properly establish[] a lack of utility rejection under 35 U.S.C. § 101 in view
of requirements and obligations set forth in relevant MPEP provisions”
(App. Br. 6). Appellant also contends that evidence of commercial success
and operability of the invention support a finding that the claimed invention
has patentable utility (see id. at 6-8).
Appellant further contends that a preparation need not be a
pharmaceutical to be useful, and that receptor binding is not required for
pharmacological activity, as evidenced by the activity of the anti-diabetic
drug metformin (id. at 9-11). Thus, Appellant argues, the Examiner
improperly remains unreceptive to the concept advanced by Appellant -- that
placing a drug/active agent in or on the body in a liquid impermeable, but
gas permeable coating allows “signaling communication with [the] body‟s
exocrine glands via gases in the surrounding environment and may exert its
function via influencing cell signaling and therefore delivering a desirable
therapeutic effect without the substance having to be metabolized at all”
(App. Br. 11 (citing Spec. 16:20-23)).
Appellant explains that the “communicating gases may include water
vapor in the air and residual water vapor retained within the coating layer.
In addition, as the coating layer is made aqueous liquid impermeable and
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hence hydrophobic, water vapor in the air is attracted through the layer”
(id.).
Appellant contends that the viability of this concept is supported by
the activity of cellular ion channels, in which “the proximity of a potassium
ion to a cell causes electrical activity in the ion channel” (id. at 12 (citing
2003 Nobel Lecture of Roderick Mackinnon (App. Br. Evidence Appendix,
Exhibit 5))). Appellant explains how, consistent with the opening of cellular
ion channels, placing the medicament near the channels in the manner
described in the Specification allows for their opening:
One or more embodiments of Appellant‟s invention allow for
sodium chloride and other medically efficacious substances to
be placed in close proximity to body cells, and thus ion
channels, the sodium chloride or other substances being
surrounded by water vapour. Further water vapour, in the case
of skin patches, or liquid water, in the case of ingested
products, surrounds the coated invention.
In other words, the ion channel recognizes not the ion but
the pattern of liquid molecules and particularly water molecules
around the ion. So in the instance wherein the claimed
preparation is applied as a pill passing through the GI tract in
close proximity to epithelial cells causes cell ion channels to
open in anticipation of receiving ions, a plurality of electrical
signals can be signified by the pattern changes in the
surrounding environment generated by the opening of the ion
channels as the pill moves along.

(App. Br. 12-13.)
The Examiner responds by pointing to a number of references cited
during prosecution to support the premise that chemical agents bind to, or
activate, receptors to elicit therapeutic action (Ans. 8-11), which supports the
position that the utility asserted by Appellant is “incredible in light of the
knowledge of the art” (id. at 11 (emphases removed)).
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In reply, Appellant cites additional references to support the concept
that an agent need not be absorbed by the body to provide a therapeutic
result (Reply Br. 2-4).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

We have carefully considered all of Appellant‟s arguments, and the
evidence submitted in support thereof, but are not persuaded that the
preponderance of the evidence fails to support the Examiner‟s finding that
claim 24 lacks patentable utility under 35 U.S.C. § 101.
Claim 24 recites a preparation for use as a medicament. The
preparation includes a medically efficacious substance coated with an
aqueous liquid impermeable, but gas permeable layer. Claim 24 explicitly
requires the coating to “prevent[] release of the medically efficacious
substance” (App. Br., Claims Appendix 1).
Consistent with claim 24, the Specification explains that the
preparation provides therapeutic benefit despite the fact that the therapeutic
agent is not released from the preparation or contacted by the body (Spec. 6
(“Thus administration of the substance (the sodium chloride or other agents
as detailed below, coated with / encapsulated by the agent) to a patient may
result in no metabolic change to, chemical change to, or diminution of, the
sodium chloride (or other substance as detailed below).”)).
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6
The Specification explains that modern humans have changed from an
“original genetic habituation (i.e. the status of Man in a natural habitat) to an
adverse habituation (i.e. Man‟s unnatural or modern habitat) . . . . It is
believed that such change may manifest in an altered physiology of exocrine
glands and particularly sweat glands” resulting in a number of disorders
treatable by the claimed composition (Spec. 14; see also id. at 9 (listing
treatable disorders)).
Thus, the Specification explains, because a subject‟s body can sense
the presence of the therapeutic agent inside the coated preparation due to the
coating‟s gas permeability, when the coated therapeutic agent is in close
proximity to the body, or inside the body, the agent elicits a therapeutic
effect despite the fact that the agent itself does not directly contact any
portion of the body:
The inventor then pictured the human body enveloped in fluid,
with the skin and the lungs in contact with fluid in the form of a
gas, i.e. air, and the gastro intestinal tract in contact with liquid.
The inventor concluded that, if the body senses the presence of
surplus sodium in both the gas and the liquid environment,
exocrine glands in adverse habituation are free to reset to
genetic habituation.

Thus, according to the present invention, the basis for the
treatment and prophylaxis of Miliaria [a sweat gland disorder]
and diseases mentioned above is to provide in the air and in the
liquid environment of the body an amount of sodium, which
appears to indicate a surplus to allow resetting to genetic
habituation. Furthermore, to prevent desensitisation of the
body to sodium chloride and the wearing off of the therapeutic
effect, the inventor found that treatment and prophylaxis have
to be arranged so that the body can sense new additional
sodium salt without absorbing it. Accordingly, salt used
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according to the present invention should be made not to cross
epithelial barriers. . . .

The inventor does not wish to be bound by the hypothesis, but
believes that the presence of a drug in the body environment but
not in body circulation influences cell signalling and
sensezero[, the ability to detect internal and external elements
of dissolved molecules,] can therefore have a desired
therapeutic effect without the drug being in circulation.

(Spec. 15-16.)
The Specification also presents four working examples in which
individuals were treated for dermatitis (Example 1 (six individuals)),
elevated plasma glucose (Example 2 (five individuals)), arthritic pain
(Example 3 (twelve individuals)), and hypertension (Example 4 (nine
individuals)) (Spec. 24-33).
To rebut Appellant‟s arguments, as well as the theory of therapeutic
efficacy Appellant propounds, the Examiner advanced evidence that
substances which elicit changes in cells must somehow directly interact with
the cell or associated biological component, rather than merely share the
same gaseous space at close proximity as described in the Specification (see
Answer 8-11 (citing Rastogi
2
(cell-cell signaling, hormone signaling), Vane
3

2
S.C. RASTOGI, CELL AND MOLECULAR BIOLOGY 158-169 (New Age
International 2003).
3
J. R. Vane and R. M. Botting, New insights into the mode of action of anti-
inflammatory drugs, 44 INFLAMM. RES. 1-10 (1995).
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8
and Catella-Lawson
4
(anti-inflammatory drugs inhibit COX enzyme
activity), Rashid
5
(capsaicin interacts with vanilloid receptor 1))).
As our reviewing court has stated, “the PTO is entitled to reject an
application for insufficient proof when a device by its nature occasions
reasonable skepticism as to its operativeness under § 101.” In re Newman,
782 F.2d 971, 973 (Fed. Cir. 1986).
We find that, because claim 24 explicitly prohibits the therapeutic
agent from being released from the preparation, and therefore precludes any
sort of direct contact between a subject‟s body and the therapeutic agent, the
Examiner advanced a reasonable evidentiary basis for questioning the
operability of claim 24‟s preparation. We are not persuaded that Appellant
has advanced evidence adequate to rebut the reasonable basis underlying the
Examiner‟s prima facie case.
We acknowledge the working examples in Appellant‟s Specification.
However, as the Examiner pointed out, none of those experiments included
controls in which some patients received a preparation that did not contain
the therapeutic substance, so as to verify that the results obtained were due
to the drug, as opposed to other factors, such as the placebo effect (see Spec.
24-33). Moreover, Appellant has not clearly pointed to any specific error in
the Examiner‟s assertion that the examples do not “meet the currently
accepted scientific standards for determining the efficacy of new

4
Francesca Catella-Lawson et al., Cyclooxygenase Inhibitors and the
Antiplatelet Effects of Aspirin, 345 NEW ENGL. J. MED. 1809-1817 (2001).
5
M.D. Harunor Rashid et al., Novel Expression of Vanilloid Receptor 1 on
Capsaicin-Insensitive Fibers Accounts for the Analgesic Effect of Capsaicin
Cream in Neuropathic Pain, 304 THE JOURNAL OF PHARMACOLOGY AND
EXPERIMENTAL THERAPEUTICS 940-948 (2002).
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9
pharmaceutical compositions” (Ans. 5). Also, while Appellant tested the
water impermeability of the preparations under different pH conditions,
Appellant did not test the subjects to verify that they had not actually taken
up therapeutic agents (see Spec. 24-33).
We also acknowledge the statement in the Ward Declaration,
6
that as
of the date the declaration was executed, “[t]he total number of
Equiwinner
TM
patches sold in the last five consecutive calendar years were
5000 patches, 11.000 patches, 18,000 patches, 24,000 patches and 25,000
patches, with a capital value at year 2010 of several hundred thousand
dollars” (Ward Declaration ¶ 17). The Ward Declaration explains the
construction of the Equiwinner
TM
patches:
As recited in the pending claims with particular reference
to the new claim 37, the said Equiwinner
TM
patches are
constructed to have two spheres containing sodium chloride
mounted on one side of the patch and spaced apart, and the
sodium chloride is coated with an aqueous liquid
impermeable but gas permeable layer comprising white
beeswax hardened with talc and cornstarch, all as set out in the
Application.

(Ward Declaration ¶ 12.)
The Ward Declaration explains that the patches can treat a number of
disorders in horses:
Equiwinner
TM
patches were originally designed to
activate angiogenesis of skin capillaries so as to reduce the
excessively high blood pressure of racehorses under maximum
exertion. This high pressure was known to cause exercise
induced pulmonary haemorrhage (EIPH), or horse bleeding.

6
Declaration of Warren Ward under 37 C.F.R. § 1.132 (declaration executed
April 4, 2010).
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This is a very common problem in horses. Equiwinner
TM
also
corrects anhidrosis, or non-sweating, another previously
untreatable condition in horses, particularly those in hot
climates. The „Smart Cell Signal‟
TM
is also effective throughout
the body in restoring full hydration of horse body tissues,
indicating persistence of the induced cell to cell signaling.
Another condition for which Equiwinner
TM
is rapidly effective
is equine rhabdomyolysis, or azoturia, commonly known as
“tying-up”.
I, the discoverer of the „Smart Cell Signal‟
TM
, believe
that I [also] have described for the first time in history the full
aetiology of the previously unknown cause of automatic head
shaking in horses, which can be corrected using Equiwinner
TM
.

(Ward Declaration ¶¶ 13-14.) The Ward Declaration also points out that two
equine veterinary specialists reported positive results using the
Equiwinner
TM
patches (Ward Declaration ¶¶ 18, 19, Exhibit 1 (“Gittins
Letter”) and Exhibit 2 (“Gulden Article”)).
As to the evidence of commercial success, however, the Ward
Declaration does not present any clear or specific evidence suggesting that
the patches were purchased due to their medicinal efficacy, as opposed to
superior marketing, or some other factor unrelated to the patches‟
operability, as is required when using commercial success to rebut a
showing of prima facie obviousness. Compare, In re DBC, 545 F.3d 1373,
1384 (Fed. Cir. 2008) (Proponent of commercial success evidence “must
offer proof „that the sales were a direct result of the unique characteristics of
the claimed invention-as opposed to other economic and commercial factors
unrelated to the quality of the patented subject matter.‟” (quoting In re
Huang, 100 F.3d 135, 140 (Fed. Cir. 1996))).
Thus, we are not persuaded that the evidence of commercial success
advanced by Appellant supports the operability of the preparation recited in
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11
claim 24, particularly given the absence of clear experimental evidence
having adequate scientifically accepted controls. As to the utility of treating
certain specific horse disorders (Ward Declaration ¶¶ 13-14), we
acknowledge the Specification‟s disclosure that the invention can be used to
“prevent or reduce the possibility of contracting any disorder or malfunction
of the human or animal body” and can be used for “the maintenance or
promoting of optimum health or cosmetic appearance of the human or
animal” (Spec. 10 (emphases added)).
Appellant does not, however, point to any clear assertion in the
Specification as filed suggesting that the horse disorders described in the
Ward Declaration were utilities to which the invention was directed. We are
therefore not persuaded that the Specification conveyed the utility asserted
in the Ward Declaration with adequate specificity. See In re Fisher, 421
F.3d 1365, 1371 (Fed. Cir. 2005) (“[As] to the „specific‟ utility requirement,
an application must disclose a use which is not so vague as to be
meaningless.”).
Moreover, as to the treatments described in the Gittins Letter, we note
that it is unclear how many horses were treated, what the conditions of the
treatments were, and whether the treatment conditions were of sufficient
scientific rigorousness such that an ordinary artisan would have assigned the
observed therapeutic effect to the patches. Indeed, while the Gulden Article
also reported positive results, it conceded that “the number of horses
examined is too low to assess effectiveness of Equiwinner Patches” (Gulden
Article 4).
In sum, for the reasons discussed, Appellant‟s arguments do not
persuade us that a preponderance of the evidence fails to support the
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12
Examiner‟s finding that the preparation of claim 24 lacks patentable utility
under 35 U.S.C. § 101. We therefore affirm the Examiner‟s rejection of
claim 24. Claims 7-11, 25-28, 30-33, 36, and 37 fall with claim 24. See 37
C.F.R. § 41.37(c)(1)(vii).
ENABLEMENT
In rejecting claims 7-11, 24-28, 30-33, 36, and 37, under 35 U.S.C. §
112, first paragraph, the Examiner asserted that the Specification “does not
reasonably provide enablement for how to use the claimed preparation or
composition for the treatment of diseases” (Ans. 4 (emphases removed)).
Appellant urges that the claims are of an appropriate scope, and that
the claimed preparation can be made and used as a medical device without
undue experimentation (App. Br. 13-17).
It is well established, however, that “the enablement requirement of §
112 incorporates the utility requirement of § 101.” In re Fisher, 421 F.3d at
1378.
As discussed above, we agree with the Examiner that a preponderance
of the evidence supports a finding that the preparation of claim 24 lacks
patentable utility. Accordingly, we also agree with the Examiner‟s
conclusion that claim 24 is not supported by a disclosure that adequately
meets the how-to-use prong of the enablement requirement.
We therefore also affirm the Examiner‟s enablement rejection of
claim 24, and the remaining claims fall with that claim. See 37 C.F.R. §
41.37(c)(1)(vii).
INDEFINITNESS
In rejecting claims 7-11, 24-28, 30-33, 36, and 37, as indefinite under
35 U.S.C. § 112, second paragraph, the Examiner reasoned that, while the
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13
“claim language recite[s] a preparation for use as a medicament, wherein the
agent is prevented from release . . .[, i]t is not clear whether the instantly
claimed invention is [a] pharmaceutical formulation since the medically
efficacious substances is prevented from being released” (Ans. 6-7).
Appellant urges that page 13 of the Appeal Brief directed argument to
the indefiniteness rejection (Reply Br. 4). However, page 13 of the Appeal
Brief merely mentions the rejection under 35 U.S.C. § 112, second
paragraph, and pages 13-18 of the Appeal Brief direct argument only to the
enablement rejection, and do not address the merits of the indefiniteness
rejection (see App. Br. 13-18).
We therefore summarily affirm the Examiner‟s indefiniteness
rejection. See MPEP § 1205.02 (“If a ground of rejection stated by the
examiner is not addressed in the appellant‟s brief, that ground of rejection
will be summarily sustained by the Board.”).
SUMMARY
We affirm the Examiner‟s rejection of claims 7-11, 24-28, 30-33, 36,
and 37, under 35 U.S.C. § 101, as lacking patentable utility.
We also affirm the Examiner‟s rejection of claims 7-11, 24-28, 30-33,
36, and 37, under 35 U.S.C. § 112, first paragraph, as failing to comply with
the enablement requirement.
We also affirm the Examiner‟s rejection of claims 7-11, 24-28, 30-33,
36, and 37, under 35 U.S.C. § 112, second paragraph, as indefinite.

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14
TIME PERIOD
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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