Ex Parte Schwartz

Board of Patent Appeals and Interferences

Oct 29, 2009

10425209 (B.P.A.I. Oct. 29, 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.
10/425,209 04/29/2003 Yitzhack Schwartz BIO-5006 4838
27777 7590 10/30/2009
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
SMITH, RUTH S
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
10/30/2009 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 YITZHACK SCHWARTZ
__________

Appeal 2009-005392
Application 10/425,209
Technology Center 3700
__________

Decided: October 30, 2009
__________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for performing a medical procedure in the septal wall of the heart.
The Patent Examiner rejected the claims for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
The Specification states that “[i]n medical procedures involving a
patient’s heart . . . , there are numerous diagnostic and therapeutic
procedures that require transeptal left heart catheterization.” (Spec. 1:11-
12.) According to the Specification, “the methods and devices in accordance
with the present invention are useful for accurately identifying the location
of the fossa ovalis and for facilitating the penetration of the septal wall at the
fossa ovalis . . . .” (Id. at 4:15-18.)
Claims 1-23, which are all the pending claims, are on appeal. Claim 1
is representative and reads as follows:
1. A method for performing a procedure at a fossa ovalis in a septal wall
of a heart, the method comprising the steps of:

providing a sheath comprising a body, the body having a lumen
extending therethrough and an open end at a distal end of the body,
the body having at least one electrode for recording and measuring
electrical properties of the heart for determining an injury pattern, the
body also having a position sensor at the distal end of the body the
position sensor generating signals indicative of a location of the distal
end of the body;

identifying the septal wall of the heart;

identifying the fossa ovalis in the septal wall based on the injury
pattern detected by the at least one electrode;

tagging a point at the fossa ovalis; and

navigating the sheath to the fossa ovalis at the tagged point using the
position sensor.

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The Examiner rejected the claims as follows:
• claims 1-23 under 35 U.S.C. § 103(a) as unpatentable over Gilboa1 in
view of Bidoggia alone;2 or
• claims 1-23 under 35 U.S.C. § 103(a) as unpatentable over Gilboa in
view of Bidoggia and further in view of Govari.3 (Ans. 3.)
Claims 2-23 have not been argued separately and therefore, stand or
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
Appellant characterizes the rejections on appeal as a single rejection
based on a combination of three references. (App. Br. 3.) We do not agree.
The Examiner rejected all claims over Gilboa “in view of Bidoggia et al
alone or further in view of Govari.” (Final Rej. 2; Ans. 3.) We understand
this phrasing as meaning two rejections: (A) Gilboa and Bidoggia, and
(B) Gilboa, Bidoggia, and Govari. We treat Appellant’s arguments against
rejection (B) as if also lodged against rejection (A).

OBVIOUSNESS
The Issues
A. The Rejection over Gilboa and Bidoggia
The Examiner’s position is that Gilboa taught a method for
penetrating the heart septum at the fossa ovalis. The Examiner found that
Gilboa’s method comprised most of the claimed steps, but Gilboa did not

1 WO 01/80922 A2, by Pinhas Gilboa, published Nov. 1, 2001.
2 Hector Bidoggia et al., Transseptal Left Heart Catheterization: Usefulness
of the Intracavity Electrocardiogram in the Localization of the Fossa Ovalis,
24 Catherization and Cardiovascular Diagnosis, 221-225 (1991).
3 Pub. No. US 2003/0018246 A1, by Assaf Govari et al., published Jan. 23,
2003.
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“disclose the use of an electrode at the distal end of the sheath to record and
measure electrical properties of the heart in order to confirm the location of
the fossa ovalis.” (Ans. 3.) The Examiner found that Bidoggia taught a
method of penetrating the heart septum at the fossa ovalis that included
using an electrode determined injury pattern in order to accurately locate the
fossa ovalis. (Id.) The Examiner concluded that modifying Gilboa’s method
to confirm the fossa ovalis location with Bidoggia’s method would have the
advantage of confirming an accurate location and would have been obvious.
(Id.)
Appellant contends that Gilboa “lacks any teaching, suggestion or
even inference, relating to identifying the fossa ovalis on the septum.” (App.
Br. 5.) Further, the image guided procedure mentioned in Gilboa is
“completely different” from the injury pattern identification as claimed.
(Id.) Similarly, Appellant contends that “[t]here are no relevant teachings
in” Bidoggia or Gilboa that would have lead persons of ordinary skill in the
art to the claimed invention. (Id. at 6.)
The issues with respect to this rejection are:
did Gilboa have any teaching, suggestion or inference relating to
identifying the fossa ovalis on the septum?
was Gilboa’s method “completely different” from the claimed
method? and
did Bidoggia have any teachings relevant to the claimed invention?

B. The Rejection over Gilboa, Bidoggia, and Govari
The Examiner interpreted claim 1’s “tagging a point” step as
including marking the tissue on an image or “tagging” the tissue with a
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physical tag. The Examiner found that Gilboa taught marking or tagging the
fossa ovalis on an image, but it was also well known to physically tag tissue.
(Ans. 4.) Given the teachings in Gilboa and Bidoggia, the Examiner found it
would have been further obvious to use Govari’s physical tag where Gilboa
called for marking the tissue. (Id.)
Appellant first contends that Govari is not prior art under 35 U.S.C.
§ 102(e), and therefore cannot be applied under § 103. (App. Br. 3-4.)
Applicant then argues that “[a]lthough Govari teaches implantable tags in
medical procedures, the reference does not in any way address a method . . .
with the novel method steps of the Applicant’s claimed present invention.”
(Id. at 6-7.)
The issues with respect to this rejection are
is Govari available as prior art? and
did Govari address “in any way” a method as claimed?

Findings of Fact
1. Gilboa described a method for guiding an apparatus to a location
inside a cavity in the body. (Gilboa at 3:17-25.)
2. Gilboa’s method included (a) providing a sheath having a lumen;
(b) inserting a position sensor along the lumen; (c) employing position
information generated by the sensor during guiding the sheath to a
location in the body; and (d) withdrawing the position sensor to
replace it with an apparatus at the location within the body. (Id. at
6:13-21.)
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3. Gilboa taught that the method could be used for performing a
procedure at the fossa ovalis in the heart septum, and described more
specific steps comprising:
leading an introducer sheath trans-septaly from the right atrium
into the left atrium. Under the current invention that is done by
taking an image that is registered to the reference system of
coordinates as defined by the positioning system, marking a
coordinate on the septum, preferably the fossa ovalis, to be
penetrate through, insert a tube having a position sensor inside
the lumen of an introducer sheath, leading the tip of the sheath
to the said coordinate on the septum, replacing the tube having
the positioning sensor by a long needle and puncturing the
septum by pushing the sheath t[h]rough it.

(Id. at 14:15-23.)
4. Bidoggia taught that a “major difficulty in left heart catheterization
through the interatrial septum is to ensure that the Brockenbrough
needle tip is correctly laid on the fossa ovalis floor (FOF), which is
the only area where the puncture must be done.” (Bidoggia,
Abstract.)
5. “In order to reduce the hazards of the septal puncture,” Bidoggia
taught “using the Brockenbrough needle as an exploratory electrode.”
(Id.)
6. “When the tip of the needle was laid against the FOF, the endoatrial
electrocardiogram (EAE) registered a slight or no injury curve . . . .
[T]he pressure on any other area of the muscular septum or atrial
walls elicited a bizarre monophasic injury curve.” (Id.)
7. Bidoggia taught: “[t]he peculiar electrocardiographic response of the
FOF to the pressure exerted by the Brockenbrough needle tip was a
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valuable aid to identify the area where the transseptal puncture must
be done.” (Id.)
8. Govari described an acoustic tag that could be fixed to the tissue and
used for locating the tissue within a body of a subject. (Govari,
Abstract.)
9. Concerning the “tagging a point” step, Appellant’s Specification
states:
A point is identified on the fossa ovalis and the point is then
tagged at the fossa ovalis. . . . In one example, the tagged point
is a location coordinate (having position and orientation
coordinates) displayed on a map such as an electroanatomical
map. In another example in accordance with the present
invention, the tagged point is a physical tag, such as an active
tag or a passive tag, which is placed at the point (at the
identified location, i.e. position and/or orientation coordinates),
at the fossa ovalis of the septal wall.

(Spec. at 6:7-18.)

Principles of Law
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). The proper question to ask is whether a person of
ordinary skill in the art, facing the wide range of needs created by
developments in the field of endeavor, would have seen a benefit to
combining the prior art teachings. KSR, 550 U.S. at 424; see also In re
Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (the desirability of the
combination may arise from nature of the problem, teachings of references,
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or the ordinary knowledge of those skilled in the art). “[I]f a technique has
been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
using the technique is obvious unless its actual application is beyond his or
her skill.” KSR, 550 U.S. at 417.
A prior art reference is said to teach away from an Applicant’s
invention “when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).

Analysis
A. The Rejection over Gilboa and Bidoggia
Gilboa explicitly taught a method of puncturing the heart’s septum at
the fossa ovalis, including a step of marking the fossa ovalis. (FF3.)
Appellant’s assertion that Gilboa has no teaching, suggestion or inference
relevant to identifying the fossa ovalis simply contradicts the evidence,
which supports the Examiner’s findings. We also disagree that Gilboa’s
method is “completely different” from the claimed method; we find the
Examiner correctly identified the similarities and the difference (Ans. 3).
Similarly, Appellant’s claim that Bidoggia has no relevant teachings
also contradicts the evidence. Bidoggia taught using an electrode to detect
injury patterns as a way to reduce the hazards of cardiac septal puncture (FF
5-7.) The evidence supports the Examiner’s finding that Bidoggia taught
hazard reduction as a reason to adopt the electrode method to detect injury
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patterns for accurately locating the fossa ovalis prior to puncture, providing
the relevance and reason to have used it in Gilboa’s method.
We find no evidence that Gilboa discouraged those of skill in the art
from using Bidoggia’s hazard reduction method. Appellant has not
persuaded us of error in the Examiner’s fact findings or legal conclusion of
obviousness.

B. The Rejection over Gilboa, Bidoggia, and Govari
It is undisputed that Govari was published before Appellant’s filing
date. We agree with the Examiner that Govari was available under § 102(a)
as evidence to support an obviousness rejection because it was published
prior to the filing date of the instant application and was authored by others
(i.e., Govari and Schwartz, rather than just Schwartz).
Appellant argues that Govari “does not in any way address” the
claimed method. Govari’s acoustic tag was disclosed as useful for
identifying a tissue within the body. (FF8.) Both Gilboa and Bidoggia
concerned identifying a tissue within the body. While Govari did not
expressly suggest using the acoustic tag to identify the fossa ovalis, we agree
with the Examiner that a person of ordinary skill in the cardiac procedures
art at the time would have been aware of Govari’s method, and would have
seen the advantage of using it where Gilboa called for marking the fossa
ovalis.

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CONCLUSIONS OF LAW
Gilboa taught identifying and marking the fossa ovalis on the septum.
Gilboa’s method of transeptal puncture at the fossa ovalis was not
“completely different” from Appellant’s method.
Bidoggia’s disclosure was relevant to Appellant’s invention.
Gilboa did not discourage a person of ordinary skill in the art from
adding Bidoggia’s hazard reduction technique to Gilboa’s method.
Govari was prior art under 35 U.S.C. §§ 102(a) and 103.
A person of ordinary skill in the art would have found it obvious to
adopt Govari’s acoustic tag as a fossa ovalis marker in Gilboa’s method.

SUMMARY
We affirm the rejections of claims 1-21 under 35 U.S.C. § 103(a) as
unpatentable over the combined teachings of Gilboa and Bidoggia “alone or
further in view of Govari.”
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
lp

PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK NJ 08933-7003