Ex Parte 5855920 et al

Board of Patent Appeals and Interferences

Jan 25, 2006

90005867 (B.P.A.I. Jan. 25, 2006)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte EverYoung Technologies, Inc.
____________

Appeal No. 2005-2593
Application No. 90/005,867
____________

ON BRIEF1
____________

Before MARTIN, HANLON, and DELMENDO, Administrative Patent Judges.
HANLON, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1, 2, 4-8, 10, 11, 13-17 and 25-36.2 The claims on appeal are directed to a
method for replenishing certain hormones as well as a hormone replenishment kit.

1 The appellant requested an oral hearing. See Request for Oral Hearing dated January 31, 2005. The
request was granted, and a hearing date was set for November 14, 2005. See Notice of Hearing mailed September
29, 2005. Counsel for the appellant did not attend the hearing. Therefore, this appeal has been decided on brief.
2 Claims 3, 9, 12, 18 and 37 were also finally rejected. However, the examiner withdrew the rejection of
claims 3, 9, 12, 18 and 37 in the Answer. See Examiner’s Answer at 4-5, 28. Additionally, claims 19 through 24 are
subject to reexamination, but the examiner previously indicated that these claims are patentable. See Final Office
action (Paper No. 11).
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The examiner relies on the following references:
Fahy WO 95/32991 Dec. 7, 1995
Umbreit DE 43 26 948 Nov. 17,
1994

Robert O. Scow & Susie N. Hagan, Effect of Testosterone Propionate and Growth
Hormone on Growth and Chemical Composition of Muscle and Other Tissues in
Hypophysectomized Male Rats, 77 Endocrinology 852-57 (1965) (hereinafter “Scow”).

Walter Pierpaoli & William Regelson, The Melatonin Miracle, Nature’s Age-Reversing
Disease Fighting Sex-Enhancing Hormone 259-75 (Pocket Books 1995) (hereinafter
“Pierpaoli”).

The following rejections are at issue in this appeal:
(1) Claims 1, 2, 7, 8, 10 and 11 are rejected under 35 U.S.C. § 102(b) as
being anticipated by Fahy.
(2) Claims 1, 2, 4-8, 10, 11, 13-17 and 25-36 are rejected under 35 U.S.C. §
103 as being unpatentable over the combined teachings of Fahy, Scow, Umbreit and
Pierpaoli.
Discussion
A. Rejection of claims 1, 2, 7 and 8 under 35 U.S.C. § 102(b)
Claims 1, 2, 7 and 8 are rejected under 35 U.S.C. § 102(b) as being anticipated
by Fahy. Claim 1 is directed to a hormone replenishment method and reads as follows:
1. A hormone replenishment method comprising:
measuring hormone levels in a sample of an otherwise healthy
human subject’s blood to determine that the level of human growth
hormone and the supplemental hormones selected from the group
consisting of sex hormone, melatonin hormone, adrenal hormone, thyroid
hormone, and thymus hormone are below pre-determined physiological
levels for an adult human; and
replenishing said level of said deficient hormones to pre-determined
physiological levels.
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Before we address the examiner’s position and the appellant’s arguments, it is
necessary to interpret claim 1. The method of claim 1 requires (1) measuring hormone
levels in a sample of an otherwise healthy human’s blood, (2) determining that the
levels of human growth hormone
and certain supplemental hormones are below “pre-determined” levels for an adult
human, and (3) replenishing the levels of those hormones to the “pre-determined”
levels. We note that a “pre-determined” level may be a range of values. See claim 9.
Also, claim 1 does not require that the “pre-determined” levels represent optimal values.
The claim includes a Markush group, i.e., “the supplemental hormones selected
from the group consisting of sex hormone, melatonin hormone, adrenal hormone,
thyroid hormone, and thymus hormone.” The claim does not expressly indicate the
number of supplemental hormones selected from the group. Nevertheless,
“supplemental hormones” is plural and reasonably connotes at least two supplemental
hormones. Therefore, we interpret claim 1 as requiring that the level of human growth
hormone as well as the levels of at least two supplemental hormones selected from the
group consisting of sex hormone, melatonin hormone, adrenal hormone, thyroid
hormone, and thymus hormone be determined to be below “pre-determined” levels.
This interpretation is consistent with the appellant’s specification. See, e.g.,
specification at col. 10, lines 5-8.
Furthermore, the appellant does not expressly define the term “pre-determined”
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in the specification. The American Heritage Dictionary of the English Language 1031
(William Morris ed., New College ed. 1976) (copy attached), defines the term “predetermine” as
“1. To determine, decide, or establish in advance . . . .” This definition appears to be consistent
with the appellant’s use of the term throughout the specification. Therefore, we further interpret
claim 1 as requiring that the “pre-determined physiological levels” of the hormones be
determined in advance of at least the determining step, i.e., step (2). See Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1584 n.6, 39 USPQ2d 1573, 1578 n.3 (Fed. Cir. 1996) (judges
may rely on a dictionary definition when construing a claim term, so long as the dictionary
definition does not contradict any definition found or ascertained by a reading of the patent
documents, including the specification).
We now turn to the examiner’s rejection of claim 1 and the teachings of Fahy.
Fahy teaches administering to a patient an amount of human growth hormone in
combination with an amount of DHEA (adrenal hormone). Fahy recognizes that human
growth hormone is a powerful approach to the treatment of aging. However, its
widespread use is inhibited by its serious side effects, the most important of which is
elevation of fasting and glucose-stimulated insulin levels. See Fahy at 1, lines 15-19.
Fahy discloses that a patient’s level of human growth hormone can be increased
without causing a corresponding increase in serum insulin levels by administering
human growth hormone in combination with DHEA. See Fahy at 4, lines 4-10. Thus,
one of ordinary skill in the art would have recognized that the invention disclosed in
Fahy would be useful in the treatment of aging.
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The examiner sets forth the rejection based on Fahy as follows (Answer at 5):
Fahy teaches measurement of hormones (page 8, lines 1-5),
determination of normal levels, (page 5, lines 25-30); followed by
concomitant administration of growth hormone (GH) and
dehydroepiandrosterone (DHEA). These compounds were administered
to reduce those effects associated with aging. Additionally,

these compounds were administer[ed] to provide “a radical increase in
longevity” (page 1, lines 20-30).
The appellant argues that Fahy does not disclose (i) measuring human growth
hormone and the supplemental hormones listed in claim 1 to determine that the
hormones are below pre-determined physiological levels for an adult human or (ii)
replenishing the level of the hormones to pre-determined physiological levels. Brief at
8.
Contrary to the examiner’s arguments, claim 1 does not merely require the
measurement and concomitant administration of human growth hormone and a
supplemental hormone such as DHEA. Rather, as explained above, the method of
claim 1 requires (1) measuring hormone levels in a sample of a human’s blood, (2)
determining that the levels of human growth hormone and at least two of the listed
supplemental hormones are below “pre-determined” levels, and
(3) replenishing the levels of those hormones to the “pre-determined” levels. Although
the predetermined levels are not limited to particular amounts, the term “pre-
determined” requires that the levels be decided in advance of at least the determining
step, i.e., step (2).
In “Experiment 1,” Fahy establishes “basal values for glucose, insulin,
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somatomedin C (a marker for growth hormone), DHEA-sulfate[3], serum lipids, and
testosterone” in a human patient before administration of arginine (a human growth
hormone releaser) and DHEA. See Fahy at 8, lines 1-3. Thus, Fahy measures
hormone levels in a human subject’s blood, including the recited “human growth
hormone” (via somatomedin C), “adrenal hormone” (DHEA), and “sex hormone”
(testosterone). Furthermore, Fahy compares the circulating level of somatomedin C to
a predetermined level (a target range of 700-3000 units/L, particularly 1000-1600
units/L) and replenishes any measured deficiency. See Fahy at 5, lines 15-17.
As for testosterone, Fahy does not disclose that the measured level is
determined to be below a predetermined level or administered to any level, including a
predetermined level. As for DHEA, Fahy discloses that the amount of DHEA
administered to a patient is based on two considerations, the circulating DHEA level and
the circulating insulin level, neither of which satisfies claim 1. According to the first
consideration, the amount of DHEA is not to exceed a predetermined level which is
100% greater than the level found in individuals 20-25 years of age. Id. at 5, lines 20-
25. Significantly, this predetermined level is not a replenishment or target level. Rather,
it is an upper limit on the amount of DHEA to be administered according to the second
consideration, i.e., circulating insulin levels, which likewise does not require
replenishment to a predetermined level. Id. at 5, lines 25-26. As explained in Fahy (p.
6, lines 17-20):

3 Fahy discloses that DHEA-sulfate is an example of a DHEA precursor. Fahy at 6, line 30.
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DHEA should be given “to effect.” “To effect” is defined as
sufficient to lower that particular patient’s insulin levels down to either
basal levels or, if basal levels are elevated in comparison to an accepted
standard for good health and long life, to levels deemed to maximize
longevity and health.

See also claim 2 of Fahy (“said second component [DHEA] is administered at doses
sufficient to maintain serum insulin levels at about the levels found in normal, healthy
patients”).
At most, Fahy suggests that one supplemental hormone (DHEA) is determined to
be below a predetermined level. Furthermore, Fahy does not disclose that any of the
supplemental hormones listed in claim 1 are replenished to predetermined levels.
Therefore, the rejection of claim 1 under 35 U.S.C. § 102(b) as being anticipated by
Fahy is reversed. See Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631, 2
USPQ2d 1051, 1053 (Fed. Cir.) ("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.”), cert. denied, 484 U.S. 827 (1987).
Claims 2, 7 and 8 are dependent on claim 1. Therefore, the rejection of claims 2,
7 and 8 under 35 U.S.C. § 102(b) as being anticipated by Fahy is also reversed. See
37 CFR § 1.75(c) (2002) (“Claims in dependent form shall be construed to include all
the limitations of the claim incorporated by reference into the dependent claim.”).
B. Rejection of claims 1, 2 and 4-8 under 35 U.S.C. § 103
Claims 1, 2 and 4-8 are rejected under 35 U.S.C. § 103 as being unpatentable
over the combined teachings of Fahy, Scow, Umbreit and Pierpaoli.
The examiner relies on the teachings of Scow, Umbreit and Pierpaoli to
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supplement the teachings of Fahy. However, the appellant argues that Scow, Umbreit
and Pierpaoli fail to cure the deficiencies of Fahy. See Brief at 13.
Scow discusses the effect of testosterone and growth hormone on the growth of
muscle and other tissues in rats. The examiner explains that this combination of
hormones was taught as useful for ameliorating conditions associated with aging and
for increasing the mass of musculature important to the sexual activity of the male.4
See Answer at 6. Pierpaoli relates to administering melatonin to mice to preserve
aspects of their youthful state. Finally, the disclosure of Umbreit relates to measuring
and administering estrogen to delay the aging process in men.
Relying on In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069 (CCPA 1980), the
examiner argues that (Answer at 6-7):
It is generally considered prima facie obvious to combine two
compounds each of which is taught by the prior art to be useful for the
same purpose, in order to form a composition which is to be used for the
very same purpose. The idea for combining them flows logically from their
having been used individually in the prior art. As shown by the recited
teachings, the instant claims define nothing more than the concomitant
use of two, or more conventional anti-aging agents. It would follow that
the recited claims define prima facie obvious subject matter.

Assuming for the sake of argument that it would have been obvious to administer
the combination of hormones disclosed in Fahy (human growth hormone and DHEA),
Scow (growth hormone and testosterone), Umbreit (estrogen) and Pierpaoli (melatonin)

4 The appellant denies that Scow discloses administering growth hormone and testosterone to treat the
effects of aging: “There is not one teaching [in Scow] of the combination as useful for ‘ameliorating conditions
associated with aging.’ ” Reply Brief at 6. However, as explained hereinafter, the teachings of Scow, either alone or
in combination with Fahy, Umbreit and Pierpaoli, fail to suggest the invention of claim 1. Therefore, it is not
necessary to address this issue.
Appeal No. 2005-2593 9
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to a human patient, claim 1 requires more. As discussed above, the method of claim 1
requires (1) measuring hormone levels in a sample of a human’s blood, (2) determining
that the levels of human growth hormone and at least two of the listed supplemental
hormones are below “pre-determined” levels, and (3) replenishing the levels of those
hormones to the “pre-determined” levels.
As explained above, Fahy, at most, suggests that one supplemental hormone
(DHEA) is determined to be below a predetermined level. Furthermore, Fahy does not
disclose that any of the supplemental hormones listed in claim 1 are replenished to
predetermined levels. Scow, Pierpaoli and Umbreit fail to cure the deficiencies of Fahy.

Specifically, neither Scow nor Pierpaoli discloses that one or more supplemental
hormones listed in claim 1 are determined to be below “pre-determined” levels and are
replenished to those levels. Umbreit, on the other hand, does suggest that estrogen is
measured and determined to be below a particular level. See EXAMPLE in Umbreit at
6.5 Specifically, the trial group discussed in Umbreit’s EXAMPLE consisted of thirty-
eight men having an estradiol blood level of less than 25 pg/ml. While estradiol and
other hormone levels were monitored throughout the trial, all of the subjects received
the same dosage (1 mg) of estradiol valerate per day for one to three years. Umbreit
indicates that when practicing estrogen therapy, “[t]he dose may depend on different
factors such as age or individual health status, including the level of the estrogen lever

5 Reference herein to Umbreit is to the English translation of record in the application.
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[sic] in man” and that “[t]he level of the daily estrogen dose ranges from 0.15 to 2.0 mg.”
Umbreit at 5, lines 20-22. However, Umbreit does not expressly identify an estrogen
replenishment level. Even assuming for the sake of argument that Umbreit does
suggest that estrogen is to be replenished to a predetermined level (25 pg/ml) and that
it would have been obvious to combine Umbreit’s estrogen therapy with Fahy, the result
would not satisfy claim 1 because the combination of Umbreit and Fahy would only
replenish one “supplemental hormone” (per the teachings of Umbreit) to a
predetermined level.6
For the reasons set forth above, the rejection of claim 1 under 35 U.S.C. § 103
as being unpatentable over the combined teachings of Fahy, Scow, Umbreit and
Pierpaoli is reversed. Claims 2 and 4-8 are dependent on claim 1. Therefore, the
rejection of claims 2 and 4-8 under

6 As a result, we do not reach the appellant’s additional argument that the rejection of claim 1 fails to take
into account the possibility of adverse side effects when combining different hormone therapies.
35 U.S.C. § 103 as being unpatentable over the combined teachings of Fahy, Scow,
Umbreit and Pierpaoli is also reversed. See 37 CFR § 1.75(c) (2002).
C. Rejection of claims 10 and 11 under 35 U.S.C. § 102(b)
Claims 10 and 11 are rejected under 35 U.S.C. § 102(b) as being anticipated by
Fahy. Claim 10 is directed to a hormone replenishment method and reads as follows:
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10. A hormone replenishment method comprising:
measuring hormone levels in a sample of an otherwise healthy
human subject’s blood to determine that the level of human growth
hormone and at least two of the supplemental hormones selected from the
group consisting of sex hormone, melatonin hormone, adrenal hormone,
thyroid hormone, and thymus hormone are below pre-determined
physiological levels for an otherwise healthy adult human; and
administering amounts of said deficient hormones to replenish said
level of said deficient hormones to pre-determined physiological levels.
Similar to claim 1, we interpret claim 10 as requiring (1) measuring hormone
levels in a sample of an otherwise healthy human’s blood, (2) determining that the
levels of human growth hormone and at least two of the listed supplemental hormones
are below “pre-determined” levels, and (3) replenishing the levels of those hormones to
the “pre-determined” levels.7

7 As in claim 1, we interpret claim 10 as requiring that the “pre-determined physiological levels” of the
hormones be determined in advance of at least the determining step, i.e., step (2).
As explained above, Fahy, at most, suggests that one supplemental hormone
(DHEA) is determined to be below a predetermined level. Furthermore, Fahy does not
disclose that any of the supplemental hormones listed in claim 10 are replenished to
predetermined levels. See section “A.,” supra. Therefore, we reverse the rejection of
claim 10 under 35 U.S.C. § 102(b) as being anticipated by Fahy. See Verdegaal Bros.,
814 F.2d at 631, 2 USPQ2d at 1053 ("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
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single prior art reference.”).
Claim 11 is dependent on claim 10. Therefore, the rejection of claim 11 under 35
U.S.C. § 102(b) as being anticipated by Fahy is also reversed. See 37 CFR § 1.75(c)
(2002).
D. Rejection of claims 10, 11 and 13-17 under 35 U.S.C. § 103
Claims 10, 11 and 13-17 are rejected under 35 U.S.C. § 103 as being
unpatentable over the combined teachings of Fahy, Scow, Umbreit and Pierpaoli.
Again, the examiner relies on the teachings of Scow, Umbreit and Pierpaoli to
supplement the teachings of Fahy. However, for the reasons discussed above, Scow,
Umbreit and Pierpaoli fail to cure the deficiencies of Fahy. See section “B.,” supra.
For this reason, the rejection of claim 10 under 35 U.S.C. § 103 as being
unpatentable over the combined teachings of Fahy, Scow, Umbreit and Pierpaoli is
reversed. Claims 11 and 13-17 are dependent on claim 10. Therefore, the rejection of
claims 11 and 13-17 under
35 U.S.C. § 103 as being unpatentable over the combined teachings of Fahy, Scow,
Umbreit and Pierpaoli is also reversed. See 37 CFR § 1.75(c) (2002).
E. Rejection of claim 25 under 35 U.S.C. § 103
Claim 25 is rejected under 35 U.S.C. § 103 as being unpatentable over the
combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 25 reads as follows:
25. A hormone replenishment kit comprising human growth
hormone and at least two of the supplemental hormones selected from the
group consisting of sex hormone, melatonin hormone, adrenal hormone,
thyroid hormone, and thymus hormone, said human growth hormone and
said at least two supplemental hormones present in an amount sufficient
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in establishing a regimen for the replenishment of said human growth
hormone and at least two of said supplemental hormones to
predetermined physiological levels.

Claim 25 is directed to a kit comprising an amount of human growth hormone
and an amount of least two supplemental hormones such as adrenal hormone and sex
hormone. As explained above, Fahy suggests that human growth hormone and DHEA
can be administered to a patient for the treatment of aging, and Umbreit discloses that
estrogen can be administered to a patient to slow down the aging process. Umbreit
also discloses that estrogen may be administered in combination with other active
substances and medications such as additional hormone compositions. See Umbreit at
4, lines 19-21. The examiner explains that it is generally considered prima facie obvious
to combine several compounds which are useful for the same purpose and use them for
that purpose. Therefore, the examiner concludes that it would have been prima facie
obvious to combine human growth hormone, DHEA and estrogen in a kit for the
treatment of aging. See Answer at 28-29.
The appellant argues that there is no indication in the cited references that the
supplemental hormones, e.g., adrenal hormone and sex hormone, are to be
administered to establish a predetermined physiological level of each of these
hormones in the blood of, for example, a human. See Brief at 22.
However, claim 25 does not impose such a requirement. Claim 25 merely recites
a hormone replenishment kit wherein human growth hormone and at least two of the
listed supplemental hormones are “present in an amount sufficient in establishing a
regimen” to replenish those hormones to predetermined physiological levels.
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Significantly, the combination of any amount of human growth hormone and at least two
of the listed supplemental hormones satisfies this claim limitation, including the amount
of human growth hormone and DHEA disclosed in Fahy and the amount of estrogen
disclosed in Umbreit.8
The appellant further argues that Fahy and the Fahy Declaration note the
functional relationship between hormones and the significant health risks or possible
adverse side effects associated with hormone administration. Therefore, the appellant
concludes that the cited references in combination do not teach or suggest that more
than one supplemental hormone could be combined in a kit to be administered with
human growth hormone. Brief at 22.
The appellant’s argument is not persuasive. First, the appellant does not point to
a specific teaching in Fahy to support its argument. Nevertheless, a review of the Fahy
reference by this panel reveals that Fahy indicates that administering a male
contraceptive to humans would not be desirable for a variety of reasons, including major
testicular shrinkage, and administering thyroid hormone is considered hazardous. See
Fahy at 3, lines 17-26. However, Fahy does not discuss significant health risks or

8 The amount of human growth hormone and the amount of at least two of the listed supplemental
hormones “sufficient in establishing a regimen” is dependent on a number of factors including the hormone
levels in the particular patient, the hormone replenishment levels, and the length of the regimen.
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possible adverse side effects associated with estrogen administration.9
Second, in his Declaration, George M. Fahy states (Declaration of George M.
Fahy dated March 19, 2002, at 3):

9 Fahy does not identify the male contraceptive referred to in the disclosure. Nevertheless, the appellant
has failed to establish that estrogen is used as a male contraceptive.
10. The ‘991 Application [Fahy] does not give any indication of
the possible effect of administering HGH plus two “unrelated” hormones,
though
it points out, in the “Background of the Invention” section, interest in
multiple hormones among proponents of anti-aging medicine.
11. To my knowledge, there can be side effects or health risks
associated with hormone supplementation such as increased serum levels
of insulin with HGH supplementation that increases the risk of heart
disease, and possibly an increased risk of prostate cancer in men with
testosterone supplementation[.]
Significantly, Dr. Fahy does not discuss any significant health risks or possible adverse
side effects associated with administering estrogen in combination with human growth
hormone and DHEA.
For the reasons set forth above, the rejection of claim 25 under 35 U.S.C. § 103
is affirmed.
F. Rejection of claims 26 and 27 under 35 U.S.C. § 103
Claims 26 and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over
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the combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 26 reads as
follows:
26. The kit of claim 25, wherein the amount of human growth
hormone is provided in intravenous unit form in doses of less than 0.5 mg
per day.

Fahy discloses that human growth hormone is administered by subcutaneous
injection or other efficacious route every day, every other day or three times a week at
an HGH equivalent dose of 0.01 to 0.05 mg/kg of body weight. See Fahy at 5, lines 6-
10. According to the teachings in Fahy, a dose of less than 0.5 mg per day would be
administered to a patient weighing less than 50 kg and receiving 0.01 mg/kg of human
growth hormone.10 It would have been prima facie obvious to one of ordinary skill in the
art to provide that dose in intravenous unit form as recited in claim 26.11 See In re
Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (suggestion to
modify may come explicitly from statements in the prior art, the knowledge of one of
ordinary skill in the art or may be implicit from the prior art as a whole). The appellant
has failed to present any evidence to the contrary. Therefore, the rejection of claim 26
under 35 U.S.C. § 103 is affirmed.
The appellant argues claims 26 and 27 as a group. Brief at 6. Therefore, the
rejection of claim 27 under 35 U.S.C. § 103 is also affirmed.
G. Rejection of claim 28 under 35 U.S.C. § 103

10 Claims 25 and 26 are not limited to human patients.
11 The appellant does not argue that intravenous application is patentably distinct from subcutaneous
injection. See Reply Brief at 24.
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Claim 28 is rejected under 35 U.S.C. § 103 as being unpatentable over the
combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 28 reads as follows:
28. The kit of claim 25, wherein said sex hormone comprises at
least one of testosterone, progesterone, and estrogen.

As discussed above, Umbreit discloses administering estrogen to a patient. The
appellant has failed to establish otherwise. Therefore, the rejection of claim 28 under
35 U.S.C. § 103 is affirmed.
H. Rejection of claim 29 under 35 U.S.C. § 103
Claim 29 is rejected under 35 U.S.C. § 103 as being unpatentable over the
combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 29 reads as follows:

29. The kit of claim 25, wherein said adrenal hormone comprises
dehydroepiandrosterone and pregnenolone.

The appellant argues that the references in combination fail to teach or suggest
the kit of claim 25 wherein the adrenal hormone includes both DHEA and pregnenolone.
Brief at 23; Reply Brief at 25. We agree. Fahy discloses administering DHEA to a
patient but does not disclose administering pregnenolone. The teachings of Scow,
Umbreit and Pierpaoli fail to cure this deficiency in Fahy. Therefore, the rejection of
claim 29 under 35 U.S.C. § 103 is reversed.
I. Rejection of claim 30 under 35 U.S.C. § 103
Claim 30 is rejected under 35 U.S.C. § 103 as being unpatentable over the
combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 30 reads as follows:
30. A kit for increasing life expectancy and life span comprising
human growth hormone and at least two of the supplemental hormones
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selected from the group consisting of sex hormone, melatonin hormone,
adrenal hormone, thyroid hormone, and thymus hormone, said kit for
establishing a regimen for the replenishment of said human growth
hormone and at least two of said supplemental hormones to
predetermined physiological levels.

Claim 30 is directed to a kit comprising human growth hormone and at least two
supplemental hormones such as adrenal hormone and sex hormone. As explained
above, Fahy suggests that human growth hormone and DHEA can be administered to a
patient for the treatment of aging, and Umbreit discloses that estrogen can be
administered to a patient to slow down the aging process. Umbreit also discloses that
estrogen may be administered in combination with other active substances and medications such
as additional hormone compositions. See Umbreit at 4, lines 19-21. The examiner explains that
it is generally considered prima facie obvious to combine several compounds which are useful
for the same purpose and use them for that purpose. Therefore, the examiner concludes that it
would have been prima facie obvious to combine human growth hormone, DHEA and estrogen
in a kit for the treatment of aging. See Answer at 31-33.
The preamble of claim 30 also indicates that the kit is “for increasing life
expectancy and life span.” However, this language is merely a statement of intended
use and fails to limit the scope of the claim. See In re Paulsen, 30 F.3d 1475, 1479, 31
USPQ2d 1671, 1673 (Fed. Cir. 1994) (the preamble of a claim does not limit the scope
of the claim when it merely states a purpose or intended use of the invention). In any
event, as discussed above, Fahy suggests that human growth hormone and DHEA are
useful in the treatment of aging, and Umbreit discloses that estrogen can be used to
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slow down the aging process. We find that one of ordinary skill in the art would have
expected a patient’s life expectancy and life span to be increased by treating or slowing
down the aging process using a combination of human growth hormone, DHEA and
estrogen.
The appellant argues that claim 30 is not prima facie obvious over the cited
references because none of the references teaches administering more than two
hormones. Brief at 24. It is of no moment that one reference does not teach
administering human growth hormone in combination with at least two of the
supplemental hormones listed in claim 30. See In re Keller, 642 F.2d 413, 426, 208 USPQ
871, 882 (CCPA 1981) (one cannot show nonobviousness by attacking references individually
where, as here, the rejection is based on a combination of references). As explained above, the
combined teachings of at least Fahy and Umbreit suggest

combining human growth hormone, DHEA and estrogen in a kit to treat or slow down the aging
process.
The appellant further argues that there is no motivation to combine human growth
hormone and at least two of the supplemental hormones listed in claim 30 because the cited
references recognize that possible health risks or adverse side effects may result from combining
hormones. Brief at 24. As discussed above, the appellant has failed to point to any evidence in
the record which establishes that combining human growth hormone, DHEA and estrogen would
have been expected to result in possible health risks or adverse side effects. See In re Schulze,
Appeal No. 2005-2593 20
Application No. 90/005,867

346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) (arguments in the brief do not
take the place of evidence in the record).
Finally, the appellant argues that the references do not provide any motivation for
a kit comprising the recited hormones which establishes a regimen for replenishing the
hormones to pre-determined physiological levels. Brief at 24. Significantly, the phrase
“said kit for establishing a regimen for the replenishment” of the recited hormones to
predetermined physiological levels is merely functional language and does not further
limit the structure of the kit. Cf. In re Casey, 370 F.2d 576, 580, 152 USPQ 235, 238
(CCPA 1967) (the manner or method in which a machine is to be utilized is not germane
to the issue of the patentability of the machine itself). In any event, the appellant has
failed to establish that the amount of human growth hormone and DHEA administered in
Fahy and the amount of estrogen administered in

Umbreit is not sufficient to establish a regimen for replenishing these hormones to
predetermined physiological levels.12
For the reasons set forth above, the rejection of claim 30 under 35 U.S.C. § 103
is affirmed.

12 Again, we note that the amount of human growth hormone and the amount of at least two of the
listed supplemental hormones “for establishing a regimen” for replenishing those hormones to
predetermined physiological
levels is dependent on a number of factors including the hormone levels in the particular patient, the
hormone replenishment levels, and the length of the regimen.
Appeal No. 2005-2593 21
Application No. 90/005,867

J. Rejection of claims 31 and 32 under 35 U.S.C. § 103
Claims 31 and 32 are rejected under 35 U.S.C. § 103 as being unpatentable over
the combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 31 reads as
follows:
31. The kit of claim 30, wherein the amount of human growth
hormone is provided in intravenous unit form in doses of less than 0.5 mg
per day.

Fahy discloses that human growth hormone is administered by subcutaneous
injection or other efficacious route every day, every other day or three times a week at
an HGH equivalent dose of 0.01 to 0.05 mg/kg of body weight. See Fahy at 5, lines 6-
10. According to the teachings in Fahy, a dose of less than 0.5 mg per day would be
administered to a patient weighing less than 50 kg and receiving 0.01 mg/kg of human
growth hormone.13 It would have been prima facie obvious to one of ordinary skill in the
art to provide that dose in intravenous unit form as recited in claim 31.14 See Kotzab,
217 F.3d at 1370, 55 USPQ2d at 1317 (suggestion to modify may come explicitly from
statements in the prior art, the knowledge of one of ordinary skill in the art or may be
implicit from the prior art as a whole). The appellant has
failed to present any evidence to the contrary. Therefore, the rejection of claim 31
under
35 U.S.C. § 103 is affirmed.

13 Claims 30 and 31 are not limited to human patients.
14 The appellant does not argue that intravenous application is patentably distinct from subcutaneous
injection. See Reply Brief at 26.
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Application No. 90/005,867

The appellant argues claims 31 and 32 as a group. Brief at 6. Therefore, the
rejection of claim 32 under 35 U.S.C. § 103 is also affirmed.
K. Rejection of claim 33
Claim 33 is rejected under 35 U.S.C. § 103 as being unpatentable over the
combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 33 reads as follows:
33. The kit of claim 30, wherein said sex hormone comprises at
least one of testosterone, progesterone, and estrogen.

As discussed above, Umbreit discloses administering estrogen to a patient. The
appellant has failed to establish otherwise. Therefore, the rejection of claim 33 under
35 U.S.C. § 103 is affirmed.
L. Rejection of claim 34 under 35 U.S.C. § 103
Claim 34 is rejected under 35 U.S.C. § 103 as being unpatentable over the
combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 34 reads as follows:
34. The kit of claim 30, wherein said adrenal hormone comprises
dehydroepiandrosterone and pregnenolone.
The appellant argues that the references in combination fail to teach or suggest a
kit containing an adrenal hormone comprising dehydroepiandrosterone and
pregnenolone. Brief at 25; Reply Brief at 27. We agree. Fahy discloses administering
DHEA to a patient but does not

disclose administering pregnenolone. The teachings of Scow, Umbreit and Pierpaoli fail
to cure this deficiency in Fahy. Therefore, the rejection of claim 34 under 35 U.S.C. §
Appeal No. 2005-2593 23
Application No. 90/005,867

103 is reversed.
M. Rejection of claims 35 and 36 under 35 U.S.C. § 103
Claims 35 and 36 are rejected under 35 U.S.C. § 103 as being unpatentable over
the combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 35 reads as
follows:
35. A method of inhibiting physiological conditions associated
with biological aging comprising:
measuring hormone levels in a sample of an otherwise healthy
human subject’s blood to determine that the level of human growth
hormone and at least two of the supplemental hormones selected from the
group consisting of sex hormone, melatonin hormone, adrenal hormone,
thyroid hormone (T-3), and
thymus hormone are below pre-determined physiological levels for an
adult human; and
replenishing said level of human growth hormone and said at least
two supplemental hormones to pre-determined physiological levels.

The examiner argues that claim 35 defines nothing more than the use of two or
more conventional anti-aging agents. Answer at 35. We disagree. Similar to claims 1
and 10, the method of claim 35 requires (1) measuring hormone levels in a sample of
an otherwise healthy human subject’s blood, (2) determining that the levels of human
growth hormone and at least two of the listed supplemental hormones are below “pre-
determined” levels, and (3) replenishing the levels of those hormones to the “pre-
determined” levels.15

15 As in claims 1 and 10, we interpret claim 35 as requiring that the “pre-determined physiological levels”
of the hormones be determined in advance of at least the determining step, i.e., step (2).
Appeal No. 2005-2593 24
Application No. 90/005,867

As explained above, Fahy, at most, suggests that one supplemental hormone
(DHEA) is determined to be below a predetermined level. Furthermore, Fahy does not
disclose that any of the supplemental hormones listed in claim 35 are replenished to
predetermined levels. The teachings of Scow, Pierpaoli and Umbreit fail to cure the
deficiencies in Fahy. See section “B.,” supra. Therefore, the rejection of claim 35 under
35 U.S.C. § 103 as being unpatentable over the combined teachings of Fahy, Scow,
Umbreit and Pierpaoli is reversed.
Claim 36 is dependent on claim 35. Thus, the rejection of claim 35 under 35
U.S.C.
§ 103 as being unpatentable over the combined teachings of Fahy, Scow, Umbreit and
Pierpaoli is also reversed. See 37 CFR § 1.75(c) (2002).

Appeal No. 2005-2593 25
Application No. 90/005,867

Conclusion
The rejection of claims 1, 2, 7, 8, 10 and 11 under 35 U.S.C. § 102(b) as being
anticipated by Fahy is reversed.
The rejection of claims 1, 2, 4-8, 10, 11, 13-17, 29 and 34-36 under 35 U.S.C. §
103 as being unpatentable over the combined teachings of Fahy, Scow, Umbreit and
Pierpaoli is reversed.
The rejection of claims 25-28 and 30-33 under 35 U.S.C. § 103 as being
unpatentable over the combined teachings of Fahy, Scow, Umbreit and Pierpaoli is
affirmed.

AFFIRMED-IN-PART

JOHN C. MARTIN )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
ADRIENE LEPIANE HANLON ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
Appeal No. 2005-2593 26
Application No. 90/005,867

)
)
)
ROMULO H. DELMENDO )
Administrative Patent Judge )

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