Ex Parte Schouenborg

Patent Trial and Appeal Board

Sep 26, 2012

11543825 (P.T.A.B. Sep. 26, 2012)

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.
11/543,825 10/06/2006 Jens O. Schouenborg C2432.0070 7519
32172 7590 09/27/2012
DICKSTEIN SHAPIRO LLP
1633 Broadway
NEW YORK, NY 10019
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
09/27/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JENS O. SCHOUENBORG
__________

Appeal 2011-004288
Application 11/543,825
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an electrode bundle for implantation into soft tissue. The Examiner has
rejected the claims as anticipated, obvious, lacking adequate written
description, and as being indefinite. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in part. Specifically, we reverse the anticipation,
obviousness, and written description rejections, but affirm the indefiniteness
rejection based on a new ground under 37 C.F.R. § 41.50(b).

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STATEMENT OF THE CASE
The Specification describes a medical electrode bundle for insertion
into soft tissue, such as the brain, spinal cord, and muscles (Spec. 1). The
electrode bundle comprises two or more electrodes, each comprising an
electrically conducting electrode element and an anchoring element (id. at
3). The electrode element has a rear end and a front end, and the anchoring
element functions in the manner of a barb (id.).
Claims 1-5, 7-24, and 28-30 are on appeal. Independent claim 1 is
representative and reads as follows (line spacing added):
1. Electrode bundle for implantation by insertion into soft tissue
comprising two or more electrically independent electrodes each
having a front and rear end aligned in parallel, the front ends forming
the front end of the bundle and the rear ends forming the rear end of
the bundle, each electrode comprising
(a) an oblong electrically conducting electrode element having a front
end and a rear end,
(b) an anchoring element having a free end and a second end joined to
the electrode element at the front end or a portion thereof intermediate
between the front end and the rear end, the anchoring element forming
an angle α with the electrode element of from 0° to 60° and extending
in the direction of the rear end thereof,
(c) a plurality of electrical conductors each of which is attached to a
different one of said two or more electrodes at the rear end thereof,
and
(d) an element bundling the electrodes disposed between the
anchoring element and the rear end.
Independent claim 30 is identical to claim 1, except that it recites an
electrode bundle “consisting of two or more electrically independent
electrodes …” (emphasis added) (App. Br. 12; see also Claim Appendix A).
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The claims stand rejected as follows:
I. Claims 1-5, 10, 15-17, 19-21, and 30 under 35 U.S.C. § 102(b) as
anticipated by Latterell et al. (U.S. Pat. No. 5,300,110, issued Apr. 5, 1994).
II. Claims 22, 23, 28 and 29 under 35 U.S.C. § 102(b) as anticipated
by Latterell, or alternatively, under 35 U.S.C. § 103(a) as obvious over
Latterell.
III. Claims 7-9, 11-14, 18, and 24 under 35 U.S.C. § 103(a) as
obvious over Latterell.
IV. Claim 30 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement, and § 112, second
paragraph, as being indefinite.
ANTICIPATION
Issue
Does the Examiner establish a prima facie case of anticipation of
independent claim 1 or 30?
Findings of Fact
1. As shown in Figure 1 in the instant Specification, electrode (2)
comprises an electrically conducting electrode rod (3) having a tip (4) at its
front end, as well as an anchoring element (5) having a tip (6) (Spec. 10).
Electrode element (3) and anchoring element (5) form an angle α in relation
to each other (id. at 10-11). As shown in Figures 2 and 3a-3c, the electrodes
have “a front and rear end aligned in parallel” to each other, as recited in
claim 1.
2. Figures 1-4 in the Specification are reproduced below:
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Figure 1 depicts an axial section of an electrode of an electrode bundle
(Spec. 7). Figure 2 depicts a top view of an array of 12 electrodes of an
electrode bundle (id. at 8). Figures 3a and 3b show transverse sections B-B
and C-C (as indicated in Figure 4), respectively, of an electrode bundle;
Figure 3c shows a top view of the electrode bundle depicted in Figure 2, in a
folded state (id.). Figure 4 is an axial section D-D (as indicated in Figure 3c)
of the electrode bundle, in a folded state.
3. As described in the Specification, an electrode bundle may be
“bunched at or near its distal end by means of a collar, a sleeve, a ring, an
adhesive or similar” (id. at 4). Such bunching can be used “to obtain a
desired electrode bundle geometry for insertion into tissue” (id.).
4. As shown in Figures 3a and 4, electrodes “are mounted by clamping
them to the cylinder 7 by means of a sleeve 8” (id. at 11). Thus, cylinder (7)
and/or sleeve (8) act as an “element bundling the electrodes” as recited in (d)
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of claim 1, and are disposed entirely between the anchoring element (5) and
the rear end of the electrode.
5. Latterell describes epicardial defibrillation electrodes comprising
conductive dirk members that penetrate the epicardium (Latterell, col. 1, ll.
6-9). Each dirk member has an elongated body (an oblong electrode
element) and a terminal barb (an anchor element) that anchors the dirks in
the myocardium (id. at col. 3, ll. 1-4, 16-19).
6. Figures 3-6 in Latterell are shown below:

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Figures 3-6 show different embodiments of a dirk-based defibrillation patch
electrode device (id. at col. 2, ll. 14-23). Latterell states that Figure 6 is a
cross-sectional view of the dirk-based epicardial patch electrode of Figure 3
(id. at ll. 22-23).
7. In relation to Figures 3 and 6, Latterell discloses that “dirks 25 are
electrically connected to the common current carrier 22 which is held in or
on the substrate 24 of the electrode” (id. at col. 3, ll. 14-16).
8. Latterell also states that a “further benefit of the dirk based electrodes
of this invention is that one or two of the dirks may be individually or
separately wired” (id. at col. 4, ll. 7-9). This embodiment is depicted in
Figure 4, which “shows an electrode embodiment 35 having two separate
pacing and sensing dirks 46 and 47, each having separate conductors 37 and
38” (id. at ll. 19-22). Also in this embodiment:
A high current conductor ring 36 is shown mounted to support
structure 40 for the dirk members 41 that are designed to carry
the defibrillation current. ... The pacing/sensing conductor
leads 37 and 38 are show to extend from the insulated
conductor structure 39 to the support structure 40 from which
extend the pacing/sensing dirk members 46 and 47 and the
defibrillation dirk members 41.
(Id. at ll. 22-31.)
9. When describing support structures shown in Figures 3, 4, or 5,
Latterell states that “the defibrillation current conductors are mounted to or
imbedded in the respective support substrates whereby the dirk members
extend outwardly therefrom” (id. at col. 5, ll. 23-33). Thus, Latterell teaches
that dirks of Figure 3 or 4 may be embedded in the respective support
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substrate shown in each figure, i.e., an element bundling the electrodes in the
figures.
Principles of Law
The Examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). If the Examiner fails to
establish a prima facie case of unpatentability in the first instance, however,
the rejection is improper and must be reversed. Id.; In re Rijckaert, 9 F.3d
1531, 1532 (Fed. Cir. 1993).
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
Analysis
The Examiner has rejected independent claims 1 and 30, as well as
dependent claims 2-5, 10, 15-17, 19-21, as anticipated by Latterell.
Appellant argues that while “dirks 46 and 47 may be electrically separate
from each other” in Figure 4, nothing “functions to bundle two or more of
dirks 36, 46 and 47 disposed anywhere between that the front and rear ends
of any of these dirks” as required in (d) of claims 1 and 30 (App. Br. 10).
As an initial matter, we agree with the Examiner that Latterell, when
presenting and discussing Figure 4, describes “two or more electrically
independent electrodes … aligned in parallel” as recited in claim 1 by
disclosing dirks 46 and 47, where each have separate conductors 37 and 38
(Ans. 5; FF 6,8). That said, as noted by Appellant, we must consider (d) in
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claims 1 and 30, which recites “an element bundling the electrodes disposed
between the anchoring element and the rear end.”
In relation to (d), the Examiner asserts that “Latterell discloses in
figures 4 and 6 that the dirks are embedded in bundling support 24 and that
the support, 24, is both above the rear end and below the rear end (e.g. col.
3, line 15, lines 28-38, etc.)” (Ans. 6). We agree with the Examiner on this
point. Both Figure 6 and discussions of Figure 4 in Latterell teach that
conductors connected to dirks (comprising electrode elements and anchoring
members) may be “mounted to or imbedded in the respective support
substrates,” such as substrate 24 in Figures 3 and 6 or support structure 40 in
Figure 4 (FF 9; see also FF 6-8 and Figure 6). Moreover, even if we agree
with Appellant that “support 24 only appears in Figure 6” and that Figure 6
is “not a cross-section of Figure 4, but rather is a cross-section of Figure 3”
which does not show electrodes 46 and 47 (Reply Br. 2), Latterell describes
that dirks shown in Figure 4 may be embedded in support structure 40,
similarly to what is shown in Figure 6 in relation to dirks shown in Figure 3
(FF 9).
Support structure 40 in Figure 4 (analogous to support substrate 24 in
Figures 3 and 6) acts as “an element bundling” two or more electronically
independent electrodes, i.e., dirks 46 and 47, which each have separate
conductors 37 and 38. As found by the Examiner, Latterell discloses that
dirks are embedded in a support substrate/structure, which acts as a bundling
element, where the support substrate/structure is both above and below the
rear end. Thus, Latterell teaches that a portion of a bundling element (e.g.,
top half of structure 40 in Figure 4) is located between an anchoring element
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in a dirk and the rear end of an electrode in the dirk, in a manner akin to
what is shown in Figure 6 in Latterell.
We must also consider, however, whether element (d) requires that the
entire “element bundling the electrodes” be “disposed between the anchoring
element and the rear end” of the electrode element, or whether (d)
encompasses an electrode bundle where only a part of the element is located
between an anchoring element and the rear of an electrode.
The ordinary meaning of “between” in relation to two points refers to
being “in the space separating” the two points. (See, e.g., RANDOM HOUSE
WEBSTER‟S COLLEGE DICTIONARY 131 (1995); Dictionary.com (Sept. 24,
2012) http://dictionary.reference.com/browse/between). Disclosures in the
Specification are consistent with this dictionary definition. For example,
cylinder (7) and/or sleeve (8) in Figures 3a and 4 of the Specification
disclose as an “element bundling the electrodes” that is disposed entirely
between, i.e., in the space separating, anchoring element (5) and the rear end
of electrode (3) (FF 2-4).
Thus, we interpret (d) of claims 1 and 30 as requiring that the
“element bundling” be disposed entirely between an anchoring element and
a rear end of an electrode. We do not find, and the Examiner does not
indicate, that Latterell teaches such an element. Rather, at most, by
describing embedding of dirks in a substrate/structure (FF 6, 9), the
reference teaches disposing a portion of an element bundling the electrodes,
i.e., part of substrate (24)/structure (40) in Figures 3, 4, and 6 in Latterell,
between an anchoring element and a rear end of an electrode. Such a
teaching does not expressly or inherently disclose element (d).
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Conclusion of Law
The Examiner fails to establish a prima facie case of anticipation of
independent claim 1 or 30. Because the Examiner fails to establish that
Latterell discloses an element of independent claim 1, the Examiner likewise
fails to establish a prima facie case of anticipation of dependent claims 2-5,
10, 15-17, 19-21, and dependent claims 22, 23, 28 and 29.
OBVIOUSNESS
Issue
Does the Examiner establish a prima facie case of obviousness of
claims 22, 23, 28, and 29, or claims 7-9, 11-14, 18, and 24, over Latterell?
Analysis
As discussed above, the Examiner fails to establish that Latterell
discloses element (d) of claim 1, i.e., an “element bundling the electrodes”
that is disposed “between,” i.e., entirely in the space separating, an
anchoring element and a rear end of an electrode. In the anticipation
rejection, the Examiner does not explain if/how Latterell suggests disposing
an “element bundling the electrodes” entirely between an anchoring element
and a rear end of an electrode, when the reference only describes having
dirks “mounted to or imbedded in the respective support substrates” (FF 9)
(Ans. 6, 9). Nor does the Examiner refer to anything in Latterell that might
suggest an advantage in disposing a bundling support (24)/(40) entirely
between an anchoring element and the rear end of a dirk electrode (id. at 6,
8-9).
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In the obviousness rejections, the Examiner does not address element
(d) recited in independent claim 1, but rather focuses on elements recited in
each of the dependent claims. Thus, the Examiner fails to make a prima
facie case of obviousness of claim 1 over Latterell, and therefore likewise
fails to establish that any claims that depend on claim 1 are obvious.
Conclusion of Law
The Examiner fails to establish a prima facie case of obviousness of
claims 22, 23, 28, and 29, and claims 7-9, 11-14, 18, and 24, over Latterell.
35 U.S.C. § 112
Issue
Does the Examiner establish that claim 30 fails to comply with the
written description requirement and/or is indefinite under 35 U.S.C. § 112,
first and second paragraphs?
Analysis
The Examiner asserts that the use of “consisting of” in claim 30 is
vague, and therefore lacks written description support, because that language
is closed-ended and “the electrode bundle as set forth in the specification
contains more than those elements, such as element 10, insulating coating [],
etc.” (Ans. 3) (citation omitted). Based on the same language, the Examiner
also contends that the “claim‟s use of „or more‟ electrodes does not set forth
the number of electrodes present,” and “[i]t is unclear how many electrodes
to find in the prior art” (id. at 10; see also, id. at 4).
As noted by Appellant, the phrase “consisting of two or more
electrically independent electrodes” indicates that “there are only electrically
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independent electrodes present” in the electrode bundle (App. Br. 13). The
claim also recites that each of those electrodes comprises elements (a) – (d).
Claim 30 is not vague or indefinite merely because it does not recite the
exact number of electrodes present in the electrode bundle beyond indicating
that it is “two or more.”
That said, we agree with the Examiner that claim 30 is indefinite.
Specifically, claim 30 requires that the electrode bundle only consists of two
or more electrodes, i.e., “only electrically independent electrodes [are]
present” (App. Br. 13). That notwithstanding, the claim recites that each
electrode comprises (c) “a plurality of electrical conductors each of which is
attached to a different one of said two or more electrodes at the rear end
thereof,” and (d) “an element bundling the electrodes ….”
In relation to (c), it is not clear how/if each and every electrode in the
bundle comprises a “plurality” (two or more) electrical conductors, where
each conductor is attached to a different electrode of the “two or more
electrodes” in the bundle. This is in contrast to the electrode bundle itself
(rather than each electrode) comprising element (c), which is not what claim
30 recites. Element (d) has the same conundrum. It is not clear how/if each
and every electrode comprises an element that bundles all of the electrodes.
Again, this is in contrast to an electrode bundle itself, rather than each
electrode in the bundle, comprising an element (d). Thus, claim 30 fails to
clarify the subject matter which Appellant regards as his invention, as
required under 35 U.S.C. § 112, second paragraph.
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Conclusion of Law
The Examiner does not establish that claim 30 fails to comply with the
written description requirement and/or is indefinite. That said, we affirm the
rejection of claim 30 as being indefinite. Because our reasoning differs from
that of the Examiner, we designate this affirmance as a new ground of
rejection.
SUMMARY
We reverse the rejection of claims 1-5, 10, 15-17, 19-21, and 30 as
anticipated by Latterell. We also reverse the rejection of claims 22, 23, 28
and 29 as anticipated by Latterell, or alternatively, as obvious over Latterell,
as well as the rejection of claims 7-9, 11-14, 18, and 24 as obvious over
Latterell. In addition, we reverse the rejection of claim 30 as failing to
comply with the written description requirement. That said, we affirm the
rejection of claim 30 as being indefinite, albeit on a new ground.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of
rejection . . . shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
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and have the matter reconsidered by the examiner, in which event the
proceeding will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record. . . .

AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b)

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