Ex Parte Rahimian et al

Patent Trials and Appeals Board

Mar 6, 2019

13399704 - (D) (P.T.A.B. Mar. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/399,704 02/17/2012
20995 7590 03/08/2019
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Javad Rahimian
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
VOXR.003A 5451
EXAMINER
DIETERLE, JENNIFER M
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
03/08/2019 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JA V AD RAHIMIAN and MOHAMMAD SHENASA
Appeal2017-005598
Application 13/399,704
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134 involving
claims to methods and systems for navigating within body structures to
cardiac ablation targets without the use of ionizing radiation or iodinated
agents. The Examiner rejected the claims for lack of patent-eligible subject
matter, for lack of written description, and for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the Real Party in Interest as VOXEL RAD, LTD. App.
Br. 3.
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Application 13/399,704
STATEMENT OF THE CASE
The Specification discloses that "[ t ]ranscatheter procedures are
rapidly replacing surgical procedures, such as coronary interventions ... and
catheter ablation of complex arrhythmias for arrhythmia surgery." Spec. ,r 2.
However, "[t]ypically transcatheter approaches are done under fluoroscopy
which uses ionizing radiation," exposure to which is of concern for patients
and medical personnel. Id. According to the Specification, "[a]ngiography
comprises obtaining x-ray fluoroscopic imaging that involves guiding a
catheter through femoral or carotid arteries ... with x-ray fluoroscopic
image guidance, and frequent injection of iodinated contrast agent to
visualize internal anatomy of the vasculature ... and plan an appropriate
treatment." Id. ,r,r 3--4 ("X-ray angiography is considered the industry's
typical imaging standard for the evaluation of cardiovascular anatomy within
the body."). 2
Further to the transcatheter treatment of arrhythmias, the Specification
explains that "AF [i.e., atrial fibrillation] ablation using RF typically requires
multiple site bums and is typically a lengthy procedure with high radiation
exposure." Spec. ,r 11. "Successful AF ablation can depend on completely
ablating target tissue without any gaps," where such "gaps are usually the
cause of reconnection and recurrence of AF." Id. According to the
Specification, "[ t ]raditional ablation catheters and electrodes do not identify
2 The Specification discloses that other methods "such as magnetic
resonance angiography (MRA)" may be "used to delineate the cardio-
vascular system." Yet, the Specification explains, "[ w ]hile MRA has the
advantage of using non-ionizing radio frequency (RF) energy, it does not
provide by itself real-time guidance within the vasculature." Spec. ,r 5.
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the characteristics of the arrhythmogenic substrate via direct visualization
and monitoring while ablating, nor do they ablate uniformly without possible
gaps." Id. ,r 13.
Appellants' invention "relates to a system for navigating within body
structures utilizing non ionizing and non iodinated agents." Spec. ,r 21.
According to the Specification, a "main advantage" with embodiments of the
invention "is that it can be completely ionizing radiation free." Id.
Moreover, in embodiments, a steerable catheter with a camera ( e.g., CCD or
CMOS) for direct imaging is included with the disclosed angiovision system
and methods, and an ablation catheter may also be "integrated with the
angiovision catheter to uniformly or non-uniformly generate heat or
cryoablation of the arrhythmogenic substrate." Id. ,r,r 18-19. "The uniform
ablation reduces gaps in the ablation which are often the cause of
reconnection and recurrence of AF and other cardiac arrhythmias." Id. ,r 19.
Claims 1--4, 6-8, 10, 11, 23, 25, and 27-38 are on appeal. Claim 1 is
illustrative and is reproduced below:
1. An ionizing radiation-free method to navigate within body
structures to cardiac tissue ablation targets, the method
compnsmg:
capturing and loading a digital image identifying a
vascular system of a patient into a memory storage device, the
digital image acquired without using ionizing radiation and
iodinated agents, the digital image comprising a magnetic
resonance angiogram (MRA) including images of the vascular
system and at least one infrared (IR) marker placed external to
the patient prior to acquiring the digital image, the digital image
further including images of the at least one IR marker taken by
two IR cameras, each IR camera capturing the image of the at
least one IR marker from a different position with respect to the
patient;
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generating stereotactic coordinates in a stereotactic
coordinate system based at least in part on the digital image,
locations of the at least one IR marker detected by the MRA and
the two IR cameras, and an entry point of a first catheter, the
locations of the at least one IR marker providing registration
information for the stereotactic coordinate system, the first
catheter including a first camera operationally coupled to a first
fiber optic bundle and at least one electromagnetic sensor
associated with an electromagnetic coordinate system;
generating from the digital image a 3D rendering of the
patient's vascular system in stereotactic space, the 3D rendering
including an indication of the entry point and a cardiac ablation
target using the stereotactic coordinate system;
generating a roadmap from the entry point to the cardiac
ablation target on the 3D rendering;
co-registering the electromagnetic and the stereotactic
coordinate systems in order to fuse positional information of the
at least one electromagnetic sensor with the 3D rendering;
obtaining a position associated with the first catheter from
an in-room global positioning system (GPS) configured to track
the at least one electromagnetic sensor;
fusing the position associated with the first catheter on the
3D rendering, the position comprising the longitudinal, lateral,
anterior-posterior, pitch, roll, and yaw location of the first
catheter;
displaying the 3D rendering including indications for the
position of the first catheter, the cardiac ablation target, the entry
point, and the roadmap, the 3D rendering used to navigate the
first catheter to the cardiac ablation target, the first camera
providing an angioscopic view of the cardiac ablation target.
App. Br. (Claims App'x A, i-ii).
Claims 23 and 27, the other independent claims on appeal, are similar
to claim 1. Claim 23 is a method and also recites, inter alia, "deploying a
second catheter through the first catheter at the cardiac ablation target."
Claims App'x iii-iv. Claim 23 further recites that this second catheter
includes certain features, such as "including a multi-strut ablation electrode
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having an ellipsoid shape after deployment," and that it is configured to
deliver RF energy to each strut and simultaneously ablate tissues in multiple
linear positions. Id. Claim 27 is an ionizing radiation-free system for
angionavigation and includes, among several limitations, first and second
preoperative imaging systems. Id. at iv-v. The first system includes at least
two infrared cameras that capture an image of external stereotactic fiduciary
markers, and the second system captures a digital image of the patient's
vasculature and the external stereotactic fiduciary markers using non-
ionizing radiation and non-iodinated agents ( e.g., MRA). Claim 27 also
recites, inter alia, computer image and tracking systems, and first and
second catheters that include (respectively) a camera and an ablation
electrode configured to ablate in multiple linear positions.
The claims stand rejected as follows:
I. Claims 1--4, 6-8, 10, 11, 23, 25, and 27-38 under 35 U.S.C.
§ 101 for lack of patent-eligible subject matter. Ans. 2--4.
("Rejection I").
II. Claims 27-35 under 35 U.S.C. § 112, first paragraph, as failing
to comply with the written description requirement. Id. at 4--5.
("Rejection II").
III. Claims 1, 7, 8, 10, and 11 under 35 U.S.C. § I03(a) as
unpatentable over Greenan, 3 Tremblay, 4 and Hunter. 5 Id. at 5-
9. ("Rejection III").
3 Greenan et al., US 2008/0171934 Al, published July 17, 2008.
4 Tremblay et al., US 2005/0054910 Al, published Mar. 10, 2005.
5 Hunter et al., US 2004/0097806 Al, published May 20, 2004.
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IV. The Examiner also rejects other claims that depend from
independent claim 1 over the Greenan, Tremblay, and Hunter
combination, in further combination with one or more
additional references: Wemeth6 (claim 2); Rothe7 (claim 3);
Ben-Haim8 (claim 4); Anderson9 (claim 6); Wemeth and Rothe
(claim 25). Id. at 9-13. ("Rejection IV").
V. Claim 23 under 35 U.S.C. § I03(a) as unpatentable over
Greenan, Tremblay, Hunter, and Rothe. Id. at 13-16.
("Rejection V").
VI. The Examiner also rejects claims 37 and 38, which depend
from independent claim 23, over the Greenan, Tremblay,
Hunter, and Rothe combination, in further combination with
Maschke 10 and Wemeth. Id. at 22-24. ("Rejection VI").
VII. Claims 27-31, 34, and 35 under 35 U.S.C. § I03(a) as
unpatentable over Maschke, Tremblay, Greenan, and Rothe. Id.
at 16-21. ("Rejection VII").
VIII. The Examiner also rejects claims 32 and 33, which depend
from independent claim 27, over the Maschke, Tremblay,
Greenan, Rothe combination, in further combination with
Anderson (claim 32) or Hunter (claim 33). Id. at 21-22.
("Rejection VIII").
6 Wemeth et al., US 2007/0083193 Al, published Apr. 12, 2007.
7 Rothe et al., US 2010/0094081 Al, published Apr. 15, 2010.
8 Ben-Haim, US 6,083,170, issued July 4, 2000.
9 Anderson, US 2009/0088756 Al, published Apr. 2, 2009.
10 Maschke, US 2008/0043901 Al, published Feb. 21, 2008.
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I. SUBJECT MATTER ELIGIBILITY
1. Supreme Court Eligibility Framework
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
Nevertheless, the Supreme Court has interpreted § 101 to include certain
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208, 216
(2014). 11
The Supreme Court has further established a two-step framework,
described in Mayo and Alice for assessing whether a claim falls within one
of those excepted, patent-ineligible, categories. Id. at 217-218 ( citing Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)).
Under that framework, the Supreme Court explains, first "we determine
whether the claims at issue are directed to one of those patent-ineligible
concepts." Id. "If so, we then ask, ' [ w ]hat else is there in the claims before
us?"' Id. (quoting Mayo, 566 U.S. at 78). In answering this second
question, the Court explains,
we consider the elements of each claim both individually and as
an ordered combination to determine whether the additional
elements transform the nature of the claim into a patent-eligible
application. . . . We have described step two of this analysis as a
search for an inventive concept-i.e., an element or combination
of elements that is sufficient to ensure that the patent in practice
11 For instance, concepts determined to be abstract ideas, and thus patent
ineligible, include certain methods of organizing human activity, such as
fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski v.
Kappas, 561 U.S. 593, 611 (2010)); mathematical formulas (Parker v.
Flook, 437 U.S. 584, 594--95 (1978)); and mental processes ( Gottschalk v.
Benson, 409 U.S. 63, 67 (1972)).
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amounts to significantly more than a patent upon the [ineligible
concept] itself.
Id. (internal citations and quotation marks omitted) (alteration in original).
2. Subject Matter Eligibility Guidance
The Patent Office recently published revised guidance on the
application of§ 101 in proceedings taking place before the Office. 2019
Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7,
2019) (hereafter "Revised Guidance"). Under that guidance, we look to
whether the claim recites:
(1) Step 2A - Prong One: any judicial exceptions, including certain
groupings of abstract ideas (i.e., mathematical concepts, certain
methods of organizing human activity, such as a fundamental
economic practice, or mental processes); and
(2) Step 2A - Prong Two: additional elements that integrate the
judicial exception into a practical application (see MPEP 12
§ 2106.05(a}-(c), (e}-(h)). 13
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
12 All Manual of Patent Examining Procedure (MPEP) citations herein are to
MPEP Rev. 08.2017, January 2018.
13 We acknowledge that some of the considerations at Step 2A, Prong Two,
properly may be evaluated under Step 2 of Alice (Step 2B of the Office
guidance). For purposes of maintaining consistent treatment within the
Office, we evaluate them under Step 1 of Alice (Step 2A of the Office
guidance). See 2019 Revised Patent Subject Matter Eligibility Guidance, 84
Fed. Reg. at 55 n. 25, 27-32. "As before, Step 1 of the USPTO's eligibility
analysis entails considering whether the claimed subject matter falls within
the four statutory categories [e.g., process, machine, etc.]" and the Revised
Guidance "does not change Step 1 ... analysis." Id. at 53-54.
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(3) adds a specific limitation beyond the judicial exception that is not
"well-understood, routine, conventional" in the field (see MPEP
§ 2106.0S(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See Revised Guidance 56 ("Step 2B: If the Claim Is Directed to a Judicial
Exception, Evaluate Whether the Claim Provides an Inventive Concept").
3. Examiner's §101 Rejection
According to the Examiner, the pending claims are "directed to a
method of navigating a catheter by generating a roadmap using stereotactic
markers and images that were not acquired using contrast agent." Ans. 2;
see also Final Act. 2--4. Moreover, the Examiner asserts, "the claimed
invention relies upon obtaining and comparing intangible data, which is
considered an abstract idea ... as it involves mathematically relating data or
is an idea of itself." Ans. 2. As for the "additional steps," the Examiner
asserts that those steps are simply "insignificant post-solution activity,"
"data-gathering," or "routine and conventional data processing steps"
applying an abstract idea in a computer environment. Id. at 2-3. The
claims, the Examiner finds, fail to improve the functioning of a computer
itself or improve any other technology. Id. at 3 ("While ... the claims result
in an image-guided treatment technique, this is not considered a meaningful
limitation beyond generally linking the use of an abstract idea to a particular
technological environment."). Moreover, the Examiner finds, "the claimed
invention ... fails to recite any specific machine for performing the apparent
computational steps." Id. at 3.
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Appellants argue the claims are not directed to an abstract idea. App.
Br. 18-19. To the contrary, Appellants argue, the "claimed inventions
provide a specific approach to solving the problem of how to navigate a
catheter to perform functions, such as ablation without gaps to avoid
reconnection and reoccurrence of atrial fibrillation, without exposing the
patient and staff to ionizing radiation." Id. at 18. According to Appellants,
the Examiner's assertion "that the claims are directed to the abstract idea of
'obtaining and comparing intangible data"' is "undoubtedly an
oversimplification." Id. at 18-19 ( quoting Final Act. 2 ). Appellants
highlight that the claims include, among other limitations, "navigating a
catheter through a patient using a 3 D rendering in stereotactic space that is
generated by fusing a MRA image and two IR images taken by IR cameras,"
"fusing positional information in electromagnetic coordinates from a sensor
on the catheter with the stereotactic coordinates in the 3D rendering ...
using a GPS system," and also "using the 3D rendering and an angioscopic
image from a camera on the catheter to provide 3D stereoscopic vision in
stereoscopic space of an ablation site." Id. at 19. For at least these reasons,
Appellants contend, "[t]he present claims could not be viewed as a generic
description of obtaining and comparing intangible data, and thus are not
'directed to' that purported concept." Id.
4. Analysis
Appellants' arguments are persuasive, and we disagree with the
Examiner's conclusion that the claims are patent-ineligible under§ 101. We
explain further below.
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Alice/Mayo Step 1; Revised Guidance Step 2A
From the standpoint of Alice/ Mayo Step 1 ( and Revised Guidance
Step 2A), we do not agree with the Examiner's determination14 that the
claims are directed to an abstract idea. As a threshold matter, we note that
the Examiner first states that the claims "are directed to a method of
navigating a catheter by generating a roadmap using stereotactic markers
and images that were not acquired using contrast agent." Ans. 2 ( emphasis
added). We do not agree that the claims, so characterized by the Examiner,
are necessarily an abstract idea. The Examiner does not demonstrate how
this distillation of the claimed subject matter falls within any of the well-
recognized categories of abstract ideas (i.e., mathematical concepts or
formulas, methods of organizing human activity, such as those involving
economic principles or commercial interactions, or mental processes
performed in the human mind). See Revised Guidance 52 (Step 2A).
The Examiner continues, however, and asserts that the claimed
invention "relies upon obtaining and comparing intangible data, which is
considered an abstract idea." Ans. 2. That a claim may "rely upon"
ineligible subject matter is not enough to show that a claim is directed to
ineligible subject matter. Were it so, most every invention might be found
unpatentable under § 101. Indeed, the Supreme Court has long recognized
that all inventions, at some level, embody or apply laws of nature, natural
phenomena, and abstract ideas and, thus, we must "tread carefully in
construing this exclusionary principle lest it swallow all of patent law."
14 We recognize that the Revised Patent Subject Matter Eligibility Guidance
was not available to the Examiner when formulating this rejection.
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Alice, 573 U.S. at 217; Thales Visionix Inc. v. United States, 850 F.3d 1343,
1349 (Fed. Cir. 2017) (holding "it is not enough to merely identify a patent-
ineligible concept underlying the claim; we must determine whether the
patent-ineligible concept is what the claim is 'directed to."').
Insofar as the Examiner's position is that the claims are directed to the
abstract idea of "obtaining and comparing intangible data," as Appellants
contend, that is an oversimplification of the claims. App. Br. 19. On that
point, we must neither overgeneralize the claims nor overemphasize
limitations that might recite an abstract idea dissected from the whole. 15
Thales, 850 F.3d at 1347 ("[We] ensure at step one that we articulate what
the claims are directed to with enough specificity to ensure the step one
inquiry is meaningful").
When the claims as a whole are considered, even if some aspects of
the invention may rely on comparing data or on mathematical concepts,
those aspects have been sufficiently integrated into a practical application.
Claim 1, for example, requires and recites specific physical structures,
hardware, data, and computing operations that provide a technologically
advantageous, radiation-free method for navigating a catheter to an ablation
target within a patient's vasculature. These features include, inter alia: a
digital image acquired of an infrared (IR) marker placed external to a
patient, without using ionizing radiation (i.e., comprising a magnetic
resonance angiogram) and with the use two IR cameras placed at different
positions relative to the patient; a catheter including an electromagnetic
15 The Examiner does not identify on this record the particular language in
the claims that allegedly recites an abstract idea. See Revised Guidance
(Step 2A, Prong 1 ).
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sensor as well as a camera; generating a 3D rendering of a patient's vascular
system using a stereotactic coordinate system and co-registering an
electromagnetic coordinate system ( associated with the sensor on the
catheter) with the 3D rendering; and tracking the catheter's electromagnetic
sensor from an in-room GPS. Like the system in Thales, comprising an
arrangement of inertial sensors and object-tracking calculations based on
certain reference frames, the claims here are sufficiently specific and
concrete, providing a practical and real-world technological solution, that we
conclude satisfies the requirements of§ 101. Thales, 850 F.3d at 1348--49.
Having reached the decision above, we need not analyze the claims
under Step 2B of the Revised Guidance or Step 2 of Alice. See Revised
Guidance 51; Thales, 850 F.3d at 1349 ("Because we find the claims are not
directed to an abstract idea, we need not proceed to step two").
II. WRITTEN DESCRIPTION
The Examiner has rejected independent claim 27 (and its dependent
claims) for non-compliance with the written description requirement of 3 5
U.S.C. § 112, first paragraph. Ans. 4--5. Claim 27 recites, inter alia, "a
second preoperative imaging system to capture a digital image of a vascular
system of the patient and the external stereotactic fiduciary markers using []
non ionizing radiation and non iodinated agents." Claims App'x v. Yet,
according to the Examiner, "the specification does not disclose a second
imaging system." Ans. 5.
We disagree. As Appellants point out, the Specification describes a
first imaging system comprising at least two IR cameras, and further
describes "[a] second preoperative imaging system [that] captures a digital
image of the patient's vasculature and the [IR] markers using non ionizing
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radiation ... , such as the MR system disclosed at least at ,r,r 37 and 77 of
the specification." App. Br. 21; see Spec. ,r 37 ("A planning MR
angiography scan is acquired prior to angionavigation with stereotactic
fiduciary markers to produce digitally reconstructed 3D rendering of
vascular system.").
The Examiner responds that "these paragraphs disclose an image that
has been acquired ahead of time." Ans. 26. But the Examiner fails to
explain why the timing of the image acquisition is germane to claim 27,
which does not exclude a system that acquires an MRA before the 3D
renderings are generated and the catheter is tracked to its ablation target.
Indeed, the claim itself recites that the "second" system is a ''preoperative
imaging system." Claims App'x v. (emphasis added). Based on the
disclosures cited to us by Appellants, we are persuaded the skilled artisan
would understand that the inventors were in possession of a method
employing, for example, a preoperative system for acquiring MRA images-
sufficiently describing the "second preoperative imaging system" with the
features recited in claim 27.
III. OBVIOUSNESS
Rejections III-IV
The Examiner rejected independent claim 1, and various claims that
depend from claim 1 as obvious over the combination of Greenan,
Tremblay, and Hunter (Rejection III). Ans. 5-9. Certain other claims that
depend from claim 1 are rejected over the Greenan, Tremblay, Hunter
combination, adding further references to address limitations added to those
dependent claims (Rejection IV). Ans. 9-12. For purposes of addressing
Rejections III and IV, we focus principally on claim 1 and the Examiner's
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findings and reasoning as to the combination of Greenan, Tremblay, and
Hunter.
The Examiner finds that Greenan discloses an ionizing radiation-free
method for navigating within body structures. Ans. 5. According to the
Examiner, Greenan's method includes capturing a digital image of a
patient's vasculature, the image comprising MRA "and at least one
electromagnetic marker placed external to the patient prior to acquiring the
digital image." Id. (citing Greenan ,r,r 16, 17, 55-59, 64, and 68). Further,
the Examiner finds, Greenan discloses generating stereotactic coordinates
and 3D renderings of the patient's vascular system. Ans. 6. The Examiner
also finds that Greenan discloses a catheter that includes a camera and at
least one sensing coil, along with the step of obtaining the position of the
catheter from a GPS system. Id. ( citing, e.g., Greenan ,r,r 23-24, 28, 58, and
63).
The Examiner finds that Greenan does not disclose infrared (IR)
markers, fiber optic bundles, cardiac ablation targets, and 3D renderings of
roadmaps. Ans. 7. The Examiner, thus, turns to Tremblay and Hunter.
According to the Examiner, Tremblay discloses digital images of IR markers
taken by two IR cameras, fiber optic bundles for operating such cameras,
and a camera providing a view of an ablation target. Id. ( citing Tremblay
,r,r 63, 70-71, 78, 88, and Fig. IA (items I la and I lb)). Because Tremblay
does not disclose 3D renderings of roadmaps, the Examiner cites Hunter. Id.
at 7-8 (discussing Hunter's teaching of generating a roadmap for a catheter
to an ablation target on a 3D rendering).
The Examiner concludes it would have been obvious to combine
Greenan, Tremblay, and Hunter to arrive at the method recited in claim 1.
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According to the Examiner, the ordinarily skilled person would "add an IR
marker, as disclosed by Tremblay, for the purpose of tracking a device that
is being imaged by an infrared camera" ( citing ,r 88) and "couple a camera to
a fiber optic bundle ... for the purpose of operating the infrared cameras."
Ans. 8. The Examiner concludes it would have been obvious to obtain
views of an ablation target, as disclosed in Tremblay, to treat a region of
interest. Id. And, the Examiner reasons, the person of ordinary skill would
have generated "a 3D rendered cardiac ablation roadmap, as disclosed by
Hunter, for the purpose of navigating through a portion of the anatomy." Id.
We are unpersuaded on the record before us, that the Examiner has
met the burden to show that claim 1 would have been obvious over the cited
disclosures in Greenan, Tremblay, and Hunter. In re Oetiker, 977 F .2d
1443, 1445 (Fed. Cir. 1992) (The Examiner "bears the initial burden ... of
presenting a primafacie case ofunpatentability.").
As an initial matter, the Examiner did not show or sufficiently explain
how the alleged tracking system in Greenan discloses the in-room global
positioning system configured to track the electromagnetic sensor (in the
catheter) as recited in claim 1. We are not persuaded, at present, that
tracking a catheter in an electromagnetic field would necessarily satisfy the
claimed in-room GPS system. See Greenan ,r,r 23-24.
Second, the Examiner states that Greenan's digital images include
images of "at least one electromagnetic marker placed external to the patient
prior to acquiring the digital image." Ans. 5 (citing Greenan ,r,r 16, 17, 68).
However, as Appellants note, the Examiner's finding does not appear to be
accurate. The cited paragraphs disclose electromagnetic markers positioned
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inside the patient-not images of IR markers placed external to the patient
as claimed. App. Br. 12-13.
Third, with respect to Tremblay, Appellants contend that "Tremblay
uses two IR cameras placed within line of sight to track [0078] two
precision-machined plastic tools [0088]." App. Br. 12. Hence, Appellants
contend:
Tremblay' s use of two IR cameras does not involve placing at
least one IR marker external to the patient prior to acquiring the
digital image, where the digital image includes the MRA image
and the images of the at least one IR marker taken by the two IR
cameras, each image of the at least one IR marker taken from a
different position with respect to the patient.
App. Br. 12. The Examiner summarily responds, and "disagrees and
submit[ s] that this limitation is disclosed in paragraph [0088]." Ans. 25
(citing Tremblay ,r,r 35, 88). But the Examiner's findings and response are
inadequate to explain clearly and sufficiently how those cited teachings in
Tremblay disclose the specific arrangement of IR cameras and external IR
markers ( and images captured of such markers) that would satisfy the
elements of claim 1. 16
Finally, in the Examiner's rationale for combining the references, the
Examiner states that it would be obvious to couple a camera to a fiber optic
bundle "for the purpose of operating the infrared cameras." Ans. 8. But the
"fiber optic bundle" in claim 1 is associated with the camera included on the
catheter, not the two differently-placed IR cameras configured to obtain
images of the one or more IR markers external to the patient. The Examiner
16 We decline to decide, in the first instance on appeal, whether other (un-
cited) disclosures in Tremblay would be sufficient to meet the claim
limitations related to IR cameras and external IR markers.
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appears to be mixing the required elements of the camera systems that are
claimed, adding to the lack of clarity to the rejection.
For the above reasons, we determine that the preponderance of the
evidence cited by the Examiner does not support the Examiner's conclusion
that claim 1 would have been obvious over the Greenan, Tremblay, and
Hunter combination. The rejection of the claims that depend from claim 1
(remainder of Rejection III and Rejection IV), fall for the same reasons as
the Examiner has not shown that the cited teachings in the other references
make up for the deficiencies of the Greenan, Tremblay, and Hunter
combination on this record.
Rejections V-VI
Rejections V and VI relate to independent claim 23 and its dependent
claims (claims 37 and 38). Those rejections (as with Rejections III-IV,
related to claim 1) rely on substantially the same teachings in Greenan,
Tremblay, and Hunter. See, e.g., Ans. 13-15. Rothe is relied upon by the
Examiner solely for purposes of disclosing the features of the second,
ablation catheter recited in claim 23. Id. at 15. Because claim 23 includes
substantially the same limitations from claim 1, for which we concluded that
the Examiner had not made a sufficient showing that those limitations were
disclosed in the cited teachings of Greenan, Tremblay, and Hunter, we also
reverse Rejections V and VI.
Rejections VII-VIII
For Rejection VII, the Examiner rejects independent claim 27 over the
combination of Maschke, Tremblay, Greenan, and Rothe. Other claims
depending from claim 27 are rejected over that same combination, or that
combination along with additional references (Rejection VIII) to address
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elements added to certain dependent claims (e.g., Anderson is relied on for
claim 32, and zeroing an electromagnetic coordinate system). Ans. 21.
According to the Examiner, Maschke discloses an ionizing radiation-
free system for angionavigation and ablation of cardiac tissue. Ans. 16.
Appellants, however, argue that the Examiner is incorrect because "Maschke
suggests a hybrid imaging system that uses radiographic and nuclear medical
examinations, with a gamma radiation source arranged in the body." App.
Br. 16 ( citing Maschke ,r 17 ("To this end, a diagnosis device is proposed for
combined and/or combinable radiographic and nuclear medical examinations
with an x-ray source, with an examination room for accommodating a
patient, with a gamma radiation source arranged in the body .... ")). The
Examiner provides no response to Appellants' argument on this point and,
thus, we agree with Appellants here.
Although the Examiner cites Greenan as teaching obtaining images
with non-ionizing radiation, the Examiner does not provide a persuasive
rationale for how and why Maschke' s system would be modified in light of
Greenan. Ans. 18. Instead, the Examiner simply states that it would have
been obvious to use Greenan's method "to obtain images using non-ionizing
radiation ... for the purpose of generating an electromagnetic field around
markers which will be used for tracking." Id. at 19. That reasoning is
insufficient, particularly in view of Maschke' s teaching that, for instance, by
using its system and method, "high costs of MRI as well as the effects of
strong magnetic fields on other components can be avoided." Maschke ,r 63
("Also, MRI may not provide functional image data .... ").
For the reasons above, we reverse the Examiner's rejection of claim
27 (as well as dependent claims 28-31, 34, and 35) over Maschke,
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Tremblay, Greenan, and Rothe. We similarly reverse Rejection VIII, related
to claims 32 and 33, which depend from claim 27, because Rejection VIII
relies on the same Maschke, Tremblay, Greenan, and Rothe combination,
and the Examiner has not shown that the additional references (Anderson
and Hunter) make up for the noted deficiencies on this record.
SUMMARY
We reverse the rejections for ineligible subject matter, lack of written
description, and obviousness that are on appeal.
REVERSED
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