Ex Parte Cohen et al

Patent Trial and Appeal Board

Jul 24, 2017

12651031 (P.T.A.B. Jul. 24, 2017)

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.
12/651,031 12/31/2009 Amit Cohen 0K-042200US/065513-000231 8357
67337 7590 07/26/2017
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
07/26/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
MN_IPMail @ dykema. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMIT COHEN and IT AY KARIV1
Appeal 2016-003750
Application 12/651,031
Technology Center 3700
Before TAWEN CHANG, RYAN H. FLAX, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for three-dimensionally mapping a volume
within a region of interest (ROI) located within a body. Claims 1, 3—9, 11,
and 22—33 are on appeal as rejected under 35 U.S.C. §§ 112, second
paragraph, and 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as St. Jude Medical, Atrial
Fibrillation Division, Inc. App. Br. 1.
Appeal 2016-003750
Application 12/651,031
STATEMENT OF THE CASE
The Specification states the “invention is directed to a system and
method for real-time surface and volume mapping of anatomical structures,”
where the system “is configured to compute a contour for a medical device
disposed within the ROI as a function of at least one of a positional
constraint and a shape constraint” and “to translate the contour into a
plurality of three-dimensional positions wherein the plurality of three-
dimensional positions include both known and virtual positions.” Spec. 7.
The Specification’s Figures 3A and 3B illustrate a medical device (16) for
use in such a system and method, and are reproduced below:
Figures 3A and 3B show a contoured (bent in a general, question-mark-
shape), elongate medical device (16) having position sensors (14i—M3), for
detecting a magnetic field and producing a positioning signal for real-time
tracking in three dimensions, at the device’s distal tip and regularly spaced
along the shown-portion of its length. Spec. Tflf 29—34. In addition to the
FIG.3A FIG.3B
2
Appeal 2016-003750
Application 12/651,031
position sensors (14), Figures 3A and 3B also show virtual points (28) along
the device’s length between the position sensors, which correspond to a
computed contour of the medical device based on positional constraints of
the device’s location within the anatomy and the known physical/mechanical
constraints of the device, e.g., relating to its dimensions and materials. Id.
38-43. The position sensors (14) and virtual points (28) provide data
points (32) for identifying the location, position, and orientation of the
medical device (16) and, thus, for mapping an interior volume of anatomy.
Id. 140.
Claims 1, 6, 26, and 29 are the independent claims. Claim 1 is
representative and is reproduced below:
1. A method for three-dimensionally mapping a volume
within a region of interest (ROI) located within a body,
comprising:
tracking a position of an invasive medical device within
said ROI in real-time, said tracking comprising:
computing an initial contour for said medical device as a
function of said position and at least one positional constraint,
said at least one positional constraint comprising an anatomically
restraining location within the body; and
translating said initial contour into a first plurality of three-
dimensional positions wherein said plurality of three-
dimensional positions include both known and virtual positions
based on said at least one positional constraint;
recording at least one of said virtual positions;
determining an initial real-time spatial volume using at
least said recorded virtual positions as input;
3
Appeal 2016-003750
Application 12/651,031
computing a subsequent contour for said medical device
as a function of at least one of a shape constraint and a positional
constraint;
translating said subsequent contour into a second set of a
plurality of three-dimensional positions wherein said second set
of said plurality of three-dimensional positions includes both
known and virtual positions;
determining, for each three-dimensional position in said
second set of three-dimensional positions, whether said position
falls outside of said determined real-time spatial volume;
revising said initial real-time spatial volume to include three-
dimensional positions from said second set that fall outside of
said initial real-time spatial volume; and
rendering a real-time three-dimensional graphical
representation of said revised spatial volume.
App. Br. 10 (Claims App’x).
The following rejections are on appeal:
Claims 1 and 3—5 stand rejected under 35U.S.C. § 112, second
paragraph, as indefinite. Final Action 2—3.
Claims 1, 3—9, 11, and 22—33 stand rejected under 35 U.S.C. § 103(a)
over Verard2 and Reisfeld3 or Markowitz.4 Id. at 4.
2 U.S. Patent Appl. Pub. No. US 2004/0097805 A1 (pub. May 20, 2004)
(“Verard”).
3 U.S. Patent No. US 6,546,271 B1 (issued Apr. 8, 2003) (“Reisfeld”).
4 U.S. Patent Appl. Pub. No. US 2009/0264738 A1 (pub. Oct. 22, 2009)
(“Markowitz”).
4
Appeal 2016-003750
Application 12/651,031
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
Indefiniteness
Claim 1 recites “determining an initial real-time spatial volume using
at least said recorded virtual positions as input.” The Examiner found claim
1 indefinite “because it is unclear how the ‘real-time spatial volume’ can be
determined based only on the recorded virtual positions as input,” and the
Specification describes “the spatial volume is determined based on both
known and virtual positions and not just the virtual positions as claimed.”
Final Action 3 (citing Spec. 170).
“[A] claim is indefinite when it contains words or phrases whose
meaning is unclear,” i.e., “ambiguous, vague, incoherent, opaque, or
otherwise unclear in describing and defining the claimed invention.” In re
Packard, 751 F.3d 1307, 1310-13 (Fed. Cir. 2014); see also MPEP
§ 2173.02(1) (Rev. 07.2015, Nov. 2015) (advising examiners that a rejection
for indefmiteness is appropriate “after applying the broadest reasonable
interpretation to the claim, if the metes and bounds of the claimed invention
are not clear”). We ask whether one of ordinary skill in the art would
understand what is claimed when the claim is read in light of the
Specification. Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1350
(Fed. Cir. 2010).
We do not find the claim language indefinite. The Examiner does not
persuasively demonstrate ambiguity as to the metes and bounds of claim 1,
5
Appeal 2016-003750
Application 12/651,031
at least with respect to determining real-time spatial volume using virtual
data. Virtual positions are described sufficiently in the Specification to
explain the scope of this term. See, e.g., Spec. 138. The rejection focuses
on whether it is actually possible to develop a real-time 3D representation of
anatomy based solely on virtual data or whether the Specification discloses
actually doing so, but this inquiry relates to whether the claimed subject
matter is enabled or whether the Specification provides the necessary written
description support. We are unpersuaded the skilled person would fail to
understand what is being claimed; whether it is enabled or supported by the
Specification is not at issue.
For these reasons, we reverse the indefmiteness rejection.
Obviousness
Unless otherwise indicated herein, we adopt the Examiner’s findings
of fact, reasoning on scope and content of the claims and prior art, and
conclusions set out in the Final Action and Answer. The findings of fact set
forth below are provided to highlight certain evidence.
Findings of Fact
FF1. Verard discloses methods and a catheter for navigation
within and the mapping of human anatomy, including the catheter’s
position and orientation in 2D, 3D, or 4D, measured in real-time using
axially-spaced location sensors tracked by electromagnetic detectors,
using virtual data based on a “curve fitting algorithm that is selectable
based on the type of catheter used, and based on the flexibility of the
catheter,” and using anatomical structures (landmarks), where new
anatomy mapping information is collected and stored during the
6
Appeal 2016-003750
Application 12/651,031
process to create an anatomical atlas. Verard, Abstract, || 15—17, 23,
25, 26, 62, 71, 88, 96, 108-09, 112, 122-123, and 132, Figs. 6-10,
15A—C; see also Final Action 4, 7, and Ans. 3—5 (discussing Verard).
FF2. Markowitz discloses a method and a catheter system for
3D mapping the inner anatomy of a patient in real time using
anatomical landmarks, and using an electrode tracking element in a
generated electric field to identify new data points within the patient
and add them together to create a map, where newly acquired data
points can be either included in the anatomy mapping or disregarded
in favor of a representative data point; such a representative data point
can be
[a] single sphere data icon (or managed point) illustrated on the
display device 58 . . . when [several] data points have been
collected for a respective voxel of the mapping data 194[,]
[therefore a single data point representation 198 on the display
device 58 can be representative of one or more position data
points acquired with the mapping catheter 100,
i.e., the system determines whether a newly acquired data point is
represented by an existing data point for a given 3D space and,
therefore, excluded, or not so represented and, therefore, included as
the map is expanded. Markowitz Abstract, || 9, 64, 118, 122—25,
129-30, 144, 147-48, 156, 160-62, 171-72, 271-74, and 290, Figs.
5—8, 10, 17—20, 24C, 28, 29A, and 35; see also Final Action 4—8 and
Ans. 3, 5—6 (discussing Markowitz).
Analysis
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
7
Appeal 2016-003750
Application 12/651,031
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v.
Adams, 383 U.S. 39, 50-51 (1966). “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” Id. As to motivation to combine separately
disclosed subject matter, “the question is whether there is something in the
prior art as a whole to suggest the desirability, and thus the obviousness, of
making the combination, not whether there is something in the prior art as a
whole to suggest that the combination is the most desirable combination
available.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation
omitted).
It is prima facie obvious to combine two [things] each of which
is taught by the prior art to be useful for the same purpose, in
order to form a third [thing] which is to be used for the very same
purpose. . . . [T]he idea of combining them flows logically from
their having been individually taught in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Reviewing the Examiner’s rationale for the obviousness rejection and
the cited prior art combination, we find that under the above-cited precedent
the Examiner has established that Appellants’ claims would have been
obvious. In agreement with the Examiner, we find that the prior art
combination teaches the method of claim 1, including “determining, for each
three-dimensional position in said second set of three-dimensional positions,
whether said position falls outside of said determined real-time spatial
volume” and “revising said initial real-time spatial volume to include three-
dimensional positions from said second set that fall outside of said initial
real-time spatial volume,” as recited by the claim. FF1, FF2. Appellants
8
Appeal 2016-003750
Application 12/651,031
have not produced evidence showing, or persuasively argued, that the
Examiner’s determinations are incorrect.
Appellants argue that none of Verard, Reisfeld, and Markowitz
teaches or suggests, “determining for each three dimensional positions,
whether said position falls outside of said determined real-time spatial
volume,” as recited by claim 1. App. Br. 7—9. Appellants contend that the
cited art fails to disclose the step of identifying whether a data point is new
or not (and, per the subsequent claim element, adding the data point if it is
new). Appellants contend that, even if Markowitz teaches a process of
updating surface data with new/additional data points, that does not mean its
system considers whether these new data points are “outside the previous
spatial volume.” Reply Br. 4. We do not find these arguments persuasive.
The methods of Markowitz do consider whether new data points are
inside (represented by) or outside (not represented by) previous data points
(which would be within the spatial volume). As identified above at FF2 and
also found by the Examiner (at, e.g., Ans. 5—6), Markowitz teaches that its
3D interior anatomy mapping system and process is additive so that new
data supplements previously collected data to further render an anatomy
reconstruction in real-time. In this process, each data point represents a
spatial volume (called a “voxel” by Markowitz); new data points can either
be within an already sampled spatial volume or outside such a spatial
volume. Markowitz also teaches that in this process its system determines
whether collected data points are represented by existing data points, i.e.,
whether new data points are inside the same spatial volume represented by
previously collected data points. Because Markowitz’s system has the
9
Appeal 2016-003750
Application 12/651,031
sophistication to include only representative data points in its anatomy
rendering, if desired, it determines whether or not a new data point is
represented by an already mapped voxel (inside the collected spatial
volume) and to be included or excluded in updated renderings.
For these reasons, we affirm the obviousness rejection.
SUMMARY
The rejection of claims 1 and 3—5 under 35U.S.C. § 112, second
paragraph, as indefinite is reversed.
The rejection of claims 1, 3—9, 11, and 22—33 under 35 U.S.C.
§ 103(a) over Verard and Reisfeld or Markowitz is affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
10