Ex Parte Caubel et al

Board of Patent Appeals and Interferences

Oct 31, 2007

10385867 (B.P.A.I. Oct. 31, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PATRICK MICHEL CAUBEL and ANDREW JOSEPH
FRIEDMAN
__________

Appeal 2007-4127
Application 10/385,867
Technology Center 1600
__________

Decided: October 31, 2007
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Before, TONI R. SCHEINER, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Claim 1 is the only pending claim.
1. A method of contraception comprising the step of administering to
a menstruating female a cycle of contraceptive therapy, said cycle of therapy
including the continuous administration for the length of the cycle of a
potent sulfatase inhibiting progestogen in a contraceptively effective and
breast protecting dose, in the absence of the administration of an estrogen,
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Application 10/385,867

wherein the progestogen is selected from the group consisting of
norgestimate and norelgestromin.

Grounds of Rejection
Claims 1 stands rejected under 35 U.S.C. § 103, as obvious over de
Nijs and Appellants admission in the specification.

Reference Cited
de Nijs 4,957,119 Sept. 18, 1990

DISCUSSION

Background
"The present invention relates to progestogen-only contraceptive
regimens for menstruating females. More particularly, the present invention
relates to progestogen only contraceptive regimens containing a potent
sulfatase inhibiting progestogen, such as, norgestimate (NGM) or
norelgestromin (NGMN)." (Specification 1.)
"A substantial percentage of human breast carcinomas are hormone-
dependent. Animal studies and clinical trials have confirmed that estrogens,
particularly estradiol, are the most important hormones involved in
supporting growth of hormone-dependent breast tumours." (Specification
1.)
Since estradiol is one of the main factors involved in
supporting growth of hormone-dependent breast tumours and
the sulfatase pathway is the main pathway for the formation of
estradiol in the breast, then a decrease of estradiol formation by

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Application 10/385,867

suppression of the sulfatase pathway would have potential
therapeutic activity in the management of breast cancer…
Suppression of the sulfatase pathway will have a breast
protective effect.

(Specification 1.)

Obviousness
Claims 1 stands rejected under 35 U.S.C. § 103, as obvious over de
Nijs and Appellants’ admission in the specification.
According to the Examiner, de Nijs discloses an implant containing a
contraceptive agent (abstract). The preferred active agent is a progestogen,
for example, levonorgestrel. It can be administered in a daily dosage of
15-30 µg (col. 2, lines 20-27). The implant is used for application in
humans, which and can bring about a virtually constant release of the active
substance. The implant may be applied to the uterus (col. 3, lines 44-58).
The constant release of progestogen is over a predetermined term (col. 8,
lines 10-12). (Answer 4.)
The Examiner acknowledges that de Nijs fails to disclose the patient
population to be menstruating females and fails to specifically mention the
claimed progestrogens, norgestimate and norelgestromin. (Answer 4.)
The Examiner relies on Appellants’ own admission of the prior art,
that norgestimate and norelgestromin are known progestogens, and are each
well known in the art of contraception therapy (Specification 6: 26-27;
Answer 4).

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The Examiner concludes that
[i]t would have been prima facie obvious to a person of
ordinary skill in the art, at the time the claimed invention was
made, to administer this contraceptive implant to menstruating
females and to substitute norgestimate or norelgestromin for
levonorgestrel.
A person of ordinary skill in the art would have been
motivated to administer menstruating females an implant
comprising a contraceptive agent because of the reasonable
expectancy of successfully preventing contraception.
A person of ordinary skill in the art would have been
motivated to substitute norgestimate or norelgestrornin for
levonorgestrel because: (1) De Nijs teach the general usefulness
of progestogen; (2) all three compounds are disclosed to be
progestogens; (3) all three are recognized to be art-equivalent.
Thus, one of ordinary skill in the art would have had a
reasonable expectation of successfully producing a
contraceptive regimen with norgestimate or norelgestromin as
taught by De Nijs.

(Answer 4-5.)

We agree with the Examiner's analysis and reasoning and find that the
Examiner has provided sufficient evidence to support a prima facie case of
obviousness.
In order to determine whether a prima facie case of obviousness has
been established, we considered the factors set forth in Graham v. John
Deere Co., 383 U.S. 1, 17 (1966); (1) the scope and content of the prior art;
(2) the differences between the prior art and the claims at issue; (3) the level
of ordinary skill in the relevant art; and (4) objective evidence of
nonobviousness, if present.

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The Examiner's evidence establishes that it is known in the art to use a
progestogen (progestin) in the absence of estrogen as a contraception agent
in a menstruating female. de Nijs indicates that the active progestogen may
be selected from known progestogens such as 3-ketodesogestrel,
levonorgestrel or gestodene. (de Nijs, col. 2, ll. 20-25.) Appellants also
admit that other progestins are known in the art of contraceptive therapy,
including norgestimate and norelgestromin. (Specification 6: 26-27.)
In making an obviousness determination over a combination of prior
art references, it is important to identify a reason why persons of ordinary
skill in the art would have attempted to make the claimed subject matter.
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741, 82 USPQ2d 1385,
1396 (2007). The Examiner has indicated a reason why one of ordinary skill
in the art would have been motivated to substitute other progestins such as
norgestimate and norelgestromin known for their contraceptive use, for the
levonogestrel implant described in de Nijs. It is noted that the motivation to
combine references does not have to be identical to patent owner’s to
establish obviousness. In re Kemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309,
1311 (Fed. Cir. 1996). “[W]hen the question is whether a patent claiming
the combination of elements of prior art is obvious” the relevant question is
“whether the improvement is more than the predictable use of prior art
elements according to their established functions.” KSR Int’l Co. v. Teleflex
Inc., 127 Ct. 1727, 82 USPQ2d 1385 (2007). In the present case, a
progestogen is being predictably used in accordance with its established
function, as a contraceptive agent.

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The Appellants contend that the Examiner admits that de Nijs
nowhere teaches or suggests norgestimate or norelgestromin as the active
agent. (Br. 9.) Appellants point out that de Nijs nowhere teaches or
suggests the continuous administration of a progestin-only contraceptive in
which the progestin is a sulfatase inhibiting progestin administered in a dose
that is both contraceptive and breast protective. Id. Moreover, Appellants
argue de Nijs nowhere teaches or suggests such a regimen wherein the
sulfatase inhibiting progestin is either norgestimate or norelgestromin. Id.
Appellants contend that the de Nijs reference fails to appreciate that
certain progestins are both sulfatase inhibiting and contraceptive and,
therefore, provide both a breast protective effect and a contraceptive effect.
(Id.) Appellants argue that the absence of this appreciation in de Nijs would
prevent a person skilled in the art from using this reference as the starting
point to the claimed invention. (Br. 9.)
Appellants further argue that the deficiency in de Nijs is not addressed
by the prior art statement in the specification cited by the Examiner, since
this portion of the specification merely states that norgestimate and
norelgestromin are progestogens known in the contraceptive art. Id. "The
teaching that norgestimate and norelgestromin are both sulfatase inhibiting
and contraceptive is provided only by the instant invention, which cannot be
used to fill in the deficiencies in the prior art." (Id., at 10.)
While each of Appellants’ observations may be true, they are not
sufficient to support patentability of the claimed invention. Using the same
composition claimed, a progestogen, in the same manner claimed, as a
contraceptive agent, naturally results in the same claimed benefit of

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contraception. (Perricone v. Medicis Pharmaceutical Corp. 432 F. 3d 1368,
1384 77 USPQ2d 1321, 1327 (Fed. Cir. 2005) (“The discovery of a
previously unappreciated property of a prior art composition … does not
render the old composition patentably new to the discoverer.”); EMI Group,
N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1349, 60
USPQ2d 1423,1428 (Fed. Cir. 2001); Atlas Powder Co. v. Ireco Inc., 190
F.3d 1342, 1349 (Fed. Cir. 1999) (“discovery of an inherent property of the
prior art [does] not [constitute] the addition of a novel element” and
therefore does not serve as patentable subject matter).
This is not a case in which the patentee is claiming a method that
consists of a new way of using a previously known product in order to
achieve a new result. The Supreme Court explained that “if an old device or
process be put to a new use which is not analogous to the old one, and the
adaptation of such process to the new use is of such a character as to require
the exercise of inventive skill to produce it, such new use will not be denied
the merit of patentability.” Ansonia Brass & Copper Co. v. Elec. Supply
Co., 144 U.S. 11, 18 (1892). The Federal Circuit qualified that rule by
adding that “the application of an old process or machine to a similar or
analogous subject, with no change in the manner of application and no result
substantially distinct in its nature, will not sustain a patent even if the new
form of result had not before been contemplated.” Perricone v. Medicis
Pharmaceutical Corp. 432 F. 3d 1368, 77 USPQ2d 1321, 1332 (Fed. Cir.
2005).

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Appellants claim a known method of contraception of administering a
known contraceptive agent, a progestin. Progestins are known contraceptive
agents as evidenced by the cited prior art. Thus Appellants claim nothing
more than use of a known contraceptive agent as a contraceptive.

In view of the above, the obviousness rejection is affirmed.

SUMMARY
The rejection of claims 1 under 35 U.S.C. § 103, as obvious over de
Nijs and Appellants admission in the specification is 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).

AFFIRMED

dm

Philip S. Johnson
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933-7003

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