Intuitive Surgical Operations, Inc.

Patent Trials and Appeals Board

Dec 11, 2020

IPR2019-01173 (P.T.A.B. Dec. 11, 2020)

Trials@uspto.gov Paper No. 34
571-272-7822 Entered: December 11, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

AURIS HEALTH, INC.,
Petitioner,
v.
INTUITIVE SURGICAL OPERATIONS, INC.,
Patent Owner.
____________

IPR2019-01173
Patent 8,801,601 B2
____________

Before ULRIKE W. JENKS, ZHENYU YANG, and JAMES A. WORTH,
Administrative Patent Judges.

JENKS, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)

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I. INTRODUCTION
Auris Health Inc. (“Petitioner”) filed a Petition requesting an inter
partes review of claims 1–18 of Patent No. US 8,801,601 B2 (Ex. 1001, “the
’601 patent”). Paper 1 (“Pet.”). Intuitive Surgical Operations, Inc. (“Patent
Owner”) filed a Preliminary Response to the Petition. Paper 8 (“Prelim.
Resp.”). With our authorization, Petitioner and Patent Owner filed
supplemental briefing addressing claim construction. Papers 13, 15. On
December 16, 2019, we instituted an inter partes review of claims 1–18 of
the ’601 patent. Paper 16 (“Dec. Inst.”), 40.
Patent Owner filed a Response to the Petition. Paper 18 (“PO Resp.”).
Petitioner filed a Reply. Paper 22 (“Pet. Reply”). Patent Owner filed a Sur-
reply (Paper 24, “PO Sur-reply”).
An oral hearing was held on September 15, 2020, a transcript of
which has been entered in the record. Paper 33 (“Tr.”).
Pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73, we issue this
Final Written Decision. Having considered the record before us, we
determine that Petitioner has shown by a preponderance of the evidence that
claims 1–18 of the ’601 patent are unpatentable. See 35 U.S.C. § 316(e)
(2018).
A. Real Parties-in-Interest
Petitioner identifies itself, Ethicon, Inc., and Johnson & Johnson as
real parties-in-interest to this proceeding. Pet. 1. Patent Owner identifies
itself and Intuitive Surgical, Inc. as real parties-in-interest. Paper 4, 1.
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B. Related Proceedings
Petitioner identifies that the ’601 patent has been asserted in: Intuitive
Surgical, Inc. v. Auris Health, Inc., Action No. 18-1359-MN (D. Del.)
(pending). Pet. 1; Paper 4.
C. The ’601 Patent (Ex. 1001)
The ’601 patent issued on Aug. 12, 2014 from Application No.
13/678,917 (“the ’917 application”), filed Nov. 16, 2012, which claims
priority to U.S. Application No. 12/411,515, filed on Mar. 26, 2009, now
U.S. Patent No. 8,337,397.
The ’601 patent is titled “Method and System for Providing Visual
Guidance to an Operator for Steering a Tip of an Endoscopic Device Toward
One or More Landmarks in a Patient.” Ex. 1001, (54). A recognized
difficulty when operating a steerable endoscope is that the tip may wind up
looping around itself disorienting the operator when the captured image of
the endoscope tip fails to clearly indicate the direction of the endoscope in
relation to the target site. Id. at 2:31–39.
The ’601 patent discloses an endoscope, a medical device that is
inserted into the body and allows a physician to diagnose problems with
internal body organs. Id. at 1:52–54. The endoscope includes an image
capturing device, such as a camera, as well as “surgical tools, such as those
used for cutting, grasping, cauterizing, etc., [that] may extend out of the
endoscope’s distal tip.” Id. at 1:59–65. The device includes an “endoscopic
navigation tool, [that provides] graphical indications showing steering
directions to previously defined landmarks.” Id. at 8:51–53.
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The objective disclosed in the ’061 patent is to provide “visual
guidance to an operator for steering an endoscopic device towards one or
more landmarks in a patient.” Id. at 2:56–58.
[T]he operator of the steerable endoscope 110 is provided a
view of the current shape of the endoscope 110 relative to the
patient’s body in order to provide guidance to the operator for
navigating the endoscope 110 to a target site within the patient.
A visual indication of the target site may also be displayed as
well as computer models or other indications of any anatomic
structures or body lumens that the endoscope 110 may
encounter or pass through in its path to the target site.
Id. at 7:21–29. Graphical indications showing steering directions to
previously defined landmarks are provided. Id. at 8:51–54. There are two
types of graphical indications disclosed. The first type is “a primary display
screen displaying an image captured by a steerable endoscope as viewed in a
system.” Id. at 3:46–48. This is the display that is captured by the camera at
the tip of the endoscope. See id., Figures 6, 10, and 11. This image can
include directional guidance in the form of arrows indicating the position of
landmarks. See id., Figure 15. “The directions of the 3-D arrows are
referenced to the endoscope tip’s reference frame so that they correspond to
directions that the operator should steer the endoscope’s tip 112 using the
handle or electromechanical interface 116.” Id. at 10:10–15.
The second type of graphical displays provide a view of the patient
including “anterior-posterior view 750 of the patient computer model 720
and endoscope computer model 710 . . . along with indications of various
landmarks along the endoscope’s path (e.g., mouth entry, esophagus,
stomach entry, and colon) on the auxiliary display screen 160.” Id. at 7:42–
46 (citing Figure 7). The position of landmarks within the patient may be
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registered with preoperative measurements such as Magnetic Resonance
Imaging (MRI), Computer Axial Tomography (CAT), or X-rays. Id. at
9:51-63. The position of the endoscope tip is determined using a fixed
reference frame. Id. at 9:26–27.
[A] vector connecting the current position of the endoscope tip
112 to the position of each landmark to which guidance
indications are to be provided is determined by the display
processor 150 using the endoscope tip position determined in
1202 and landmark positions stored in the memory device 155.
Id. at 9:35–40. This allows for “directional guidance to landmarks in front of
the endoscope tip 112 (i.e., between the current position of the endoscope tip
and the target site), not just behind it (i.e., between the entry point into the
patient and the current position of the endoscope tip).” Id. at 9:66–10:3.
D. Illustrative Claims
Claims 1 and 10 of the ’601 patent are illustrative and reproduced
below:
1. A method for navigating a steerable instrument in a patient
anatomy, the method comprising:
[(1a)] receiving a first landmark establishment request;
[(1b)] responsive to receiving the request, recording
information about a reference portion of the steerable
instrument located at a first anatomic landmark in the patient
anatomy;
[(1c)] referencing the recorded information as first
landmark information;
[(1d)] registering the first landmark information to a
model of the patient anatomy; and
[(1e)] providing guidance for navigating the steerable
instrument along a path through a plurality of anatomic
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landmarks, including the first anatomic landmark, to a target
location within the patient anatomy.
Ex. 1001, 13: 2–16 (bracketing and numbering added for reference
convenience).
10. A method for navigating a steerable instrument in a patient
anatomy, the method comprising:
[(10a)] recording first information about a reference
portion of the steerable instrument located at a first anatomic
landmark in the patient anatomy;
[(10b)] referencing the recorded first information as first
landmark information, the recorded first information including
position information for the reference portion located at the first
anatomic landmark and including an image captured by the
steerable instrument while the reference portion is located at the
first anatomic location;
[(10c)] recording second information about the reference
portion of the steerable instrument located at a second anatomic
landmark in the patient anatomy;
[(10d)] referencing the recorded second information as
second landmark information, the recorded second information
including position information for the reference portion located
at the second anatomic landmark and including an image
captured by the steerable instrument while the reference portion
is located at the second anatomic location; and
[(10e)] providing guidance for navigating a guided
instrument along a path through the first and second anatomic
landmarks.
Id. at 13:37–14:18 (bracketing and numbering added for reference
convenience).
E. Prior art
Petitioner relies upon the following prior art references (Pet. 15–74):
References Patent / Reference Date Exhibits
Ganatra US 2009/0227861 A1 Sept. 10, 2009 Ex. 1004
Larkin US 2007/0156019 A1 July 5, 2007 Ex. 1005
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References Patent / Reference Date Exhibits
Soper US 7,901,348 B2 Mar. 8, 2011 Ex. 1007
Petitioner also relies upon the Declaration of Blake Hannaford, Ph.D.
(Ex. 1003) to support its contentions. Patent Owner relies upon the
Declarations of Vincent Duindam, Ph.D. (Ex. 2007) and Kevin Cleary,
Ph.D. (Ex. 2010) to support its opposition to the Petition.
F. The Instituted Grounds of Unpatentability
We instituted trial to review the patentability of claims 1–18 of the
’601 patent on the following grounds. Dec. Inst. 40.
Claim(s Challenged Basis1,2 References
1, 2, 5–9 § 102(a) Ganatra
1–3, 5–18 § 103(a) Ganatra, Soper
4, 18 § 103(a) Ganatra, Larkin
4, 18 § 103(a) Ganatra, Larkin, Soper

1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16,
2013. Because the application from which the ’601 patent issued was filed
before that date, our citations to Title 35 are to its pre-AIA version.
2 We view each instance of Petitioner’s use of the phrase “and/or” in its
discussion of the grounds as raising two separate grounds. See, e.g., Pet. 70
(“Ganatra and Larkin, with or without Soper”). Therefore, we include each
in our listing of the grounds. Compare id. at 3 (identifying three grounds)
with Section I.E. above (identifying four grounds).

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II. ANALYSIS
A. Person of Ordinary Skill in the Art
Petitioner asserts that a person of ordinary skill in the art would have
had at least “an undergraduate education in electrical engineering,
mechanical engineering, robotics, biomedical engineering, or a related field
of study, along with about two years of experience in academia or industry.”
Pet. 9 (citing Ex. 1003 ¶ 30).
Patent Owner contends that a person of ordinary skill in the art would
either have (a) a master’s or doctoral degree or (b) a bachelor’s degree in
mechanical engineering, electrical engineering, biomedical engineering,
robotics or similar discipline. PO Resp. 6 (citing Ex. 2010 ¶ 28). Patent
Owner acknowledges that “[s]ignificant experience in the relevant field
could substitute for formal education.” Id.
On this record, we determine that the ordinary artisan is a person
having at least at a bachelor’s level educational experience in either
mechanical engineering, electrical engineering, biomedical engineering, or
robotics, in addition to at least two years’ experience in the field of medical
robotics or image-guided navigation. This definition is consistent with the
level of skill in the art at the time of the invention as reflected by the prior
art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
2001) (explaining that specific findings regarding ordinary skill level are not
required “where the prior art itself reflects an appropriate level and a need
for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State
Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Furthermore, the panel
does not perceive that any differences between the definition adopted by the
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panel and either of the definitions suggested by the parties would impact our
Decision.
B. Principles of Law
To prevail in its challenge to Patent Owner’s claims, Petitioner must
demonstrate by a preponderance of the evidence3 that the claims are
unpatentable. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). To establish
anticipation under 35 U.S.C. § 102, each and every element in a claim,
arranged as recited in the claim, must be found in a single prior art reference.
See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir.
2008); Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed.
Cir. 2001). Although the elements must be arranged or combined in the
same way as in the claim, “the reference need not satisfy an ipsissimis verbis
test,” i.e., identity of terminology is not required. In re Gleave, 560 F.3d
1331, 1334 (Fed. Cir. 2009) (accord In re Bond, 910 F.2d 831, 832–33 (Fed.
Cir. 1990)).
A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
between the claimed subject matter and the prior art are such that the subject
matter, as a whole, would have been obvious at the time of the invention to a
person having ordinary skill in the art. KSR Int’l Co. v. Teleflex, Inc., 550
U.S. 398, 406 (2007). The question of obviousness is resolved on the basis
of underlying factual determinations, including “the scope and content of the

3 The burden of showing something by a preponderance of the evidence
requires the trier of fact to believe that the existence of a fact is more
probable than its nonexistence before the trier of fact may find in favor of
the party who carries the burden. Concrete Pipe & Prods. of Cal., Inc. v.
Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 622 (1993).
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prior art”; “differences between the prior art and the claims at issue”; and
“the level of ordinary skill in the art.” Graham v. John Deere Co., 383 U.S.
1, 17–18 (1966).
A patent claim “is not proved obvious merely by demonstrating that
each of its elements was, independently, known in the prior art.” KSR, 550
U.S. at 418. An obviousness determination requires finding “both ‘that a
skilled artisan would have been motivated to combine the teachings of the
prior art references to achieve the claimed invention, and that the skilled
artisan would have had a reasonable expectation of success in doing so.’”
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–
68 (Fed. Cir. 2016) (citation omitted); see KSR, 550 U.S. at 418 (for an
obviousness analysis, “it can be important to identify a reason that would
have prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does”). Further, an assertion
of obviousness “cannot be sustained by mere conclusory statements; instead,
there must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting
In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); In re NuVasive, Inc., 842
F.3d 1376, 1383 (Fed. Cir. 2016) (a finding of a motivation to combine
“must be supported by a ‘reasoned explanation’” (citation omitted)).
C. Claim Construction
In an inter partes review for a petition filed on or after November 13,
2018, “[claims] of a patent . . . shall be construed using the same claim
construction standard that would be used to construe the [claims] in a civil
action under 35 U.S.C. § 282(b), including construing the [claims] in
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accordance with the ordinary and customary meaning of such claims as
understood by one of ordinary skill in the art and the prosecution history
pertaining to the patent.” 37 C.F.R. § 42.100(b); see Changes to the Claim
Construction Standard for Interpreting Claims in Trial Proceedings Before
the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018)
(codified at 37 C.F.R. § 42.100(b) (2019)) (amending 37 C.F.R. § 42.100(b)
effective November 13, 2018). A term’s ordinary and customary meaning
“is its meaning to the ordinary artisan after reading the entire patent.”
Phillips v. AWH Corp., 415 F.3d 1303, 1321 (Fed. Cir. 2005) (en banc).
Nevertheless, “it is always necessary to review the specification to determine
whether the inventor has used any terms in a manner inconsistent with their
ordinary meaning,” because “[t]he specification acts as a dictionary when it
expressly defines terms used in the claims or when it defines terms by
implication.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
(Fed. Cir. 1996).
Petitioner requests construction of the terms “anatomic landmark,” “a
path through,” and “fixed reference frame.” Pet. 10–15.
1 “anatomic landmark”
The term “anatomic landmark” appears in independent claims 1 and
10, and therefore, by virtue of dependency effectively appears in claims 2–9
and 11–18 as well. Petitioner, for the purpose of this proceeding, proposes
that the term “‘anatomic landmark’ [refers] to a user established anatomical
feature.” Pet. 11 (citing Ex. 1003 ¶ 48).
The ’601 specification describes, “providing visual guidance to an
operator for steering an endoscopic device towards one or more landmarks
in a patient.” Ex.1001, 2:56–58. Landmarks as understood in light of the
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’601 specification, are known structures that can be used for positioning
purposes and are not limited to user-defined structures. This understanding is
supported by the ’601 specification’s explanation that the computer model
can show “indications of various landmarks along the endoscope’s path
(e.g., mouth entry, esophagus, stomach entry, and colon) on the auxiliary
display screen.” Id. at 7:43–46, see also id. at 12:45–51 (“the establishment
of landmarks while navigating the endoscope [] towards a target site within
the patient, anatomic structures (such as the esophagus, stomach, colon, etc.)
may be measured using position information of the endoscope tip [] as it
moves from one end of the anatomic structure to the other.”).
We construe “anatomic landmark” as encompassing any anatomic
structure that has been registered and recorded (not necessarily by the user),
examples of which include, but are not limited to, the esophagus, stomach,
colon, etc. See Dec. Inst. 11–12. Neither Petitioner not Patent Owner contest
this construction. Pet. 11–12; PO Resp. 7 (citing in support Ex. 1001,
Abstract, 9:41–52, 10:25–11:3, 11:59–12:63, Fig. 13; Ex. 2010 ¶ 33).
2. “guidance”
The term “guidance” appears in independent claims 1 and 10, and
therefore by virtue of dependency effectively appears in claims 2–9 and 11–
18 as well. For the reasons provided in our Institution Decision, we construe
“guidance” as graphical indicators such as vectors or arrows that point in the
direction the endoscope is to travel. Dec. Inst. 14. Neither Petitioner nor
Patent Owner contest this construction. Pet. Reply 2; PO Resp. 9–13 (citing
in support Ex. 1001, Title, id. at Abstract, id. at 1:21–25, id. at 2:59-3:23, id.
at 2:63-67, id. at 8:51-54, id. at 9:35–40, id. at Fig. 12, id. at Fig. 15; Ex.
2008, 81).
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3. “a path through”
The term “a path through” appears in independent claims 1 and 10,
and therefore, by virtue of dependency, effectively appears in claims 2–9
and 11–18 as well. Petitioner contends the term “should be construed to
mean a path that runs in one side of the anatomic landmark and out of
another.” Pet. 12–13 (citing Ex. 1003 ¶¶ 53–57; Ex. 1001, 1:33–36, id. at
1:52–56, id. at 2:18–19; id. at 9:44–48; Ex. 1002, 303).
Patent Owner contends that no construction is necessary and the plain
and ordinary meaning should apply. PO Resp. 7. However, if construction is
needed Patent Owner contends that “a path through” does not have to enter
and exit through an anatomic landmark but may be present along the path
and the endoscope may encounter an anatomic landmark along the way to
the target. Id. at 8 (citing Ex. 1001, 7:25–29 (“A visual indication of the
target site may also be displayed as well as computer models or other
indications of any anatomic structures or body lumens that the endoscope
110 may encounter or pass through in its path to the target site.”), id. at
9:41–43 (“the landmarks are established by the operator as he or she guides
the steerable endoscope 110 along its path from an entry point to a target site
in the patient.”)).
We agree with Patent Owner that “a path through” is not limited to
situations in which an endoscope has to enter and exit through a physical
structure. Therefore, we construe “a path through” as a path traveled by the
endoscope to a final destination that encounters landmarks along the way,
and encompasses situations in which the endoscope travels in on one side of
the landmark and out on the other side as well as situations where the
endoscope only passes in close proximity to the landmark.
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4. “guidance for navigating . . . along a path through . . . anatomic
landmarks”
The phrase “guidance for navigating . . . along a path through . . .
anatomic landmarks” appears in independent claims 1 and 10, and therefore
by virtue of dependency effectively appears in claims 2–9 and 11–18 as
well.
Petitioner contends that the ordinary meaning of “guidance for
navigating . . . along a path through” encompass providing guidance only
when decisions about which way to go need to be made. Pet. Reply. 16–17.
“Just like directions for driving to a destination might provide instructions
only for what to do at intersections (e.g., go straight, turn left, take the exit
ramp), a system can provide guidance to a target by instructing the operator
what to do at each branching point.” Id. at 17 (citing Ex. 1007, 13:53–56).
Patent Owner contends that guidance along a path requires the arrows
to continuously point the operator in the direction of travel. See PO Sur-
reply 15 (arguing that Petitioner provides “no explanation why or how a
skilled artisan would have applied [Ganatra’s] arrows ‘along a path’ to
continuously point the operator ‘in the direction to travel’ as required by the
claims.”) Patent Owner contends that both parties’ experts agree that
“guidance for navigating . . . along a path through” requires continuous
guidance that spans a path from starting point to target. PO Sur-reply 21
(citing Ex. 1003 ¶ 118). Patent Owner contends that the limitation of
“guidance for navigating . . . along a path through . . . anatomic landmarks”
does not encompass intermittent guidance because it requires continuous
steering instructions. See Tr. 42:20–23; 56:14–57:2.
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The claim requires “guidance for navigating . . . along a path through
. . . anatomic landmarks.” The ’601 specification discloses two types of
guidance,4 the first guidance is in the form of a patient model that shows a
“patient computer model 720 and endoscope computer model 710 is shown
along with indications of various landmarks along the endoscope’s path
(e.g., mouth entry, esophagus, stomach entry, and colon) on the auxiliary
display screen 160.” Ex. 1001, 7:42–46, Figure 7. In addition to the patient
model, the computer screen can also show a view of the endoscope’s
captured image. Id. at 7:47–61, Figure 6. The ’601 specification describes
the second type of guidance as “an additional endoscopic navigation tool [a
landmark direction guidance mode], [as] graphical indications showing
steering directions to previously defined landmarks in the patient are also
provided as an aspect of the present invention.” Id. at 8:51–54, see also id. at
11:16–26 (“FIG. 15 shows . . . a current image 1501 (i.e., an image currently
captured by the endoscope 110 . . . ) displayed on it along with arrows 1511,
1512 and 1513 respectively providing directional guidance to the mouth
entry, stomach entry and colon entry landmarks.”). The ’601 specification
describes that the landmark direction guidance mode can be turned on and
off by the operator. Id. at 8:61–62. The specification discloses that even
when the landmark directional guidance mode is turned off the operator can
still guide the endoscope to the target site. Id. at 11:48–54. Thus, neither the
’601 specification nor the claims require that the graphical indicators need to
be continuously displayed.

4 Patent Owner acknowledges that guidance in the claims is not limited to
the display view from the point of the tip of the endoscope. See Tr. 37:3–
38:23.
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Based on these disclosures in the specification, we do not read the
phrase “guidance for navigating . . . along a path through . . . anatomic
landmarks” as requiring a continuous visual guide, as argued by Patent
Owner. See PO Sur-reply 15; see Tr. 42:20–23; 56:14–57:2. As discussed
above, we construe guidance as graphical indicators in the form of vectors or
arrows that point in the direction the endoscope is to travel. See supra § II.
C.2. Nothing in that construction requires that the indicators need to be
continuously displayed and updated. We agree with Petitioner and determine
that intermittent guidance provides sufficient information to maneuver the
endoscope to a desired destination. For example, when guiding an
endoscope through lumens such as those associated with the lung, guidance
at bifurcations provides sufficient information for the operator to thread the
endoscope through the lumens to a final destination. Once an endoscope is
inserted into a lumen there is no need for instructions until an intersection
(branch point) is reached. Accordingly, we construe the phrase “guidance for
navigating . . . along a path through . . . anatomic landmarks” as
encompassing either intermittent or continuous guidance.
D. Ground 1: Anticipation of Claims 1, 2, and 5–9 by Ganatra
Petitioner contends that claims 1, 2, and 5–9 are unpatentable as
anticipated by Ganatra. Pet. 15–43. Patent Owner opposes. PO Resp. 22–30.
1. Overview of Ganatra (Ex. 1004)
Ganatra teaches “systems and methods for navigating a medical
instrument within a branched structure of a body.” Ex. 1004 ¶ 1. The method
uses predetermined points for defining a pathway along the branches of a
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body structure. Id. Abstract. Figures 3A and 3B of Ganatra, reproduced
below, show the navigation system in operation.

Figure 3 shows a patient and an operator positioning a bronchoscope
as well as an external reference frame.
Those skilled in the art will appreciate that tracked locations of
bronchoscope 200 will be reported by the tracking system as
coordinates with respect to a coordinate system 32, which is in
a frame of reference of the tracking system and the patient’s
body, which is within the field of the tracking system, and that
the model has a separate frame of reference and a
corresponding coordinate system 34, to which tracking
coordinate system 32 needs to be registered in order to
accurately display representations of locations of bronchoscope
200 on display 30.
Id. ¶ 19.
[T]he operator of bronchoscope 200 may sequentially position
bronchoscope 200 within the actual bronchial tree of the patient
so that sensor X is located at multiple reference, or fiduciary
points, which correspond to known points of the model, and
then the coordinates for corresponding points may be used to
find a mathematical transformation, for example, an affine
transformation, which relates the two frames of reference to one
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another, thereby registering tracking coordinate system 32 with
model coordinate system 34.
Id. ¶ 20. The problem with having the clinician/operator locate fiduciary
points for registration is that the process is time consuming. Id. Instead,
Euclidean distance from a reference point can be used to facilitate the
collection of additional fiduciary points. Id.
Figure 4, reproduced below, shows a bronchial tree model that serves
as reference points in the model coordinate system. Id. ¶ 21.

FIG. 4A illustrates predetermined points 405 including
the subset of designated points identified as M0, M1, M2 and
M3; designated point M0, which serves as a reference point of
model coordinate system 34, is shown located at a first
branching point of a main airway, or trachea, of the tree, in
proximity to the carina of the bronchial tree. . . . According to a
first step of a method of the present invention, the
bronchoscope operator locates bronchoscope 200 in proximity
to the carina of the actual bronchial tree 400, so that tracking
sensor X is located at a point T0, which corresponds to
designated point M0 of model 40, and then instructs processor
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522 to establish point T0 as an anchor point of tracking
coordinate system 32.
Id. ¶ 21. “[I]t may be appreciated that the operator of bronchoscope need not
look for [all] fiduciary points along the branches of tree 400 because spatial
information . . . is compared with positional information provided by
tracking system 51 to automatically collect the fiduciary points.” Id. ¶ 23.
Figures 4C–4E, reproduced below, show the pre-determined or pre-
programed instructions for the registration process.

Figures 4C–4E show “an exemplary visual indicator [in the form of arrows]
43A, 43B, 43C is shown overlaid on each displayed representations 30 of
the model; indicators 43A, 43B, 43C may provide guidance to a user of the
navigation system for carrying out the above-described registration process
according to a particular sequence.” Id. ¶ 24. The indictors show the
sequential positioning of the bronchoscope in the various branches in order
to find points T1, T2, and T3 as shown above in Figure 4B. Id.
[A]dditional indicators may also be displayed along each
branch, to direct the operator to backtrack the bronchoscope
back to anchor point T0, following travel to each of points T1,
T2 and T3. Although arrows are illustrated as indicators 43A,
43B, 43C, it should be appreciated that other forms of indicator
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may be used in alternate embodiments of the invention in order
to provide similar guidance in the movement of the
bronchoscope, and for providing an indication, or feedback that
the bronchoscope has been advanced far enough in each branch;
examples of the other forms of indicators include, without
limitation, color coding of branches and blinking or flashing
points or zones along each branch; alternately words may be
used to provide written, explicit instructions and feedback on
display 30.
Id.
After initial registration, the system can then track the medical
instrument position on the display.
According to the illustrated embodiment a sphere 52,
which is superimposed on display 30, represents a location of
the medical instrument that corresponds to a collected
registered set of coordinates, which is reported to display
element 523 by processor 522 as the medical instrument is
moved through the branched structure of the patient.

Id. ¶ 25. Ganatra uses “a tracking sphere 52 on displayed representation 30
of the model, to mark a current position of the bronchoscope.” Id. ¶ 28.
Figure 6C, reproduced below, shows a site 620 a point of interest in
the patient.

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FIG. 6C illustrates tracking sphere 52 as a[n] indicator of a
current location of the medical instrument after having been
moved away from site 620, upon completion of a procedure at
site 620. According to the illustrated embodiment, the indicator
at site 620, which may be displayed in any suitable manner and
is not limited to the illustrated cross hatching, serves as a key
reference for the operator of the medical instrument, as he or
she continues to move the instrument through the branched
structure of the patient, for example, to perform another
procedure at another site.
Id. ¶ 29.
2. Analysis
Petitioner asserts that Ganatra discloses every limitation of the ’601
patent. Pet. 15–43. Patent Owner opposes. PO Resp. 22–30.
a. Claim 1: “A method for navigating a steerable instrument in a
patient anatomy”
Petitioner asserts that Ganatra teaches a method of navigating a
bronchoscope through the bronchial tree structures of a patient’s anatomy.
Pet. 20–21. The exemplary bronchoscope “includes a tracking sensor X near
a distal end 202 of the bronchoscope and that is steered by an operator.” Id.
at 20–21 (citing Ex. 1004 ¶¶ 18–20, Figure 2; Ex. 1003 ¶¶ 86–87).
Patent Owner does not contest that Ganatra’s instrument is steerable.
See PO Resp. 22–30.
Preamble language that merely states the purpose or intended use of
an invention is generally not treated as limiting the scope of the claim. See
Boehringer Ingelheim Vetmedica, Inc. v. Schering–Plough Corp., 320 F.3d
1339, 1345, (Fed. Cir. 2003). Regardless of whether the preamble is
limiting, we determine that Petitioner has shown that the recitation in the
preamble is satisfied by Ganatra. See Ex. 1004 ¶¶ 18–20.
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b. “receiving a first landmark establishment request”
Petitioner asserts that Ganatra’s registration method requires that
the operator navigates the bronchoscope through (in one side
and out the other) the designated points in the patient’s
anatomy, and when the bronchoscope is located at each
designated point, the system registers the tracking system
coordinates (one of T0, T1, T2, T3, T4, and T5) to the model
system coordinates (one of M0, M1, M2, M3, M4, and M5).
Pet. 22 (citing Ex. 1004 ¶¶ 20, 22, 23; Ex. 1003 ¶ 93). Because Ganatra
describes performing these initial registration steps at the start of the
procedure, the step of “receiving a first landmark establishment request” is
included in the process. Id. at 23 (citing Ex. 1004 ¶ 21).
Patent Owner does not contest this limitation. See PO Resp. 22–30.
We determine that Ganatra’s registration process includes receiving a
landmark establishment request thereby meeting the recited limitation. See
Ex. 1004 ¶¶ 20, 22, 23.
c. “responsive to receiving the request, recording information about a
reference portion of the steerable instrument located at a first
anatomic landmark in the patient anatomy”
Petitioner asserts that “Ganatra explains that the operator navigates
the bronchoscope so that [when] ‘tracking sensor X is located at a point T0,
which corresponds to designated point M0 of model 40’” and the operator
instructs the processor to establish an anchor point in the tracking coordinate
system that is then recorded. Pet. 25 (citing Ex, 1004 ¶¶ 21, 22). “[T]he
instruction to register M0/T0 meets this claim element.” Id. at 26 (citing
Ex. 1003 ¶¶ 99–100).
Patent Owner does not contest this limitation. See PO Resp. 22–30.
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We determine that Ganatra’s registration process records and obtains
information from the coordinate system that is in a frame of reference with
the patient’s body using the tracking sensor at the tip of the endoscope and
registering that location within the computer model coordinate system
marking the various designated points. Ex. 1004 ¶¶ 19–24, Figures 4A–E.
Accordingly, we determine that Ganatra meets this limitation.
d. “referencing the recorded information as first landmark
information”
Petitioner asserts that “the processor continuously references anchor
point M0/T0 to calculate Euclidean distances between sensor X and anchor
point T0.” Pet. 27 (citing Ex. 1004 ¶ 22; Ex. 1003 ¶¶ 101–03).
Patent Owner does not contest this limitation. See PO Resp. 22–30.
We determine that Ganatra’s registration process includes referencing
the recorded information as landmark information. See 1004 ¶ 22.
e. “registering the first landmark information to a model of the patient
anatomy”
Petitioner asserts that “Ganatra registers the location information it
records for each designated point to the coordinates of that designated point
in the computer model.” Pet. 27 (citing Ex. 1004 ¶ 21). Petitioner asserts that
T0/M0 point registered in Ganatra meets the limitation of “registering the
first landmark information to a model of the patient anatomy.” Id. at 28
(citing Ex. 1003 ¶¶104–05).
Patent Owner does not contest this limitation. See PO Resp. 22–30.
We determine that Ganatra’s registration process includes assigning
coordinates from the tracking sensor onto the computer model of the
patient’s anatomy, which meets this limitation. See Ex. 1004 ¶ 21.
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f. “providing guidance for navigating the steerable instrument along a
path through a plurality of anatomic landmarks, including the first
anatomic landmark, to a target location within the patient anatomy”
Petitioner asserts that “Ganatra’s navigation system 50 provides
navigation guidance to the operator to assist in the initial registration process
and in navigating the instrument to a target site.” Pet. 28 (citing Ex. 1004
¶ 22; Ex. 1003 ¶106). Petitioner asserts that Ganatra “superimposes arrows
on the displayed model to inform the operator” about the direction to move
bronchoscope in order to “reach each of M1/T1, M2/T2, and M3/T3”
targets. Id. (citing Ex. 1004 ¶ 21, Figures 4C–4E). Petitioner asserts that
because each designated point is an ‘“anatomic landmark’ . . . the path
through, M0/T0, M1/T1, M2/T2, and M3/T3 runs through a plurality of
anatomic landmarks.” Id. at 30 (citing Ex. 1003 ¶ 108).
Petitioner further asserts that Ganatra teaches other types of visual
indicators that may be marked on the display and are used for navigating the
medical instrument to the target site. Pet. 32 (citing Ex. 1004 ¶ 29).
Petitioner asserts that Ganatra “shows how arrows can be used, showing use
of arrows to guide the operator along a path to designated points in the
context of the initial registration process.” Id. (citing Ex. 1004 ¶ 24). “As
[Petitioner’s expert] Dr. Hannaford explains, Ganatra generally discloses
using such arrows to guide a user to an intended destination, even though
Ganatra only illustrates these arrows in the context of the initial registration
process.” Id. at 33 (citing Ex. 1003 ¶¶ 114–15). Dr. Hannaford further
concludes that the use of arrows disclosed in Ganatra for guiding the
registration process would similarly work “in the same manner to guide the
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operator to [c]ite 620 to perform a procedure.” Id. at 33 (citing Ex. 1003
¶¶ 115–16).
Patent Owner contends that “Petitioner concedes that Ganatra
illustrates using arrows (‘visual indicators’ 43A, 43B, and 43C) only during
the initial registration process (Pet. 33) and that Ganatra does not “explicitly
illustrate” using ‘additional visual indicators’ to navigate to target site 620
(Pet., 32).” PO Resp. 23–24. Patent Owner contends that Dr. Hannaford’s
testimony cannot be used to fill in gaps in Ganatra’s disclosure. Id. at 24–25
(citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir.
2008) (to establish anticipation, “it is not enough that the prior art reference
discloses part of the claimed invention, which an ordinary artisan might
supplement to make the whole.”)); see also Scripps Clinic & Research
Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991)). Patent
Owner contends that Ganatra explains that the model coordinate system and
the tracking coordinate system need to be registered in order to accurately
display representation of locations of bronchoscope on the display. PO Resp.
27 (citing Ex. 1004 ¶ 19; Ex. 2010 ¶ 56). Patent Owner contends that it is
only after the registration process is complete that Ganatra’s system can
“track the position of bronchoscope 200 . . . on display 30.” Id. (citing Ex.
1004 ¶ 25). Patent Owner contends that Ganatra’s guidance during the
registration process is not “navigation guidance…‘to a target location’” as
required by claim 1. Id. at 28 (“one skilled in the art would have concluded
that initial registration and guidance for navigation to a target were distinct
and separate concepts. See Ex. 2010, ¶¶52–56.”).
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The burden is on Petitioner to prove unpatentability by a
preponderance of the evidence. Dynamic Drinkware, LLC v. Nat’l Graphics,
Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015).
On this record, we find that Ganatra teaches a registration process that
plots the fiducial points and marks the path the endoscope needs to traverse
in order to register the computer model with the coordinate tracking system.
Ex. 1004 ¶¶ 19– 24, Figures 4A–4E. Ganatra explains that the operator
“selects a registration path, for example, a sequence of directions, or
branches along which to move sensor X and inputs this information into
workstation 500.” Id.¶ 22. Ganatra’s registration path and registration targets
are thereby preplanned before the procedure begins. After registration is
complete, Ganatra’s visual display allows the operator to establish whether
the bronchoscope moves towards or away from the point of interest 620 by
following movement of tracking sphere 52. See Ex. 1004 ¶ 29 (“tracking
sphere 52 as a[n] indicator of a current location of the medical instrument
after having been moved away from site 620”), Figure 6C. We agree with
Patent Owner, however, that Ganatra does not disclose the use of guidance
in the form of vectors or arrows when navigating the bronchoscope to reach
a particular target site, such as site 620. In other words, Ganatra does not
disclose using a pre-procedural path to a target site, such as site 620, for the
endoscope to follow in order to reach the target location within the patient.
Accordingly, we determine that Petitioner has not established that Ganatra
anticipates the subject matter of independent claim 1.
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g. Claims 2 and 5–9
For the same reasons discussed above (see supra § II.D.2.f) for claim
1, we determined that the evidence presented by Petitioner does not establish
anticipation for dependent claims 2 and 5–9.
h. Alleged Obviousness Ground over Ganatra Alone
Petitioner states the claims would have been obvious over Ganatra
alone. See Pet. 35 (“Even if the Board were to determine Ganatra does not
disclose this navigation technique, it would have been obvious for the same
reasons, as described below.”), 46; see also Tr. 12:4–5 (“In the petition,
petitioner also has grounds asserting that Ganatra alone suggested
implementing its navigation guidance using arrows.”).
Patent Owner argues that Petitioner’s alternative obviousness ground
based on Ganatra alone is legally insufficient. PO Resp. 29–30 (citing
Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (The
obviousness inquiry is “whether a skilled artisan not only could have made
but would have been motivated to make the combinations or modifications of
prior art to arrive at the claimed invention.”) (emphases in original)).
We agree with Patent Owner that Petitioner’s single sentence
obviousness ground based on Ganatra alone (see Pet. 35 and 46) does not
meet the burden of identifying the specific evidentiary support from which
to reach a conclusion of obviousness. As the Federal Circuit has explained,
“[i]n an IPR, the petitioner has the burden from the onset to show with
particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (emphasis added)
(citing 35 U.S.C. § 312(a)(3)); see also Intelligent Bio-Sys., Inc. v. Illumina
Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (“It is of the utmost
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importance that petitioners in the IPR proceedings adhere to the requirement
that the initial petition identify ‘with particularity’ the ‘evidence that
supports the grounds for the challenge to each claim.’” (quoting 35 U.S.C.
§ 312(a)(3)); In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364, 1380 (Fed.
Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot
employ mere conclusory statements. The petitioner must instead articulate
specific reasoning, based on evidence of record, to support the legal
conclusion of obviousness.”).
E. Ground 2: Obviousness of Claims 1–3 and 5–18 over Ganatra and Soper
Petitioner contends that claims 1–3 and 5–18 are unpatentable as
obvious over Ganatra and Soper. Pet. 15–43. Patent Owner opposes. PO
Resp. 30–60.
1. Overview of Soper (Ex. 1007)
Soper teaches “a method and apparatus for providing three-
dimensional (3-D) guidance to a catheter-scope or flexible endoscope that is
being advanced through a branching lumen in a patient’s body.” Ex. 1007,
1:13–16.
A position sensor on the endoscope produces a signal indicating
the position (and orientation) of the distal tip of the endoscope
in a Cartesian coordinate system during the procedure. A visual
display is continually updated, showing the present position and
orientation of the marker in a 3-D graphical surface model of
the airways that is generated through segmentation of medical
images.
Id. at 3:1–7. Identification by the clinician of bifurcations on video images
allows for recalibration of the scope head within the 3-D model. See id. at
3:30–36.
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The system relies on the visual identification of branch points
by a physician, to continually recalibrate the current position of
the flexible endoscope to the corresponding branch point on the
static 3-D model. This methodology uses measurements of
absolute position relative to a sensor, in order to generate
positional data comprising a device “history” that simplifies the
position of the flexible endoscope to a series of choices made
along a binary decision tree in which the decisions determine
which branch to take with the flexible endoscope at each
junction of the bronchial tree.
Id. at 8:27–36.
A graphic marker 192 is displayed in the user interface . . . to
show the position of the catheter in airways 190, and the
intended navigation routes 204 to the points of biopsy are
shown in a static 3-D airway surface model 200 . . . along with
a current position 202 of the flexible endoscope.
Id. at 13:62–67 (emphasis added). Soper explains that “[a]s the scope
traverses the airways, the graphical interface is continually updated, charting
progress from both global and fly-through perspectives.” Id. at 14:2–4.
Before steering the scope down a branch point, the clinician must verify the
position of the endoscope either via touch sensor or by visual assessment. Id.
at 14:9–12. “Based on the chosen route and the known position and
orientation of the catheter tip, a visual graphic is presented on a video
monitor to instruct the clinician on how to proceed.” Id. at 14:23–25.
2. Analysis
In its Petition, Petitioner sets forth how the limitations of the claims
are rendered obvious over Ganatra and Soper. Pet. 43–50. According to
Petitioner, Ganatra and Soper are analogous art because “[b]oth are directed
to systems for providing navigation guidance to an operator steering an
endoscope through a patient’s airways.” Pet. 45 (citing Ex. 1003 ¶¶ 80–81).
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Petitioner asserts that both references combine information from 3-D
computer models of a patient’s anatomy with the position of a tracking
sensor at the tip of an endoscope in order to register the location of the
endoscope tip on the computer model. Id. Petitioner relies on the declaration
of Dr. Hannaford (Ex. 1003) to support its contentions.
Patent Owner opposes. PO Resp. 30–60.
a. Independent claim 1
As discussed above (see II.D.2.a– II.D.2.e), Petitioner contends that
Ganatra meets elements (1a)–(1d) as recited in claim 1. See Pet. 20–28.
Patent Owner does not dispute these limitations. See PO Resp. 22–30.
Instead, the dispute lies with the element (1e) of the ’601 patent, which
recites “providing guidance for navigating the steerable instrument along a
path through a plurality of anatomic landmarks, including the first anatomic
landmark, to a target location within the patient anatomy.”
Petitioner acknowledges that Ganatra uses arrows “to guide the
operator along a path to designated points [only] in the context of the initial
registration process.” Pet. 32 (citing Ex. 1004 ¶ 24). Petitioner also
acknowledges that “Ganatra does not explicitly describe the details how its
system provides ‘another type of visual indicator’ ‘on display 30’ for use ‘as
a reference for navigating the medical instrument to site 620.’” Id. at 46
(Ex. 1004 ¶ 29). “Ganatra does not, for example, include any figures that
explicitly illustrate both site 620 and additional visual indicators (e.g.,
arrows) that assist in navigating to that site.” Id. (citing Ex. 1003, ¶ 123).
Petitioner asserts that Ganatra “describe[s] a process for using arrows to
guide a user through landmarks to a target location” during the registration
process and reasons that the same process would similarly be applied for
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navigating the endoscope along a path to a target location. Id. at 46 (citing
Ex. 1003 ¶ 125); see also id. at 50 (citing Ex. 1003 ¶ 125 (A person of
ordinary skill in the art would “configure the system [of Ganatra] to use a
line (instead of or in addition to arrows) to display the entire path from
M0/T0 to target site 620 as taught by Soper (see [Ex. 1007] Figs. 4A and
4D, above).”)); Tr. 15:6–8 (Petitioner asserts that “the same navigation
system that was used during registration process [in Ganatra] to provide the
arrows. So this [same] system is available to Ganatra during navigation.”).
Ganatra discloses that after the registration process is complete the
system can be used to navigate to a site of interest in order to perform a
medical procedure. Ex. 1004 ¶ 29. Ganatra provides guidance in the form of
arrows for “registering tracking coordinate system 32 with model coordinate
system 34.” Id. ¶ 20. Ganatra’s figures 4A-4E are reproduced below:

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“FIG. 4A is a schematic representation of a model of the bronchial tree
structure of the patient, the model including predetermined points defining a
pathway along branches of the tree, and some designated points of the
predetermined points” Id. ¶ 10. “FIG. 4B is a schematic representation of an
actual bronchial tree structure of the patient.” Id. ¶ 11.

“FIGS. 4C-E are schematics of the display element of the navigation system
presenting a representation of the model of the bronchial tree structure and
including indicators for providing instructions to a user of the navigation
system.” Id. ¶ 12.
[Visual] indicators 43A, 43B, 43C [in the form of arrows] may
provide guidance to a user of the navigation system for carrying
out the above-described registration process according to a
particular sequence. . . . FIGS. 4C-E[, reproduced above,]
illustrate a sequential series of displays 30, presented by display
element 532, to guide the bronchoscope operator to move the
bronchoscope along branches of the patient’s bronchial tree,
according to indicators 43A, 43B and 43C, in order to
sequentially find points T1, T2 and T3 (FIG. 4B), which
correspond to designated points M1, M2 and M3 [in the model]
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(FIG. 4A[, reproduced above]). According to some
embodiments, once the operator has moved the bronchoscope
far enough in direction A (FIG. 4B[, reproduced above]), for
example to point T1, such that processor 522 has matched the
Euclidean distance for sensor X to that of designated point M1,
indicator 43A disappears from display 30 and then indicator
43B appears, as shown in FIG. 4D; likewise, once the operator
has moved the bronchoscope far enough in direction B, for
example to point T2, such that processor 522 has matched the
Euclidean distance for sensor X to that of designated point M2,
indicator 43B disappears from display 30 and indicator 43C
appears, as shown in FIG.4E, and likewise for movement in
direction C. It should be appreciated that additional indicators
may also be displayed along each branch, to direct the operator
to backtrack the bronchoscope back to anchor point T0,
following travel to each of points T1, T2 and T3. Although
arrows are illustrated as indicators 43A, 43B, 43C, it should be
appreciated that other forms of indicator may be used in
alternate embodiments of the invention in order to provide
similar guidance in the movement of the bronchoscope, and for
providing an indication, or feedback that the bronchoscope has
been advanced far enough in each branch; examples of the other
forms of indicators include, without limitation, color coding of
branches and blinking or flashing points or zones along each
branch; alternately words may be used to provide written,
explicit instructions and feedback on display 30.
Ex. 1004 ¶ 24; see Pet. 29. Thus, Ganatra exemplifies using arrows during
the registration process, and acknowledges other types of indicators for
providing similar guidance with the movement of the bronchoscope. Ex.
1004 ¶ 24. Ganatra explains that during the registration process, once the
designated points are reached with the bronchoscope (i.e. T1, T2, T3, . . .),
then the arrow disappears from the display and the next arrow guiding to the
next registration point in the sequence appears. Id.
[D]esignated points M2 and M3 of predetermined points 405 of
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model 40, are preferably located at branching points, and it may
be appreciated that downstream designated points, such as M4
and M5, are also preferably located at branching points, since
branching points can serve as effective demarcations for the
initiation and termination of each subsequent set of distance
calculations, so that, as the bronchoscope is moved deeper into
the branching structure 400, and continues to encounter new
branching points (this detail is not shown in FIGS. 4A-B, but
may be appreciated with reference to FIGS. 1 and 3C), the
registration of coordinate systems 32 and 34 can be
automatically refined throughout the bronchoscopy procedure,
without interruption of navigation guidance provided by
navigation system 50 to the operator, for example, via
movement of tracking sphere 52 along display 30.
Ex. 1004 ¶ 26.
According to Petitioner’s expert, Dr. Hannaford, it would have been
obvious to one of ordinary skill in the art to also use “arrows to guide a user
to an intended destination, even though Ganatra only illustrates these arrows
in the context of the initial registration process.” Pet. 33 (citing Ex. 1003
¶¶ 114–15). Petitioner contends that a person of ordinary skill in the art
would have looked to analogous art, such as Soper (see Pet. 47 (citing Ex.
1003 ¶¶ 80, 81, 122–125; Ex. 1007, 13:58–66)), to provide details with
respect to visual navigation introduced in Ganatra but not explicitly
described in the context of reaching the target. Pet. 46 (citing Ex. 1004 ¶ 29
(“Ganatra does not explicitly describe the details how its system provides
‘another type of visual indicator’ ‘on display 30’ for use ‘as a reference for
navigating the medical instrument to site 620.’”)).
Soper discloses a road-map decision model that is “[b]ased on the
chosen route and the known position and orientation of the catheter tip, a
visual graphic is presented on a video monitor to instruct the clinician on
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how to proceed.” Ex. 1007, 14:23–25, see also id. at 20:15–18 (An extended
model to navigate beyond the 3D model “from the current position, a step []
will then provide an arrow on the virtual interface that indicates a direct path
and the distance to the intended destination.”).
Figures 4A and 4D of Soper are reproduced below:

Figure 4A shows a display in the user interface of the 3-D lung surface
model and pre-procedural path planning (Ex. 1007, 13:58–60) including
“selected points targeted for a biopsy, and an automated course planning
through the lung passages (where the generation index of each branch point
is indicated).” Id. at 5:56–60. Figure 4D shows the static 3D airway surface
model along with navigation route 204 and the current position of the
flexible endoscope. Id. at 13:65–68.
Based on the combination of Ganatra and Soper, Petitioner concludes
that it would have been obvious to a person of ordinary skill in the art at the
time of the invention “to illustrate the navigation path to the operator using
arrows and/or a line superimposed on the computer model of the patient’s
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lungs as taught by Soper.” Pet. 48 (citing Ex. 1003 ¶ 125). In other words,
Petitioner is relying on Soper’s teaching of providing a preplanned
navigation route to a target point of interest and Petitioner explains that one
of ordinary skill in the art would use Ganatra’s arrows in the same manner
that Ganatra applies the arrows to a preplanned route during the initial
registration process. See Pet. Reply 18 (citing Pet. 48–49; Ex. 1003 ¶¶ 125–
126); see also Pet. 47 (“Soper explains that its user interface includes
‘windows displaying the 3-D lung surface model and pre-procedural path
planning (Fig. 4A)’ and displaying ‘the intended navigation routes to the
points of biopsy are shown in FIG. 4D.’ Ex.1007, 13:58-66.”); 50 (arguing
that a person of ordinary skill in the art would “configure the system [of
Ganatra] to use a line (instead of or in addition to arrows) to display the
entire path from M0/T0 to target site 620 as taught by Soper (see Figs. 4A
and 4D, above).” (emphasis added)), 56 (“As integrated into Ganatra, these
lines [of Soper] are a model of the path through the ‘plurality of anatomic
landmarks’ and are displayed on the model of the patient’s anatomy.”); Ex.
1003 ¶ 126 (Petitioner’s expert Dr. Hannaford avers: “[A] person of ordinary
skill in the art could configure the system to use a dotted line (instead of or
in addition to arrows) to display the entire path from M0/T0 to target site
620 as shown by Soper (see Soper Figs. 4A and 4D []) or both a dotted line
and arrows.”).
A person of ordinary skill in the art is not an automaton and can fit
teaching of multiple patents together like pieces of a puzzle. KSR, 550 U.S.
at 420, 421; Pet. Reply 18. Here, Petitioner’s combination5 does not rely on

5 Petitioner presents three reasons of unpatentability based on obviousness:
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the incorporation of Soper’s arrows into Ganatra’s navigation but instead is
looking to Soper for providing a preplanned route, i.e. a model path, for
reaching an intended target and then applying Ganatra’s arrows just like in
the registration process. Pet. Reply 18 (A person of ordinary skill in the art
“configuring Ganatra to use arrows to provide navigation guidance to target
site 620, as suggested by Soper, would have done so in the same manner that
Ganatra uses arrows in the registration process. Pet., 48–49; Ex.1003,
¶¶125–26.”); Pet. 56 (“As integrated into Ganatra, these lines [of Soper] are
a model of the path through the “plurality of anatomic landmarks” and are
displayed on the model of the patient’s anatomy.”).
Patent Owner contends that the Petition fails because the combination
of Ganatra and Soper lacks an element as claimed, lacks motivation to
combine the references, lacks a reasonable expectation of success, and
hindsight. PO Resp. 30–55. Additionally, Patent Owner also contends that
even if the Board finds that the combination renders the claims obvious,

(1) Ganatra renders guidance for navigating obvious: “[A person of ordinary
skill in the art] would have understood Ganatra to describe a process for
using arrows to guide a user through landmarks to a target location” (Pet.
46); (2) Soper renders guidance obvious: “A [person of ordinary skill in the
art] considering how to provide additional indicators to help guide an
operator to the target site as taught by Ganatra would have looked to other
references [such as Soper] for examples of how others in the field had
provided such guidance” (Pet. 47); and (3) The combination of Ganatra and
Soper renders guidance obvious: a person of ordinary skill in the art would
“configure the system [of Ganatra] to use a line (instead of or in addition to
arrows) to display the entire path from M0/T0 to target site 620 as taught by
Soper (see Figs. 4A and 4D, []).” Pet. 50. We agree with Patent Owner that
individually, neither Ganatra nor Soper renders the claimed guidance
obvious. However, for the reasons discussed in this decision we determine
that the combination of Ganatra and Soper renders the claims obvious.
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secondary considerations should rebut any showing of obviousness. Id. at
55–60. We address Patent Owner’s contentions below.
1. Missing element
i. “guidance”
Patent Owner contends that “Soper’s planned paths or intended
navigation routes are not updated based on a current position or orientation
of the bronchoscope,” therefore Soper does not provide “guidance” as
required by independent claim 1. PO Resp. 33–34.
We are not persuaded by Patent Owner’s contention that Soper does
not update the display. Petitioner explains that Soper describes the use of
visual indicators in the form of a preprocedural path for navigating to a point
of biopsy. Pet. 47 (citing Ex. 1003 ¶¶ 125–125). Soper’s user interface
includes “windows displaying the 3-D lung surface model and pre-
procedural path planning (Fig. 4A)” and displaying “the intended navigation
routes to the points of biopsy [as] shown in FIG. 4D.” Pet. 47 (citing Ex.
1007, 13:58–66). Soper includes:
A position sensor on the endoscope [that] produces a signal
indicating the position (and orientation) of the distal tip of the
endoscope in a Cartesian coordinate system during the
procedure. A visual display is continually updated, showing the
present position and orientation of the marker in a 3-D
graphical surface model of the airways that is generated through
segmentation of medical images.
Ex. 1007, 3:1–7, see also id. at 10:1–10. Based on these disclosures in
Soper, we agree with Petitioner and are not persuaded by Patent Owner’s
contention that Soper does not update the current position or orientation of
the endoscope.
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We are also not persuaded by Patent Owner’s contention that Soper
does not provide “guidance” because Petitioner is not solely relying on
Soper for this limitation. Petitioner is relying on Ganatra’s arrows for
directing the endoscope along a path such as the path disclosed in Soper. See
Pet. 48 (“[A person of ordinary skill in the art] considering Ganatra would
have found it obvious to illustrate the navigation path to the operator using
arrows and/or a line superimposed on the computer model of the patient’s
lungs as taught by Soper. Ex. 1003, ¶ 125.” (emphasis added)), 50 (A person
of ordinary skill in the art would “configure the system to use a line (instead
of or in addition to arrows) to display the entire path from M0/T0 to target
site 620 as taught by Soper (see Figs. 4A and 4D, []). [Ex. 1003] ¶ 126”). In
other words, Petitioner is relying on the combination of Ganatra’s arrows in
conjunction with the line of the pre-procedural path superimposed on the
computer model to a target location as described in Soper to arrive at the
limitations recited in claim 1(e).
We determine that the evidence of record supports Petitioner’s
position that the combination of Ganatra and Soper teaches the “guidance”
limitation of claim 1(e). As discussed above (see supra § II.C.2), we
construe guidance as graphical indicators in the form of vectors or arrows
that point in the direction the endoscope is to travel. We further determined
that guidance can be either continuous or intermittent as long as it provides
the operator sufficient information to reach the final destination (see supra §
II.C.4). We next determine whether the combination of Ganatra and Soper
teaches reaching a target of interest by navigating through anatomic
landmarks.
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ii. “guidance for navigating . . . along a path through . . .
anatomic landmarks”
Patent Owner contends that Soper does not overcome the deficiencies
of Ganatra, arguing, specifically, that the combination lacks “guidance for
navigating . . . along a path through . . . anatomic landmarks” as recited in
claim 1(e). PO Resp. 30. Patent Owner contends that “[a] plot of the planned
path or intended route to the target, as shown in Soper’s Figures 4A and 4D
(annotated below), does not constitute ‘graphical indicators’ that ‘point in
the direction the endoscope is to travel.’” Id. at 32. “Soper’s displays of
static, preplanned paths or intended navigation routes (or a mere showing of
current position of the bronchoscope relative to an intended route) are not
sufficient to meet the ‘guidance’ limitation of claim[] 1.” Id. at 34.
We agree with Petitioner, that Patent Owner’s focus on Soper alone is
unpersuasive when the proposed grounds of unpatentability are premised on
the combination of Ganatra and Soper. Pet. Reply. 18–20 (citing In re Merck
& Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); see also In re Keller, 642
F.2d 413, 425 (CCPA 1981) (the test for obviousness is “what the combined
teachings of the references would have suggested to those of ordinary skill
in the art”)). According to Petitioner, one of ordinary skill in the art based on
the teachings of Ganatra would have found it obvious to illustrate the
navigation path to the operator using arrows in conjunction with Soper’s line
superimposed on the computer model of the patient’s lung. See Pet. 50 (A
person of ordinary skill in the art would “configure the system [of Ganatra]
to use a line (instead of or in addition to arrows) to display the entire path
from M0/T0 to target site 620 as taught by Soper (see Figs. 4A and 4D, []).
[Ex.1003] ¶ 126.” (emphasis added)).
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Petitioner acknowledges that Ganatra only provides guidance arrows
during registration but finds that a person having ordinary skill in the art
would nevertheless have reasonably inferred “Ganatra to generally disclose
that the[] arrows can be used to guide a user to a destination” and that the
same technique would apply during the navigation to a target of interest. Pet.
Reply 4–5 (citing Ex. 1003 ¶¶ 114–115, 122; Pet. 46, 48). Ganatra explains
that once the operator has moved the endoscope far enough from one
registration target to the next registration target, the indicator (an arrow)
disappears from the display and the next indicator (an arrow) for the next
registration target appears on the display. Ex. 1004 ¶ 24; Fig. 4. Both
Petitioner’s expert and Patent Owner’s expert agree that Ganatra’s arrows
direct the endoscope to registration points during the registration process.
See Ex. 1003 ¶ 114 (Petitioner’s expert, Dr. Hannaford testifying: “Ganatra
shows how arrows can be used to guide the operator along a path to the
appropriate designated points in the context of the initial registration
process.”); Ex. 1020, 42:21–24 (Patent Owner’s expert, Dr. Cleary
testifying: “Yes, I would think that the arrows, you know, would be useful to
helping an operator move the scope to the registration points.”), 50:2–7
(Patent Owner’s expert, Dr. Cleary further testifying: “In this case, Ganatra
is using the arrows for the registration process to show the operator where to
move the scope in order to get to the next registration point, that is
correct.”). Petitioner additionally points out that it is the same system in
Ganatra that is used during the registration process is also used in the
navigation process. Tr. 15:6–8 (“[The] same navigation system that was
used during registration process [in Ganatra] to provide the arrows. So this
[same] system is available to Ganatra during navigation.”). The evidence
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supports the position that Ganatra’s arrows point in the direction the
endoscope is to travel and thereby guide the endoscope movement even if
this guidance is only expressly taught in connection with the registration
process.
Soper provides a preplanned path through the bronchial passages to
reach a desired biopsy point. “The layout of this course is analogous to a
roadmap where navigation relies on a series of decisions or turns one would
make in route to reach a desired destination.” Ex. 1007, 13:53–56. “Based
on the chosen route and the known position and orientation of the catheter
tip, a visual graphic is presented on a video monitor to instruct the clinician
on how to proceed.” Id. at 14:23–35. “[T]he intended navigation routes 204
to the points of biopsy are shown in a static 3-D airway surface model 200
. . . along with a current position 202 of the flexible endoscope.” Id. at
13:64–67, Figure 4D. The evidence supports the position that Soper teaches
a preplanned route to a designated biopsy target.
The obviousness analysis “can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR,
550 U.S. at 418. “A person of ordinary skill is also a person of ordinary
creativity, not an automaton.” Id. at 421.
We agree with Petitioner that it is reasonable to infer from the
teachings of Ganatra that arrows used for guiding the endoscope from one
registration target to the next registration target along a preplanned route
would similarly guide the endoscope to a target of interest along a
preplanned route as taught by Soper. See Pet. 48 (citing Ex. 1003 ¶ 125), 50
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(citing Ex. 1003 ¶ 126); Pet. Reply 4–5.6 Based on the combined teachings
of Ganatra and Soper, we determine that the preponderance of evidence of
record supports Petitioner’s position that the combination of Ganatra and
Soper teaches the limitation of “guidance for navigating . . . along a path
through . . . anatomic landmarks” of claim 1(e).
2. Motivation to combine
Patent Owner contends that Petitioner fails to adequately explain the
motivation to modify Ganatra in view of Soper. PO Resp. 47–50.
We are not persuaded by Patent Owner’s contention that Petitioner
has not sufficiently articulated a reason for combining Ganatra and Soper.
“The combination of familiar elements according to known methods is likely
to be obvious when it does no more than yield predictable results.” KSR, 550
U.S. at 416. “[T]he analysis need not seek out precise teachings directed to
the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. “[E]vidence of a motivation to combine
need not be found in the prior art references themselves, but rather may be
found in ‘the knowledge of one of ordinary skill in the art or, in some cases,
from the nature of the problem to be solved.’” Dystar Textilfarben Gmbh &
Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir.
2006) (citation omitted).

6 Indeed, in the next section, we conclude that a person of ordinary skill
would have sought to apply Ganatra’s arrows used for guiding the
endoscope during registration to the preplanned route taught as by Soper for
purposes of navigation.
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Here, Petitioner directs us to teachings in Ganatra that suggest using
the system to navigate to a site of interest. Pet. 18 (“[Ganatra] displays the
computer model and superimposes a visual indicator 52 on the model to
identify the current location of the bronchoscope.” (citing Ex. 1004 ¶ 29)),
see id. at 30–31, 33, 35, 46.
As Dr. Hannaford explained, Ganatra’s lack of explicit detail on
providing navigation guidance to a target “provides a specific
motivation to the [person of ordinary skill in the art] to look to
other references for additional details on how such indications
could be implemented.” [] Thus, Ganatra provides an explicit
motivation or suggestion for a [person of ordinary skill in the
art] to look to other references for ways to implement
navigation guidance.
Pet. Reply 8 (citing Ex. 1003 ¶ 122). Patent Owner’s expert, Dr. Cleary
testified:
Q. So does Ganatra have any figures depicting all the different
forms of navigation guidance that can be provided to the
operator during the procedure?
A. No, I would not agree with that statement because I would
imagine there are many different types of guidance that can be
provided, so I would not think that all those different types are
shown in the figures in Ganatra.
Ex. 1020, 63:9–18. We agree with Petitioner’s articulated motivation that
Ganatra’s lack of detail of how to traverse through the bronchial passages to
arrive at an intended target, i.e. a biopsy site, would have motivated one of
ordinary skill in the art to consult similar references for such teachings.
Petitioner identifies Soper as disclosing an analogous bronchoscope
system that contains similar features to Ganatra’s system (Pet. 45), and
teaching use of a preplanned path to direct an operator of a bronchoscope to
a site of interest. Pet. 46–48 (Ex. 1007, 13:58–66, 20:15–18; Ex. 1003 ¶¶ 80,
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81, 122–25). Petitioner contends that “Soper also describes the benefits of
navigation guidance, which provides additional motivation to incorporate
such features into Ganatra.” Pet. Reply 10 (citing Ex. 1003 ¶¶ 80–81).
Soper discloses that the benefit of providing instructions for
navigating through a complex structure such as the lung using its navigation
system is that it avoids the use of more specialized equipment such as C-arm
fluoroscopy units, CT, or MRI scanners during the examination. Ex. 1007,
7:51–52. Soper explains that navigation of endoscope devices
typically relies on an optical view from the head of the scope,
this does not necessarily aid in directing the catheter through a
system where there is extensive branching. The exponential
increase in complexity underscores the need for some means of
visually tracking the position of this endoscope on a [high-
resolution computed tomography] HRCT generated 3-D model
so that it may effectively guide the physician at each branch
point as well as recording the regions that have been inspected.
Id. at 7:39–47. Soper discloses displaying intended navigation routes to the
point of biopsy in a static 3D airway surface model along with a current
position of the flexible endoscope. Id. at 13:62–67.
We determine that the evidence of record supports Petitioner’s
position that there is sufficient motivation to arrive at the combination of
Ganatra and Soper.
3. Reasonable expectation of success
Patent Owner contends that Petitioner fails to establish that there
would have been a reasonable expectation of success in combining Ganatra
and Soper. PO Resp. 52–55.
“An obviousness determination requires finding both ‘that a skilled
artisan would have been motivated to combine the teachings of the prior art
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references to achieve the claimed invention, and that the skilled artisan
would have had a reasonable expectation of success in doing so.’” CRFD
Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–
1368 (Fed. Cir. 2016)). “The reasonable expectation of success requirement
refers to the likelihood of success in combining references to meet the
limitations of the claimed invention.” Intelligent Bio-Sys., Inc., 821 F.3d at
1367. A reasonable expectation of success “does not require a certainty of
success.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir.
2006).
We already determined that there is sufficient motivation to combine
Ganatra and Soper (see supra § II.E.2.a.3), we next address whether there is
also a reasonable expectation of successfully navigating to a biopsy site
based on the combination.
Ganatra shows how arrows are used “to guide the operator along a
path to designated points in the context of the initial registration process.”
Pet. 32 (citing Ex. 1004 ¶ 24, Figures 4C–4E), 49. Both Petitioner’s expert
and Patent Owner’s expert agree that Ganatra’s arrows direct the endoscope
to registration points during the registration process. See Ex. 1003 ¶ 114, Id.
(Petitioner’s expert, Dr. Hannaford testifying: “Ganatra also shows how
arrows can be used, showing use of arrows to guide the operator along a path
designated points in the context of the initial registration process.”); Ex.
1020, 42:21–24 (Patent Owner’s expert, Dr. Cleary testifying: “Yes, I would
think that the arrows, you know, would be useful to helping an operator
move the scope to the registration points.”), 50:2–7 (Patent Owner’s expert,
Dr. Cleary further testifying: “Ganatra is using the arrows for the registration
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process to show the operator where to move the scope in order to get to the
next registration point, that is correct.”). We find that Ganatra’s arrows can
reasonably guide the movement of the endoscope from one target point to
the next target point.
Soper discloses an analogous bronchoscope system that contains
similar features to Ganatra’s system (Pet. 45), and provides a preplanned
path to direct an operator of a bronchoscope to a site of interest. Pet. 46–48
(Ex. 1007, 13:58–66, 20:15–18; Ex. 1003 ¶¶ 80, 81, 122–25). Soper teaches
that regions of interest are selected as intended points of biopsy. See Ex.
1007, 13:45–56. Soper’s method plots a series of paths through the bronchial
passages leading to the points of biopsy. “The layout of this course is
analogous to a roadmap where navigation relies on a series of decisions or
turns one would make in route to reach a desired destination.” Id. at 13:53–
56.
Based on the combination of Ganatra and Soper, Petitioner concludes
that it would have been obvious to a person of ordinary skill in the art “to
illustrate the navigation path to the operator using arrows and/or a line
superimposed on the computer model of the patient’s lungs as taught by
Soper.” Pet. 48 (citing Ex. 1003 ¶ 125) (emphasis added). In other words,
Petitioner is relying on Soper’s teaching of providing a preplanned
navigation route to a target point of interest and explains that one of ordinary
skill in the art would similarly use Ganatra’s arrows in the same manner that
Ganatra applies these arrows to following a preplanned route during
Ganatra’s registration process. See Pet. Reply 18 (citing Pet. 48–49; Ex.
1003 ¶¶ 125–126); see also Pet. 50 (A person of ordinary skill in the art
would “configure the system [of Ganatra] to use a line (instead of or in
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addition to arrows) to display the entire path from M0/T0 to target site 620
as taught by Soper (see Figs. 4A and 4D []).”), 56 (“As integrated into
Ganatra, these lines [of Soper] are a model of the path through the ‘plurality
of anatomic landmarks’ and are displayed on the model of the patient’s
anatomy.”). We agree with Petitioner that there is a reasonable expectation
of success in using Ganatra’s arrows to provide navigation guidance along a
preplanned path because “Ganatra already teaches how arrows can be used
to provide guidance to a user during the registration process.” Pet. Reply 14
(citing Ex.1004 ¶ 29; Ex.1003 ¶¶115–119). Accordingly, we are not
persuaded by Patent Owner’s contention that the combination of references
lacks a reasonable expectation of success.
Patent Owner also contends that “Petitioner has not identified any
prior art that discloses dynamic navigation guidance7 using graphical
indicators along a path to a target site, as disclosed and claimed in the ’601
patent.” PO Resp. 54. Patent Owner contends that in order “to provide
‘guidance’ all along a path, the system has to continuously track not just the
position but also the orientation of the endoscope within the patient’s
anatomy, and use the current position and orientation information to
generate a continuously-updated ‘roadmap’ in the form of arrows or other
graphical indicators.” Id. at 53.
We are not persuaded by Patent Owner’s contention. We do not
construe “guidance for navigating . . . along a path through . . . anatomic

7 We note that “guidance” in the claims is not limited to the perspective of
the endoscope camera, i.e. the camera view, but also encompasses tracking
the movement of the endoscope on a model display of the patient’s anatomic
structure. See supra § II.C.4; Tr. 37:3–38:23.
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landmarks” to require graphical indicators to be continuously updated. See
supra § II.C.4. As explained above (see § II.C.4), the phrase encompasses
either intermittent or continuous guidance in the form of arrows or vectors.
Because our construction of the claim does not require continuous guidance,
we are not persuaded by Patent Owner’s arguments that address dynamic or
continuous updating requirement with respect to guidance. See PO Resp. 54
(“a continuously-updated ‘roadmap’ in the form of arrows or other graphical
indicators.” (citing Ex. 2010 ¶ 94)).8 Here, the claims are broad enough to
encompass either continuous or intermittent guidance. Arguments focusing
on continuous or dynamic guidance when the combination as proposed by
Petitioner encompasses intermittent guidance does not persuade us that there
is a lack of reasonable expectation of success in combining the teachings of
Ganatra and Soper.
4. Hindsight
Patent Owner contends that Petitioner’s motivation for the
combination is tainted by hindsight. PO Resp. 50–52. “Neither Ganatra nor
Soper recognizes the scope disorientation problem explained in the ’601
patent, let alone suggest solutions to overcome that problem.” Id. at 50
(citing Ex. 2010 ¶ 92). Absent hindsight, “there is still no explanation why or
how a skilled artisan would have applied the arrows ‘along a path’ to
continuously point the operator ‘in the direction to travel’ as required by the
claims.” PO Sur-Reply 15.
The ’601 patent specification provides two types of displays, a
computer model and a captured image display. A computer model display

8 We note that the burden of proof rests with Petitioner. 35 U.S.C. § 316(e).
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“is shown along with indications of various landmarks along the
endoscope’s path (e.g., mouth entry, esophagus, stomach entry, and colon)
on the auxiliary display screen.” Id. at 7:43–46, Fig. 7. The same auxiliary
screen can also show images captured by the endoscope. Id. at 7:47, Fig. 6.
The endoscope image can additionally contain superimposed images of
steering directions. Id. at 10: 27–28, Fig. 15.
Patent Owner’s argument with respect to continuously pointing the
operator in the direction of travel, however, are directed to limitations that
are not in the claims and therefore not persuasive.
Petitioner’s analysis does not suffer from the hindsight selectivity
because Petitioner proposes the incorporation of a model path as disclosed in
Soper into Ganatra’s navigation system. See Pet. 50 (“Alternatively, a
[person of ordinary skill in the art would] configure the system [of Ganatra]
to use a line (instead of or in addition to arrows) to display the entire path
from M0/T0 to target site 620 as taught by Soper (see Figs. 4A and 4D, []).
[Ex. 1003] ¶126.”); KSR, 550 U.S. at 416 (“The combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.”). Petitioner explains that Ganatra’s
arrows shown to be used for guidance during the registration process can
similarly be used to guide an operator along a path to a destination during a
procedure. Pet. 32 (citing Ex. 1003 ¶ 114–115); Pet. Reply 18 (“[A person of
ordinary skill in the art] configuring Ganatra to use arrows to provide
navigation guidance to target site 620, as suggested by Soper, would have
done so in the same manner that Ganatra uses arrows in the registration
process. Pet., 48-49; Ex.1003, ¶¶ 125-26.”). Petitioner supports its reasoning
that a person of skill in the art would have found it obvious to implement
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Ganatra’s arrows not just during the registration process but also during
navigation with testimony from Dr. Hannaford, which we credit. See Ex.
1003 ¶¶ 114–115, 125–126 (explaining how that same process used during
registration can similarly be implemented to reach a target of interest).
5. Secondary considerations
We must consider any evidence of objective indicia of non-
obviousness before reaching our conclusion on obviousness vel non. WBIP,
LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016). Notwithstanding
what the teachings of the prior art would have suggested to one of ordinary
skill in the art at the time of the invention, the totality of the evidence
submitted, including objective evidence of non-obviousness, may lead to a
conclusion that the challenged claims would not have been obvious to one of
ordinary skill. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984).
Patent Owner presents the following objective indicia of non-obviousness:
(1) unexpected results and (2) long-felt need. PO Resp. 55–60; PO Sur-
Reply 21–25.
i. Unexpected results
Patent Owner argues that they have “shown nexus by showing the
secondary considerations are a ‘direct result of the unique characteristics of
the claimed invention,’ i.e., the ‘guidance’ element” by showing that the Ion
system is “essentially the same invention” as claimed in the ’601 patent. PO
Sur-Reply 23 (citing FOX Factory, Inc. v. SRAM, LLC, 944 F.3d 1366,
1373–74, 1377–78 (Fed. Cir. 2019)). Patent Owner explains that “the Ion™
System supplements the[] standard navigation views with a simulated
endobronchial view of the airways superimposed with a graphical indicator
in the form of a 3D line.” PO Resp. 57 (citing Ex. 2007 ¶ 18; Ex. 2009 (Ion
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Manual) at 8-3 (Figure 8.4)). According to Patent Owner, “the closest prior
art methods (such as those disclosed in Ganatra and Soper) only track a
position of the bronchoscope tip, provide some form of visual indication at
the target location, and/or provide select directional guidance at airway
bifurcations.” Id. at 58.
Patent Owner’s expert, Dr. Duindam, explains that “[t]he lung tree is a
complex anatomical space, which makes it difficult to navigate to a target
biopsy location.” Ex. 2007 ¶ 21. Dr. Duindam avers that the Ion system
navigation method embodies the methods of claims 1 and 10 of the ’601
patent. Id. ¶¶ 17–22. Dr. Duindam explains that the system provides “a
graphical indicator in the form of a 3D line that is superimposed on a
simulated endobronchial view of the airways, as depicted in the image below
(the blue 3D line in the bottom-left image).” Id. ¶ 18. Figure 8.4 from the
Ion User manual is reproduced below.

Id. (citing Ex. 2009 at 8-3). Figure 8.4 is an illustration of an example of a
planned pathway to target. Ex. 2009 at 8-3. Patent Owner explains that
“there was concern at Intuitive that bronchoscopist, who are mainly
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accustomed to viewing only CT scans or airway tree models, would not be
able to understand and follow the real-time, dynamic navigation guidance
provided by the Ion™ System,” and that the commercial embodiment
“provides surprisingly effective guidance to the operators when
navigating to a target in the far periphery of the lung.” PO Reply 57–58
(citing Ex. 2007 ¶ 19). Dr. Duindam explains that “the Ion system provides
continuous visual guidance for steering the bronchoscope, which operators
are easily able to follow and use when traversing the lung airways. In
particular, the virtual rendering from inside the patient (i.e., the
endobronchial view), superimposed with the continuously updated 3D
graphical line, provides surprisingly effective guidance to the operators
when navigating to a target in the far periphery of the lung.” Ex. 2007 ¶ 19.
Petitioner argues that Patent Owner has not established the requisite
nexus. Pet. Reply 21 (citing Nevro Corp. v. Boston Sci. Neuromodulation
Corp., IPR2017-01812, Paper 79 at 55-57 (Feb. 1, 2019)). Specifically,
Petitioner contends that a solid line is not directional guidance in the form or
arrows or vectors as required by the claim. “Dr. Duindam maps a solid, 3-D
line that ‘represents the planned pathway’ to the ‘guidance’ limitation, but
he fails to show that the line meets the construction of that term. Ex.2007,
¶ 18. A line alone has no directionality, and does not point in any direction.”
Pet. Reply 21. Petitioner further contends that the “use of the line was
known in the art, and therefore, cannot be used to demonstrate a nexus
between any secondary consideration and the claimed invention.” Pet.
Reply. 22 (citing Ex. 1007, 13:58–67). “Where the offered secondary
consideration actually results from something other than what is both
claimed and novel in the claim, there is no nexus to the merits of the claimed
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invention.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011); see also Fox
Factory, 944 F.3d at 1373 (“In order to accord substantial weight to
secondary considerations in an obviousness analysis, the evidence of
secondary considerations must have a nexus to the claims, i.e., there must be
a legally and factually sufficient connection between the evidence and the
patented invention.”) (internal quotations omitted).
We construe “guidance” as graphical indicators such as vectors or
arrows that point in the direction the endoscope is to travel. See supra §
II.C.2. As disclosed above, we are not persuaded that the phrase “guidance
for navigating . . . along a path through . . . anatomic landmarks” requires
continuous visual guidance along the route to the final destination. See supra
§ II.C.4. We determine that intermittent guidance provides sufficient
information to maneuver the endoscope to a desired destination. See id. Dr.
Duindam attributes the success of ION system to its ability to continuously
provide visual guidance by superimposing the 3D graphical line onto the
virtual rendering of the endobronchial view. Ex. 2007 ¶ 19. Because the
claim does not require the guidance to be continuous, we are not persuaded
by Patent Owner’s expert’s evidence of unexpected results. See Ex. 2007
¶¶ 17–19. Specifically, Dr. Duindam’s declaration shows a “3D line that is
superimposed on a simulated endobronchial view of the airways . . . The 3D
line represents the planned pathway and it updates continuously in real-time
relative to the position and orientation of the bronchoscope.” See Ex. 2007, ¶
18. The Declaration, therefore, establishes the need for a simulated
endobronchial view, that is different from the navigation view, i.e. the view
from the endoscope camera, and different from the bronchial tree view. See
Ex. 2007, Exhibit A, 5. The simulated endobronchial view also requires
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continuous updating in-real time, again a requirement that is not claimed.
See Ex. 2007, ¶¶ 18–19. Because these features materially impact the
functionality of the product and are not recited in the claims we determine
that there is no nexus, and therefore, these features cannot form a basis for a
finding of non-obviousness.
Furthermore, as Petitioner points out, and we agree, “[a] line alone has
no directionality, and does not point in any direction.” Pet. Reply 21; see
also PO Resp. 32 (“A plot of the planned path or intended route to the target,
as shown in Soper’s Figures 4A and 4D . . . , does not constitute ‘graphical
indicators’ that ‘point in the direction the endoscope is to travel.’ Ex. 2010
¶ 72; see also Ex. 2007 ¶ 13.”). Patent Owner, therefore, has not established
a connection between the evidence presented and the claims of the ’601
patent.
For the foregoing reasons, we agree with Petitioner and find that
Patent Owner has failed to establish a nexus between the claimed invention
and the purported unexpected results. Accordingly, we find that the evidence
of unexpected results that Patent Owner has provided is entitled to no weight
and that Patent Owner has failed to establish unexpected results.
ii. Long-felt need
Patent Owner’s expert, Dr. Duindam avers that the lung tree is a
complex anatomical space and there is a persistent need for improved
navigation systems. Ex. 2007 ¶¶ 20–22. According to Dr. Duindam,
“bronchoscopists were largely relying on their knowledge of anatomy and
CT scans to find their way in the lung tree, but that required specialized
training and some trial-and-error to reach the target.” Id. ¶ 22.
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Petitioner argues that Patent Owner has not provided an evidentiary
basis to establish long-felt need or evidence to establish how persons in the
market place would have viewed the method as claimed. See Pet. Reply 23
(citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1332 (Fed.
Cir. 2009)).
We agree with Petitioner that Patent Owner has not provided a
sufficient evidentiary basis from which to conclude that there was a long-felt
need. To establish long-felt need Patent Owner must establish that the
product that is the subject to secondary considerations is coextensive with
the claims. We understand that “the mere existence of one or more
unclaimed features does not necessarily mean presuming nexus is
inappropriate.” See Fox Factory, 944 F.3d at 1376. However, reliance on
features not claimed that materially impact the functionality of the product
means that nexuses cannot be presumed. Id. Dr. Duindam’s declaration
attributes the success of ION system to its ability to continuously provide
visual guidance by superimposing the 3D graphical line onto the
continuously updated virtual rendering of the endobronchial view. See Ex.
2007 ¶¶ 18–19. The Declaration, therefore, establishes the need for a
simulated endobronchial view, that is different from the navigation view, i.e.
the view from the endoscope camera, and different from the bronchial tree
view. See Ex. 2007 ¶ 18, Exhibit A, 5. Because these features materially
impact the functionality of the product and are not recited in the claims we
determine that there is no nexus, and therefore, these features cannot form a
basis for a finding of non-obviousness.
“A finding that a presumption of nexus is inappropriate does not end
the inquiry into secondary considerations. . . . [patent owner may still show]
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that the evidence of secondary considerations is the ‘direct result of the
unique characteristics of the claimed invention.’” Fox Factory, 944 F.3d at
1373–74 (citing In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996). Patent
Owner explains that that the commercial embodiment of the Ion system
“solves the limitations of previous navigation systems by providing step-by-
step visual guidance for steering the bronchoscope, and thereby helps
bronchoscopists find their way through the lung tree more efficiently and in
shorter time, which in turn may lead to better patient outcomes.” PO Reply
59–60 (citing Ex. 2007 ¶¶ 18, 22). Dr. Duindam’s declaration attributes the
success of ION system to its ability to continuously provide visual guidance
by superimposing the 3D graphical line onto the continuously updated
virtual rendering of the endobronchial view. See Ex. 2007 ¶¶ 18–19.
Because these features materially impact the functionality of the product but
are not recited in the claims, these features can not form a basis for finding
non-obviousness based on unique characteristics of the claimed method. For
the foregoing reasons, we agree with Petitioner and find that Patent Owner
has failed to establish a nexus between the claimed invention and the
purported long-felt need. Accordingly, we find that the evidence of long-felt
need that Patent Owner has provided is entitled to no weight and that Patent
Owner has failed to establish unexpected results.
6. Summary
Having considered the arguments and evidence presented at trial, we
determine that Petitioner has shown by a preponderance of the evidence that
claim 1 is unpatentable under 35 U.S.C. § 103(a). We also find that Patent
Owner has failed to persuasively show secondary considerations of non-
obviousness because the Intuitive’s Ion Endoluminal System is not shown to
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be coextensive with the “guidance” of claim 1, and because Patent Owner
has not established that the alleged unexpected results and satisfaction of
long felt need were the direct result of the unique characteristics of the
claimed method. We are therefore unable to accord Patent Owner’s evidence
any weight. Fox Factory, 944 F.3d at 1373.
b. Independent Claim 10
Petitioner contends that Ganatra teaches a steerable instrument, that
records information about anatomic landmarks and that references the
recorded information. Pet. 56–59 (citing Ex. 1004 ¶¶ 22, 23, 24, 26; Ex 1003
¶¶ 187–92). Petitioner contends that Ganatra discloses the use of a video
camera coupled to the imaging system, and that such images can help the
operator find fiducial points. Id. at 51 (citing Ex. 1004 ¶¶ 20, 30). Petitioner
concedes that “Ganatra does not explicitly state that the images collected at
each designated point are stored.” Id. at 52. Petitioner relies on Soper for
teaching “a bronchoscope that captures and saves images of branching
points and other features of the bronchial passages as it passes through
them.” Id. at 53 (citing Ex.1007, 18:30-35, 19:1-5, 19:21-32; Ex.1003
¶ 140). Petitioner contends that Soper’s annotations allow the clinician to
record notes with the model. Id. at 54–55 (citing Ex. 1007, 22:40–45
(“Annotations could be logged in a textual or audible form for comparison at
a later date. Regions that could not be accessed in previous examinations
would have some visual indicator that links to a set of comments or notes
made by the same or different physician at an earlier date.”). Petitioner
contends that one of ordinary skill in the art would have understood that
adding such an annotation scheme to Ganatra’s system would provide the
same benefit. Id. at 55 (citing Ex. 1003 ¶ 144). Petitioner asserts that
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Ganatra teaches an initial registration process and that “the registration
continues to be refined throughout the procedure as the operator navigates
the bronchoscope through additional designated points,” and can be used to
further refine the registration process. Id. at 58–59 (citing Ex. 1004 ¶¶ 23,
26; Ex. 1007, 22:40–45; Ex. 1003 ¶¶ 144, 190–92, 195–96). Petitioner
contends that because “Ganatra calculates the distance between the two
points, . . . Ganatra references the recorded information for each designated
point.” Id. at 62 (citing Ex. 1004 ¶ 28; Ex. 1003 ¶¶ 204–6). Finally,
Petitioner contends that the combination of “Ganatra and Soper teach
providing navigation guidance on path from M0/T0 to M3/T3 to M4/T4 (a
‘plurality of anatomic landmarks’) to target site 620.” Id. at 64 (citing Ex.
1003 ¶¶ 211–12).
Patent Owner does not provide a separate argument with respect to
claim 10, instead relying on arguments presented for claim 1. For the same
reasons discussed above (see supra § II.E.2.a), after considering the
arguments and evidence, we determine that Petitioner has shown by a
preponderance of the evidence that the combination of Ganatra and Soper
teach each limitation of claim 10 of the ’601 patent. We conclude that claim
10 is unpatentable under 35 U.S.C. § 103(a) over Ganatra and Soper.
c. Claims 2, 3, 5–7, 11–13, and 16–18
With respect to dependent claims 2, 3, 5–7, 11–13, and 16–18, we
find that Petitioner has shown by a preponderance of the evidence that
Ganatra and Soper account for the limitations in these claims. Pet. 59–65,
67–70. We reviewed all the arguments and evidence of record, including Dr.
Hannaford’s testimony and find that a preponderance of the evidence
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supports the contention that the cited references collectively disclose or
suggest each and every limitation of claims 2, 3, 5–7, 11–13, and 16–18.
Patent Owner does not present separate and specific arguments for
any of these dependent claims. See PO Resp. 53–57. We, therefore, adopt
the teachings set forth in the Petition and in Dr. Hannaford’s Declaration as
mapped to the limitations of the challenged claims as our own findings. See
In re NuVasive, Inc., 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the
Board need not make specific findings about claim limitations that a patent
owner does not dispute are disclosed in the prior art).
d. Claims 8, 9, 14, and 15
Patent Owner contends that dependent claims 8 and 14 recite that the
“guidance” recited in claim 1 includes “a model of the path,” and dependent
claims 9 and 15 further recite “displaying the model of the path registered
with the model of the patient anatomy” and, therefore, based on “[t]he
doctrine of claim differentiation . . . Soper’s display of preplanned paths or
intended navigation routes cannot be equated to the claimed ‘guidance’ in
independent claims 1 and 10.” PO Resp. 34; PO Sur-reply 20 (citing Ex.
2011 ¶¶ 577–578). “That is, interpreting the ‘model of the path’ recited in
the dependent claims as the ‘guidance’ recited in claims 1 and 10 would
vitiate any substantive claim differences between the independent claims (1
and 10) and the dependent claims.” Id. at 35.
“Under the doctrine of claim differentiation, dependent claims are
presumed to be of narrower scope than the independent claims from which
they depend” and, thus, independent claims are presumed to be “at least as
broad as the claims that depend from them.” AK Steel Corp. v. Sollac, 344
F.3d 1234, 1242 (Fed. Cir. 2003); see Alcon Research, Ltd. v. Apotex Inc.,
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687 F.3d 1362, 1367 (Fed. Cir. 2012) (holding that where a dependent claim
recited a specific range of concentrations, the independent claim “must cover
at least that range”). Here, we do not find that claim 8 is adding a new
limitation but instead is narrowing an already recited limitation in claim 1. In
other words, claim 1 defines the genus “guidance,” while claim 8 specifies
that the genus includes the species “a model of the path.” Claims 9, 14, and
15 similarly recite species of guidance. A determination that a combination
of references teaches a claimed species means that the same combination
will also meet the limitations of the genus.
Here, Petitioner is not relying on Soper’s preplanned path alone as
providing the guidance limitation of claim 1. See Pet. 46–50, 55–56.
Petitioner is instead relying on the teaching of Soper’s lines that include a
preplanned path or model path to a designated point of biopsy within the
patient in conjunction with arrows disclosed in Ganatra. See Pet. 48 (citing
Ex. 1003 ¶ 125). Petitioner contends that in addition to a line taught by
Soper, the system additionally includes arrows taught by Ganatra to display
the entire path to the target site of interest. Id. at 50 (citing Ex. 1003 ¶ 126).
In other words, a person of ordinary skill in the art would have understood
that the arrows of Ganatra would “be used in the same manner [as used in
the registration process] to guide the operator to site 620 to perform a
procedure” following the preplanned path or model path taught in Soper. Id.
at 33 (citing Ex. 1003 ¶¶ 115–116), 49, 50 (“[A person of ordinary skill in
the art would] configure the system to use a line (instead of or in addition to
arrows) to display the entire path from M0/T0 to target site 620 as taught by
Soper (see Figs. 4A and 4D, []). [Ex. 1003] ¶126.”). Thus, “guidance” based
on the combination of Ganatra and Soper as proposed by Petitioner, includes
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the line to the designated point of interest (i.e. a model path) as taught by
Soper in addition to the arrows for navigation as taught by Ganatra.
Petitioner’s “guidance” as proposed by the combination of Ganatra and
Soper encompasses the narrower limitation of “guidance includes a model of
the path between the plurality of anatomic landmarks” as recited in claim 8.
For the same reasons just discussed for claim 8, the combination of
Petitioner’s “guidance” as proposed by the combination of Ganatra and
Soper similarly encompasses the narrower limitation of “guidance includes a
model of the path between the plurality of anatomic landmarks” as recited in
claim 14.
Petitioner is relying on the combination of Soper and Ganatra to teach
the limitation of reaching a designated point of interest along a model of a
path that is registered with the model of the patient anatomy as set out in
claims 9 and 15. See Pet. 56 (“As integrated into Ganatra, these lines are a
model of the path through the ‘plurality of anatomic landmarks’ and are
displayed on the model of the patient’s anatomy.”), see also id. at 55–56
(“Soper teaches superimposing on the computer model of the lungs both the
‘preprocedural path planning’ to a user . . . as well as ‘the intended
navigation routes 204.”. . . . These paths are depicted as dotted lines . . . that
extend from the entrance way of the trachea, though branching points in the
lungs, to various points of biopsy. ” (citing Ex.1007, 13:58–66, Fig. 4A, Fig.
4D; Ex. 1003 ¶ 177)). Here, the combination of Soper and Ganatra as
proposed by Petitioner teaches a model path that is mapped to a model of the
patients anatomy, thereby meeting the narrower limitation of “guidance” that
encompasses “displaying the model of the path registered with the model of
the patient anatomy” as set out in claims 9 and 15.
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Because independent claims are presumed to be at least as broad as
the claims that depend from them, we are not persuaded by Patent Owner’s
contention that that Petitioner’s identification of a species of guidance based
on the combination of Ganatra and Soper vitiates any differences between
independent and depend claims. Accordingly, we are not persuaded by
Patent Owner’s contention that Petitioner’s recited ground of unpatentability
violates the doctrine of claim differentiation.
e. Conclusion as to obviousness
In sum, we find that the combination of Ganatra and Soper teaches or
suggests each and every element of claims 1–3 and 5–18. We find that an
ordinarily skilled artisan would have been motivated to combine Ganatra
and Soper, and would have had a reasonable expectation of success in
achieving the claimed invention. We also find that Patent Owner has failed
to persuasively show secondary considerations of non-obviousness for
failure to show persuasively that the Intuitive’s Ion Endoluminal System is
coextensive with the “guidance” of claim 1. We are therefore unable to
accord Patent Owner’s evidence any weight. Fox Factory, 944 F.3d at 1373.
F. Ground 3: Obviousness of Claims 4 and 18 over Ganatra and Larkin
Petitioner contends that claims 4 and 18 are rendered obvious based
on the combination of Ganatra and Larkin. Pet. 70–71. Patent Owner
opposes. PO Resp. 60–61.
For the reasons discussed above with respect to the anticipation
rejection of claim 1 based on Ganatra alone (see II.D.2.f), we agree with
Patent Owner that Petitioner has not established a reasonable likelihood of
prevailing on its contentions that Ganatra in conjunction with Larkin would
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render the subject matter obvious. Here, Petitioner is not relying on Larkin
for providing guidance for navigating to a target location as recited in
claim 1, an element missing from Ganatra. Accordingly, the combination
with Larkin is not sufficient to establish that the claims are unpatentable.
G. Ground 4: Obviousness of Claims 4 and 18 over Ganatra, Larkin, and
Soper
Claim 4 depends from claim 1, and further recites “wherein the first
landmark information includes shape information.” Ex. 1001, 13:22–23.
And claim 18 depends from claim 10, and further recites “wherein the first
and second landmark information each include at least one of: information
about a shape of the steerable instrument; a timestamp, and a graphical
representation.” Ex. 1001, 14:38–42.
Petitioner contends that claims 4 and 18 are rendered obvious based
on the combination of Ganatra, Larkin, and Soper. Pet. 70–71. Patent Owner
opposes. PO Resp. 60–61 Petitioner asserts that Ganatra teaches determining
contours or trajectories of a passageway. Pet. 72 (citing Ex. 1004 ¶ 31; Ex.
1003 ¶¶ 79, 147–49). Petitioner relies on Larkin for teaching a Fiber Bragg
Grating sensor. Pet. 72–74 (Ex. 1005 ¶¶ 42 (“[a]n optical fiber bend sensor
comprising one or more optical fibers is provided in the bendable region of
the body. Each of these optical fibers includes a Fiber Bragg Grating,
preferably a collinear array of Fiber Bragg Gratings.”), 44, 95, 99; Ex. 1003,
150–51). “The combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416. Petitioner concludes that it would have been
obvious to include Larkin’s sensor in Ganatra’s endoscope to assist in
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“determining the ‘characteristic curvatures, or contours’ of the airways.” Pet.
73 (citing Ex. 1003 ¶¶ 150–51).
Patent Owner does not separately dispute these limitations, instead
relying on deficiencies set out in the prior art and in Petitioner’s obviousness
theories of claims 1 and 10. PO Resp. 60–61. Because a preponderance of
the evidence supports Petitioner’s arguments relating to the teachings of the
prior art, we adopt Petitioner’s arguments as our own. See Pet. 71–74; see
also In re Nuvasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the
Board need not make specific findings as to claim limitations that Patent
Owner does not dispute are disclosed in the prior art).
For the reasons discussed above (see supra § II.E.2), we determine
that Petitioner has sufficiently shown, that the combination of Ganatra and
Soper teaches all the elements recited in claims 1 and 10. We find that
Petitioner has provided a sufficiently articulated rationale for making the
combination with respect to Larkin. For the same reasons as discussed above
(see supra § II.E.2), we are not persuaded by Patent Owner’s argument that
a person of ordinary skill would not have combined Ganatra with Soper. See
PO Br. 60–61.We determine Petitioner has shown by a preponderance of the
evidence that claims 4 and 18 are unpatentable.
III. CONCLUSION
For the foregoing reasons, we conclude that Petitioner has established
by a preponderance of the evidence that claims 1–18 of the ’601 patent are
unpatentable as obvious over the cited prior art.
IV. ORDER
In consideration of the foregoing, it is hereby:
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ORDERED that Petitioner has proved by a preponderance of the
evidence that claims 1–18 of the ʼ601 patent are unpatentable; and
FURTHER ORDERED that, because this is a final written decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.
In summary:
Claims 35
U.S.C
§
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1, 2, 5–9 102(a) Ganatra 1, 2, 5–9
1–3, 5–18 103(a) Ganatra, Soper 1–3, 5–18
4, 18 103(a) Ganatra, Larkin 4, 18
4, 18 103(a) Ganatra, Larkin,
Soper
4, 18
Overall
Outcome
1–18

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PETITIONER:

Ching-Lee Fukuda
Thomas A. Broughan III
SIDLEY AUSTIN LLP
clfukuda@sidley.com
tbroughan@sidley.com

PATENT OWNER:

Erika Harmon Arner
Daniel C. Tucker
Arpita Bhattacharyya
Benjamin Saidman
Alexander M. Boyer
A. Grace Klock Mills
FINNEGAN, HENDERSON, FARABOW,
GARRETT & DUNNER, LLP
erika.arner@finnegan.com
daniel.tucker@finnegan.com
arpita.bhattacharyya@finnegan.com
benjamin.saidman@finnegan.com
alexander.boyer@finnegan.com
gracie.mills@finnegan.com