Ex Parte Fleischner

Board of Patent Appeals and Interferences

Sep 27, 2007

10693442 (B.P.A.I. Sep. 27, 2007)

The opinion in support of the decision being entered today
is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ALBERT M. FLEISCHNER
__________

Appeal 2007-1615
Application 10/693,442
Technology Center 1600
__________

DECIDED: September 27, 2007
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and ERIC GRIMES,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134 from a final rejection of
claims 1, 2, 7, 35, and 36. The Examiner has rejected the claims as
unpatentable under 35 U.S.C. § 103(a).1 We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

1 Written description and enablement rejections of the claims under the first
paragraph of 35 U.S.C. § 112 have been withdrawn (Answer 4).
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DISCUSSION
“The Hoodia gordonii cactus has been used safely and effectively for
decades to temporarily stave off hunger and thirst” (Spec. 2). According to
Appellant, “temporary or opportunistic use appears . . . to cause a long-term
increase in body mass” (id. at 3) because “one-time administration creates a
transient appetite suppression phase . . . followed by an appetite stimulation
phase of indeterminate duration” (id. at 5).
Nevertheless, Appellant teaches that Hoodia gordonii “can be used to
safely and effectively control obesity . . . [by regulating] the timing of the
hoodia administration” (id. at 4). In particular, Appellant “propose[s] repeat
administration, before the onset of the appetite stimulation phase. In other
words, [ ] administration [that] occurs at least as frequently as the length of
the appetite suppression phase” (id. at 5), “over an extended period of time
. . . enabl[ing] the user’s body to adjust to a lower basal body weight” (id. at
6).
Claims 1, 2, 7, 35, and 36, the only claims at issue in this appeal,2 are
as follows:
1. A method of body weight reduction, comprising administering
to a human in need thereof a body weight reducing amount of
hoodia gordonii at least once every about 48 hours, for at least
about 45 days.

2. The method of claim 1, said hoodia gordonii administered at
least three times every 24 hours.

2 Claims 3-6, 17-26, 28-34, and 37-40, are also pending, but have been
indicated allowable (Answer 3). Claims 8-16 and 27 have been canceled
(Br. 1).
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7. The method of claim 2, comprising administering from about 5
to about 200 milligrams of hoodia gordonii, together with from
about 50 to about 200 micrograms of chromium, from about 10
to about 50 micrograms of vanadium, 0 to about 400 milligrams
of glucomannan, from about 25 to about 200 milligrams of
sodium carboxymethylcellulose, 0 to about 15 milligrams of
citrus naringinine, 0 to about 200 milligrams of glucosamine, 0
to about 500 milligrams of cocoa PEA standardized extract, and
0 to about 250 milligrams of green tea extract.

35. A method of body weight reduction, comprising administering
to a human in need thereof hoodia gordonii in an amount
sufficient to suppress the appetite after said administration, said
administration repeated a plurality of times, each one of said
times occurring before said hoodia gordonii causes an appetite
stimulating effect.

36. The method of claim 35, said hoodia gordonii administered at
least three times every 24 hours.

The Examiner relies on the following references:
Van Heerden US 6,376,657 Apr. 23, 2002
Fleischner US 6,420,350 Jul. 16, 2002

Tulp et al., Effect of Hoodia Plant on Food Intake and Body Weight in Lean
and Obese LA/Ntul//-cp Rats, 15 FASEB Journal A404 (March 7, 2001).

Barnett, In Africa the Hoodia Cactus Keeps Men Alive. Now Its Secret is
‘Stolen’ to Make Us Thin, The Observer (June 17, 2001).

Habeck, A Succulent Cure to End Obesity, 7 Drug Discovery Today 280-281
(March 2002).

Kahn, Prickly Dispute Finally Laid to Rest: San Reach Agreement with
CSIR Over Use of Appetite-Suppressing Cactus, Business Day
(Johannesburg) (March 22, 2002).

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Obviousness
I. Claims 1, 2, 35, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tulp, Barnett, Habeck, Kahn, or Van Heerden.
Tulp teaches that “[c]onsumption of the [South] African Hoodia plant
has been used for many years to control appetite in humans” (Tulp,
Abstract). “To determine the effects of Hoodia sp. on food intake [ ] and
body weight [ ], groups of young adult male lean and obese LA/Ntul//-cp
rats were administered a dehydrated crude homogenized preparation
obtained from . . . Hoodia [sp.] or fed normally (controls)” (id.).
“Spontaneous [food intake] decreased by < 50% within 2h of administration
of crude plant mixture or extract” and “[a]d libitum administration (< 3 w.)
resulted in sustained decrease in voluntary [food intake] in lean and obese
rats and with marked reduction in [body weight] (< 100 g/rat) in obese and
moderate reduction (< 50 g/rat) in lean rats, while control rats fed normally
gained [body weight] normally” (id.). Tulp concluded that “these results
indicate that Hoodia sp. may have strong potential for clinical appetite
regulation and weight control” (id.).
Both Kahn and Barnett report that P57, the appetite-suppressing
ingredient in the Hoodia cactus, has been isolated and patented.
Habeck teaches that extracts from the Hoodia plant have been shown
to be “highly effective in reducing weight” (Habeck 280), and that P57, the
active ingredient in Hoodia, “produced a significant weight loss and had a
good safety profile in a variety of preclinical studies using rats, mice and
dogs” (id.). The results of a “proof-of-principle” study in humans were
consistent with the results observed in animals. “60 patients took part in [a]
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double blind, placebo controlled study. During the first two-stages of the
study . . . the safety, tolerability and pharmacokinetics of ascending single
doses [of P57] and of repeated dosing in healthy overweight volunteers
[were assessed]” (id.). “In the third phase, . . . the effects on calorie intake
in [ ] overweight men who took the compound or placebo twice daily for 15
days [were investigated]” (id.). “By the end of the study, men in the
treatment group achieved a 30% reduction in calorie intake, accompanied by
a significant reduction in body fat content by 1 kg” (id.). Habeck reports
that an independent consultant, responsible for advising researchers on the
dietary aspects of their clinical trials “agree[d] that the results of the proof-
of-principle study are very encouraging” and suggested “longer studies in
more people to demonstrate that this is a consistent effect[,] [since] [o]besity
is a chronic relapsing problem” (id.). Habeck also reports that the
researchers’ “next step will be to look at the dosing interval” (id.).
Van Heerden describes appetite suppressing extracts of Hoodia, a
pharmaceutical composition containing P57, a compound from the Hoodia
plant responsible for appetite suppression, and derivatives and analogs of
P57. Test rats given a single dose of an extract of Hoodia “on day 5 [of an
experiment described in Examples 1 and 2] displayed a substantially
diminished food intake over the next two days, while the control group did
not disclose a comparable reduced food intake. The food intake of the test
group returned to normal, and in fact increased from day 8 onwards” (Van
Heerden, col. 37, l. 50 to col. 38, l. 4). In other words, the appetite
suppressive effect of a single dose lasted 2 to 3 days, after which appetite
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rebounded. No data on body mass gain or loss were provided for the
experiments discussed in Examples 1 and 2.
However, in several other experiments, Van Heerden showed that the
appetite suppressive effect of Hoodia is associated with reductions in body
weight or decreased growth rate when compared to controls. For example,
in Example 44, an eight day study, Hoodia sap (Sample 1), administered
orally, “produced marked, dose-related reductions in daily food
consumption[,] [and] [t]he duration and amplitude of these reductions . . .
were dose-dependent . . . The highest dose of Sample 1 (sap) produced
statistically significant reductions in food consumption on a daily basis up to
5 days post-dose” (Van Heerden, col. 58, ll. 18-27). “Sample 1 (pure sap)
[also] produced dose-related, statistically significant effects on bodyweights
when compared with the vehicle-treated control group . . . These effects
were statistically significant from 48 hours post-dose until the end of the
study” (id. at col. 58, ll. 46-53). Spray dried sap (Sample 2), also “produced
marked and statistically significant reductions in food consumption . . .
[which] lasted 48 hours post-dose” (id. at 58, ll. 28-31), and “statistically
significant reductions in growth of the animals when compared with the
vehicle-treated control group . . . These effects were statistically significant
between days 3 (48 hours post-dose) and 5 inclusive” (id. at 58, ll. 54-59).
The Examiner acknowledges that the “references do not expressly
teach the time periods/intervals instantly claimed” (Answer 15). However,
the Examiner argues that the cited references “teach that the cactus plant
Hoodia gordonii (and/or extracts thereof - such as the sap: as disclosed in
[Van Heerden]) is effective as a weight loss and/or anti-obesity agent for
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losing weight when orally administered” (Answer 5), and contends that
“[t]he adjustment of particular conventional working conditions - e.g.,
determining appropriate, suitable time periods and intervals for orally
administering [ ] a Hoodia gordonii weight-loss product - is deemed merely
a matter of . . . routine optimization which is well within the purview of the
skilled artisan, especially given that the skilled dietary artisan would clearly
take into account the amount of weight an overweight/obese subject needs to
lose and administer such a weight-loss product accordingly - e.g., on a
commonly-employed once or more daily basis for an extended period of
time (as instantly claimed) so as to achieve a desired amount of weight
loss/reduction in the . . . subject” (id. at 5-6).
We agree with the Examiner. All of the references relied on by the
Examiner discuss the appetite suppressive effect of the Hoodia plant and its
extracts, and Tulp, Habeck, and Van Heerden, at the very least, teach that
Hoodia’s appetite suppressive effect facilitates weight loss in animals,
including humans (in the case of Habeck). In addition, Van Heerden
provides evidence that the appetite suppressive effect of Hoodia is
temporary, and the appetite rebounds shortly after administration is ended;
thus, one skilled in the art would have found it obvious to continue
administration for an extended period of time. Habeck also provides
evidence that it would have been obvious for those skilled in the art to
administer Hoodia for longer periods of time than those used in the clinical
trials, since “obesity is a chronic relapsing problem and you need a treatment
that is going to work safely and effectively over a long period of time”
(Habeck 281). Habeck additionally provides evidence that it would have
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been obvious to optimize the dosing interval based on empirical observation.
Indeed, Habeck indicates that “the next step will be to take a look at dosing
intervals” (id.).
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). “Often, it will be
necessary for a court to look to interrelated teachings of multiple patents; the
effects of demands known to the design community or present in the
marketplace; and the background knowledge possessed by a person having
ordinary skill in the art, all in order to determine whether there was an
apparent reason to combine the known elements in the fashion claimed” (id.
at 1740-41).
We find that the Examiner has established that the combined
teachings of the cited references, all of which pertain to the appetite
suppressive effects of the Hoodia gordonii plant, and at least some of which
correlate that appetite suppressive effect with weight loss, would have
provided a reason for one of ordinary skill in the art to administer Hoodia
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for an extended period of time, and to adjust the dosage to prevent the
appetite from rebounding for the duration of the treatment period.
We have carefully considered all of Appellant’s arguments, but are
not persuaded otherwise.
In particular, Appellant argues that the Examiner equates appetite
suppression and weight control, but “one of skill in the art would recognize
that the two concepts are not coterminus” (Appeal Br. 12). Relying on the
Declaration of Albert M. Fleischner (dated December 21, 2005, hereinafter
“Decl. I”), Appellant argues that “[i]t is possible to cause weight loss
without suppressing appetite” and “it is possible to suppress appetite without
causing weight loss” (Appeal Br. 13), thus, “appetite suppression may have
no effect on body weight” (id. at 14). We do not disagree, but the distinction
is of no consequence in the present case because, as discussed above, the
references cited by the Examiner teach that the appetite suppressive effect of
Hoodia can indeed facilitate weight loss.
In a similar vein, Appellant argues that “[a]ppetite suppression . . .
may cause weight gain” (Appeal Br. 14). Appellant cites Blundell3 for the
proposition that food, “the most widely-used appetite suppressant in the
world can also cause weight gain” (id.). We are not persuaded. Again, the
references cited by the Examiner establish that Hoodia can suppress appetite
while reducing food intake, i.e., calorie intake, at the same time, and can
facilitate weight loss.

3 Blundell, “Pharmacological Approaches to Appetite Suppression,” 2
Trends in Pharmacol. Sci. 147157 (1991).
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Appellant argues that Van Heerden “teaches a reasonable expectation
not of success, but of failure” (Appeal Br. 18), because Van Heerden’s data
shows that the active ingredient in Hoodia “suppresses appetite transiently,
then stimulates appetite” (id. at 15), which “causes marked weight gain”
(id.). Appellant cites Van Heerden’s Figures 5 and 6 in support of this
contention. Figures 5 and 6 represent data from Example 45, and they do
show some inconsistencies - some animals given certain extracts lost body
mass, while some gained. However, Van Heerden states that
[a]nimals in this study received a restricted diet i.e. animals
only received food between 12:00 and 3:00 pm daily. This is
different from all other biological assays conducted thus far,
whereby food was available to the rats a[d] lib. Animals were
acclimati[z]ed over a seven day period (days -7 to -1), dosing
took place from day 0 to day 6 at 9:00 am by oral gavage . . .

The results generated during the study showed that the
acclimatization period was too short. Rats feed mainly during
the night and the sudden change to a restricted access to feed
for three hours during day-time, resulted in low daily feed
intakes. The daily intake of feed was still increasing in most
groups at the end of the acclimatization period when dosing
with the test items started. As a result of this, the effect of the
test materials did not significantly affect the food intake of the
rats during the period of dosing.

Van Heerden, col. 63, l. 53 to col. 64, l. 57. In other words, Van Heerden
acknowledges that this particular experiment was flawed. Therefore, we
find that the data shown in Figures 5 and 6 do not support Appellant’s
contention that “hoodia extracts cause body mass to increase, not decrease”
(Decl. I, ¶ 17). Indeed, as discussed above, Van Heerden’s Example 44
shows just the opposite.
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Appellant also argues that “one of skill in the art would read Habeck
to imply that [the active ingredient in Hoodia] was not effective to reduce
body fat” (Appeal Br. 21) because Habeck “specifically withheld the results
of the control group” (id. at 20). “Therefore,” Appellant argues, Habeck
“fails to inform one of skill in the art about whether the body fat change was
due to, for example, the prison-like conditions under which test subjects
were held, or the bad quality of food which they were given” (id.). We do
not find this argument persuasive. Habeck’s article is a summary of a 15
day double-blind, placebo controlled proof-of-principle study described as
“a very demanding clinical study because people had nothing to do but eat
and watch TV” (Habeck 280). Habeck does not reproduce the data
underlying the summary, but does report that the “men in the treatment
group achieved a 30% reduction in calorie intake, accompanied by a
significant reduction in body fat content by 1 kg” (id.). We do not agree that
one of skill in the art would conclude that the active ingredient in Hoodia
“was not effective in reducing body fat” (Appeal Br. 21), given the premise
of the article: Hoodia “has shown promise as an appetite suppressant in
clinical trials and could have potential as a new anti-obesity drug” (id.).
Appellant acknowledges that Tulp concludes that “Hoodia sp. may
have a strong potential for clinical appetite regulation and weight control”
(Declaration of Albert M. Fleischner, dated March 10, 2006, ¶ 21,
hereinafter “Decl. II”), but argues that “one of skill in the art would read this
as an invitation to pursue further experimentation” (id.), rather than an
“assurance of success in humans[,] because LA/Ntul//-cp mutants are so
different from normal rats (and from normal human beings)” (Appeal Br.
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24). Appellant points out that LA/Ntul//-cp rats used in Tulp’s experiments
have a number of mutations that result in morbid, early-onset obesity. This
argument is not persuasive. First, Appellant does not dispute that the
LA/Ntul//-cp rat is a recognized animal model of morbid obesity in humans
(see e.g., Decl. II, ¶17). Second, obviousness does not require an assurance
of success; on the contrary, only a reasonable expectation of success is
required.
Finally, Appellant argues that “[t]he claimed invention has several
secondary indicia of non-obviousness” (Appeal Br. 27), specifically,
“unexpectedly successful results” and “achieving a new and different
function” and “evidence of copying by competitors” (id.). With respect to
the first two indicia, Appellant has provided a number of Exhibits (clinical
trial results, appended to Decl. I), purportedly showing that “Hoodia
gordonii is effective for weight loss” (Appeal Br. 27), and argues that this
result “is not only different from the prior art, but the direct opposite of it”
(id. at 28). Even accepting that the clinical trials described in the exhibits
demonstrate that Hoodia is effective for weight loss in humans, we do not
agree with Appellant’s conclusion that the effect would have been
unexpected, or that the prior art would have suggested that Hoodia facilitates
weight gain when administered in multiple doses. For the reasons discussed
above, we do not agree that the prior art teaches that ingesting multiple
doses of Hoodia results in weight gain, and we find that the prior art of
record would have provided one of ordinary skill in the art with a
reasonable expectation that Hoodia gordonii would facilitate weight loss in
humans.
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Moreover, we are not persuaded by Appellant’s contention that
widespread copying of the instant invention is evidence of the present
invention’s non-obviousness. Appellant points to copies of Appellant’s
TrimSpa® brand Hoodia gordonii weight control product, “sold as
TrimSmartTM, TrimClubTM and HoodiaSpaTM, [which] copied the original
TrimSpa® product, the TrimSpa® formula, and used trade marks and trade
dress deceptively similar to the original TrimSpa® packaging” (Appeal Br.
29) as evidence of non-obviousness. While we agree that widespread
copying may be an indicator of non-obviousness, copying may be
attributable to other factors as well. See e.g., Cable Electric Products, Inc.
v. Genmark, Inc., 770 F.2d 1015 (Fed. Cir. 1985). In the present case,
Appellant has not established that copying is not attributable to others
capitalizing on Appellant’s advertising campaign and exposure in the market
place, particularly as Appellant’s trademarks and trade dress were copied in
an apparent attempt to pass off the copies as Appellant’s TrimSpa® product.
Similarly, Appellant points to “a large number of sources advertising Hoodia
weight loss products for sale . . . includ[ing] . . . www.hoodoba.com,
www.weightlossguide.com, www.h57.com, www.hoodithin.com and
www.phenterlean.com” (Appeal Br. 30). However, Appellant has not
established that these products were not based on disclosures in the prior art,
for example, Van Heerden’s disclosure of P57.
We find that the Examiner has established a prima facie case that the
claimed invention would have been obvious over the cited prior art, which
Appellant has not overcome by argument or evidence. The rejection of
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claims 1, 2, 35, and 36 under 35 U.S.C. § 103(a) as unpatentable over Tulp,
Barnett, Habeck, Kahn, or Van Heerden is affirmed.

II. Claims 1, 2, 7, 35, and 364 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tulp, Barnett, Habeck, Kahn, or Van Heerden, in view of
Fleischner.
The Examiner relies on Fleischner as disclosing additional “weight-
loss compositions comprising conventional art-recognized ingredients
commonly employed therein such as glucosamine, caffeine, green tea
extract, ma huang (ephedra/ephedrine), chromium, and/or vanadium”
(Answer 7), and contends that it would have been obvious to combine
Hoodia with these additional ingredients “for their known benefit” (id.).
Appellant’s arguments with respect to this ground of rejection are
essentially the same as for the previous rejection, and are not persuasive for
the reasons discussed above.
The rejection of claims 1, 2, 7, 35 and 36 under 35 U.S.C. § 103(a) as
unpatentable over Tulp, Barnett, Habeck, Kahn, or Van Heerden, in view of
Fleischner is affirmed.

4 The Examiner listed the claims subject to this rejection as claims 1, 2, 7-9,
35 and 36, but according to Appellant, claims 8 and 9 have been canceled
(Br. 1).

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SUMMARY
Both rejections of the claims under 35 U.S.C. § 103(a) are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2006).

AFFIRMED

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