Ex Parte Zenk et al

Board of Patent Appeals and Interferences

Nov 24, 2008

10433043 (B.P.A.I. Nov. 24, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________________

Ex parte RONALD J. ZENK
and
JOHN L. ZENK,
Appellants
____________________

Appeal 2008-5341
Application 10/433,0431
Technology Center 1600
____________________

Decided: November 24, 2008
____________________

Before CAROL A. SPIEGEL, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL

1 Application 10/433,043 (“the 043 specification”), Treatment of Chronic
Fatigue Syndrome and Fibromyalgia Syndrome, filed 27 May 2003 is the
national phase under 35 U.S.C. § 371 of international application
PCT/US01/46241, filed 31 October 2001, which claims benefit of
provisional application 60/250,227, filed 30 November 2000. The real party
in interest is said to be Humanetics Corporation (Appeal Brief filed 15
October 2007 (“Br.”) at 1).
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Application 10/433,043

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This is an appeal under 35 U.S.C. § 134 from an Examiner’s final
rejection of all pending claims, claims 1-7 and 10-16. We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM-IN-PART.
The subject matter on appeal is directed to therapeutic and
prophylactic methods of treating chronic fatigue syndrome (“CFS”) by
administering Δ5-androstene-3ß-ol-7,17 dione or a defined metabolizable
precursor thereof. Claims 1 and 10, the only independent claims on appeal,
are illustrative and read (Br., Claims App’x 1-2):
1. A method of treating chronic fatigue syndrome
comprising administering a therapeutically
effective amount of a compound to a mammal in
need of such treatment wherein the compound is
selected from Δ5-androstene-3ß-ol-7,17 dione, Δ5-
androstene-3ß, 17ß-diol-7-one, Δ5-androstene-3ß,
7α-diol-17-one, Δ5-androstene-3ß, 7ß-diol-17-one
and the corresponding acetyl esters of these
steroids.
10. A method of prophylactically protecting
against the onset of chronic fatigue syndrome
comprising administering a prophylactically
effective amount of a compound to a mammal
desiring prophylactic protection against the onset
of chronic fatigue syndrome wherein the
compound is selected from Δ5-androstene-3ß-ol-
7,17 dione, Δ5-androstene-3ß, 17ß-diol-7-one, Δ5-
androstene-3ß, 7α-diol-17-one, Δ5-androstene-3ß,
7ß-diol-17-one and the corresponding acetyl esters
of these steroids.
The Examiner has rejected claims 10-16 as unpatentable under 35
U.S.C. § 112, first paragraph (enablement) (FR2 2; Ans.3 3-5). The

2 Final Office action mailed 21 May 2007 (“FR”).
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Application 10/433,043

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Examiner has rejected claims 10-13, 15, and 16 as unpatentable under 35
U.S.C. § 102(b) over Weeks4 (FR 4-6; Ans. 5-6). The Examiner has rejected
claims 1-7 as unpatentable under 35 U.S.C. § 103(a) over the combined
teachings of Weeks and White5 (FR 7-8; Ans. 7-8).
Appellants argue that claim breadth alone is not an appropriate basis
for rejecting a claim as not enabled (Br. 4). Appellants argue that the
subjects treated by Weeks are not the same subjects treated by the method of
claim 10 (Br. 5-6). Appellants argue there is no motivation to substitute the
anabolic steroids disclosed in White for treatment of fibromyalgia and CFS
with the non-anabolic steroids disclosed in Weeks for treatment of
fibromyalgia and no reasonable expectation of success in doing so (Br. 7-8).
The issues are whether Appellants have shown the Examiner erred
(a) in determining the 043 specification fails to enable claims 10-16;
(b) in finding Weeks inherently teaches the method of claims 10-13,
15, and 16, and
(c) in concluding it would have been obvious to substitute the
anabolic steroids of White for the non-anabolic steroids of Weeks with a
reasonable expectation of success to treat CFS.
II. Findings of Fact (“FF”)
The following findings of fact are supported by a preponderance of
the evidence of record.

3 Examiner’s Answer mailed 10 January 2008 (“Ans.”).
4 International publication WO/1999/025192, Use of Δ5-Androstene-3ß-ol-
7,17-dione in the Treatment of Arthritis, published 27 May 1999, by Charles
E. Weeks (“Weeks”).
5 U.S. Patent 5,935,949, Use of Androgen Therapy in Fibromyalgia and
Chronic Fatigue Syndrome, issued 10 August 1999, to Hillary D. White
(“White”).
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[1] The 043 specification (“Spec.”) defines CFS as “a clinically defined
condition characterized by severe disabling flu-like fatigue and a
combination of symptoms that include impairment in concentration
and short-term memory, sleep disturbances, and musculoskeletal
pain” (Spec. 1:20-22).
[2] According to the 043 specification, “there are no known
medications which permanently resolve the symptoms of . . . CFS . .
. and many of the currently used medications produce undesirable
side effects . . .” (Spec. 1:29-31).
[3] White treats the symptoms of CFS and fibromyalgia with androgen
therapy (White 2:10-12).
[4] White defines “androgen therapy” as “administration of a single
androgen or a combination of androgens” (White 2:67-3:2).
[5] White preferably administers “testosterone, an active metabolite of
testosterone such as dihydrotestosterone or androstenedione or a
testosterone derivative such as methyltestosterone, testosterone
enanthate or testosterone cypionate” (White 4:10-15).
[6] However, according to the 043 specification, “prolonged
administration of adrogens [sic] [as taught by White] involves a
number of undesirable side effects such as hirsutism in women”
(Spec. 3:1-3).
[7] Thus, the 043 specification describes treating CFS by administering
therapeutic amounts of a steroid “which does not appreciably
stimulate, increase or otherwise enhance the production of sex
hormones” (Spec. 3:27-29).
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[8] Androgens and estrogens are generic terms for the male and female
sex hormones responsible for the development of secondary sex
characteristics.6 Anabolic steroids are a class of steroid hormones
related to testosterone, i.e., they are androgenic steroids.7
[9] Specifically, the 043 specification describes administering Δ5-
androstene-3ß-ol-7,17 dione and metabolizable precursors thereof
for prophylactic, modulatory, ameliorative or curative treatment of
CFS (Spec. 3:20-32).
[10] According to the 043 specification, the dosage ranges and rates
“may be determined in accordance with standard industry practices”
and will differ depending upon a number of well known factors
including “whether the desired response is prophylactic,
modulatory, ameliorative or curative in nature” (Spec. 5:12-18).
[11] Weeks discloses using “Δ5-androstene-3ß-ol-7,17-dione and
precursors thereof which are readily metabolized in vivo to Δ5-
androstene-3ß-ol-7,17-dione but essentially incapable of being
metabolized to androgens, estrogens or dehydroepiandrosterone” to
treat all forms of arthritis, including fibromyalgia, in patients, e.g.
humans (4:8-12; 1:22-23; claims 1, 3 and 5).
[12] According to Weeks, the “treatment can be prophylactic,
ameliorative or curative in nature[]” (Weeks 4:24).

6 See e.g., White, Handler, and Smith, PRINCIPLES OF BIOCHEMISTRY,
fourth edition (1968), McGraw-Hill Book Company, New York, page 937.
7 See e.g., the definition of “anabolic steroid” in Wikipedia at
http://en.wikipeida.org/w/index.php?title=Anabolic&steroid&printable=yes downloaded 19
November 2008 or the definition of “anabolic-androgenic steroids” in the
online Encyclopedia of Sports Medicine and Science,
http://www.sportsci.org/encyc/anabster/anabster.html downloaded 19 November 2008.
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III. Discussion
A. Rejection of claims 1-7 under § 103(a)
1. Legal principles
“Where claimed subject matter has been rejected as obvious in view
of a combination of prior art references, a proper analysis under § 103
requires, inter alia, consideration of two factors: (1) whether the prior art
would have suggested to those of ordinary skill in the art that they should
make the claimed composition or device, or carry out the claimed process;
and (2) whether the prior art would also have revealed that in so making and
carrying out, those of ordinary skill would have a reasonable expectation of
success.” In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991).
“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the product
not of innovation but of ordinary skill and common sense. In that instance
the fact that a combination was obvious to try might show that it was
obvious under §103.” KSR International Co. v. Teleflex Inc., 127 S. Ct.
1727, 1742 (2007).
2. Analysis
Here, White and Weeds teach that fibromyalgia may be treated by
administering androgenic or non-androgenic steroids, respectively (FF 3 and
11). White further teaches that CFS may also be treated by administering
androgenic steroids (FF 3). The Examiner concluded it would have been
obvious to treat CFS using non-androgenic steroids, such as those described
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in Weeds, “since it is known that chronic fatigue syndrome and
fibromyalgia can be treated with androgen compounds” (Ans. 8).
The Examiner has failed to explain why an ordinarily skilled artisan
would have reasonably expected non-androgenic steroids used to treat
fibromyalgia to also treat CFS successfully. For example, the Examiner has
not provided evidence that fibromyalgia and chronic fatigue syndrome
sharing a common etiology or pathogenesis. As pointed out by Appellants,
androgenic steroids and non-androgenic steroids differ in both structure and
function, e.g., the former are responsible for secondary sexual
characteristics, while the latter is not (Br. 8). The Examiner has provided no
explanation or reference bridging the androgenic/non-androgenic
function/structure gap argued by Appellant. Rather, the Examiner expressly
states “steroidal compounds have very specific structural-activity
relationship. Changing one moiety would totally changes [sic] the activity
of the steroid compound” (Ans. 5). Thus, an “obvious to try” combination
of White and Weeks is insufficient to support a establish obviousness under
§ 103 in this case because of the unpredictable changes in biological activity
associated with changes in steroid structure.
Therefore, we reverse the rejection of claims 1-7 under § 103(a) over
the combined teachings of White and Weeks.
B. Rejection of claims 10-16 under § 112, ¶ 1 (enablement)
1. Legal principles
“[The] purpose of “enablement” requirement is to assure that the
inventor provides sufficient information about the claimed invention that a
person of skill in the field of the invention can make and use it without
undue experimentation, relying on the patent specification and the
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knowledge in the art.” Scripps Clinic & Research Foundation v. Genentech,
Inc., 927 F.2d 1565, 1566 (Fed. Cir. 1991). “Factors to be considered in
determining whether a disclosure would require undue experimentation”
include “(1) the quantity of experimentation necessary, (2) the about of
direction or guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or unpredictability of
the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d 731, 737
(Fed. Cir. 1988). It is well established the Examiner has the initial burden of
establishing, by compelling reasoning or objective evidence, that one of
ordinary skill in the art would be unable to practice the claimed invention
without undue experimentation. In re Strahilevitz, 668 F.2d 1229, 1232
(CCPA 1982); In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971); In re
Armbruster, 512 F.2d 676, 677 (CCPA 1975).
2. Analysis
Here, the 043 specification describes conventional administration of a
specifically defined set of steroids in a dosage regime said to be within skill
in the art to determine (FF 9-10). The Examiner contends the 043
specification fails to provide guidance for determining a subject desiring
protection against the onset of CFS or working examples of prophylactic
treatment (Ans. 8). The Examiner states the level of skill in the art is high
and the 043 specification provides working examples of therapeutic
treatment (Ans. 4). The Examiner also states that anyone who does not have
CFS will desire not to contract it (Ans. 9).
The Examiner has not satisfied his initial burden of establishing that
undue experimentation would be required to practice the method of claims
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10-16. The compound to be administered is defined by essentially a single
core steroid structure (and its metabolic precursors). The Examiner has not
provided any compelling reasoning or objective evidence that the “highly
skilled” artisan would have been unable to determine an appropriate dosage
regimen or that the steroid could not have been administered by
conventional means. A person does not have to understand the pathogenesis
of a disease to have a desire not to get the disease, e.g., a person does not
have to know how an influenza virus infects cells to desire a prophylactic flu
shot.
Therefore, the rejection of claims 10-16 under § 112, first paragraph
(enablement), is reversed.
C. Rejection of claims 10-13, 15, and 16 under § 102(b)
1. Legal principles
“During patent examination the pending claims must be interpreted as
broadly as their terms reasonably allow.” In re Zletz, 893 F.2d 319, 321
(Fed. Cir. 1989).
A claim is anticipated only if each and every element as set
forth in the claim is found, either expressly or inherently described, in a
single prior art reference. Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d
628, 631 (Fed. Cir. 1987). As set forth by the court in Kalman v. Kimberly-
Clark Corp., 713 F.2d 760, 772 (Fed. Cir. 1983), it is only necessary for the
claims to "'read on' something disclosed in the reference, i.e., all limitations
of the claim are found in the reference, or 'fully met' by it."
2. Analysis
The prophylactic treatment method of claim 10 differs from the
therapeutic treatment method of claim 1 in that the method of claim 1
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requires the recited steroid to be administered to a mammal that has CFS.
The mammal given the recited steroid in the method of claim 10 broadly
encompasses any mammal that does not have CFS. This broad
interpretation is consistent with the mammal being a dog or a cat, for
example, as recited in claim 12. To interpret the “mammal” recited in claim
10 otherwise would be to endow dogs and cats with the ability to decide
when to seek prophylactic treatment.
The Examiner found administering the claimed steroid compound to a
patient as described by Weeks inherently results in the method of claims 10-
13, 15, and 16 because the compound inherently possesses the claimed
utility (Ans. 6). Appellants argue “the class of subjects explicitly set forth in
the rejected claims is anyone desiring prophylactic protection against the
onset of chronic fatigue syndrome” (Br. 6, original emphasis). However, the
question is not whether a mammal desiring prophylactic protection against
the onset of arthritis, including fibromyalgia, necessarily desires
prophylactic protection against the onset of CFS. The salient question is
whether administration of the recited steroid compound to a mammal
inherently protects against the onset of CFS. Appellants have submitted no
compelling reasoning or objective evidence that prevention of the onset of
CFS is not an inherent property of the recited steroid compound. Therefore,
we agree with the Examiner that the method of claims 10-13, 15, and 16
reads on the method of Weeks. See Kalman, 713 F.2d at 772.
The rejection of claims 10-13, 15, and 16 under § 102(b) over Weeks
is sustained.
IV. Order
Upon consideration of the record, and for the reasons given, it is
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ORDERED that the decision of the Examiner rejecting claims 1-7 as
unpatentable under 35 U.S.C. § 103(a) over the combined teachings of
White and Weeks is REVERSED,
FURTHER ORDERED that the decision of the Examiner rejecting
claims 10-16 as unpatentable under 35 U.S.C. § 112, first paragraph
(enablement), is REVERSED,
FURTHER ORDERED that the decision of the Examiner rejecting
claims 10-13, 15, and 16 as unpatentable under 35 U.S.C. § 102(b) over
Weeks is AFFIRMED, and
FURTHER ORDERED that no time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a).
AFFIRMED-IN-PART

MAT

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