Ex Parte Frey et al

Board of Patent Appeals and Interferences

Mar 16, 2007

10301185 (B.P.A.I. Mar. 16, 2007)

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for publication and is not binding precedent of the Board.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
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Ex parte WILLIAM H. FREY II and ROBERT GARY THORNE
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Appeal 2007-0542
Application 10/302,185
Technology Center 1600
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ON BRIEF
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Before SCHEINER, GREEN, and LEBOVITZ, Administrative Patent
Judges.

LEBOVITZ, Administrative Patent Judge.

STATEMENT OF CASE
The claims in this appeal are drawn to a method of delivering nerve
growth factor (NGF) or fibroblast growth factor (FGF) to the central nervous
system through transdermal administration at a skin region innervated by the
trigeminal nerve, but outside the nasal cavity. Claims 45-48, 50, 52, and 53,
all the pending claims in the case, are on appeal. Br. 1. We have
jurisdiction under 35 U.S.C. § 134.
There are two prior art rejections on appeal: 1) Claims 45-48, 50, 52,
and 53 stand rejected under 35 U.S.C. § 103(a) as obvious over Frey in view
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of Appellants’ statements in the application, Lee, and Cronk; and 2) Claims
45-48, 50, 52, and 53 stand rejected under 35 U.S.C. § 103(a) as obvious
over Frey in view of Appellants’ statements in the application, Zakzewski,
and Cronk. Br. 1.
The Examiner relies on the following evidence in rejecting the claims
in this appeal:
Frey U.S. Pat. 5,624,898 Apr. 29, 1997
Lee et al. U.S. Pat. 5,250,023 Oct.05, 1993
Cronk et al. U.S. Pat. 6,244,265 B1 Jun. 12, 2001
Zakzewksi, C.A. et al. “Transdermal delivery of regular insulin to chronic
diabetic rats: effect of skin preparation and electrical enhancement,” Journal
of Controlled Release, Vol. 50 ppp.267-272 (1998)

CLAIMS
For the purpose of deciding this appeal, we select claim 45 as
representative of the appealed claims. It reads as follows:
45. A method for delivering a neurologic agent to the central
nervous system of a mammal in need of treatment for a central
nervous system disorder, said method comprising transdermally
administering a composition comprising said neurologic agent
at a region of the skin of a mammal that is innervated by the
trigeminal nerve and outside the nasal cavity of the mammal,
said neurologic agent selected the group consisting of a nerve
growth factor and a fibroblast growth factor.

ISSUE
The Examiner contends that the prior art teaching of administration of
NGF and FGF through the nasal cavity would have led the skilled worker to
administer these agents transdermally to skin regions innervated by the
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trigeminal nerve. Appellants contend that cited prior art does not provide
the motivation to have applied NGF or FGF to skin regions innervated by
the trigeminal nerve. The question for this appeal is whether the Examiner
has shown that the cited prior art provides sufficient motivation to have
made it obvious under 35 U.S.C. § 103 to have applied NGF or FGF to a
skin region outside the nasal cavity, but innervated by the trigeminal nerve.

STATEMENT OF FACTS
1. Claim 45 is a method of “delivering a neurologic agent to the
central nervous system.” It is the only independent claim on appeal.
2. The claimed method comprises “transdermally administering a
composition comprising said neurologic agent.”
3. The “neurologic agent” is administered “at a region of the skin . . .
that is innervated by the trigeminal nerve and outside the nasal cavity.”
4. The agent is NGF or FGF.
Specification
5. “The trigeminal nerve innervates tissues of a mammal’s (e.g.
human) head including skin of the face and scalp, oral tissues, and tissues of
and surrounding the eye. The trigeminal nerve has three major branches, the
ophthalmic nerve, the maxillary nerve, and the mandibular nerve.”
Specification 3: 9-14. “The ophthalmic nerve innervates tissues including
superficial and deep parts of the superior region of the face, such as the eye,
the lacrimal gland, the conjunctiva, and skin of the scalp, forehead, upper
eyelid, and nose.” Specification at 3: 18-20.
Frey
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6. Frey describes “a method for delivering neurologic agents to the
brain by means of the olfactory neural pathway.” Col. 1, ll. 12-14.
7. The neurologic agents are administered to a patient’s nasal cavity,
where they are absorbed by the peripheral olfactory neurons which innervate
the cavity. Col. 2, l. 50 to col. 3, l. 20. The agents are transported along the
olfactory neuronal pathway into the brain. Id.
8. NGF and FGF are in a list of preferred neurologic agents. Col. 3,
ll. 50-55. NGF is among a list of two “particularly preferred” agents. Col.
3, ll. 55-57. FGF is recited in claim 1 for use in Frey’s method. Col. 9, ll.
15. NGF is recited in claim 8. Col. 10, ll. 16.
9. The Examiner asserts that “Frey clearly teaches the ability of the
claimed proteins to reach the trigeminal nerves when applied to the sites,
which are enriched with these nerves.” Answer 6.
Cronk
10. Cronk teaches a nasal strip that can be applied across the bridge
of the nose. Col. 4, ll. 16-26. The strip can comprise a transdermal drug.
Col. 4, l. 64-65. Cronk lists at least twelve classes of agents which can be
transdermal delivered by its nasal strip, including “wound healing agents.”
Col. 11, l. 18-63.
DISCUSSION
The Examiner bears the initial burden of showing unpatentability.
See, e.g., In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed.
Cir. 1993). To establish a prima facie case of obviousness, there must be
some suggestion or motivation, either in the references themselves or in the
knowledge generally available to one of ordinary skill in the art, to modify
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the reference or to combine reference teachings. See In re Vaeck, 947 F.2d
488, 20 USPQ2d 1438 (Fed. Cir. 1991); In re Dembiczak, 175 F.3d 994,
999, 50 USPQ2d 1614, 1617 (Fed. Cir. 1999).
In this case, the Examiner is required to provide a teaching,
suggestion, or motivation to have administered neurologic agents to a skin
region which is innervated by the trigeminal nerve, but outside the nasal
cavity. The Examiner asserts that the motivation arises from Frey’s clear
teaching that the claimed proteins are able “to reach brain through the
trigeminal nerves when applied” to skin regions “which are enriched with
these nerves.” Answer 6-7. But, we find no evidence in the record to
support the Examiner’s assertion.
As we understand it, the Examiner’s position is that the skilled worker
would infer from reading Frey that, when the neurologic agents (e.g., NGF
and FGF) are administered to the nasal cavity, they would be absorbed
through the trigeminal nerve. The Examiner contends that this inference
arises from the teaching in the specification that branches of the trigeminal
nerve are present in the nasal cavity. Answer 8. According to the Examiner,
these teachings supply the motivation to have administered neurologic
agents to skin regions innervated by the trigeminal nerve, including the nose
bridge as taught by Conk. Id. at 7-8.
The flaw in this argument is that the Examiner has not established that
the skilled worker would have recognized that drug absorption in Frey’s
method occurs through the trigeminal nerves. Frey expressly teaches that
the mechanism is through the olfactory nerve pathways. Col. 2, l. 50 to col.
3, l. 20. There is no mention of the trigeminal nerve. While the presence of
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trigeminal nerves in the nasal cavity may be an inherent mechanism (in
addition to the absorption along the olfactory neurons) responsible for
transport into the brain, the Examiner has not provided evidence that this
mechanism would have been recognized by the person of ordinary skill in
the art. “That which may be inherent is not necessarily known. Obviousness
cannot be predicated on what is unknown.” In re Spormann, 363 F.2d 444,
448, 150 USPQ 449, 452 (CCPA 1966). See also Rijckaert, at 9 F.3d 1534,
28 USPQ2d 1957. The Examiner’s burden is not discharged by the mere
fact that trigeminal nerves are present in the nasal cavity.
CONCLUSION OF LAW
The Examiner has not shown that Frey provides adequate motivation
to have made it obvious under 35 U.S.C. § 103 to administer NGF or FGF to
a skin region outside the nasal cavity, but innervated by the trigeminal nerve.
We reverse the Examiner’s rejection of claims 45-48, 50, 52, and 53.

REVERSED

Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Lora M. Green )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Richard M. Lebovitz )
Administrative Patent Judge )

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