OxyFile #440


Posted by Joseph Passero on Wed, Nov 20, 1996 

Samuel W. Murdoch
Attorney at Law
10529 Sheldon Roars
Elk Grove, California 95624
Telephone (916) 682-8912
FAX Machine (916) 682-4782

May 19, 1992

Mr. Michael Thesz
Office of Assistant Commissioner for Patents
Washington, D.C. 20231

RE: Ozone - Treatment of Blood; Treatment of HIV

Dear Mr. Thesz:

This is in response to our telephone conversation of May 19,1992.

     Please consider this a petition for reconsideration of the
determinations of issuance of patents nos. 4,632,980 (hereinafter
called "the Zee patent") and no._________(hereinafter called "the
Harley patent." The grounds on which this petition for
reconsideration is based are:

     1.  With reference to the Zee patent, most claims
incorporated in the patent are covered in a previously issued
patent, no. 3,063,904 (hereinafter called "the Ryan patent"),
thereby creating a conflict in patent claims; and

     2. With reference to the Zee patent, prior art as ;
described in numerous publications set forth herein was such
that, at the time of application of the patent, the application
claims contained nothing novel or unobvious, and presented no
actual improvement or advance over prior art; and

     3. With reference to the Harley patent, the claims
incorporated in the patent are covered by the claims contained in
two previously issued patents, the Ryan patent and the Zee
patent, thereby creating a conflict in patent claims; and

     4.  With reference to the Harley patent, prior art as
described in numerous publications set forth herein was such
that, at the time of application of the patent, the application
claims contained nothing novel or unobvious, and presented no
actual improvement or advance over prior art; and

     5.  With reference to both the Zee and Harley patents the
prior issuance of the Ryan patent and its contents were not
considered in the review of the claims in the applications for
the Zee and Harley patents, and the Ryan patent therefore
constitutes new relevant and material evidence which should be
considered with reference to the propriety of the issuance of
patents covering claims in the Zee and Harley patents; and

     6. With reference to both the Zee and Harley patents the
true state of prior art as set forth and revealed in numerous
publications set forth herein was not considered in the review of
the claims in the applications for the Zee and Harley patents,
and such publications describing the true state of prior art are
therefore new relevant and material evidence which should be
considered with reference to the propriety of the issuance of
patents covering claims in the Zee and Harley patents.

     I represent the Hippocratic Medical Foundation which
operates a research assistance program for medical researchers,
doctors and medical-interest groups. The foundation makes no
claims to ownership of any patent rights. The issuance of patents
containing apparently conflicting claims concerning blood
treatment and HIV treatment has caused considerable disturbance
in the medical research community. Persons making conflicting
claims have threatened researchers with litigation and demand
access to confidential medical and clinical data. These persons
also claim rights to royalties and propose to charge patients
huge fees (e.g. $500.00 per treatment) for procedures which are
regarded as highly experimental. We believe this activity is
caused and/or encouraged by the practice of issuing patents which
should not have been issued in that there was nothing novel or
unobvious about the claims in the patents we protest in that
these matters have long been known in the international medical
and scientific community. These claims do not represent
improvement over prior art but rather the attempt of
entrepreneurs to take credit for and exploit the creative and
scientific work of others. This is not merely a personal opinion
but reflects the opinion of many in the international research
community. We are advised that attorneys for the Canadian
national government have determined that several patents issued
by the U. S. Patent Office are conflicting with reference to
usage of ozone in treatment of blood for treatment of viral
diseases, including HIV, which is presumed to be the original
causative agent of AIDS.


     Ozone is a highly unstable common gas sometimes called
triatomic or polymeric oxygen. It is manufactured by passing
oxygen though a high voltage discharge (corona). Ozone (03) is
triatomic oxygen regardless of the exact technique used for its
manufacture. It was discovered by Schonbein in 1840 and has been
used to purify water and treat patients for more than 100 years.
Some major cities in Europe have used ozone to purify the
municipal water supply since the turn of the century. At present
the Los Angeles municipal water treatment facility (ozone) is the
largest in the world. Most swimming pools in Europe use ozone
rather than chlorine to purify water. It has been known for at
least 100 years that ozone is highly germicidal in that it will
almost instantly kill virtually all viruses, bacteria, fungi,
parasites, mycoplasma, etc. This germicidal and virucidal
(including HIV) effect occurs in human blood as well as water at
concentrations 1/7 to 1/3 the concentration necessary to result
in hemolysis (damage to blood cells) (Carnendale. Freeberg,

     Although medical ozone (mixtures of oxygen and ozone made
from pure oxygen) is still regarded as experimental in this
country it has been the subject of widespread and intensive
investigation in medical research for many decades. The
International Ozone Association has long sponsored regular world
conventions and sponsors an international medical convention as a
part of the general conference, in which doctors and researchers
from around the world present papers f on the results of the use
of ozone in medicine, both in vitro and in vivo. As I stated in
our telephony conversation the safety and efficacy of ozone in
many areas of medicine has long been accepted in Europe and in
Germany alone there are probably thousands of doctors who use
ozone in daily clinical practice.  . . .

     Enclosed is a copy of the foundations AIDS LIBRARY SURVEY on
medical ozone. This is considerably shortened and has not been
recently updated but it may help you to realize that the subject
of medical ozone is very big, very old and-very international.
All of the papers listed on the library survey are available to
you or to any doctor or researcher free of charge.

     German researchers have been prominent in the field of ozone
research since Schonbein's discovery of ozone in 1840. Several
German companies manufacture and distribute ozone generators made
specifically for treatment of human blood in a clinical setting
Hansler (the pioneer in the field), Biozon and Humares by
Humazon. Many companies around the world make ozone generators
for treatment of human blood. The field is quite old and
geographically widespread.

     "Major ozone autohemotherapy" is a procedure by which some
50 to 500 cc. venous blood is drawn into a sterile vacuum bottle;
then an appropriate quantity of ozone/oxygen mixture, at an
appropriate concentration of ozone, is bubbled through the
(heparinized) blood and the treated blood is then returned to the
patient's vein. Concentrations of ozone in the ozone-oxygen
mixture which will kill extracellular HIV and other viruses are
estimated to be 45 micrograms per milliliter (Carpendale, S.F.
V.A. Med. Center) and concentrations known to kill intracellular
viruses (HIV infected cells) are 55 micrograms per milliliter
(Wagner, U.S. Naval Hosp. and N.I.H. researchers). Some ozone in
the form of micro-bubbles is put into the patient's bloodstream
with the "major". It isn't just the transfer of gas that is
effective to kill germs however. The gas immediately interacts
with elements, including lipids, in the blood and blood
components to create a sequence of short-lived biochemical
products, mostly ozonides and peroxides, all of which are highly
oxidative. This ongoing biochemical process is thought to be
transferred to the patient's bloodstream.

     Rectal insufflation of ozone/oxygen mixture has been; used
to treat viral diseases and other diseases for at least 50
years.; Ozone is absorbed through linings of the colon and enters
the bloodstream where it has germicidal (including antiviral)
activity. Rectal administration is mentioned in the Ryan patent
together with other means of parenterally injecting the gas for
treatment of patients.

     In addition to its germicidal effects, ozone is known to
improve circulation, reduce cholesterol, decrease a diabetic's.
need for insulin, enhance the healing of wounds, and oxidize
toxins. It is also used to treat cancer. Cancer cells and
viral-infected cells seem to lack enzymatic protection to ozone,
or peroxides it creates in vivo, whereas healthy cells are able
to defend themselves against ozone and its biochemical products.
Therefore cancer cells and viral-infected cells die but healthy
cells are-unharmed. It has long been noted that tumors directly
injected with ozone will disintegrate and ozone is therefore
useful in de-bulking tumors.

     Ozone has long been used to create vaccines made of
whole-killed viruses. In the area of HIV, this is conceptually no
different from Dr. Jonas Salk's whole-killed HIV vaccine made of
HIV virions killed by gamma radiation, and a number of other
vaccines made of whole-killed (envelope-depleted) viruses, some
of which have been in use for decades. "Minor ozone
autohemotherapy" describes a: procedure by which a small quantity
of blood (10 cc.) is drawn from the patient's vein, treated with
some 10 cc. ozone/oxygen mixture at 45 micrograms 03 per ml. or
more, and the treated blood, containing the destroyed or envelope-
depleted virions present in the host's whole blood, is then 
returned to the patient. When injected IM into the patient it is 
regarded as a vaccine, as it is thought that in general IM 
injection is the most effective way of administering a vaccine. 
When used in HIV treatment the vaccine or immunogen is made up of 
the antigenic remnants of whole-killed HIV extracellular virus 
killed by ozone. These conclusions are the result of research 
conducted by a number of credible researchers over a period of a 
number of years. No individual can properly appear and claim he 
has "discovered" that ozone kills enveloped viruses, and 
particularly HIV, or that it is an effective treatment for HIV. 
Ozone has been used to treat ARC and AIDS since the period prior 
to the discovery of HIV as the probable causative agent. Preuss 
(see references, infra.) points out that ozone is appropriate for 
treatment of the disease (AIDS and ARC) because of its well-known 
germicidal characteristics regardless of the exact identity of the 
causative agent. We might also mention that some credible 
researchers (Sonnabend, Duesberg) do not believe HIV causes AIDS.


     Enclosed is a copy of Patent no. 3,063,904, issued to Edmund
J. Ryan Nov. 13, 1962. The title of the patent is "Polymeric
Oxygen in Blood and Sera Treatment and the Product Thereof". The
claims in the patent are as follows:

1.  A living body injectable fluid comprising blood and
serums aerated with oxygen/ozone mixture (5 to 50,000 p.p.m.

2.   A living body injectable fluid comprising blood and
serums which has been aerated prior to injection into a human
body with oxygen/ozone mixture (5 to 50 p.p.m. ozone);

3.   A living body injectable fluid comprising blood and serums,
having its living bacteria content destroyed by aeration thereof,
prior to injection in the human body with oxygen/ ozone mixture
This involves bubbling the gas through the injection fluid for a
short period of time (fractional portion of a minute to several
minutes) at a concentration of 5 to 50,000 p.p.m. ozone;

4.   Human blood useful in human body transfusions which has been
aerated a short period of time with oxygen/ozone mixture (5 to
50,000 p.p.m. ozone);

5.   Method of treating human blood comprised of passing gas into
blood consisting of oxygen/ozone mixture;
6. Method of medicating a living body with oxygen/ozone mixture
through the blood and then injecting the blood intravenously into
the human body;

7. Method of medicating a living body comprising
parenterally injecting into the human body oxygen/ozone mixture.
( 5 to ozone);

8. Method of treating blood in the human body first IV injection
of dilute aqueous solution eta. and then injecting oxygen/ozone
mixture. ( 5 to 30 p.p.m. ozone);

9. Method of medicating human body comprising aerating a body
injectable carrier with oxygen/ozone mixture and then injecting
the aerated carrier into the body parenterally.

10. Method of medicating human body comprising withdrawing spinal
fluid and replacing it with ozone/oxygen mixture ( 5 to 30 p.p.m.

Column 1 of the patent states:

"This invention * * * relates to treatment of living bodies, both
animals and humans, by direct injection parenterally, including
intravenously, of polymeric oxygen into the living body, and
particularly treatment of blood and serums normally used for
injection into the human body as in blood transfusions,
vaccination, inoculation, etc. and to polymeric oxygen aerated
products such as whole blood, citrated blood, products in
improved sterile, activated and stabilized form.
* * *
According to the present invention, blood and various commercial
forms thereof such as whole blood, citrated blood, blood serum,
blood plasma or dried blood plasma, as well as vaccines, serums,
antigens or antibodies may be improved to destroy bacterial and
chemical contamination, to render the same stable in storage and
more acceptable to a patient in transfusion without certain
adverse effects of pyrogen blood, or otherwise contaminated
innoculants by aerating such products in these various forms with
an activated polymeric oxygen gas.

The treatment according to the present invention comprises
aerating the blood, serum, vaccine, etc. with the therapeutically
active gas hereof by bubbling the gas therethrough or otherwise
homogeneously contacting the same with an activated polymeric
oxygen gas hereof under therapeutic conditions."
Column 2 of the patent states:

"In this form the gas comprises pure oxygen gas containing 5 to
5,000 p.p.m. of higher polymers of oxygen.  "The present
disclosure, therefore, sets forth the treatment of gas and the
properties thereof as they are now understood

* * *

and it will be understood that it is not intended to be limited
to any theory as to the exact reactions that take place in
effecting activation of the oxygen gas."

Column 3 states:

"* * * this gas as described herein generally suffices to
sterilize such inoculant substance without heat."

Column 5 states (line 30):

"The actual aeration of blood is effected in about 10 seconds to
a few minutes of bubbling the gas therethrough."* * * Thus it is
suitable to bubble the gas through for a period of 0.1      to 10
mins., preferably from 0.2 to 3 mins." .

     Columns 6 and 7 of the patent, examples VI, VII, and VIII
specifically name virus pneumonia as a disease treated by the
described procedures using ozone/oxygen mixture. Example IX
mentions undulant fever which may has a probable bacterial
causative agent. Column 6, example V, Table 1 lists some 27 types
of bacteria which are killed by the germicidal effect of
polymeric oxygen gas (ozone).

One reference in paragraph 10 specifically mentions ozone.

     Other ozone (polymeric oxygen) patents issued to Edmund J.
Ryan are as follows:

1. Method of Polymerizing Oxygen, May S. 1953, No. 2,637,688;

2. Water Purification, Nov. 20, 1956, No. 2,771,416;

3. Apparatus and Method for Producing a Controlled ozone Content
   in Oxygen, May 24, 1960, No. 2,937,983;

4.Treatment of Alcoholic Beverages, No. 2,637,747;

5. Disinfecting Solution and Method, June 20, 1967, No.

6. Apparatus and Method for Producing a Controlled Ozone Content
   in Oxygen, filed Aug. 4, 1969 and assigned serial no. 849,588;
   February 6, 1973, No. 3,715,430;

     Some American doctors and researchers treated patients for
various viral diseases for many years  operating under this
patent. Doctors throughout the world have been treating patients
infected with viral diseases with ozone during most of the
Twentieth century.


     Enclosed is a copy of U. S. Patent no. 4,632,980, issued to
Yuan C. Zee, et al, on December 30, 1986. The title of this
patent is "Ozone Decontamination of Blood and Blood Products".
The "brief-description of the prior art mentions European patent
application no. 0 086 071 which describes the use of ozone to
inactivate enveloped viruses for use as a vaccine. The claims are
as follows:

     1. A method for freeing blood and blood components of viable
enveloped viruses while retaining the physiological
characteristics of the blood or blood component, said method
          contacting said blood or blood product in an aqueous
          medium within enveloped virus inactivating amount of
          ozone  under mild conditions for a sufficient time to
          inactivate all enveloped viruses present; and isolating
          the blood or blood component free of viable enveloped

2.  A method according to claim 1, wherein said contacting is at
    a temperature in the range of 4 degrees to 37 degrees C. and
    at an ozone concentration of 1 to 100 ppm.

3. A method according to claim 2, wherein said blood or blood
   component is contacted as a thin film.

4. A method according to claim 2, wherein the contacting is for a
   duration of 0.5 hr. to 4 days.

5.  A method according to claim 2, wherein blood is contacted
    with ozone.

6.  A method according to claim 2, wherein an aqueous solution of
    a blood component is contacted with ozone.
      The references cited make no mention of the above-described
Ryan patent, no. 3,063,904. In paragraph 1 specific mention is
made of the virus LAV/HTLV-III. The summary of the invention,
paragraph 1, states:

     "Blood and proteinaceous blood components are freed of
     infectious enveloped viral agents by treating the blood
     under mild conditions for a short period of time, where any
     virus is inactivated, while retaining the physiological
     properties of the blood or blood components."

Paragraph 2 states:

"The subject method is effective with a wide variety of enveloped
viruses, both RNA and DNA. Illustrative viruses include hepatitis
virus, HTLV-I, -II, and -III, influenza virus, etc."  "Generally,
a bubbling of the ozone through the blood will not be employed *

Other techniques described for contacting blood or blood
products with ozone are:

(1) pumping the medium through a chamber containing ozone,
employing a thin film;

(2) passing the blood through porous fibers where the chamber
containing the fibers contains the ozone;

(3) using tubing where the medium is in contact with an ozone



     Claim 1 of the Zee patent refers to "freeing" blood and
blood components of viable enveloped viruses. The great majority
of viruses are enveloped viruses. As ozone has been used for
decades prior to the Zee application to kill or inactivate
viruses of virtually all types, enveloped and non-enveloped, in
blood, water and other media, it cannot be said that anything
novel or unobvious was added by referring specifically to
enveloped viruses. No less than three examples set forth in the
Ryan patent specifically refer to virus pneumonia and viral
pneumonitis, which is caused by an enveloped virus.

    Effective antiviral agents are generally broad-spectrum in
that their mode of action affects some characteristic which many
viruses have in common. For instance the agent may affect some
element of the envelope, such as a particular viral protein or
lipid, or affect its etiology or some step in its "life-cycle"
such as inhibiting its ability to replicate in some way, or its
ability to "dock" onto the receptor site of a target cell or to
invade that cell, once docking has been achieved. The list of
viral species affected by any given effective antiviral agent may
run into the hundreds or thousands. It is not appropriate or
workable to issue patents that cover the use of an antiviral
against any or all specific viral diseases.

   Moreover, some antiviral agents such as ozone have long been
known to be effective against both enveloped and non-enveloped
viruses and have been used for such purpose for a very long time
in treatment of both blood and water. Nothing novel or unobvious
is added by this claim which attempts to distinguish enveloped
from non-enveloped viruses. A patent which covers the use of
ozone as a general antiviral agent, without distinguishing
enveloped from non-enveloped viruses, should be construed to
include both types, particularly when published medical and
scientific literature shows it has long been known that the agent
affects both types and that no such distinction is necessary for
purposes of efficacy, toxicity or mode of action.

     It is submitted that a patent for an antiviral agent should
not make a distinction between types of viruses, including the
distinction between enveloped and non-enveloped viruses, unless
it is demonstrated that prior art did not affect a given type or
that an actual improvement has been achieved which did not exist
before. It has long been published that ozone is effective to
inactivate both enveloped and non-enveloped viruses. In this
instance the distinction between enveloped and non-enveloped
viruses represents no actual improvement in any sense, but is
only an exercise in word-games.

    For a paper showing that ozone inactivates non-enveloped
viruses (poliovirus type 1) see E. Katzenelson et al,
(Environmental Health Laboratory, Hebrew University-Hadassah
Medical School, Jerusalem, Israel) "Measurement of the
Inactivation Kinetics of Poliovirus by Ozone in a Fast-Flow
Mixer", Applied and Environmental Microbiology, Apr. 1979, p.
715-718, vol. 37. no. 4. See also Kessel, "Virucidal Effect of
Ozone (03) in water" (Brunhilde strain of poliovirus), Proc. Soc.
Exp. Biol. Med. 53:71-73, May 43. (First demonstration of
virucidal action of ozone on poliovirus.) Note that in the
Katzenelson test 95% to 99% of the virus was inactivated in 1
second or less, depending on the concentration, and all virus was
inactivated within a several minute period. Both papers were
published years before the filing of the application for the Zee

       An aqueous medium is mentioned. That may be whole
blood or aqueous blood products as mentioned in the Ryan patent.

   The amount or concentration of ozone mentioned in Zee patent
claim 1 is "an enveloped virus inactivating amount of ozone". The
Ryan patent specifies ozone concentrations of 5 to 50,000 p.p.m.
(claims 1, 3, 4); 5 to 50 p.p.m. (claim 2); and 5 to 30 p.p.m.
(claims 7,8 and 10). It has been determined that the
concentration of ozone necessary to kill or inactivate
extracellular HIV is 45 micrograms per ml. and the concentration
necessary to kill intracellular HIV viruses is 55 micrograms per
ml. (Carpendale, Wagner, infra.) This concentration is
considerably below the concentration necessary to cause
clinically significant hemolysis. All or virtually all effective
but nontoxic concentrations of ozone are included in the specific
concentrations set forth in the Ryan patent. No figures are
provided in the Zee patent, claim 1.

    Claim 1 of the Zee patent mentions no specific time for
exposure required for viral inactivation, but simply states "a
sufficient time to inactivate all enveloped viruses present." The
Ryan patent provides "fractional portion of a minute to several
minutes" (claim 3), "a short period of time" (claims 2, 3 and 4).
Column 5, line 30 et seq. of the Ryan patent states:

      "The actual aeration of blood is effected in about 10
seconds to a few minutes of bubbling of the gas therethrough. * *
* Thus it is suitable to bubble the gas through for a period of
0.1 to 10 minutes, preferably from 0.2 to 3 minutes."

It is submitted that virtually all periods of time which are used
to; kill viruses and other disease microbes in blood and/or blood
products (nontoxic, effective and otherwise practicable) will be
included in the short period of time specified in the Ryan patent
(0.01 to 10 minutes).

     Claim 1 of the Zee patent mentions "isolating the blood or
blood component free of viable enveloped viruses." There is
nothing novel or unobvious about such procedure. See Column 2
which states at line 64 "After the blood or blood components has
been decontaminated, it may then be isolated and used directly
for its intended purpose."

There is no element of claim 1 of the Zee patent which is not
already covered by the Ryan patent, claims 1, 2, 3, 4, 5, and 6.


     Claim 2 of the Zee patent repeats the method described in
claim 1, and adds "wherein the contacting is at a temperature in
the range of 4 degrees to 37 degrees C. and at an ozone
concentration of 1 to 100 p.p.m."

     The methods of exposing blood or blood products described in
the Ryan patents do not use artificial heat. Blood treated
outside the body is at normal room temperature. The procedures of
major ozone autohemotherapy and minor ozone autohemotherapy have
taken place routinely in doctor's offices and other clinical
environments for decades in the United States and many other
countries of the world. This is always done at temperature ranges
which may be described as normal indoor temperatures. To the
extent that the temperature range "4 degrees to 37 degrees C"
includes normal indoor temperatures, nothing new or unobvious has
been added and those temperature ranges should be considered
incorporated into prior art and specifically into the Ryan patent
claims. Blood treated inside the human body is, of course, at
temperature ranges which are found in living humans, whether
clinically well or not. To the extent that "4 degrees to 37
degrees C" includes temperature ranges found in living humans
nothing new or unobvious has been added and these temperature
ranges should be considered incorporated into prior art
and specifically into claims set forth in the Ryan patent.

     Zee patent claim no. 2 adds to its claim no. 1 "at an ozone
concentration of 1 to 100 p.p.m." As set forth above, Ryan patent
claims set forth ozone concentrations of 5 to 50,000 p.p.m.
(claims 1, 3, and 4); 5 to 50 p.p.m. (claim 2); S to 30 p.p.m.
(claims 7, 8 and 10). To the extent that ozone concentrations in
claim 2 of the Zee patent are 5 p.p.m. or more (5 to 100 p.p.m.)
these concentrations are specifically incorporated in the claims
of the Ryan patent and nothing novel or unobvious has been added
by the Zee patent.


     Claim no. 3 states "A method according to claim 2, wherein
said blood or blood component is contacted as a thin film."
Column 2, line 32 et seq. states, "Generally, a bubbling of the
ozone through the blood will not be employed, particularly where
red blood cells are present, since this may lead to hemolysis."
Carpendale and others (see references, infra), have already
determined and published that extracellular HIV viruses are 
inactivated at ozone concentrations 1/S to 1/3 the concentration 
necessary to result in hemolysis. As stated above, doctors and 
researchers have been treating human blood in clinical practice by 
bubbling ozone/oxygen mixtures through blood in ozone 
autohemotherapy procedures for decades without evidence of 
clinically significant hemolysis or toxicity. We do not have any 
basis for believing that a thin film is appropriate or necessary.

     We are not aware that any clinicians using ozone use a thin
film in treating blood with ozone. We are not aware of any
credible medical or scientific papers which show that the use of
a thin film yields improved results either in efficacy or
toxicity. Therefore we conclude that the addition of a thin film
to the method may result in a theoretically possible improvement
but that such improvement has not actually been demonstrated. We
do not believe patents should be granted for improvements which
are merely theoretically possible but not demonstrated because
such "improvement" is not an improvement but only an unproved
idea. Unproved ideas are not patentable because they are not
really "improvements" within the meaning of patent law.


     This claim adds to claim no. 2 the phrase "wherein the
contacting is for a duration of 0.5 hr. to 4 days". The Ryan
patent mentions a short period of time, ranging from 0.1 to 10
minutes, with most germicidal activity taking place in narrower
ranges as specified. To the extent that the time of contact
mentioned in this claim no. 4 is between 0.1 to 10 minutes, the
contact time is; already incorporated in Ryan patent no.
3,063,904 and nothing novel or unobvious is added by this claim.


     This claim (NO.5) repeats the method of claim no. 2 and adds
the phrase, "wherein blood is contacted with ozone." This~~ is
clearly incorporated in the Ryan patent and routine clinical
practice in this and many other countries where ozone
autohemotherapy is used. In all cases of ozone major and minor
ozone autohemotherapy blood is contacted with ozone. Where the
researcher uses a Hansler generator, a Biozone, a Humares or a
number of other generators manufactured around the world blood is
contacted with ozone. Those generators are made specifically for
treatment of blood by exposing it to ozone/ oxygen mixtures. This
has been going on for decades. A large number of papers have been
published in international medical and scientific literature on
various aspects of the subject. This claim adds nothing novel or
unobvious to generally accepted prior art.

We repeat the specific objections raised in the discussion of
claim no. 2 hereinabove.


     This (claim (no. 6) repeats claim no. 2 and adds the phrase
"wherein ah aqueous solution of a blood component is contacted
with ozone". We repeat our objections to claim no. 2 as set forth
hereinabove. All of the 10 Ryan patent claims set forth above
contemplate an aqueous solution of blood or blood component.
Claims 1, 2 and 3 specifically mention "a living body injectable
fluid comprising blood and serums". Claim no. 8 mentions a
"dilute aqueous solution." Claim no. 9 mentions a body injectable
carrier". Claim no. 10 mentions spinal fluid. Nothing novel or
unobvious is added to this claim by referring to Jan "aqueous
solution of a blood component" being contacted by ozone.

     In summary there is nothing novel or unobvious about any
element of the Zee patent except the usage of a thin film to
prevent direct contact of ozone and blood or blood components. We
have no evidence of hemolysis resulting from either formal or
informal research using appropriate ozone concentrations and
exposure times. There are also credible published reports
(Carpendale, Wagner) indicating that there is a substantial
margin of safety (concentration necessary for efficacy in HIV
treatment vs. that necessary for toxicity) in ozone
concentrations before hemolysis will result. Therefore we do not
see any justification for concluding this addition is an
"improvement" on prior art as there is no indication that it is
necessary or appropriate.


     Enclosed is a copy of a magazine article entitled "The AIDS
Ozone Connection", East/West/September 1989 73, 74, 112. On p. 73
it states, "The actual method of treatment, McGrath explains, "is
to remove 300 cc's of the patient's blood, to treat it with
ozone, and to re-infuse the treated blood back into the body."
This is nothing other than major ozone autohemotherapy, as
described in several claims in the Ryan patent and as routinely
practiced by doctors and researchers around the world. There is
nothing new about what Medizone is doing and there is nothing
novel or unobvious presented by their patent claims. It had
already ben known for years that enveloped as well as
non-enveloped viruses of a great many species were inactivated in
vivo by ozone-oxygen mixtures through standard techniques of
ozone autohemotherapy (treatment of a patient's own blood with
ozone-oxygen mixtures and reinfusion of the treated blood into
the patient's vein.)


     By letter dated April 21, 1992, Mr. James S. Rothschild, Jr.
of the law firm of Riker, Danzig, Scherer, Highland & Perretti
sent Dr. Mayer a letter (copy enclosed) in which he stated that
"This is to inform you that my client, Richard Harley, possesses
a valid patent in the treatment of HIV positive patients with a
mixture of ozone and oxygen. * * * He has learned that you are
utilizing that treatment on your patients, We must inform you
that said use violates my client's patent rights. If you do not
desist, we will have no recourse but to bring legal action."

     Contrary to the statement in the letter no copy of the
patent was enclosed and neither Mr. Harley nor his counsel have
provided a copy, despite requests that they do so. Mr. Harley's
counsel did provide a copy of a document entitled "Notice of
Allowance and Issue Fee Due." This states:  "Richard J. Harley,
fil. date 8/15/89. Issue fee due 5/4/92. Title: "Method of in
vivo inactivation of blood-borne HIV virus using a mixture of
ozone and oxygen (as amended)". Small entity: Yes. Fee due:
$300.65. Date due: 5/4/92. Class. Surclass 434613000. Batch
no.(?) WAP appn. type : utility" The text reads: The application
identified above has been examined and is allowed for issuance as
a patent. Prosecution on the merits is closed."

     The copy is very poor and the number may be incorrect. You
stated that I may obtain a copy of the patent by sending an
order together with a  fee of $3.00. Enclosed is my check in
that amount. Please send a copy of the Harley patent.

    Since we have no information as to the actual issuance of
this alleged patent and any claims which may be incorporated
therein, we make general comments concerning the appropriateness
of issuing any patent purporting to grant exclusive rights of
exploitation to anyone for using ozone to treat HIV.

     First, the Ryan patent described above incorporates all
methods of treating human blood presently in common use as ozone
autohemotherapy (major and minor) except the method patented by
Mueller Medical International, Inc., which combines ozone, heat
and ultraviolet radiation. The Ryan patent also covers direct
injection of gas into the body IV and otherwise and rectal
insufflation and other means of parenterally administering the
ozone/oxygen mixture. Since the Zee patent contains no reference
to the Ryan patent, we may assume that the Harley patent contains
no reference to it either. Pending our receipt of the patent and
based upon the grounds that vital and relevant "new" information 
was not considered by the examiners we request that the issuance 
of the Harley patent be reconsidered. The new evidence consists of 
the Ryan patent which presents an apparent conflict of claims 
covered by the two patents. Since Medizone claims exclusive rights 
to treat blood for enveloped viruses and since that patent (the 
Zee patent) specifically mentions LAV/HTLV-III, an additional 
apparent conflict exists between the Zee patent and the Harley 
patent. Additional new evidence is in the form of published 
medical and scientific literature evidencing a state of prior art 
to which nothing novel or unobvious has been added by Harley.

     Dr. Mayer has been treating many viral diseases (both
enveloped  and non-enveloped) with ozone/oxygen mixtures by using
essentially the same methods for approximately 46 years. So have
a great many other doctors around the world. How can Medizone
(based on the Zee patent) or Harley now claim, at this late date,
that each of them now has exclusive rights to exploitation of
these methods in treatment of HIV because of an action of the
U.S. Patent Office?

    The general germicidal effects of ozone in water and blood
treatment have been known for at least 100 years. Ozone has been
used in various procedures described above to treat a broad
spectrum of viral diseases for many decades in many countries of
the world. A very large number of articles on the subject of
ozone as an antiviral agent for water treatment and treatment of
patients has been published in international medical and
scientific literature for a great many years. Ozone has been
used by researchers and doctors for ARC and AIDS treatment since
the period prior to the identification of HIV as the probable
causative agent. Preuss and Horst Kieff have published their
reports on the use of ozone to treat AIDS, ARC, and HIV for some
years. Carpendale (V.A. Med. Center, San Francisco and Wagner
(U.S. Naval Hosp. AIDS Section) presented their papers in vitro
efficacy of ozone in inactivation of extracellular and
intracellular HIV at the International AIDS Conference in
Stockholm (1988). Both have been published in medical journals,
and both were widely reported in the general media (newspapers,
etc.) The use of ozone in AIDS, ARC and HIV treatment (in many
different methods and protocols) has been so widely known, for so
long, no person can justifiably claim that he has discovered such
new use for this common gas.

       In reference to the Zee patent now owned by Medizone, that
company has for some time made claims that it owns the exclusive
rights to exploit ozone in treatment of HIV and other enveloped
viruses. Medizone International, Inc., has sponsored trials using
ozone to treat ARC and AIDS patients and has published a report
of the in vitro efficacy of ozone in inactivation of HIV. See 
"Well, et al, "Inactivation of Human Immunodeficiency Virus Type 1 
by Ozone in Vitro", Blood, vol 78, no. 7, October 1, 1991, pp.
1882-1890. A copy of the article is enclosed. Any patent
purporting to give another exclusive rights to exploit the use of
ozone to treat HIV is likely to result in litigation because of
the conflicting claims.

     It is our position that the treatment of HIV with ozone by
major and minor autohemotherapy, rectal insufflation, and other
methods described in the Ryan patent is in the public domain
because of the claims incorporated in the Ryan patent and the
publication of successful results in the use of medical ozone
(ozone/oxygen mixtures) in treatment of AIDS, ARC, HIV and other
viral diseases by Mayer, Preuss, Kieff, Carpendale and Freeberg,
Wagner, The Canadian Surgeon General's Office and Mueller Medical
International, Inc., and others as set forth hereinbelow, many of
which publications were prior to the dates of application of the
Zee and Harley patents.

     A policy which results in too freely granting patents which
almost certainly conflict with prior art as commonly understood
in the international medical research and scientific communities
and which apparently conflict with other patents previously
issued by the United States Patent Office will promote
litigation, will confuse and retard valuable medical and
scientific research, and will encourage investors to make
investments in companies and projects which are based on a patent
which may in fact be invalid or unenforceable. Does anyone
imagine that thousands of doctors around the world are going to
start paying royalties to some American company or individual for
doing what they have been routinely and legally doing in clinical
practice for many years?

     As stated above, the germicidal effect of ozone has been
generally known and exploited in water treatment and clinical
practice for a great many years. Papers on ozone as a general and
specific antiviral agent commenced to be published almost as soon
as the various viruses themselves were discovered. The Ryan
patent clearly incorporates and contemplates that ozone is an
antiviral agent in that viral diseases are specifically mentioned
in three of the examples set forth in the patent. If the patent
office starts granting a new and distinct patent for each
distinct type of microbe ozone kills, where will this lead? Are
there to be separate new patents for many thousands of types of
bacteria, viruses, fungi, parasites, mycoplasma, eta? And for
different methods of killing each of them in different
media-blood, water, air, etc.? If this is done for ozone would
it also be done for other germicidal agents which are either
common natural substances or drugs which have fallen into the
public domain?

And what is HIV itself? ARC and AIDS are thought to
be caused by at least two major types--HIV-I and HIV-II. There
may be more. But this a retrovirus which makes a "mistake"
virtually every time it replicates, thereby creating an almost
infinite antigenic diversity. These mutagenic differences can be
very consequential and can affect the types of cells the virus
will invade as well as many other important characteristics.
Therefore it is known as a quasi-species rather than a species.
See the enclosed paper, Nowak, et al., "Antigenic Diversity
Thresholds and the Development of AIDS", Science, 15 Nov. 1991,
vol 254, p. 963-969. If you start on the path of granting a
patent for the use of ozone for every germ or microbial agent it
affects, where are you going to draw the line? At what point does
a mutagenic variant of HIV become a separately recognized type?
Are you going to issue a separate patent for each and every viral
type which may exist or evolve? Must patents issued for antiviral
agents or methods specifically mention each virus or other
microbe to which the patent will apply?

     Another important factor which may not be readily apparent
to some is that it is not possible to treat only a single virus
within a living body with any reasonably effective
(broad-spectrum) antiviral or germicidal agent. Certain viruses
are virtually ubiquitous, such as Epstein-Barr virus (EBV), which
infects nearly everyone in the world and is thought to play a
role in the dying process of humans and animals. Others are very
common, such as herpes simplex (HSV), and Cytomegalovirus (CMV).
Very early in the course of AIDS research it was discovered that
ARC and AIDS patients have a complex viral disease syndrome--that
is, virtually all the symptomatic patients have EBV, CMV and HSV
as well as HIV. In addition many also have hepatitis A and/or B.
and various other diseases, some of which are viral and some of
which are not, such as Mycoplasma incognita (mycoplasma) syphilis
(bacteria), pneumocystis carinii (parasite), thrush (fungus),
etc. These diseases are co-factors in that EBV and CMV are
immunosuppressive when they activate (as in the cases of EBV and
CMV mononucleosis), and the activation of latent HIV (lying
dormant as a provirus in the infected cell) is probably triggered
by the activation of EBV and CMV. See Salk, J., "Prospects for
the control of AIDS by immunizing seropositive individuals, "
Nature, vol. 327, 11 June 1987, p. 473 where Dr. Salk states:
"Conversion of a latent asymptomatic to a productive HIV
infection with clinical sequelae may be due to the stimulation of
CD4 cells harboring HIV proviruses by a variety of agents,
including infection with cytomegalovirus or Epstein-Barr virus
(citing authorities)." Bacterial infections such as syphilis are
also immunosuppressive. Activation of these diseases is both
cause and effect, as all are opportunists in the
immune-compromised host. They  activate because of a weakened
immune system and further damage the immune system in the process
of their activation.

     When a broad-spectrum germicidal agent such as ozone is used
to treat such a complex, many-factored disease syndrome as AIDS,
who can say exactly-what disease microbes are being affected by
the treatment? A further complexity arises from the indirect
germicidal effect of certain therapies which are immune
modulators or indirect immune modulators because they
allow the immune system to bounce-back as a consequence of
relieving it of immunosuppressive effects of certain active
diseases. The immune system itself is continually fighting
disease, including viral disease, up until the moment of its
final destruction, which is virtually simultaneous with the
moment of death.

     We submit that a policy resulting in the issuance of
separate patents for each of the multitude of disease microbes
which may be involved in AIDS is not reasonable or workable,
where the agent used is a common gas occurring in nature which
has been known for a century or more to have very broad-spectrum
germicidal effects. If such policy is followed it could result in
demands for royalties against a single doctor using a standard
method of ozone/oxygen therapy from alleged patent holders for
ozone used against HIV, CMV, EBV, HSV, syphilis, hepatitis A,
hepatitis B. various types of meningitis, toxoplasmosis,
cryptosporidium, hairy leukoplatia, thrush, mycoplasma incognita
and a multitude of other disease microbes, besides the alleged
patent-holders who claim to have "discovered" other beneficial
biochemical effects of ozone such as removal of many types of
toxins, oxidation of cholesterol, oxidation of various types of
tissues, improvement of blood circulation, creation of various
biochemical substances such as complex ozonides and peroxides,
etc. etc. ad absurdum.

     We strongly believe the subject of the use of ozone to treat
viral diseases by the methods set forth in the Ryan patent
includes any viral disease affected by ozone, both enveloped and
non-enveloped (including HIV) and those claims are now in the
public domain. Other strong arguments to the same effect can be
made based on the prior art as set forth in credible published
scientific and medical literature. See illustrative references
cited below.

     Around the world researchers and doctors are asking whether
the U. S. Patent Office is granting patents to persons who merely
learn of some advance in international ozone research through
published scientific or medical reports or newspaper accounts and
then hire well-connected patent law firm to obtain a patent for
them based the already published creative and scientific work of

If Richard Harley has "invented" a new use of ozone as an
antiviral agent against HIV, a notion most researchers find
preposterous, where are the published works reporting his
findings?  Why have attorneys for the Canadian national
government concluded that the U. S. patent Office has issued
several patents concerning the use of ozone as an antiviral agent
which contain conflicting claims? Why are doctors and researchers
being attacked and threatened by attorneys for both Medizone and
Richard Harley, each claiming patent rights conferring exclusive
rights to treat HIV with ozone? What novel or unobvious
improvement over prior art was contributed by the 'inventor" in
each instance? Why is the Ryan patent omitted from the list of
references which are part of the Zee patent? When you embark upon
a course of granting patents for supposedly Novella applications
of a natural substance long recognized and used as an all-purpose
germicidal agent, how could your reviewers possibly access all
the relevant information developed in ozone research since 1840
throughout the world and presently being generated at a rapid
rate in published literature in many languages?

     Medizone claims exclusive rights to use ozone in blood
treatment of enveloped viral diseases in many countries because
of patent treaties. But thousands of European doctors,
particulars, in Germany, have for decades been treating viral
(both enveloped ad non-enveloped) diseases by treating human
blood in a clinical setting using an ozone generator made
specifically for treatment of human blood, e.g. units made by
Hansler or Biozon and others. Understandably many are denying the
validity of Medizone's patent.

     If the United States follows a practice of issuing patents
to American nationals which cover a supposedly novel application
of a common natural substance, which is in fact not novel or
unobvious and does not protect an actual improvement over prior
art, why shouldn't many other countries do the same, as all are
anxious to promote industry and encourage exports and cash
inflow? A plethora of conflicting patent claims would soon result
together with a hornet's nest of litigation. The result is to
suppress and not encourage research. Large drug companies are
able to finance expensive patent litigation but others,
particularly individuals, or spokesmen for the public interest,
rather than a profit-driven vested interest, are usually unable
to afford to litigate. The severity and international scope of
the AIDS epidemic (estimated 40 million infected by the turn of
the century) creates a potential for controversy, and controversy
on an international level, in the field of patents relating to
treatments for HIV, far beyond anything likely to occur in the
ordinary course of business and commerce.

     At the time of the application dates of the Zee patent
(April, 1985) and the Harley patent (August, 1989) international
medical and scientific literature contained numerous published
papers on the subject of viral inactivation in human blood (and
water) through the use of ozone and treatment of viral diseases
in human patients with ozone, including treatment of AIDS, ARC
and HIV. Some of these papers are referenced hereinbelow. You may
obtain any of these by request free of charge as part of the
operations of the Hippocratic Medical Foundation. As stated
above, the field is very large, very international and
fast-developing so the references below are only a sampling of
the vast quantity and diversity of the materials extant.

   1. Katzenelson, et al., "Measurement of the Inactivation
Kinetics of Poliovirus by Ozone in a Fast-Flow Mixer", Applied
and Environmental Microbiology," vol. 37, no. 4, p. 715-718,
Apr., 1979. (Described, supra). (non-enveloped viruses) (copy

     2. Kief (Med. Director for Biozone), "The Biological Basis
of the Autohomological Immuntherapy".

3. Wagner, et al. (Naval Hosp., Bethesda, Md., Georgetown U.,
Wash., D.C.)~~, "The Effect of Ozone in Experimentally Infected
Human Blood". (This famous paper was published in a prominent
medical : journal and presented at an International AIDS
Conference (Stockholm, 1988). A copy of the abstract presented at
the conference is enclosed together with a copy of newspaper
articles reporting on its presentation as well as the
presentation of the Carpendale paper. Also enclosed is a copy of
a newspaper article, "Studies say ozone may combat AIDS", The San
Diego Union, Oct. 27, 1988, p. A-3. Note the article states the
Wagner report was presented Oct. 26, 1988 during the 28th
International Conference on Antimicrobial Agents and
Chemotherapy. Note also the article states Carpendale treated
AIDS and ARC patients with ozone prior to this date (Oct., 1988).
(Note that these dates are prior to the application date of the
Harley patent in August, 1989.)

     Note that the first sentence of the report states, "Ozone
(O3) was used for many years in Europe to treat donated blood
(bid) to limit the transmission of hepatitis." This acknowledges
that for a long period prior to the filing of the applications
for both the Zee patent and the Harley patent ozone was in common
usage in treatment of human blood to inactivate hepatitis
viruses. Hepatitis is an enveloped virus. The paper concludes
that "ozone is effective at eradicating HIV from infected human
blood with a threshold of effect between 45-55 ug/ml."

     4. Freeberg, Carpendale (V.A. Med. Center, San Francisco),
"Ozone Inactivates Extracellular Human Immunodeficiency Virus at
Non-Cytotoxic Concentrations", OzoNachrichten 7 (1988) Heft 1/2.
Poster presented at IV Int. Conf. on AIDS, Stockholm, 1988. (Note
that this presentation is prior to the date of the application
for the Harley patent in August, 1989.)

     The paper states, "Ozone, the triatomic allotrope of oxygen,
is a strong oxidant and has multiple applications as a
bactericidal and virucidal agent in sewage treatment (citing
Katzenelson, et al, "Disinfection of viruses in sewage by ozone",
Water Res. 1976; 10: 629-631.) water purification, and medicine
(citing Rilling, S., et al. "The Use of Ozone in Medicine", Haug,
Heidelberg, 1987).

     The paper further states "Ozone effectively inactivates both
enveloped and non-enveloped viruses when introduced into
suspensions in water. effluent. and cell culture media."
(emphasis supplied) See authorities cited in the paper for these

     The paper states further "Ozone has been used as an
antibiotic treatment by extrapulmonary administration in Europe
for more than forty years." * * *

     "Ozone been demonstrated to be an effective treatment
in man for herpes simplex virus (an enveloped virus) (citing
Mattassi, R., et al, "Ozone as therapy in Herpes Simplex and
Herpes Zoster Diseases", Medical Applications of Ozone, Ed.
LaRaus, J.,pp. 134-37. International Ozone Association, Pan
American committee, 83 Oakwood Avenue., Norwalk, Conn. 06850,
USA, 1985.) Citing also Konrad, H. , "Ozone vs. Hepatitis and
Herpes- The Choice". Medical Applications of Ozone, 1985, supra.)
* * * and hepatitis virus (citing the last cited paper by Konrad,
supra, and Knoch, H., "Die Sauerstoff-Ozontherapie in der
Proctologie". AktueIle Coloproctologie. 1987. Band 4: 161-173.

     In the test, purified HIV was exposed to ozone in human
serum followed by exposure of the serum to purified HIV. No
infectivity remained at ozone concentrations of greater than 4
milligrams per liter.

     When cells were exposed to ozone in buffered saline and
growth media for longer time periods than required to inactivate
HIV and tested for viability, no negative effects were observed
until ozone concentrations were increased to three to seven times
the levels required to inactivate HIV.

    Among the conclusions set forth in the paper was "HIV
suspensions are completely inactivated at 1/3 of the ozone
concentration producing significant inhibition of cellular
metabolism, and 1/7 of the ozone concentration producing
significant inhibition of DNA replication;" and

     "These findings support the beneficial results reported in
ARC and AIDS patients treated with ozone/oxygen mixture (citing
Kief, "Die Behandlung von Viruskrankungen mit Ozon". reprint:
Erfahrungsheilkunde. Band 37. Heft 7, July 1988.)"(copy enclosed)

     5. Konrad, "Ozone vs. Hepatitis and Herpes - The Choice",
presented at the 6th Int. Ozone Congress, Wash., D.C., May, 1983.
(copy enclosed). The paper is dated Dec., 1982.

     Konrad treated hepatitis and herpes patients by drawing 50
ml. blood into a sterile vacuum bottle, injecting 9 mg. ozone
into the bottle, shaking the blood and ozone together for 5 to 10
seconds and then returning the ozone-treated blood to the
patient's vein. No adverse reaction was noted. All hepatitis
patients were successfully treated with ozone by clinical and
laboratory criteria, except chronic hepatitis B patients where
57.18 were successfully treated. In herpes trial 23 patients had
unquestioned successful treatment and 5 had questionable
treatment success. In conclusion the author states, "Ozone is
known, for long, for its highly virus-killing and/or
virus-inactivating effect."

     This paper is cited by Freeberg and Carpendale, supra. Its
publication is years before the application dates of either the
Zee or Harley patents. All viruses involved in the
study-hepatitis A and B and herpes zoster and simplex, are
enveloped viruses. The method employed is essentially the same as
described in the Ryan patent and the Zee patent claims added
nothing novel or unobvious and reflected no improvement in method
or results.

     6. Preuss, A., "Positive Treatment Results in AIDS Therapy,"
OzoNachrichten 5 (1986) Heft 1/2, paper presented at the 1st
Congress "Naturheilmedizin in Praxis und Apotheke in Munich the
l9th and 20th of April in 1986. Preuss specifically mentions
HLV-III (now called HIV) and the antibody test for it. Preuss
used ozone/oxygen mixture (medical ozone). (Note that this
publication date in OzoNachichten, a publication read throughout
the world, is years prior to the application date for the Harley
patent in August, 1989). OzoNachrichten, a respected medical
journal, is published by the German and Austrian Medical
Societies for Ozone Therapy. See reference no. 15, p. 65, below.

7. Preuss,  A. "The Treatment of Virus Infections with
Ozone Oxygen Mixtures", Raum & Zeit, vol. 1, no. 1, Apr.-May,
1989, p. 1719. (Note this date is prior to the date of the
application for the Harley patent in August, 1989.)

`The paper states: "Ozone * * * is in daily use in the praxis of
ozone therapists, for instance in the fighting of viral
infections such as hepatitis B. colds, herpes zoster, etc. For an
example in my lecture I selected the AIDS disease and the use of
ozone in the pre-disease stage." The ozone therapy was described
as enlarge ozone blood therapy. In this 500 ml of blood is
overpressurized with 20-40 mg. ozone and incubated for 15
minutes. Through this, according to my opinion, extra cellular
viruses are (in)activated and through this regressive
transfusion, it behaves like an immunization." (The author is
describing a form of major ozone autohemotherapy, probably done
with one of the German ozone generators manufactured specifically
for treatment of human blood in a clinical environment, such as a
Hansler or Biozon machine.)

     The paper specifically mentions that the patients were
positive for HIV and reports 8 case histories of successfully
treated patients.

     The article is preceded with the following editorial
comment: "On the occasion of the Baden-Baden Medical Week in West
Germany the Stuttgart physician, Alexander Preuss, gave a lecture
on the treatment of AIDS patients with an ozone/oxygen mixture."
The publishers deemed the work to be so consequential that they
state: "A 39-page documentation of the Preuss AIDS Therapy
including lab results can be obtained from Raum & Zeit for the
price of copying and mailing."

A copy of this paper is enclosed.

     This method of major ozone autohemotherapy is described in
the Ryan patent claims. The date of first publication of the
successful results of the Preuss ozone/oxygen therapy for HIV,
ARC or AIDS (April, 1986) precedes the date of filing the
application for the Harley patent (August, 1989).

8. Mayer, R., "Experiences of a Pediatrician Using Ozone as a
Chemotherapeutic Agent for the Treatment of Diseases in

     In this paper Mayer summarizes therapy of various kinds of
illness that were treated by ozone/oxygen in a pediatric practice
during the years between 1946 and 1964. Most patients responded

to treatment with ozone and there were no patients that were
considered treatment failures. The paper states "Asian flu virus,
Vaccinia virus, hog cholera virus poliomyelitis virus and equine
infectious anemia virus were all treated with ozone in vitro and
in vivo experiments. "Results are shown in tables and it is
evident that ozone is a true viricide." Mayer also treated
patients with various types of encephalitis, including mumps and
measles. Ozone/oxygen mixtures were administered through IV
infusions of treated blood, rectal insufflations and intraspinal
injections. The paper also reports treatment of 10 patients with
acute hepatitis with ozone/ oxygen administered intravenously and
rectally. Successful results of treatment with ozone/oxygen was
reported in nearly all the 1,943 children treated.

     Dr. Mayer has been treating patients with enveloped and
non-enveloped viral diseases using ozone/oxygen mixtures since at
least 1946-a period of 46 years. He has written, presented and
published a number of works on the subject. He assisted Ryan in
the medical research resulting in the claims set forth in the
Ryan patent described above. He is the assignee of the Ryan
patent but believes that those claims are now in the public
domain. He has treated ARC, AIDS and HIV patients with
ozone/oxygen mixtures since the disease first became widespread
in the early 1980's. The methods used are those described in the
Ryan patent and usually involve treatment of blood with an ozone
generator such as Biozon, which is manufactured specifically for
the purpose of treating human blood with Ozone/oxygen mixtures
and used for such purpose for many years by doctors throughout
the world. Dr. Mayer has presented hit findings as to HIV
treatment at medical conventions and seminars since the 1986. He
has for nearly half a century actively participated in defining
the state of the art in medical uses of ozone, including HIV
treatment and treatment of many other viral diseases. He is
widely recognized as the "dean" of ozone researchers and
practitioners in the United States.

     It is submitted that prior art as set forth in the Ryan
patent and in the many papers and presentations by Dr. Mayer over
the course of 46 years, and as set forth in the multitude of
published works reporting the virucidal effect of ozone/oxygen
mixtures on both enveloped and non-enveloped viruses, and the
several methods of treatment of human patients using ozone/oxygen
mixtures, has long been so developed and publicized that no novel
or unobvious element has been presented or "invented" by
applicants for either the Zee or Harley patents, and no actual
improvement over widespread existing technology has been advanced
by those applicants.

     It is further submitted that there is no justifiable basis
for the owners of the Zee or Harley patents to claim that Dr.
Mayer's methods of ozone/oxygen treatment of viral diseases and
HIV in particular violate their patent rights. Those methods have
been substantially unchanged for many years, and it is submitted
that it makes no difference exactly what virus or viruses might
be treated in any given case with those methods.

     8.(a). Mayer, R., "Case Report of Viral Hepatitis Treated by
Rectally Administered Polyatomic Oxygen Molecules, "
(Concentration 7,000 ppm of 03 in 02. 270 cc given in each
treatment.) Successful treatment was typical of 18 patients with
hepatitis treated in a similar manner since 1962. Presented at a
medical conference in 1969. (Copy enclosed)

     8.(b) Case report of treatment of acute viral hepatitis with
intravenous Polyatomic oxygen molecules (POM or Ozone) given at
rate of 1.5 ml./ min. for 60 mins. for a total of six days.
Successful treatment reported at medical conference. Note dates
on lab reports as 11/9/63 and 11/15/63. (Copy enclosed)

   8. (c) Mayer, R. "Polyatomic Oxygen Molecules: Reports of
Human Patients Treated Intravenously and with Oral Solutions"
(paper presented at medical conference). Discussed treatment of
more than 1,500 children with rectally administered ozone. Some
were treated with combined intravenous and rectally administered
ozone/oxygen mixture. Diseases successfully treated included
diarrheal diseases, gastroenteritis (rotovirus or reovirus),
acute infectious mononucleosis (Epstein-Barr virus or
cytomegalovirus), pharyngitis, tonsillitis, cervical adenitis,
hepatitis, Hodgkin disease (radiation burn from cobalt
irradiation therapy). Many of these patients were treated
successfully in the 1950's. In conclusion Mayer comments, "Since
at is now recognized that most cases of diarrhea that are seen
particularly in endemic or epidemics are due to viruses such as
Rotoviruses and Reovirusest it is suggested by the rapidity of
cures obtained, that direct effectiveness of POM (ozone)
administered rectally, attacks the viruses within the lumen of
the bowel demonstrating virucidal capability." (copy enclosed)

     8. (d) International Ozone Association, Pan American
Committee, "Medical Applications of Ozone". 1985. A book
containing many articles by ozone researchers from around the
world. Cited by Freeberg, Carpendale in reference no. 4, supra.
Letter from publisher and table of contents enclosed. Note that
the introduction states that most papers were presented at the
5th and 6th World Congress of the International Ozone Association
in Berlin, 1981 and in Washington, 1983. The two papers in the
book written by Mayer were presented by him at the Washington 
conference in 1983. Those include: "Ozone-A chemotherapeutic agent 
for the treatment of acute leukemia in rats and mammary cancer," 
and "Experience of a pediatrician using ozone as a 
chemotherapeutic agent in the treatment of children's diseases," 
which is the paper referenced in no. 8 (c), supra. This includes 
reports on treatment of many viral diseases, most of which are 
enveloped (EBV, CMV, rotovirus, hepatitis, etc.). This paper was 
presented at a world medical conference in 1983 and republished in 
1985. This is years before applications were filed for either the 
Zee or Harley patents. Note also that most treatments took place 
and were originally reported during the 1960's.

       It should also be noted that this book contains articles
by internationally known medical ozone researchers on the
treatment of herpes simplex, herpes zoster, hepatitis, etc. (all
enveloped viruses) and that this data was published in 1981 and
1983 and republished in 1985, all prior to the dates of
application for the Zee and Harley patents.(See the enclosed
table of contents).

    8. (e) B.T., "The AIDS-Ozone Connection", East West/Sept.
1989 73, 74, 112. This article has already been referenced in
discussion of the Zee patent above. On page 74 and 112 Dr.
Mayer's lifelong research in the field of medical ozone is descry
states "In 1986 he started treating AIDS patients with ozone." *
* * Mayer's work withholds patients began, he says, 'because I
knew (from) all the studies-animal studies as well as culture
studies that ozone could kill almost any virus there is.' Mayer
has worked with thirty AIDS patients, many of whom have visited
him from other parts of the country. They therefore have taken
equipment home with them that they use to give treatments to
themselves under Mayer's direction. Mayer remains in touch with
them and receives reports on their blood status. So far, Mayer
says the ozone treatments for AIDS have been a success. * * * "
Note that this was published in Sept., 1989 and reported
treatment by Mayer of AIDS patients with ozone since 1986. Dr.
Mayer attended many medical conferences between early 1986 and
August, 1989 and reported progress of treatment of ARC, AIDS and
HIV at a number of them. Harley filed his application August 15,
1989. Did he learn of treatment of HIV with ozone from one of Dr.
Mayer's presentations or publications? (copy of this article is

     9. Kief, H., "Derzeitiger Stand der Behandlung von HIV
positiven Patienten nit Ozon," Naturheilpraxis," 9/1988,
1043-1049. (tables enclosed for Kief's ozone treatment of
hepatitis, ARC and AIDS patients.) Note that this publication is
prior to the date of application for the Harley patent and
reports detailed results of successful treatment of HIV with
medical ozone.

     10. Fief, H., "Immunological Aspects of Ozone", 18 Biozon
Journal Nr. 6/89. The author states, "Clinical control studies of
the treatment of chronic aggressive hepatitis with hyperbaric
ozone therapy seems to suggest that ozone functions by means of
an activation of the immunological system. * * * Of interest is
the intracorporeal vaccine process which is accomplished with
killed viral material to the in vitro ozonized autogenic blood. *
* * the exclusive ozonization of blood within the I.V. bottle is
no counterargument for the extensive action of ozone within the
entire organism, especially after Kief proved the catalytic
propagation of a chain reaction of events in the peripheral blood
of treated patients * * * These results were again confirmed in a
publication with respect to data on the lymphocyte subpopulation
of AIDS and ARC patients after hyperbaric ozone therapy in which
in which in general a similar effect was obtained." (citing
Kief's article referenced supra as no. 9). (Note this article
published in June, 1989 reporting successful treatment of ARC and
AIDS with medical ozone is prior to the application date for the
Harley patent.)

     11. Schmitthauser, "The Inactivation of AIDS viruses in
Plasma Fractions,_____beim Autor. 72-74 Rue de Mar. Foch, I 67480
Lingolsheim. (cited as reference no. 5 by Kief in the paper
referenced supra, as no. 10).

      12. Roy, Engelbrecht and Chian, "Inactivation of Poliovirus
Type 1 With Ozone," Appl. environ. Microbiol. 41, 1980.

     13. "Manual of Ozone Therapy-Indication Application
Concentration-A Compilation from Existing Literature.
Published by Arztliche Gesellschaft fur Ozontherapie e.V
(recognized Non-Profit Making Society), Compiled by the
Scientific Department of Dr. J. Hansler GmbH. Valid as of
January, 1981. Published 1982. In chapter 3, Hepatic diseases,
major autohemotherapy is prescribed, with specific concentrations
and treatment protocols set forth. These are derived from Wolf,
"Das Medizinische Ozon". vfm 1979; Wolf EHK 25, 187 (1976);
Weiss, EHK 24, 138 (1975). In chapter 14 treatment of banked
blood with ozone is set forth to rid the blood of hepatitis
virus. Derived from Wolf, EHK, 22, 238 (1973); (copy enclosed)
(Note the information on treatment of banked blood with ozone to
achieve antiviral effect is published long before the application
date of the Zee patent.

     14. "Studies Say Ozone May Combat AIDS", The San Diego
Union, Oct. 27, 1988, p. A-3. This article is also mentioned in
discussion of the Wagner study, reference no. 3, supra. Note that
Carpendale is reported to have treated AIDS and ARC patients with
ozone through rectal administration prior to the date of
publication of the article

in October, 1988. The article states that as of October, 1988,
Carpendale was seeking approval to treat 20 more patients with
ozone. The article states further, "One study found ozone stops
the AIDS virus from multiplying in donated blood while leaving
more than 90 percent of blood cells undamaged, said Dr. Kenneth
Wagner, who performed the research before his October 1
retirement as head of the Naval Hospital's AIDS unit and
infectious diseases division.* * * But Wagner and Carpendale said
they want to study whether the worsening of AIDS in patients
might be slowed if some of their blood is removed, treated with
ozone and replaced, or if they are given the gas rectally so it
is absorbed quickly into their blood."

     This article, reporting on the 28th Interscience Conference
on Antimicrobial Agents and Chemotherapy, shows that as of
October, 1988, Carpendale had already treated ARC and AIDS
patients with ozone (in an FDA approved study) and that both
Carpendale and Wagner had already demonstrated in vitro efficacy
and lack of toxicity in ozone treatment of HIV. Both these
researchers are highly credible medical researchers working for
federal government agencies and the dates of publication of their
study results precede the date of application of the Harley
patent which was not until August, 1989.

     15. Rilling, S., Viebahn, R., The Uses of ozone in Medicine,
Karl F. Haug Publishers, Heidelberg, Federal Republic of Germany,

     Note p. 16, fig. 2, Inactivation of viruses (both enveloped
and non-enveloped) in river water and pure water using ozone.
Snyder and Chang, Aquatic applications of ozone (O3) IOA, 1975.

     "The elimination of microorganisms by ozone was already
observed by Fox in 1873." p. 17

     "However, a waterworks was constructed in the German city of
Wiesbaden in 1901 by Siemens, and--after typhus epidemics in 1893
and 1898, another ozone generator in the waterworks at Paderborn
(Westphalia) in 1902., p.17 (followed by the St. Petersburg ozone
waterworks) p. 18.

     Table 2, The 25 largest ozone facilities in the world (as of
1982.) Today Los Angeles is the largest.     See chapter 3, "The
historical development of ozone/oxygen therapy."

See chapter 4, "The medical application of ozone/oxygen
mixtures". p. 26 "Medical ozone is a mixture of ozone and oxygen
prepared from the purest oxygen via silent electric discharge."

   p. 29 Inactivation of viruses is one of the recognized
medically useful properties of ozone.

p. 41 "* * * when treating diseases caused by viruses, such as
herpes or hepatitis:  here, a completely different method of
application subjecting the patient to a minimum of discomfort
must be selected. Generally the choice falls upon major
autohemotherapy (Maj AHT), in which blood from the patient is
enriched extracorporeally with ozone and injected back
intravenously. * * * there are two other processes to be
discussed here which probably take place simultaneously: 1. Virus
inactivation through ozone or ozone peroxides. and 2. A Peroxide
intolerance of those body cells infected by viruses."    p. 43,
fig. 18 Inactivation of viruses through oxidation at the virus
spikes (or acceptors) (a) mechanical model and (b) chemical
      Chapter 4.3, p. 58. Application and indication. This lists
and discusses the following methods of application:

1. Intraarterial
2. Intestinal (enema)
3. Ozonized water
4. Intracutaneous ozone application ("blistering")
5. Ozone gas application
6. Subatmospheric ozone gas treatment
7. Subcutaneous injection
8. Intravenous injection
9. Intraarticular application
10. Intramuscular application
11. Major and minor autohemotherapy
12. Ozonized medicinal olive oil
13. Ozone gas application in body cavities

       It is submitted that if the method of administration
described in the Harley patent claims is actually one of these
widely recognized and internationally used methods of application
of medical ozone/oxygen mixtures), there is nothing novel
or unobvious about such claims and no actual improvement or
advance has been put forth. It is merely part of the prior art as
recognized and practiced throughout the world. Many of these
methods are incorporated in the Ryan patent, as set forth above.

   Chapter 11, p. 64. Major and minor autohemotherapy.
"Based on the methods and publications of his predecessor Wehrli,
H. Wolff has used both of these treatment methods since 1968, and
repeatedly drawn attention to their application in arthritis (now
thought to have a viral causative agent). hepatitis. allergies.
herpes infections and RES weakness (reticuloendothelial system)."

     As described above, Mayer has used major and minor ozone
autohemotherapy since before 1968, and the Ryan patent claims
which include major and minor ozone autohemotherapy, were issued
in 1962. AR the Ryan patent claims are now in the public domain,
and as major and minor autohemotherapy methods have been used in
treatment of human viral diseases and reported and published in
Europe and other parts of the world since at least 1968, it is
submitted that the field of treatment of viral diseases, whether
enveloped viruses or not, by ozone autohemotherapy and other
methods of administration covered by the Ryan patent claims, is
in the public domain. It is further submitted that it is not
appropriate, workable or proper to issue a patent covering use of
any of these established methods to treat any specifically named
viral disease unless it is demonstrated that prior art was not
adequate to treat ouch disease and that an actual advance or
improvement has been achieved by the applicant. Anything less is
not an improvement or "invention", but is merely an exercise in
word-games placing an unjustified any unrealistic emphasis upon
express specificity.

     An example might be arthritis. It is now reported that
certain types of arthritis (e.g. rheumatoid) are (or might; be)
caused by a viral causative agent or agents. Arthritis has long
been treated with medical ozone and a number of studies on the
subject have been published. Is an entire industry which may have
evolved internationally going to be suddenly attacked and taken
over by the issue of a patent who claims that he now has an
exclusive right to treat arthritis with medical ozone because he
has a patent covering the use of ozone to treat a certain virus
thought to be a causative agent of certain forms of arthritis?
What if, as is the case with AIDS, more than one virus may be
involved? Is the patent itself going to be rendered worthless if
subsequent to its issue another patent is issued covering
treatment of a different virus or other causative agent now
thought (because of the evolution of medical research) to be more
important in the cause of arthritis? What if certain viruses are
thought to cause rheumatoid arthritis and other types are thought
to cause other types of arthritis? Are doctors going to be
subjected to the threats and demands of a number of
patent-holders, depending on the exact type or types of arthritis
which may be diagnosed? Is the science of diagnosis really that
exact and certain? What if the consensus of medical opinion is 
radically changed again within a few years? Bear in mind that the
doctors are continuing to treat arthritis in the same methods of
administration of medical ozone they have always used, since a
period long before the patent office started issuing patents for
the use of medical ozone to treat every known microbial agent
which may, or may not, be implicated as a causative agent of a
very long and varied list of human diseases. This is more than a
hypothetical exercise as it seems to be the situation created by
the patent office in the field of the use of medical ozone to
treat AIDS or HIV. There questions and considerations go to
fundamental policies governing the issuance of patents in the
field of medicine.

     Another and even larger example is cancer. A number of
common viruses have long been known to be oncogenic. Now it is
generally acknowledged, and reported in newspapers, that most
cancer is directly caused by viruses, rather than indirectly as
previously supposed. For example, most of the world is liver
cancer is thought to be caused directly by hepatitis B virus.
Medical ozone has long been used to treat cancer of many types in
humans and animals. It has long been known that direct injection
of medical ozone into a tumor will cause prompt disintegration of
the tumor. Many cases have reported no clinically significant
toxic effect to the patient resulting from the rapid death of the
tumor, but animal studies have shown infection presumably
resulting from the death of the tumor cells. Is the patent office
going to issue a patent for use of medical ozone to treat
hepatitis B as the presumed causative agent of liver cancer?
Several patents already exist giving the holder an apparent right
to claim the exclusive right to use medical ozone to treat
hepatitis (e.g. the Ryan and Zee patents). But neither
specifically mention hepatitis B or liver cancer. Is the patent
office going to continue to make fine distinctions between types
of viruses and types of diseases which may be caused by a given
virus, and types of cancer that may be caused by the same type of
virus? And what of the many other factors that may  be involved
in the clinical appearance of cancer, and the many other forms of
treatment that a clinician may employ in treating any given case
of cancer? The fact that a virus is thought to directly cause
certain cancers obviously does not make cancer simply a viral
disease, as the presumption that HIV is the probable causative
agent of AIDS does not make AIDS a single viral disease--with its
many co-factors, complex immunological perturbations and
abnormalities, its complex autoimmune component, its mysterious
hormonal and neurological elements. How many different royalties
is the clinician going to be expected to pay for the use of
medical ozone alone, in any given clinical case?
     The future is murkier as viruses emerge from international
medical research as being implicated in the origin of many other
great diseases of man, such as multiple sclerosis, and as ozone
has been found helpful in treatment of such diseases as dementia,
Alzheimer's and Parkinson's, diseases for which the cause is not
yet known. Will a patent granted for ozone treatment of such
disease be invalidated when another patent is granted for
treatment of the same disease shortly after discovery of some
microbe as the probable causative agent?

    What of the investors who have been lured into investing
capital in securities of a company which has a patent for some
use of medical ozone which conflicts with other patents issued,
more generally or more specifically, covering the same subject?
Which investors are going to lose their investment because of a
flaw in an issued patent?

   The origin of these patent problems is the practice of the
U.S. Patent Office in issuing "use" patents which purport to
grant exclusive rights to an issue over some general or specific
medical "use" of a common natural substance where anyone can make
the substance; where the substance has been in widespread
international use for a wide variety of treatment purposes for a
long period of time; and where international research concerning
the medical applications of the substance has been proceeding for
decades and is accelerating together with the pace of medical
research in general.
     p. 65. Please note that ozone therapists from around the
world send treatment data to the Medical Society for Ozone
Therapy (founded 1972), in Austria, Germany and Switzerland d:
@'Arztliche Gesellschaft fur Ozontherapie" (see p. 25).
Significant reports on studies are published in "O3 OzoNews
OzoNchrichten - Ozonouvautes, published by the German and
Austrian Medical Societies for Ozone Therapy (Deutsche &
Osterreichische Gesellschaften fur Ozontherapie).
       Chapter 4.4.3, p. 68. Ozone therapy in virus infections.
"For the treatment of diseases caused by viruses, such as herpes
and hepatitis major autohemotherapy (Maj AHT) with ozone offers
itself as a method of choice." The reference cited is Dorstewitz,
H.: "Behandlung der Virushepatitis mit Ozon.", Kongressbericht
der Arztlichen Gesellschaften fur Ozontherapie, Baden-Baden 1981.
Please note that this date is prior to the date of application of
t he Zee patent (April 3, 1985) and major ozone autohemotherapy
is the procedure which Medizone claims to have patented under the
Zee patent. Also note that herpes (simplex and zoster) and
hepatitis are enveloped viruses, as is supposed to be covered by
the Zee patent. Please note also that the Ryan patent, which
incorporates various methods of autohemotherapy, specifically
mentions viral pneumonitis and virus pneumonia in at least three
examples described in the patent. What is novel or unobvious
about the claims or discoveries reported to have been "invented in 
the Zee patent? In the Harley patent?

     See also chapter 4.4.4, "Herpes simplex and herpes zoster."
Note that the reference here is Matassi, R., D'Angelo, F.,
Franchina, A.: "Ozontherapie bei Virustrankungen,"
Kongressbericht der Arztlichen fur Ozontherapie, Baden-Baden,
1981. Note that this date precedes the application dates of the
Zee patent and that of the Harley patent.

   p. 85. Note that herpes labialis was at one time in the early
1980's thought to be implicated in the origin of AIDS. Major and
minor autohemotherapy were recommended (for treatment of AIDS),
as for other viral diseases.

       16. Konrad, H. "Ozone vs. Herpes and Hepatitis-The Best
Option", Abstract of paper presented at the IOA 6th Ozone World
Congress. May, 1983, Washington, D.C. Note these are enveloped
viruses, that Konrad's paper described above shows he used major
ozone autohemotherapy, and that the date of publication precedes
the dates of application of the Zee and Harley patents.

       17. Dorstewitz, H., "The treatment  of Viral-Hepatitis
with Ozone-Oxygen Therapy," abstract of paper presented at the
IOA 6th Ozone World Congress, Washington, D.C., May, 1983. Note
hepatitis is an enveloped virus, that Dorstewitz's paper shows he
used major ozone autohemotherapy, and that the date of
publication precedes the dates of application of the Zee and
Harley parents.

     18. Hippocratic Medical Foundation, "Library Survey Ozone",
short list (26 pages), needs updating. Contains section on use of
ozone in treatment of viral diseases.

     19. Letter dated 1/2/89 from Canadian Surgeon General's
Office, National Defense Headquarters, Ottawa, Canada, to Dr.
Alastair J. Clayton, Federal Centre for AIDS, Health and Welfare,
Canada. This advises of approval granted to co-fund a proposed
Phase 1b Clinical trial. It encloses a "Statement of Work." This
reports completion of a trial involving ten HIV-1 infected
patients with minor ozone autohemotherapy (p. 3). With the
exception of one "terminal" patient all improved clinically and
at least three improved in laboratory values (p. 3). The absolute
CD4 count significantly increased over the eight week treatment
phase for P24-antigen negative patients with an initial CD4 count
above 200. Since only those patients with absolute CD4 counts
above 250 appeared to have derived benefit from this form of
therapy, it was proposed that 10 new patients be added to the
trial. No toxic or adverse effects were noted.

     Initial reports of this trial conducted in 1988 and its
long range follow-up have been widely distributed since early
1989 by the Surgeon General's Office, and Mueller Medical
International, Inc., which manufactured the equipment used in the
study. Subsequent wide dissemination was done by the AIDS Library
Survey Program of the Hippocratic Medical Foundation. This
includes presentations at medical conferences. Presentation of
the results of this study precedes the date of application for
the Harley patent (August, 1989). The efficacy of ozone in
treatment of HIV had already been demonstrated and "published" by
the Canadian Surgeon General's Office and others. The efficacy of
ozone in treatment of HIV had also been demonstrated and
published by Mayer, Preuss, Kieff and others before commencement
of the Canadian trial, as described above, and before the August,
1989 date of the Harley patent application.
      We reserve and request the right and opportunity to amend
this petition for reconsideration of the determinations resulting
in issuance of the Zee and Harley patents upon receipt and
examination of the Harley patent, a copy of which is ordered
herein (check for $3.00 enclosed together with self-addressed,
stamped envelope.)

     You asked me to send you a letter setting forth our position
relative to our request for reconsideration and the reasons
therefor together with references to new information that may not
have been considered in the review of the applications for the
protested patents. Please advise if our argument and references
should be presented in another form or if further information is

                    Respectfully submitted,
                    Samuel W. Murdoch Attorney for Petitioner,
                    Hippocrati Medical Foundation,
                    A California not-for-profit corporation
                    with letter rulings recognizing exempt
                    status from Internal Revenue Service
                    and California Franchise Tax Board