Ex Parte Simoes-Nunes et al

Patent Trial and Appeal Board

Sep 26, 2012

10942172 (P.T.A.B. Sep. 26, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CARLOS SIMOES-NUNES and GILBERT M. WEBER
__________

Appeal 2011-013275
Application 10/942,172
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a method of manufacturing a bone strengthening food, a
bone strengthening food premix, a method of improving bone strength, and a
composition. The Patent Examiner rejected the claims for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appeal 2011-013275
Application 10/942,172

2
STATEMENT OF THE CASE
Claims 18-30 are on appeal. Claims 18 and 27 are representative and
read as follows:
18. A method of manufacturing a bone strengthening food or veterinary
composition for weaner piglets comprising admixing 25-hydroxy vitamin
D3 and Vitamin D3 with at least one food or veterinary composition,
wherein the amount of 25-hydroxy vitamin D3 is from about 10 to about 30
μg/kg and the amount of Vitamin D3 is from about 500 to about 2,000
IU/kg.

27. A composition comprising:
from about 10 μg to about 30 ug[sic]/kg 25-hydroxy vitamin D3 and
from about 300 to about 2,000 IU/kg Vitamin D3.

The Examiner rejected the claims as follows:
A. claims 27-30 under 35 U.S.C. § 103(a) as unpatentable over
Mazzaro,
1
Tritsch,
2
and Roberson;
3
and
B. claims 18-30 under 35 U.S.C. § 103(a) as unpatentable over Mazzaro,
Tritsch, Roberson, Hardy,
4
and Jefferies.
5

1
Stephen Thomas Mazzaro et al., WO 03/059358 A1, published July 24,
2003.
2
Jean-Claude Tritsch et al., US 2003/0170324 A1, published Sept. 11, 2003.
3
K. D. Roberson, Effect of 25-hydroxycholecalciferol level on performance
and bone strength in weanling pigs, 75 J. ANIM. SCI. (Suppl 1) 14 (1997),
Abstract 48, 89th Annual Meeting of the American Chemical Society of
Animal Science, Southern Section; Birmingham, Alabama, USA, Feb 1-4,
1997.
4
Malcom Edwards Hardy, Jr., WO 90/09179, published Aug. 23, 1990.
5
David Jefferies et al., Differences in metabolic parameters and gene
expression related to Osteochondrosis/Osteoarthrosis in pigs fed 25-
hydroxyvitamin D3, 33 VET. RES. 383-396 (2002).
Appeal 2011-013275
Application 10/942,172

3
OBVIOUSNESS
A. Composition claims 27-30.
The Examiner found that Mazzaro and Tritsch each disclosed a
composition of 25-hydroxy vitamin D3 and Vitamin D3, as feed and feed
premix for swine. (Ans. 7-8.) According to the Examiner, the Mazzaro and
Tritsch compositions had Vitamin D3 in the amount Appellants claim, but
had higher amounts of 25-hydroxy vitamin D3. (Id. at 8.) The Examiner
found that Roberson disclosed feeding weanling pigs a composition that
comprised 10, 20, or 40 μg/kg 25-hydroxy vitamin D3 as a dietary
supplement for bone strength, overlapping the amounts of 25-hydroxy
vitamin D3 in Appellants’ composition. (Id.) The Examiner concluded that
Appellants’ composition would have been obvious because:
It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same
purpose in order to form a third composition that is to be used
for the very same purpose; the idea of combining them flows
logically from their having been individually taught in the prior
art.

(Id. at 9, citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).)
Appellants agree that Mazzaro and Tritsch generally taught that 25-
hydroxy vitamin D3 could be used to feed a number of animal species
including swine, but contend that no specifics were given as to particular
doses suitable for swine. (App. Br. 10.) According to Appellants, Mazzaro
and Tritsch taught using 69 μg/kg 25-hydroxy vitamin D3, in contrast to the
lower 10-30 μg/kg range in Appellants’ composition. (Id. at 11, citing the
Declaration by Dr. Simões-Nunes submitted Mar. 31, 2009.) Appellants
stress that the amount of 25-hydroxy vitamin D3 in their composition “is
Appeal 2011-013275
Application 10/942,172

4
less than half of that used in the Mazzaro and Tritsch compositions,” and in
claim 28 “is less than one-third.” (Id. at 12.)
Turning to Roberson, Appellants summarize Roberson’s results in
tabular form (with 25-hydroxy vitamin D3 abbreviated as 25-OH D3):

(Id. at 13, citing the Declaration by Dr. Simões-Nunes.) Appellants state
that their own data confirms that 40 μg/kg 25-hydroxy vitamin D3 with no
Vitamin D3 results in increased bone strength, as Roberson showed.
However, Appellants contend that their own results demonstrate that “by
adding 1000 IU of Vit D3, one could use half the amount of 25-OH D3 and
still observe an increased bone strength.” (Id., citing the Declaration by Dr.
Simões-Nunes.) Dr. Simões-Nunes states:
Our data on weaner pigs (Example 2) can be summarized below. The
data are presented in the specification. The numbers below represent
the strength of the bone compared to the control group (no 25-OH D3
but with 1000 IU Vit D3), which is 100.

Appeal 2011-013275
Application 10/942,172

5
(Declaration 4.) Appellants contend:
Without this combination (i.e. using 20 μg of 25-OH D3 and no Vit
D3), Roberson observed weaker femurs. A person skilled in this art
would not expect beneficial results using a significantly lower
amount. There is no reasonable expectation of success, the claimed
methods and compositions would not have been obvious. There is no
suggestion in Roberson that one should add Vit D3 to 25-OH D3 for
an increased effect, let alone a synergistic result.

(App. Br. 13-14 (citation omitted).) However, according to the Declaration,
Roberson also disclosed that 20 μg of 25-OH D3 resulted in “equivalent
bone strength as the 40 μg D3 group,” and the Declaration states that the 40
μg D3 group had “increased bone strength.” That is, the 20 μg of 25-OH D3
diet and the 40 μg D3 diet had a beneficial result in common: an equivalent
increase in bone strength. One of ordinary skill in the art would have been
motivated to use 20 μg of 25-OH D3 to get an increase in bone strength
equivalent to that provided by 40 μg D3 that Roberson reported, even if
stronger femurs would not have been expected. Each of 25-OH D3 and D3
was known to produce beneficial bone strength results. It would have been
obvious to combine both in a third composition to be used for the same
purpose. It also would have been obvious that because the two each
individually promote bone strength, in combination they would have been
expected to supplement each other, and thus lower amounts could be used.
See, e.g., Merck & Co., Inc. v. Biocraft Labs, Inc., 874 F.2d 804, 809 (Fed.
Cir. 1989) (“Given the prior art teaching that both amiloride and
hydrochlorothiazide are natriuretic, it is to be expected that their co-
administration would induce more sodium excretion than would either
diuretic alone”); see also, In re Crockett, 279 F.2d 274, 276 (CCPA 1960)
(“[t]he [prior art] patents clearly teach that both magnesium oxide and
Appeal 2011-013275
Application 10/942,172

6
calcium carbide, individually, promote the formation of a nodular structure
in cast iron, and it would be natural to suppose that, in combination, they
would produce the same effect and would supplement each other. Even
assuming, as appellant alleges to be the case, that the two together produce
an effect somewhat greater than the sum of their separate effects, we feel
that the idea of combining them would flow logically from the teaching of
the prior art and therefore that a claim to their joint use is not patentable.”).
Appellants contend “[t]here is no suggestion in Roberson that one
should add Vit D3 to 25-OH D3 for an increased effect, let alone a
synergistic result. Further, there is nothing in Roberson relating to a feed
with synergistic results in older (finishing) pigs.” (App. Br. 14.) This
argument is unpersuasive because Appellants do not show how the observed
results differ from the expected supplementation effect, and amount to
synergism.

B. Method and composition claims 18-30
Appellants contend that “neither Hardy nor Jefferies add anything to
remedy the deficiencies of Mazzaro, Tritsch and Roberson, and in fact
actually teach away from Applicants' invention.” (Id.) Appellants explain
that tibia dysplasia is “a skeletal deformity where abnormal cartilage at the
ends of the bones fails to mineralize.” (Id.) According to Appellants, Hardy
proposed that 25-OH D3 in combination with D3 would reduce the
incidence of tibia dyschondroplasia in swine, but Jefferies disproved
Hardy’s proposal. (Id. at 14-15.) Appellants summarize:
Applicants maintain that one of ordinary skill in the art, would
conclude that in light of Jefferies, the teachings of Hardy would
extend only to poultry, and thus neither of these references
Appeal 2011-013275
Application 10/942,172

7
impact the obviousness of the present invention. Given that
Jefferies actually tested 25-OH D3 in pigs, and found no benefit
in joint health at the dosages used, one of ordinary skill in the
art certainly would not be motivated to reduce the dosage and
investigate whether this results in an increased bone strength.

(Id. at 15-16.)
Jefferies demonstrated that 25-OH D3 and D3 did not reduce tibia
dyschondroplasia in swine, thus showing that Hardy’s method of tibia
dysplasia prevention did not extend beyond poultry to swine. While
Jefferies may teach away from preventing tibia dysplasia in swine with 25-
OH D3 and D3, Hardy and Jefferies do not teach away from using 25-OH
D3 and D3 to strengthen bone, as suggested by Mazzaro, Tritsch, and
Roberson. We conclude that Mazzaro, Tritsch, and Roberson sufficiently
suggested the claimed methods and compositions. We agree with the
Examiner that “two drugs having the same action would need less amount of
each when they [are] given in combination.” (Ans. 13, emphasis omitted.)
See Merck & Co., 874 F.2d at 809. Given that the prior art demonstrates that
the effect for 25-OH D3 and for D3 varies with the dose amounts, it would
have been within the routine skill in the art to determine the effective doses.
“[W]here the general conditions of a claim are disclosed in the prior art, it is
not inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).

SUMMARY
We affirm the rejection of claims 27-30 under 35 U.S.C. § 103(a) as
unpatentable over Mazzaro, Tritsch, and Roberson.
Appeal 2011-013275
Application 10/942,172

8
We affirm the rejection of claims 18-30 under 35 U.S.C. § 103(a) as
unpatentable over Mazzaro, Tritsch, Roberson, Hardy, and Jefferies.

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

cdc