Ex Parte Welsh et al

Board of Patent Appeals and Interferences

Feb 27, 2012

10659467 (B.P.A.I. Feb. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL J. WELSH and JOHN A. WEMMIE
__________

Appeal 2011-001039
Application 10/659,467
Technology Center 1600
__________

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 lack of enablement and lack of written description. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
1. A method of treatment for post-traumatic stress disorder
comprising:
administering to a patient in need thereof a therapeutically effective amount
of an acid sensing ion channel (ASIC) antagonist and a pharmaceutically
acceptable carrier,
wherein said antagonist causes improved fear responses.

24. A method of treating a disease state associated with increased pH
which comprises:
administering to a patient a therapeutically effective amount of an acid
sensing ion channel (ASIC) antagonist capable of improving fear responses
and a pharmaceutically acceptable carrier.

30. A method of treating a CNS disorder characterized by a change in
extracellular pH in the amygdala comprising:
inhibiting the acid-sensing ion channel 1 (ASIC1) in order to improve fear
responses in a patient in need of such treatment.

Cited References

Coryell et al., Targeting ASIC1a Reduces Innate Fear and Alters Neuronal
Activity in the Fear Circuit, 62 BIOLOGICAL PSYCHIATRY 1140-1148 (2007).

Grounds of Rejection
1. Claim 24 is rejected under 35 U.S.C. § 112, first paragraph for lack
of enablement.
2. Claims 1-4, 24, 25, 30, and 31 are rejected under 35 U.S.C. § 112,
first paragraph for lack of written description.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
11.

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PRINCIPLES OF LAW
Enablement
The enablement requirement ensures that the public knowledge
is enriched by the patent specification to a degree at least
commensurate with the scope of the claims. The scope of the
claims must be less than or equal to the scope of the
enablement. The scope of enablement, in turn, is that which is
disclosed in the specification plus the scope of what would be
known to one of ordinary skill in the art without undue
experimentation.

National Recovery Technols. Inc. v. Magnetic Separation Sys., Inc.,
166 F.3d 1190, 1195-1196 (Fed Cir. 1999).
An enablement rejection can be for scope of enablement or for total
lack or enablement. In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999).
If mere plausibility were the test for enablement under section
112, applicants could obtain patent rights to “inventions”
consisting of little more than respectable guesses as to the
likelihood of their success. When one of the guesses later
proved true, the “inventor” would be rewarded the spoils
instead of the party who demonstrated that the method actually
worked. That scenario is not consistent with the statutory
requirement that the inventor enable an invention rather than
merely proposing an unproved hypothesis.

Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir.
2005).
Nascent technology … must be enabled with a “specific and
useful teaching.” The law requires an enabling disclosure for
nascent technology because a person of ordinary skill in the art
has little or no knowledge independent from the patentee’s
instruction. Thus, the public’s end of the bargain struck by the
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patent system is a full enabling disclosure of the claimed
technology.
Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1254 (Fed. Cir. 2004)
(citations omitted).

The enablement requirement is often more indulgent than
the written description requirement. The specification need not
explicitly teach those in the art to make and use the invention;
the requirement is satisfied if, given what they already know,
the specification teaches those in the art enough that they can
make and use the invention without “undue experimentation.”

Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir.
2003). Enablement is question of law based on underlying factual inquiries.
Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1369 (Fed. Cir. 1999).
Wands
1
factors (predictability, amount of direction, etc.) are factual inquiries
underlying the enablement conclusion. Id. at 1371.

Written Description

The “written description” requirement . . . serves both to
satisfy the inventor’s obligation to disclose the technologic
knowledge upon which the patent is based, and to demonstrate
that the patentee was in possession of the invention that is
claimed. . . .
The descriptive text needed to meet these requirements
varies with the nature and scope of the invention at issue, and
with the scientific and technologic knowledge already in
existence.

Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005).

1
In re Wands, 858 F.2d 731 (Fed. Cir. 1988).
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“[I]n some cases, a disclosure naming a species can support later-filed
claims to a genus that includes the species if it clearly conveys to one of skill
in the art characteristics common to all species that explain how and why
they make the invention operable.” In re Curtis, 354 F.3d 1347, 1355 (Fed.
Cir. 2004). The instant facts present a case in which there is
“unpredictability in performance of certain species or subcombinations other
than those specifically enumerated.” (Id. at 1277.)
However, we have never held that in all such cases,
including those in which persons of ordinary skill in the art
could not predict the operability of undisclosed species, the
decision in In re Smythe compels a finding that the claim to the
genus is adequately described under §112, ¶ 1. To the contrary,
we recently stated In re Smythe “discuss[es] circumstances in
which a species may be representative of and therefore
descriptive of genus claims.” Enzo, 296 F.3d at 1327 (emphasis
added). Furthermore, it has been clear since we decided Eli
Lilly that a disclosure of a species does not always suffice to
describe broadly claimed subject matter. See Eli Lilly, 119 F.3d
at 1568.

(Id. at 1281.)

[A] single embodiment would support such a generic
claim only if the specification would “reasonably convey to a
person skilled in the art that [the inventor] had possession of the
claimed subject matter at the time of filing,” Bilstad v.
Wakalopulos, 386 F.3d 1116, 1125 (Fed. Cir. 2004).

LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1346 (Fed.
Cir. 2005).

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Discussion
Enablement
ISSUE
The Examiner concludes with respect to the enablement rejection of
claim 24, that Appellants “are not enabled for a method of treating a disease
state associated with increased pH by administering an ASIC channel
antagonist.” (Ans. 4.) The Examiner argues that no data is presented in the
“Specification in which a naturally-occurring disease state is identified and
studied as far as the role of pH and as to the involvement of the ASIC
channel in the pH change.” (Id.)
Appellants argue that

[T]he specification is enabling under 35 U.S.C. § 112, first
paragraph, for three reasons. The specification sets forth for
skilled artisans the: (1) various conditions requiring treatment
under the claimed methods (including PTSD, disease states
associated with increased pH in order to improve fear responses
and CNS disorders characterized by a change in extracellular
pH in the amygdala), (2) ASIC antagonists to be administered
under the claimed methods, and (3) routes of administration for
such methods.

(App. Br. 6.) Appellants argue that they are not claiming a pharmaceutical,
but a new treatment protocol. (Id. at 12.)
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that claim 24 is not enabled?

ANALYSIS
With respect to the lack of enablement rejection of claim 24, we agree
with the Examiner’s fact finding, statement of the rejection and responses to
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Appellants’ arguments as set forth in the Answer. We find that the
Examiner has set forth a prima facie case of lack of enablement. We provide
the following additional comment.
Claim 24 is a broad claim, covering a method of treating a disease
state associated with increased pH. The claim is not limited to diseases of
increased pH associated with an acid sensing ion channel (ASIC). For
example, claim 24as written encompasses a method of treating an acidosis
condition in a diabetic or a kidney stone associated with high uric acid. An
enablement rejection can be for scope of enablement or for total lack or
enablement. In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999). A claim
must be enabled for its full scope.
As noted by the Examiner:
The instant application does not reasonably provide
enablement for a method of treating disease states associated
with a change in pH by administering an ASIC antagonist
without: 1) identifying such diseases, 2) confirming that the
diseases embraced by the claim involve a change in pH and 3)
that the diseases, furthermore, are related to perturbations of the
ASIC receptor. No data are presented in the Specification in
which a naturally-occurring disease state is identified and
studied as far as the role of pH and as to the involvement of the
ASIC channel in the pH change.
The specification gives examples in which ASIC channel
function is studied in vitro. Additional experiments
demonstrate that ASIC "knockout" mice had certain deficits in
learning fear conditioning. However, none of the experiments
measured the pH of tissue in which ASIC channels are
expressed. No nexus was made between the measured pH of
brain regions involved in fear conditioning, the conditioned
responses of the animals, and the ASIC channels.

(Ans. 4.)
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While we acknowledge that the Examiner has found the scope of
claim 1 enabled, we do not find that the Specification, or the Coryell
reference, enables a claim with the broad scope of claim 24. The
Specification’s disclosure of (2) ASIC antagonists to be administered under
the claimed methods, and (3) routes of administration for such methods,
does not enable treatment of any disease associated with increased pH.
Nor do we find that the Specification sets forth for skilled artisans the:
(1) various conditions generally associated with increased pH covered by the
broad claim scope. Pending claim 24 is not limited to PTSD, disease states
associated with increased pH in order to improve fear responses and CNS
disorders characterized by a change in extracellular pH in the amygdala.
In view of the above, the lack of enablement rejection of claim 24 is
affirmed.

Written Description
ISSUE
With respect to the lack of written description rejection, the Examiner
finds that Appellants “were not in possession of an adequate number of
compounds that specifically inhibit ASIC to be used in the claimed methods,
since only one specific compound has been disclosed and the claims read on
any compound that inhibits ASIC.” (Ans. 5.) The Examiner finds that
amiloride is the only ASIC inhibitor disclosed in the Specification. (Id.)
Thus, the Examiner finds that the Specification does not describe the full
scope of the claims.
Appellants contend that the Specification demonstrates that
Appellants had possession of the relationship between ASIC and various
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anxiety and fear responses, and various antagonists to be used with the ASIC
for the treatment of such conditions. (App. Br. 14.) Appellants contend that
the Examiner has acknowledged that the Specification discloses experiments
confirming the role of ASIC receptors in fear conditioning and short-term
memory. (Id.)
The issue is: Does the preponderance of evidence of record support
the Examiner’s finding that the Specification fails to provide written
descriptive support for claims 1-4, 24, 25, 30, and 31?

ANALYSIS
The descriptive text needed to meet the written description
requirement varies with the nature and scope of the invention at issue, and
with the scientific and technologic knowledge already in existence. Capon
v. Eshhar, 418 F.3d at 1357. “Precedent illustrates that the determination of
what is needed to support generic claims to biological subject matter
depends on a variety of factors, such as the existing knowledge in the
particular field, the extent and content of the prior art, the maturity of the
science or technology, the predictability of the aspect at issue, and other
considerations appropriate to the subject matter.” Capon v. Eshhar, 418 F.
3d at 1357 (Fed. Cir. 2005).
According to the Specification, the discovery of ASIC’s has presented
an opportunity to further explore the unknown physiological role of neuronal
H+-evoked currents. (Spec. 2, ll. 10-12.) Therefore the discovery of
physiological roles of neuronal H+-evoked currents is a nascent technology
in the unpredictable art of human physiology.
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In Curtis, the Appellant claimed a polytetrafluoroethylene (PTFE)
dental floss coated with at least one material capable of adhering to PTFE.
The only material disclosed in the Specification that would adhere to PTFE
was microcrystalline wax (MCW). The Specification indicated that it was
surprising that MCW would adhere to PTFE with a specific coefficient of
friction. Thus, the Federal Circuit found that the technology of
compositions that adhere to a PTFE floss was unpredictable, and that the
disclosure of a single species that would adhere to PTFE did not describe a
genus claim to any material that would adhere to PTFE. Just as in Curtis,
the instant facts present a case in which there is “unpredictability in
performance of certain species or subcombinations other than those
specifically enumerated.” In re Curtis, 354 F.3d 1347, 1355. Thus, we find
that the disclosure of a single ASIC inhibitor species, amiloride, does not
suffice to describe the broadly claimed subject matter of any ASIC inhibitor
in such an unpredictable technology, and does not put one of ordinary skill
in the art in possession of other ASIC inhibitors.
The written description rejection is affirmed.

CONCLUSION OF LAW
The record supports the Examiner’s lack of enablement and written
description rejections.
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
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