Ex Parte McCreery

Board of Patent Appeals and Interferences

Aug 6, 2009

10315421 (B.P.A.I. Aug. 6, 2009)

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.
10/315,421 12/10/2002 Douglas B. McCreery 8044-002-US 2631
32301 7590 08/07/2009
CATALYST LAW GROUP, APC
9710 SCRANTON ROAD, SUITE S-170
SAN DIEGO, CA 92121
EXAMINER
HELLER, TAMMIE K
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
08/07/2009 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 DOUGLAS B. MCCREERY
__________

Appeal 2009-000059
Application 10/315,421
Technology Center 3700
__________

Decided: August 7, 2009
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
electrode assembly. The Examiner has rejected the claims as anticipated.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1-44, 46-56, 58-68, and 71-77 are pending and on appeal
(App. Br. 2). We will focus on claims 1, 14, 15, 29, 41, 42, and 71, which
read as follows:
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1. An electrode assembly for surgical implantation on a nerve of
the central or peripheral nervous system, comprising:
(a) a flexible helically formed supporting matrix of dielectric material;
(b) a flexible conductive electrode secured to the surface of the
matrix, the electrode having front and rear surfaces and side edges, the front
surface being exposed and not covered by the matrix, the electrode
occupying only a portion of the cross-sectional periphery of the matrix; and
(c) at least one flexible connector connected to the electrode and
extending from the matrix; the matrix and the electrode generally forming a
multi-turn hollow helix of a selected pitch, the helix having a free end and
without a supporting core, the turns of the helix being resiliently movable
with respect to each other to enable the helix to be wrapped around an
unsevered nerve, the helix having a central passage therethrough of size and
configuration generally comforming to the external size and configuration of
the nerve, the pitch being selected such that the entire nerve or any portion
of it extending radially inward from its surface forming an annulus is
electrically stimulated to activate substantially all axons or a subpopulation
of axons of the nerve according to the amplitude of the stimulus current used
and according to the pitch actually selected in response to the desired degree
of electrical stimulation, the size of the subpopulation being determined by
the amplitude of the stimulus current and by the particular pitch selected.
14. The electrode assembly of claim 1 wherein the pitch is selected
such that substantially the entire nerve is stimulated and such that
substantially all axons are activated at nearly the same threshold.
15. The electrode assembly of claim 1 wherein the pitch is selected
such that a portion of the nerve extending radially inward from its surface
forming an annulus is stimulated and such that a subpopulation of axons is
activated, the size of the subpopulation being determined by the amplitude
of the stimulus current.
29. An electrode assembly for surgical implantation on a nerve of
the peripheral or central nervous system comprising:
(a) a flexible helically formed supporting matrix of dielectric material;
(b) a flexible conductive electrode secured to the surface of the
matrix, the electrode having front and rear surfaces and side edges, the front
surface being exposed and not covered by the matrix, the electrode
occupying only a portion of the cross-sectional periphery of the matrix; and
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(c) at least one flexible connector connected to the electrode and
extending from the matrix; the matrix and electrode generally forming a
multi-turn hollow helix of a selected pitch and with a selected number of
helical turns of the electrode, the helix having a free end and without a
supporting core, the turns of the helix being resiliently movable with respect
to each other to enable the helix to be wrapped around an unsevered nerve,
the helix having a central passage therethrough of size and configuration
generally conforming to the external size and configuration of the nerve, the
pitch of the helix and the number of helical turns being selected such that the
entire nerve or any portion of it extending radially inward from the surface
forming an annulus is electrically stimulated to activate substantially all
axons or a subpopulation of axons according to the amplitude of the stimulus
current used and according to the pitch of the helix and the number of helical
turns actually selected in response to the desired degree of electrical
stimulation, the size of the subpopulation being determined by the amplitude
of the stimulus current and by the particular pitch and the number of helical
turns selected.
41. The electrode assembly of claim 29 wherein the pitch of the
helix and the number of helical turns of the electrode are selected such that
substantially the entire nerve is stimulated and such that substantially all
axons are activated.
42. The electrode assembly of claim 29 wherein the pitch of the
helix and the number of helical turns of the electrode are selected such that a
portion of the nerve extending radially inward from the surface forming an
annulus is electrically stimulated to activate a subpopulation of axons.
71. The device of claim 58 wherein the nerve to be simulated is
selected from the group consisting of (1) the glossopharyngeal nerve to treat
obstructive sleep apnea; (2) the vagus nerve to treat epilepsy; (3) the
auditory nerve to restore hearing; (4) the phrenic nerve to produce
diaphragm convulsions; (5) a peripheral nerve in the upper extremities to
restore hand function; and (6) a peripheral nerve in the upper extremities to
regulate gait.
Claims 1-44, 46-56, 58-64, 66, 68, and 71-77 stand rejected under 35
U.S.C. § 102(b) as anticipated by Bullara '481 (US 4,573,481, Mar. 4, 1986)
(Ans. 3).
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Claims 1-44, 46-56, 58-68, and 71-77 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Bullara '979 (US 4,920,979, May 1, 1990)
(Ans. 6).
The Examiner finds that Bullara '481 discloses an electrode assembly
having all of the structural requirements of claims 1-44, 46-56, 58-64, 66,
68, and 71-77 (Ans. 3 & 7). The Examiner finds that Bullara '979 discloses
“that the apparatus disclosed by Bullara '481 is incorporated by reference
into the disclosure” and that therefore “Bullara '979 discloses each and every
aspect of claims 1-44, 46-56, 58-64, 66, 68, and 71-77 in the same manner
and detail as that disclosed in Bullara '481” (id. at 6). The Examiner also
finds that Bullara '979 discloses the features of claims 65 and 67, which are
not rejected over Bullara '481 (id.).
Appellant contends that “Bullara '481 fails to teach or suggest the
relationship between pitch and recruitment (stimulation or activation) of the
nerve fibers recited in each of these claims” (App. Br. 17). With regard to
claim 29, Appellant also contends that Bullara '481 fails to disclose the
relationship between the pitch and the number of helical turns of the helix
and recruitment of the nerve fibers (id. at 27-28). In addition, Appellant
contends that Bullara '481 does not teach the pitch selected in claims 14, 15,
41, and 42 (id. at 26 & 28). Appellant also contends that Bullara '481 does
not disclose that the assembly is configured to treat the particular conditions
or stimulate the particular nerves recited in claim 71 (id. at 27). In addition,
Appellant contends that Bullara '979 has the same deficiencies as
Bullara '481 (id. at 29-35).
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ISSUES
Has Appellant shown that the Examiner erred in concluding that
Bullara '481 and Bullara '979 anticipate claim 1?
Has Appellant shown that the Examiner erred in concluding that
Bullara '481 and Bullara '979 anticipate claim 29?
Has Appellant shown that the Examiner erred in concluding that
Bullara '481 and Bullara '979 anticipate claims 14, 15, 41, and 42?
Has Appellant shown that the Examiner erred in concluding that
Bullara '481 and Bullara '979 anticipate claim 71?
FINDINGS OF FACT
1. Bullara '481 discloses an “implantable helical electrode
assembly configured to fit around a nerve for electrically triggering or
measuring an action potential or for blocking conduction in nerve tissue”
(Bullara '481, Abstract)
2. Bullara '481 also discloses forming the electrode assembly on a
mandrel having a helical groove, the “helical pitch of the groove
correspond[ing] to the pitch desired in the finished spiral electrode” (id. at
col. 5, ll. 15-24).
3. Bullara '979 discloses that the disclosure of Bullara '481 is
incorporated by reference (Bullara '979, col. 1, ll. 17-18).
4. The Specification discloses:
By adjusting the pitch of the helix and the number of helical
turns, the difference between the field gradient at the center and
the periphery of the nerve can be adjusted. The greater this
field difference, the greater the ability to excite the axons lying
near the periphery of the nerve while not exciting the axons at
the center of the nerve. The more shallow this difference in
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field gradient, the less the degree of differentiation in
activation. Thus, by increasing the pitch of the helix and the
number of helical turns, one can configure such electrodes to
achieve an orderly recruitment of the axon population as the
stimulus current is incre[a]sed. . . . Conversely, by decreasing
the pitch of the electrodes, one can configure such electrodes to
stimulate substantially all the axons of the nerve with a
shallower difference in field gradient between the field gradient
at the center and at the periphery of the nerve.
(Spec. 11: 34 to 12: 17.)
5. The Specification also discloses:
The pitch is selected such that either the entire nerve or any
portion of it extending radially inward from its surface forming
an annulus can be electrically stimulated. This allows the easy
activation of either substantially all axons or a subpopulation of
axons such as those axons located near the periphery of the
nerve, according to the helical pitch chosen. The size of the
subpopulation is determined by the amplitude of the stimulus
current. . . . [A]s the pitch of the helix increases or as the
number of helical turns increases, there is a greater difference
between the field gradient at the center and at the periphery of
the nerve. This allows activation of the axons located near the
periphery with a relatively low voltage applied to the electrode.
The pitch of the helix is defined, as is generally known in the
art, as the distance along the helix for a 360-degree rotation of
the helix around the central axis.
(Id. at 13: 7-23.)
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., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
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“Inherency may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient to establish inherency.” Scaltech Inc. v.
Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999). “If, however, the
disclosure is sufficient to show that the natural result flowing from the
operation as taught would result in the performance of the questioned
function, it seems to be well settled that the disclosure should be regarded as
sufficient.” In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).
[I]t is elementary that the mere recitation of a newly discovered
function or property, inherently possessed by things in the prior
art, does not cause a claim drawn to those things to distinguish
over the prior art. Additionally, where the Patent Office has
reason to believe that a functional limitation asserted to be
critical for establishing novelty in the claimed subject matter
may, in fact, be an inherent characteristic of the prior art, it
possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.
In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977).
“The patentability of a product does not depend on its method of
production. If the product in a product-by-process claim is the same as or
obvious from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different process.” In re Thorpe,
777 F.2d 695, 697 (Fed. Cir. 1985). “Where a product-by-process claim is
rejected over a prior art product that appears to be identical, although
produced by a different process, the burden is upon the applicants to come
forward with evidence establishing an unobvious difference between the
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claimed product and the prior art product.” In re Marosi, 710 F.2d 799, 803
(Fed. Cir. 1983).
ANALYSIS
Claim 1 is directed to an electrode assembly comprising a matrix and
an electrode “generally forming a multi-turn hollow helix of a selected
pitch,”
the pitch being selected such that the entire nerve or any portion
of it extending radially inward from its surface forming an
annulus is electrically stimulated to activate substantially all
axons or a subpopulation of axons of the nerve according to the
amplitude of the stimulus current used and according to the
pitch actually selected in response to the desired degree of
electrical stimulation, the size of the subpopulation being
determined by the amplitude of the stimulus current and by the
particular pitch selected.
Thus, claim 1 encompasses both pitches that activate substantially all axons
of the nerve and pitches that activate a subpopulation of axons of the nerve.
According to the Specification (Findings of Fact (FF) 4-5), claim 1 therefore
clearly encompasses both helices having relatively low pitch and helices
having relatively high pitch. As a result, in the absence of any evidence to
the contrary, we interpret claim 1 to encompass the full range of helical
pitches.
Bullara '481 and Bullara '979 both disclose an “implantable helical
electrode assembly configured to fit around a nerve” (FF 1 & 3). This
electrode assembly inherently has a pitch (see FF 2). Because we interpret
claim 1 to encompass the full range of helical pitches, the electrode
assemblies described in Bullara '481 and Bullara '979 must have a pitch
within the scope of claim 1.
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Appellant argues that the Examiner has not shown that Bullara '481 or
Bullara '979 discloses that the pitch is “selected such that the entire nerve or
any portion of it extending radially inward from its surface forming an
annulus is electrically stimulated to activate substantially all axons or a
subpopulation of axons of the nerve,” as recited in claim 1 (App. Br. 17 &
27-28). However, the “patentability of a product does not depend on its
method of production.” In re Thorpe, supra. Here, Appellant has not shown
that the process limitation of claim 1 actually limits the scope of claim 1. In
the absence of such a showing, we conclude that Appellant cannot rely on
this limitation to distinguish its product from the products disclosed in
Bullara '481 and Bullara '979.
Claim 29 is similar to claim 1. However, claim 29 additionally
requires “a selected number of helical turns of the electrode, . . . the number
of helical turns being selected such that the entire nerve or any portion of it
extending radially inward from the surface forming an annulus is electrically
stimulated to activate substantially all axons or a subpopulation of axons.”
As with the process step of claim 1, Appellant has not shown that this
process step actually limits the scope of claim 1. In the absence of such a
showing, we conclude that Appellant cannot rely on this limitation to
distinguish its product from the product disclosed in Bullara '481 and
Bullara '979.
Claims 14, 15, 41, and 42 depend from either claim 1 or claim 29 and
recite that the pitch (and, in claims 41 and 42, the number of helical turns) is
selected either “such that substantially the entire nerve is stimulated”
(claims 14 and 41) or “such that a portion of the nerve extending radially
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inward from its surface forming an annulus is stimulated” (claims 15 and
42). The Specification discloses that selecting a pitch as described therein
“allows the easy activation of either substantially all axons or a
subpopulation of axons such as those axons located near the periphery of the
nerve” (FF 5 (emphasis added)). The Specification also discloses that the
size of the subpopulation of stimulated axons “is determined by the
amplitude of the stimulus current” (id.). In the absence of any evidence to
the contrary, it is reasonable to conclude that any pitch within the scope of
Bullara '481 or Bullara '979 could be used to either stimulate substantially all
of the axons or only a subpopulation thereof by adjusting the amplitude of
stimulus current. Thus, we conclude that is was reasonable for the Examiner
to shift the burden to Appellant to show that Bullara '481 and Bullara '979 do
not necessarily disclose the assemblies of claims 14, 15, 41, and 42.
Appellant has not met this burden.
Claim 71 recites that the nerve to be stimulated is one of six nerves
and that each of these nerves is being selected to treat a particular condition.
Bullara '481 and Bullara '979 both disclose an “implantable helical electrode
assembly configured to fit around a nerve” (FF 1 & 3). As with claims 14,
15, 41, and 42, we conclude that it was reasonable for the Examiner to shift
the burden to Appellant to show that Bullara '481 and Bullara '979 do not
necessarily disclose assemblies that are configured to stimulate the nerves or
treat the conditions recited in claim 71. Appellant has not met this burden.
CONCLUSION
Appellant has not shown that the Examiner erred in concluding that
Bullara '481 and Bullara '979 both anticipate claim 1. We therefore affirm
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the anticipation rejection over Bullara '481 of claim 1 and of claims 2-13,
18-24, 30-40, 46-52, 58-64, 66, and 68, which have not been argued
separately and therefore fall with claim 1, as well as the anticipation
rejection over Bullara '979 of claim 1 and of claims 2-13, 18-24, 30-40, 46-
52, and 58-68, which have not been argued separately and therefore fall with
claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellant also has not shown that the Examiner erred in concluding
that Bullara '481 and Bullara '979 both anticipate claim 29. We therefore
affirm the anticipation rejections of claim 29.
In addition, Appellant has not shown that the Examiner erred in
concluding that Bullara '481 and Bullara '979 both anticipate claims 14, 15,
41, and 42. We therefore affirm the anticipation rejections of claims 14, 15,
41, and 42, as well as of claims 25, 26, 53, and 54, which were argued with
and therefore fall with claims 14, 15, 41, and 42, respectively. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellant also has not shown that the Examiner erred in concluding
that Bullara '481 and Bullara '979 both anticipate claim 71. We therefore
affirm the anticipation rejections of claim 71. For the same reasons, we
affirm the anticipation rejections of claims 16, 17, 27, 28, 43, 44, 55, 56, and
72-77.
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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9710 SCRANTON ROAD, SUITE S-170
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