Ex Parte Miesenbock et al

Board of Patent Appeals and Interferences

Sep 13, 2010

10452879 (B.P.A.I. Sep. 13, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/452,879 06/02/2003 Gero Miesenbock MSK.P-063 5072
52334 7590 09/13/2010
Larson & Anderson, LLC
re: MSK
P. O. BOX 4928
DILLON, CO 80435-4928
EXAMINER
LEAVITT, MARIA GOMEZ
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE
09/13/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GERO MIESENBOCK and BOSIS ZEMELMAN
__________

Appeal 2010-002566
Application 10/452,879
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. MCCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for activation of eukaryotic target cells. The Patent Examiner
rejected the claims as anticipated, obvious and failing to comply with the

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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written description requirement. We have jurisdiction under 35 U.S.C.
§ 6(b). We reverse.
STATEMENT OF THE CASE
The invention relates to “heterologous stimulus-gated ion channels,
and to the triggering of such channels, when expressed in cells, to selectively
activate those cells.” (Spec. 1).
Claims 1-5, 9-11, 14-20, 22, 23, 66-71, 75, 76, 80, 81, 85 and 86 are
on appeal. Claim 1 is representative and reads as follows:
1. A method for activation of eukaryotic target cells, comprising the
steps of:
a. sensitizing target cells by expressing a heterologous stimulus-
gated ion channel in those target cells, wherein the heterologous stimulus-
gated ion channel is one that does not naturally occur in the target cell in the
absence of human intervention, and
b. applying a stimulus to the sensitized target cells to trigger the
ion channel, and thereby activate the target cells, to induce a response
characteristic of the target cell, wherein the activation results in polarization
or depolarization when the target cell is a neuronal cell, commencement or
termination of secretion from the target cell when the target cell is a
secretory cell; contraction or relaxation when the target cell is a muscle or
other contractile cell, or a sensory response when the target cell is a sensory
receptor.

The Examiner rejected the claims as follows:
• claims 1-5, 14, 15, 17, 18, 20, 22, 67, 70, 71, 75, 76, 80, 81, 85 and
86 under 35 U.S.C. § 102(e) as anticipated by Julius,2 as evidenced by
Guyton;3
• claims 1, 66 and 69 under 35 U.S.C. §102(b) as anticipated by
Savidge,4 as evidenced by Guyton;

2 US Patent No. 6,335,180 B1 issued to David J. Julius et al., Jan. 1, 2002.
3 A.C. Guyton, Textbook of Medical Physiology, 7th ed., 395, 582-83 (1986).
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• claims 1-5, 9-11, 14, 15, 17, 18, 20 and 22 under 35 U.S.C. § 103(a)
as unpatentable over Julius and Callaway;5
• claims 16, 19 and 23 under 35 U.S.C. § 103(a) as unpatentable over
Julius, Callaway and Utomo;6
• claims 1 and 68 under 35 U.S.C. § 103(a) as unpatentable over
Julius and Stokes;7 and
• claims 1-5, 9-11, 14-20, 22-23, 66-71,75, 76, 80, 81, 85 and 86
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
ANTICIPATION
The Issues
The Rejection over Julius
The Examiner’s position is that Julius disclosed a method for
activating a target cell by expressing a heterologous TRPV1 channel, i.e., a
capsaicin receptor, in HEK 293T cells (human embryonic kidney cells) and
applying a capsaicin stimulus, which depolarized the cell membrane and

4 J.R. Savidge et al., Comparison of Intracellular Calcium Signals Evoked by
Heat and Capsaicin in Cultured Rat Dorsal Root Ganglion Neurons and in a
Cell Line Expressing the Rat Vanilloid Receptor, VR1, 102 NEUROSCIENCE,
no. 1, 177-184 (2001).
5 Edward M. Callaway et al., Photostimulation using caged glutamate
reveals functional circuitry in living brain slices, 90 PROC. NATL. ACAD.
SCI., 7661-7665 (1993).
6 Ahmad R.H. Utomo et al., Temporal, spatial, and cell type-specific control
of Cre-mediated DNA recombination in transgenic mice, 17 NAT.
BIOTECHNOL., 1091-1096 (1999).
7 Patent Application Publication No. US 2004/0236377 A1 by Kenneth B.
Stokes et al., published Nov. 25, 2004.

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created an entry of extracellular calcium through the ion channel in response
to a depletion of intracellular calcium stores. (Ans. 5). The Examiner found
that Julius disclosed that capsaicin and analogs had effects on “the ability of
the heterologous transmembrane protein to control calcium flux (currents
claims 1-5 and 22).” (Id. at 6, emphasis deleted). According to the
Examiner, “any activity resulting from the expression of the heterologous
TRPV1 channel in HEK 293T cells as a result of applying a stimulus (e.g., a
capsaicin stimulus) induces a response characteristic of the target cell.”
(Id.).
Appellants contend that Julius does not teach “that the stimulation of
the ion channel results in a response that is characteristic of the HEK 293
cells, as required by claim 1.” (App. Br. 5). According to Appellants, the
Examiner has acknowledged (see Ans. 18) that HEK 293T cells are
secretory cells, however, the Examiner has not “shown that secretion occurs
as a consequence of the stimulus of the channel in the HEK 293T cells of
Julius.” (App. Br. 5).
The Rejection over Savidge
The Examiner’s position is that Savidge disclosed a method for
expressing a recombinant vanilloid receptor 1, i.e., capsaicin receptor, in
Chinese hamster ovary cells (VR1-CHO). (Ans. 6). According to the
Examiner, Savidge taught that the CHO cells expressing heterologous VR1
are activated in response to capsaicin “in turn resulting in modulation of
[calcium] flux which is a response characteristic of the target cell [which]
anticipates the scope of claim 1.” (Id. at 21).
Appellants contend that “the Examiner has not identified any teaching
that the stimulation of the ion channel results in a response that is
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characteristic of CHO cells.” (App. Br. 6). Regarding claims 66 and 69,
Appellants assert that Savidge did not disclose target cells that were
neuronal cells or sensory cells, as required by claims 66 and 69 respectively.
(Id.).
The issues with respect to these rejections are:
whether Julius disclosed that applying a stimulus to the HEK 293T
cells triggered the heterologous stimulus-gated ion channel to induce a
response characteristic of the HEK 293T cells; and
whether Savidge disclosed (a) that applying a stimulus to the CHO
cells triggered the heterologous stimulus-gated ion channel to induce a
response characteristic of the CHO cells, and (b) target cells that were
neuronal cells or sensory cells.
Findings of Fact
1. We agree with the Examiner’s findings concerning the explicit
teachings of Julius and Savidge.
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
Analysis
The Rejection over Julius
We agree with Appellants that the Examiner has not demonstrated that
Julius disclosed that capsaicin stimulation of the heterologous TRPV1 ion
channel in the HEK 293T cells induced a response that was characteristic of
the HEK 293T cells. The Examiner identified the HEK 293T target cells as
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secretory cells and found that stimulation of the ion channel “depolarizes the
cell membrane creating the entry of extracellular calcium throughout an ion
channel….” (Ans. 5.) This result does not evidence the response
characteristic of a secretory cell required by the claims, i.e., commencement
or termination of secretion from the target cell. Consequently, we find that
the Examiner has not established that Julius anticipates independent claim 1.
The Rejection over Savidge
We agree with Appellants that the Examiner has not demonstrated that
Savidge disclosed that capsaicin stimulation of the heterologous VR1
(TRPV1) ion channel in the CHO cells induced a response that was
characteristic of the CHO cells. The Examiner’s finding that the
“modulation of [calcium] flux [was] a response characteristic of the target
cell” (Ans. 21) is not supported by evidence.
Further, as the Examiner concedes (Ans. 20), Savidge did not disclose
target cells that were neuronal cells or sensory cells, as required by claims
66 and 69 respectively.
OBVIOUSNESS
Principles of Law
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention – including all its
limitations – with the teaching of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995).
Analysis
For each of the obviousness rejections, the Examiner’s position is that
Julius anticipated the elements of claim 1, including the limitation “to induce
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a response characteristic of the target cell.” The Examiner combines the
additional references solely to address elements of the dependent claims.
Appellants contend that because Julius did not disclose the invention
of claim 1, claim 1 is not obvious over the combined prior art.
We found that the Examiner did not establish that Julius taught every
limitation of claim 1, and we reversed the anticipation rejection over Julius.
The additional references used in the obviousness rejections do not make up
for Julius’ deficiency. We agree with Appellants that by relying upon Julius
as disclosing the invention of claim 1, the Examiner has not accounted for
all the limitations of the claimed method.
WRITTEN DESCRIPTION
The Issue
The Examiner’s position is that the genus encompassed by “wherein
the heterologous stimulus-gated ion channel is one that does not naturally
occur in the target cell in the absence of human intervention” was not
described in the Specification so as to reasonably convey to any person
skilled in the art that the inventors had possession of the claimed invention.
(Ans. 13). The Examiner found that the phrase “encompasses a genus of
unspecified heterologous stimulus gated channels that do not naturally occur
in a target cell without the absence of human intervention, including, for
example, heterologous recombinant stimulus-gated channels that are
truncated, mutated at any undetermined number of amino acid residues . . .”
and others. (Id.). According to the Examiner, the Specification neither
describes the complete structure of a representative number of species
encompassed by the claims, nor describes other relevant identifying
characteristics of the channels to be used. (Id. at 14-16).
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Appellants contend that the claimed invention “is not individual ion
channels … but the use of non-naturally occurring ion channels for a
specific purpose.” (App. Br. 10). Appellants assert that they have disclosed
“species that are representative of the full scope of the generic claim” and
have further provided guidance “describing the properties of an ideal
channel,” especially in the context of the claimed method. (Id. at 10-11).
The issue is whether the Examiner established that a person of
ordinary skill in the art would not credit Appellants with possession of the
claimed invention.
Additional Findings of Fact
2. The Specification states that “[p]referably, the heterologous stimulus-
gated ion channel is also one that does not naturally occur in the cell in the
absence of human intervention.” (Spec. 7).
3. The Specification disclosed that “[t]he stimulus-gated ion channels are
suitably TRPV1, TRPM8 or P2X2.” (Spec. 2).
4. The Specification described seven criteria for preferably selecting an
“ideal” stimulus-gated ion channel for use in the instant invention. (Id. at 7-
8).
5. Claims 4, 11, 20, 21, 69, 70, 71, 75, 76, 80, 81, 85 and 86 specifically
recite that the stimulus-gated ion channel is TRPV1 or TRPM8. (App. Br.
14-16, Claims App’x.).
Principles of Law
“It is not necessary that the application describe the claim limitations
exactly, but only so clearly that one having ordinary skill in the pertinent art
would recognize from the disclosure that appellants invented processes
including those limitations.” In re Herschler, 591 F.2d 693, 701 (CCPA
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1979). “The adequate written description requirement . . . serves ‘to ensure
that the inventor had possession, as of the filing date of the application relied
on, of the specific subject matter later claimed by him; how the specification
accomplishes this is not material.’” In re Alton, 76 F.3d 1168, 1172 (Fed.
Cir. 1996) (citation omitted). “Regardless whether a compound is claimed
per se or a method is claimed that entails the use of the compound, the
inventor cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing compounds
from non-infringing compounds, or infringing methods from non-infringing
methods.” Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed.
Cir. 2004).
Analysis
We agree with the Examiner that the claims “encompass[ using] a
genus of unspecified heterologous stimulus gated channels that do not
naturally occur in a target cell without the absence of human intervention.”
The Specification disclosed some members of that genus for use in the
claimed method.
Appellants emphasize that the claims are for methods, not
compositions (App. Br. 10-11), but our reviewing court has characterized
that argument as a “semantic difference without a difference.” Univ. of
Rochester, 358 F.3d at 926. The question instead is whether the
Specification disclosed a description “sufficient to distinguish . . . infringing
methods from non-infringing methods.” Id. The Rochester court
distinguished the method claims in dispute in that case from the method
claims disputed in the Herschler case. Id. at 928. Herschler has relevance
to this appeal. In Herschler, claims to a process topically administering a
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physiologically active steroidal agent and DMSO concurrently were found to
be adequately described even though the specification disclosed only one
example of a “physiologically active steroidal agent.” Herschler, 591 F.2d
at 701 (“We see nothing in patent law which requires appellant to discover
which of all those [compounds] have such properties and which will
function properly in his combination”) (citation omitted). Other steroidal
agents were known in the art when Herschler filed its application. Like
Herschler, Appellants here are not claiming novel ion channels but a method
of using ion channels in a method. Ion channels were known in the art when
Appellants filed their Application.
The written description rejection focused on the alleged absence of
structural descriptions for ion channels in addition to those disclosed,
apparently assuming that that structural data would be critical for a person of
ordinary skill in the art to distinguish infringing methods from non-
infringing methods. While the rejection focused on non-disclosed structural
data, the rejection did not establish that the structural data identified as
missing would in fact be required for a person of ordinary skill in the art to
distinguish infringing methods from non-infringing methods. Because the
rejection did not establish that in fact a person of ordinary skill in the art
would require the identified structural data before crediting Appellants with
possession of the invention, we reverse the rejection as unfounded.
CONCLUSIONS
Julius did not disclose that applying a stimulus to the HEK 293T cells
triggered the heterologous stimulus-gated ion channel to induce a response
characteristic of the HEK 293T cells.
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Savidge did not disclose (a) that applying a stimulus to the CHO cells
triggered the heterologous stimulus-gated ion channel to induce a response
characteristic of the CHO cells, and (b) target cells that were neuronal cells
or sensory cells.
The obviousness rejection did not account for every claim limitation.
The Examiner did not establish that a person of ordinary skill in the art
would require certain structural data to credit Appellants with possession of
the claimed methods.
SUMMARY
We reverse the rejection of claims 1-5, 14, 15, 17, 18, 20, 22, 67, 70-
71, 75-76, 80-81and 85-86 under 35 U.S.C. § 102(e) as anticipated by Julius;
we reverse the rejection of claims 1, 66 and 69 under 35 U.S.C.
§102(b) as anticipated by Savidge;
we reverse the rejection of claims 1-5, 9-11, 14, 15, 17, 18, 20 and 22
under 35 U.S.C. § 103(a) as unpatentable over Julius and Callaway;
we reverse the rejection of claims 16, 19 and 23 under 35 U.S.C.
§ 103(a) as unpatentable over Julius, Callaway and Utomo;
we reverse the rejection of claims 1 and 68 under 35 U.S.C. § 103(a)
as unpatentable over Julius and Stokes; and
we reverse the rejection of claims 1-5, 9-11, 14-20, 22-23, 66-71,75,
76, 80, 81, 85 and 86 under 35 U.S.C. § 112, first paragraph, as lacking
written description support.

REVERSED

Appeal 2010-002566
Application 10/452,879

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lp

LARSON & ANDERSON, LLC
RE: MSK
P. O. BOX 4928
DILLON CO 80435-4928