Ex parte Kuhne

Board of Patent Appeals and Interferences

Aug 18, 1999

08034849 (B.P.A.I. Aug. 18, 1999)

Application for patent filed March 19, 1993. Applicant1
claims the benefit under 35 U.S.C. § 119 of the March 19,
1992, filing date of Application P42 08 828.3 in the Federal
Republic of Germany.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today
(1) was not written for publication in a law journal and
(2) is not binding precedent of the Board.
Paper No. 29
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte FRIEDRICH W. KUHNE
____________
Appeal No. 95-4791
Application 08/034,8491
____________
HEARING: August 5, 1998
____________
Before WINTERS, WILLIAM F. SMITH, and GRON, Administrative
Patent Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
Introduction
Appeal No. 95-4791
Application 08/034,849
Canadian Patent 1,268,714, issued May 8, 1990,2
appears to be the English equivalent.
Australian Patent Specification 599,027, published 3
November 6, 1986, appears to be the English equivalent.
2
This is an appeal under 35 U.S.C. § 134 of an examiner’s
rejection of Claims 1-13, all claims pending in this
application. Claims 1-13 stand finally rejected under 35
U.S.C. § 103 as being unpatentable in view of the combined
teachings of Sanosa G.M.B.H. (Sanosa), UK Patent Specification
481,732, published March 16, 1938; The Merck Index, 10th
Edition, page 1236, Abstract No. 8465 (1983); Kuhne et al.
(Kuhne I), EP-200,156, published November 5, 1986; Kuhne et2
al. (Kuhne II), EP-200,157, published November 5, 1986; and3
the prior art described in appellant’s specification. The
examiner has withdrawn the final rejection of Claims 1-13
under 35 U.S.C. § 101 (Examiner’s Answer (Ans.), page 2).
Claims 1, 10 and 11 are representative of the subject matter
claimed and read:
1. A method of parenterally treating HIV
infections, comprising administering to a subject in
need of such treatment an inhibition-effective amount of
a chemically-stabilized chlorite matrix comprising an
isotonic solution containing about 5 to about 100 mMol
ClO per liter of isotonic solution.2-
10. A method according to claim 1, wherein the
Appeal No. 95-4791
Application 08/034,849
3
unbound HIV virus present in the subject is inactivated
by the treatment thereby inhibiting infection of
undamaged
cells.
11. A method according to claim 1, wherein the
concentration of T-cells and NK cells are increased
after administration of said chlorite matrix.
The examiner appears to be satisfied by the evidence of
record that (1) the method appellant claims meets the
practical utility requirements of 35 U.S.C. § 101, and (2) the
description of the claimed invention in the specification
would have enabled one skilled in the art to make and use the
full scope of the method claimed in the manner provided by the
first paragraph of 35 U.S.C. § 112. We review the merits of
the final rejection under 35 U.S.C. § 103 in that light.
Discussion
1. Claim interpretation
The claimed process of parenterally treating HIV
infections requires parenteral administration of an
inhibition-effective amount of a chemically-stabilized
chlorite matrix comprising an isotonic solution containing
about 5 to about 100 mMol ClO per liter of isotonic solution2-
to a subject in need of treatment for HIV infections. We hold
that the phrase “HIV infections” in appellant’s claims means
Appeal No. 95-4791
Application 08/034,849
4
“the various subsidiary forms of the HIV virus” (Specification
(Spec.), p. 1, l. 9-10). Therefore, appellant’s claims are
limited to a method of treating the various subsidiary forms
of the HIV virus by parenterally administering amounts of the
chemically-stabilized chlorite matrix effective to inhibit one
or more of the various forms of HIV virus to a subject
infected by one or more of the various forms of HIV virus. It
is to be understood that opportunistic infections associated
with infections by one or more of the various forms of the HIV
virus simultaneously may be treated by the method claimed.
However, the claims require the step of administering amounts
of a chemically-stabilized chlorite matrix to a subject
infected by one or more of the various forms of
the HIV virus in amounts effective to inhibit the HIV viral
infection.
2. Prior art teaching
A. Sanosa, The Merck Index, and Acknowledgments
The examiner finds that Sanosa and The Merck Index teach
stabilized chlorite solutions of the type utilized in
appellant’s claimed process for use as topical, surgical,
and/or wound disinfectants and antiseptics (Ans., pp. 3-4).
We need not dwell on the question whether the examiner erred
Appeal No. 95-4791
Application 08/034,849
Column 3, lines 35-49, of U.S. 4,507,285 read:4
The activated oxygen stabilized according to
the invention, which is contained in a matrix of
chlorite ions, can be used in various fields, for
example, in medicine and in veterinary medicine,
5
in interpreting appellant’s claims or clearly erred in finding
identity between the stabilized hypochlorite solutions Sanosa
and The Merck Index describe and the stabilized chlorite
solutions employed in the processes appellant claims (Ans.,
pp. 7-8, bridging para.). Appellant’s specification expressly
states (Spec., p. 5,
l. 27-34):
The chlorite matrix, designated as WF10 in the
following experiments, was produced in accordance with
Example 1 of [Kuhne,] U.S. 4,507,285[, patented March 26,
1985,] which is hereby incorporated by reference by
the oxidation of a chlorite solution with hypochlorite,
reaction with perborate or percarbonate and dilution
with an isotonic solution of sodium chloride or an
appropriate nutrient medium to the concentrations
given in the following examples.
The examiner correctly finds that the “solution recited
in claims 5-6 and 12-13 (set forth in U.S. . . . 4,507,285
incorporated by reference at page 5 of the instant
specification), is taught as useful for sterilization,
disinfection and therapy of viral infections (Patent (285),
column 3, lines 35-55)” (Ans., p. 8). Appellant’s4
Appeal No. 95-4791
Application 08/034,849
in cosmetics, for the sterilization of food and
drinking water, and as feed additives. General
areas of medical application are to be found in
the fields of disinfectants and chemoprophylaxis.
The stabilized activated oxygen according to the
invention can especially be used, for example, for
the treatment of skin diseases such as herpes simples
[sic], herpes zoster, acne or burns, or wound healing
disorders or for macrophage and phagocyte stimulation.
In particular, an arteriopathy and an alopecia areata
can be influenced significantly. With melanomes [sic]
significant remissions have been obtained.
We consider Canadian Patent 1,268,714 to be an5
English translation of EP-200,156 and Australia 599,027 to be
an English translation of EP-200,157. We cite the English
publications.
6
specification states (Spec., p. 2, l. 5-13):
DE-OS 32 13 389, United States Patent No. 4,507,285
and United States Patent No. 4,296,103, describe
chemically-stabilized chlorite matrices which are
suitable for an external or oral therapeutic use.
Besides various bacterial infections, the external
treatment of virus infections, such as herpes simplex
and herpes zoster, is deemed possible in this manner but
an intravenous administration for the treatment of HIV
infections is not possible.
B. Kuhne I and Kuhne II5
Canadian Patent 1,268,714 (Canada) describes “the use of
a composition consisting of an aqueous solution of a
chemically stabilized chlorite matrix for intravenous and
topical administration in tumor treatments” (Canada, p. 1, l.
13-16). Isotonic solutions of stabilized chlorite matrices
Appeal No. 95-4791
Application 08/034,849
7
are administered in conjunction with conventional radiotherapy
and chemotherapy to influence the efficiency of conventional
radio- and chemotherapeutics (Canada, p. 1, l. 27, to p. 2, l.
24). The stabilized chlorite matrices are said to influence
the body’s own defense mechanisms (Canada, p. 3, l. 29-31).
Australia 599,027 (Australia) describes “the use of an
aqueous solution of a stabilized chlorite matrix for
intravenous administration in infectious conditions caused by
parasites, fungi, bacteria, viruses and/or mycoplasmas”
(Australia, p. 2,
l. 1-5). At page 2, lines 16-22, Australia teaches:
It is known from the literature . . . that there is a
close correlation between the extent of the oxidative
response to phagocytosis and the ability to kill
microorganisms intracellularly.

Australia proffers the results of in vitro tests on select
bacterial infections which purportedly illustrate that
stabilized chlorite matrices stimulates phagocyte activation
and cellular immune responses in vivo (Australia, p. 2a, l.
19, to p. 6,
l. 26). The evidence to which Australia points purports to
support its claims that effective amounts of aqueous solutions
of a stabilized chlorite matrix with a chlorite concentration
Appeal No. 95-4791
Application 08/034,849
8
of
12 to 72 Tmol ClO per ml may be administered intravenously to2-
treat infectious conditions caused by parasites, fungi,
bacteria, viruses and mycoplasmas (Australia, p. 2a, first
para.).
3. Issues and Findings
The consistent criterion for determination of
obviousness is whether the prior art would have suggested
to one of ordinary skill in the art that this process
should
be carried out and would have a reasonable likelihood of
success, viewed in light of the prior art.
In re Dow Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531
(Fed. Cir. 1988). “[T]he appealed claims must be considered
in light of all the evidence, and the resulting decision, that
the claimed invention would or would not have been obvious, is
to be made in such light.” In re May, 574 F.2d 1082, 1089,
197 USPQ 601, 607 (CCPA 1978).
The examiner argues that persons having ordinary skill in
the art reasonably would have expected from prior art
teachings as a whole that parenteral administration of
isotonic solutions of chemically-stabilized chlorite would not
only inhibit (1) virus infections of subjects infected with
all types of viruses, and (2) retrovirus infections of
Appeal No. 95-4791
Application 08/034,849
9
subjects infected with all types of retroviruses, but also (3)
the various subsidiary forms of the HIV virus infections in
humans infected with the various subsidiary forms of the HIV
virus. We disagree for the following reasons.
First, we find that the prior art direction to (1)
topically administer stabilized chlorite solutions prior to,
or in the course of, surgery as an anti-infectant,
disinfectant, or antiseptic, (2) topically or intravenously
administer stabilized chlorite solutions as an antitumor agent
in conjunction with radio- or chemotherapy, and (3)
intravenously administer stabilized chlorite solutions for the
treatment of “infectious conditions caused by parasites,
fungi, bacteria, viruses and/or mycoplasmas,” reasonably would
not have led persons having ordinary skill in the art to
expect success in treating HIV viral infection by parenteral
administration of stabilized chlorite solutions to an infected
subject without some objective evidence indicative of
potential success. The only objective evidence of potential
success in parenterally treating HIV virus infection that the
examiner presents relates to the treatment of subjects
infected with bacteria or subjects undergoing radio- or
chemotherapy for malignant tumors. The only objective
Appeal No. 95-4791
Application 08/034,849
10
evidence of success in treating virus infections that the
examiner presents relates to the topical treatment of herpes
simplex or zoster. In short, the prior art does not
adequately support its broad allegations that viral infections
as a whole and, more specifically, infection by the HIV virus,
can be treated by intravenous administration of stabilized
chlorite solutions. The prior art applied against the
appealed claims creates no more than an “obvious-to-try”
situation. See In re Eli Lilly & Co., 902 F.2d 943, 945, 14
USPQ2d 1741, 1743 (Fed. Cir. 1990):
An “obvious-to-try” situation exists when a general
disclosure may pique the scientist’s curiosity, such that
further investigation might be done as a result of the
disclosure, but the disclosure itself does not contain a
sufficient teaching of how to obtain the desired result,
or that the claimed result would be obtained if certain
directions were pursued. See generally In re O’Farrell,
853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988)
(defining obvious-to-try as when prior art gives “only
general guidance as to the particular form of the claimed
invention or how to achieve it”).
Second, Kuhne II, U.S. 4,507,285 (incorporated by
reference in this application), and the teaching of EP-200,155
summarized at page 2 of this specification, reasonably would
have suggested that stabilized chlorite solutions act to
inhibit infections by stimulating macrophage and phagocyte
activity, activity generally associated with bacterial
Appeal No. 95-4791
Application 08/034,849
11
infections. See page 2, l. 22-27, of appellant’s
specification and page 1064, phagocyte, of Stedman’s Medical
Dictionary, 24th Edition, Williams & Wilkins, Baltimore, MD
(1982)(attached).
Third, we find that the physiological activity of the HIV
virus is sufficiently unpredictable and so distinct from that
of bacteria that persons having ordinary skill in the art
reasonably would not have expected to be able to successfully
treat
subjects infected by the HIV virus using a procedure found to
be successful for treating bacteria. Little correlation
between success in treating the HIV virus and success in
treating other RNA viruses has been found. See the Discussion
in In re Wright, 999 F.2d 1557, 1561-1564, 27 USPQ2d 1510,
1513-1515 (Fed. Cir. 1993).
Fourth, the art has long sought and continues to search
for suitable means and methods for successfully treating
infection by the HIV virus.
Fifth, appellant’s specification cites prior art which
purports to teach that chlorine dioxide-liberating chlorites
generally had been presumed to attack red blood cells and
therefore had been considered unsuitable for treating
Appeal No. 95-4791
Application 08/034,849
12
infections via parenteral administration (Spec., pp. 1-2,
bridging para.).
Having weighed the evidence favoring unpatentability
against all the evidence to the contrary, we find that the
greater weight of the evidence directs us to reverse the
examiner’s rejection. We particularly note that, prior to the
Examiner’s Answer, the examiner steadfastly held that the
evidence in appellant’s specification would not have enabled
one skilled in the art reasonably to expect to successfully
use the method appellant presently claims. In that light, we
fail to see how general prior art suggestions to parenterally
treat parasite, fungi, bacteria, virus and/or mycoplasma
infections with chlorite solutions, which are supported by far
less evidence than is presented in appellant’s specification,
reasonably would have allowed persons having ordinary skill in
the art to expect to successfully treat HIV virus infection by
parenteral treatment
of a subject infected with HIV virus with known chlorite
disinfectants.
Appeal No. 95-4791
Application 08/034,849
13
4. Conclusion
We reverse the examiner’s rejections of Claims 1-13 under
35 U.S.C. § 103.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge)
)
)
)
WILLIAM F. SMITH ) BOARD OF PATENT
Administrative Patent Judge) APPEALS AND
) INTERFERENCES
)
)
TEDDY S. GRON )
Administrative Patent Judge)
bae
Appeal No. 95-4791
Application 08/034,849
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Appeal No. 95-4791
Application 08/034,849
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