Elekta Limited

Patent Trials and Appeals Board

Mar 30, 2021

IPR2019-01659 (P.T.A.B. Mar. 30, 2021)

Trials@uspto.gov Paper 48
571-272-7822 Entered: March 30, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

ZAP SURGICAL SYSTEMS, INC.,
Petitioner,

v.

ELEKTA LIMITED,
Patent Owner.
____________

IPR2019-01659
Patent 7,295,648 B2
____________

Before BRYAN F. MOORE, JENNIFER S. BISK, and
NORMAN H. BEAMER, Administrative Patent Judges.

BEAMER, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
Denying Patent Owner’s Revised Motion to Amend
Denying Patent Owner’s Motion to Exclude
35 U.S.C. § 328(a)
IPR2019-01659
Patent 7,295,648 B2

2
I. INTRODUCTION
In response to a Petition filed by ZAP Surgical Systems, Inc.
(“Petitioner”), we instituted inter partes review of claims 1–4, 7–13, 16–18,
20, and 22–23 of U.S. Patent No. 7,295,648 B2 (Ex. 1001, “the 648 patent”).
Paper 1 (“Pet.”); Paper 7 (“Dec.”). Elekta Limited (“Patent Owner”) filed a
Response to the Petition, Petitioner filed a Reply, and Patent Owner filed a
Sur-Reply. Paper 14 (“PO Resp.”); Paper 19 (“Reply”); Paper 24 (“Sur-
Reply”). Patent Owner also filed a Motion to Amend the claims, Petitioner
filed an Opposition to that Motion, and we provided Preliminary Guidance
under the Board’s Motion to Amend Pilot Program. Papers 13, 18, 20.
Thereafter, Patent Owner filed a Revised Motion to Amend, Petitioner
filed an Opposition, Patent Owner filed a Reply, and Petitioner filed a Sur-
Reply. Paper 22 (“RMTA”); Paper 25 (“Opp. RMTA”); Paper 35 (“Reply
RMTA”); Paper 43 (“Sur-Reply RMTA”). The Revised Motion to Amend
states that it is contingent upon a finding that challenged independent
claims 1 and/or 18 are unpatentable. RMTA 1.
In addition, Patent Owner filed a Motion to Exclude evidence, which
Petitioner opposed, and in support of which Patent Owner filed a Reply.
Papers 37, 38, 41.
An oral hearing took place on January 27, 2021. The Hearing
Transcript (“Tr.”) is included in the record as Paper 47. After considering
the parties’ arguments and supporting evidence, we determine that Petitioner
has demonstrated by a preponderance of the evidence that claims 1–4, 7–13,
16–18, 20, and 22–23 are unpatentable. Also, we determine that Patent
Owner’s Revised Motion to Amend should be denied. In addition, for the
IPR2019-01659
Patent 7,295,648 B2

3
reasons explained below, we deny Patent Owner’s Motion to Exclude
evidence.
II. BACKGROUND
A. The ’648 Patent
The ’648 patent, titled “Method And Apparatus For Treatment By
Ionizing Radiation,” was filed on October 21, 2004, issued on November 13,
2007, and cites Great Britain priority applications filed October 23, 2003 and
November 4, 2003. Ex. 1001, codes (54), (22), (45), (30). The patent
describes a radiation therapy/surgery device for treatment of, e.g., tumors in
the brain. Id. at code (57). Figure 5 of the ’648 patent, annotated by the
panel to show a “rotation axis” and a “support axis,” is reproduced below.

Support
axis
Rotation
axis
IPR2019-01659
Patent 7,295,648 B2

4
Figure 5 illustrates a perspective view of the internal structure of an
exemplary apparatus of the ’648 patent. Ex. 1001, 5:8–9. A sturdy
mounting ring 20 supports rotatable ring 24, which can rotate around patient
18 lying on a table. Id. at 7:5–14. The table support can be adjusted via a
patient positioning system (not shown). Id. at 8:33–39. Mounting brackets
26 and 28 are attached to ring 24, which include pivotable mounting points
30 (only the upper such point is visible in Figure 5) spaced transversely from
the plane of the ring, wherein an imaginary line drawn through the points 30
(the “rotation axis” shown above) would pass directly through the axis of
rotation of the ring (the “support axis” shown above), and which point of
intersection is at the same height as a patient lying on the patient table. Id. at
7:14–23.
A linear accelerator (linac) 32 is mounted on the pivotal mounting
points 30 in a suitable housing 34. A motor 36 is provided to allow the linac
housing 34, and thus the linac 32, to be rotated about the pivotal mounting
points 30. The height of the linear accelerator 32 and its direction are set so
that its beam axis passes through the intersection point referred to above. Id.
at 7:24–30. This intersection point is referred to as the “isocentre.” Id. at
6:44–49.
The linac can thereby rotate about the ring axis and the pivotable
mounting point axis, allowing the beam to come from many directions and
always pass through the intersection point, which is where the patient’s head
(for example) is positioned. Id. at 7:31–40. In operation, the patient is
subjected to multiple radiation doses from multiple directions, with each
dose at a relatively low level so as not to damage the undiseased tissue
through which the beam passes, but with the cumulative doses at the target
IPR2019-01659
Patent 7,295,648 B2

5
intersection high enough to destroy the diseased tissue. Id. at 1:11–36, 7:41–
44.
Because the target tissue can have an irregular shape, as the beam is
directed to the target from different directions, its cross section is adjusted
using a collimator at the output of the linac. Id. at 8:7–14. Also, the
intensity of the beam, the speed of rotation of the linac about the axes of the
system, and the position of the table supporting the patient can be varied
during treatment. Id. at 8:1–13, 23–27, 33–37. The linac can also be used at
lower intensities as an imaging device to calibrate the position of the patient
or locate anatomical areas of the patient. Id. at 8:14–23. A control means
can control the collimation, beam intensity and movement, and patient
position, using, inter alia, feedback from the imaging device. Id. at 4:35–59.
The ’648 patent asserts that the above-described arrangement has the
advantage of accurately positioning the linac over a wide variety of approach
angles, using only rotatable joints, such that the linac is suitably balanced
around those joints, avoiding imprecision problems of prior art techniques
that were less able to accommodate the heavy linac apparatus. Id. at 3:3–31,
5:36–46, 7:50–56. In addition, spacing the pivotable mounting points
transversely from the plane of the ring allows the linac to pivot without
fouling the support or irradiating unintended areas such as the patient’s
shoulder. Id. at 4:21–28, 8:67–9:1.
B. Illustrative Claim
Independent claim 1 of the ’648 patent is illustrative of the challenged
claims, and is reproduced below.
1. A device for treating a patient with ionising radiation
comprising:
IPR2019-01659
Patent 7,295,648 B2

6
a ring-shaped support, on which is provided a mount,
a radiation source attached to the mount;
the support being rotateable about an axis coincident with
the centre of the ring;
the source being attached to the mount via a rotateable
union having a [sic] an axis of rotation axis [sic] which is non-
parallel to the support axis;
wherein the rotation axis of the mount passes through the
support axis of the support and the radiation source is collimated
so as to produce a beam which passes through the co-incidence
of the rotation and support axes.
Ex. 1001, 9:54–67 (British standard spelling in original).
C. References
Petitioner relies on the following references (Pet. iv):
• Grady et al., US 4,649,560, issued March 10, 1987. Ex. 1009
(“Grady”).
• K J Ruchala et al., “Megavoltage CT image reconstruction during
tomotherapy treatments,” Phys. Med. Biol. 45, 3545-3562 (2000). Ex.
1010 (“Ruchala”).
• Lam et al., US 5,945,684, issued Aug. 31, 1999. Ex. 1013 (“Lam”).
• Adler, US 5,207,223, issued May 4, 1993. Ex. 1012 (“Adler”).
• Valentin, WO 01/12262 A1, pub. Feb. 22, 2001. Ex. 1014
(“Valentin”).
• Roder, DE 3321057 A1, pub. Dec. 13, 1984. Ex. 1015 (“Roder”).
• Winter, US 4,998,268, issued March 5, 1991. Ex. 1016 (“Winter”).
• Schonberg, Russell G., “The History of the Portable Linear
Accelerator,” AAPM Meeting (2001). Ex. 1011 (“Schonberg”).
Petitioner also relies on the declarations of J. Michael McCarthy and George
Asmerom. Ex. 1003 (“McCarthy Decl.”); Ex. 1026 (McCarthy MTA Decl.”);
IPR2019-01659
Patent 7,295,648 B2

7
Ex. 1028 (McCarthy Reply Decl.”); Ex. 1036 (McCarthy RMTA Decl.”); Ex.
1027 (“Asmerom Decl.”).
Patent Owner relies on the declarations of K. David Steidley and
Phillip Beron, M.D. Ex. 2001 (“Steidley Decl.”); Ex. 2007 (“Steidley 2nd
Decl.”); Ex. 2040 (“Steidley 3rd Decl.”); Ex. 2008 (“Beron Decl.”).
D. Asserted Grounds of Unpatentability
Petitioner challenges the patentability of claims 1–4, 7–13, 16–18, 20,
and 22–23 of the ’648 patent on the following grounds (Pet. 3)1:
Petitioner also relies on Winter, Schonberg, and Adler as background art in
connection with Grounds 1–4. Pet. 20–21, 46–50.
E. Real Parties in Interest
Petitioner identifies itself as the real party in interest. Pet. 77. Patent
Owner identifies itself, and Elekta, Inc. as real parties in interest. Paper 5, 2.

1 The Leahy-Smith America Invents Act (“AIA”) included revisions to
35 U.S.C. §§ 102 and 103 that became effective after the filing of the
application for the ’648 patent. Therefore, we apply the pre-AIA versions of
these sections.
Claims Challenged 35 U.S.C. § References
1–4, 7–8, 11–12, 17–18, 20, 23 103(a) Grady, Ruchala
9, 10, 13, 16, 22 103(a) Grady, Ruchala, Lam
1–4, 7–8, 11–12, 17–18, 20, 23 103(a) Adler, Grady
9, 10, 13, 16, 22 103(a) Adler, Grady, Lam
1–4, 7–8, 11–12, 17–18, 20, 23 103(a) Valentin, Roder
9, 10, 13, 16, 22 103(a) Valentin, Roder, Lam
IPR2019-01659
Patent 7,295,648 B2

8
F. Related Proceedings
The parties identify Elekta Limited and Elekta, Inc. v. Zap Surgical
Systems, Inc., Case No. 4:19-cv-02269 (N.D. Cal.) as a related proceeding.
Pet. 78; Paper 5, 2.
III. ANALYSIS
A. Legal Standards
A claim is unpatentable for obviousness if, to one of ordinary skill in
the pertinent art, “the differences between the subject matter sought to be
patented and the prior art are such that the subject matter as a whole would
have been obvious at the time the invention was made.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting 35 U.S.C. § 103(a)). The
question of obviousness is resolved on the basis of underlying factual
determinations, including “the scope and content of the prior art”;
“differences between the prior art and the claims at issue”; and “the level of
ordinary skill in the pertinent art.” Graham v. John Deere Co., 383 U.S. 1,
17–18 (1966). Additionally, secondary considerations, such as “commercial
success, long felt but unsolved needs, failure of others, etc., might be utilized
to give light to the circumstances surrounding the origin of the subject
matter sought to be patented. As indicia of obviousness or nonobviousness,
these inquiries may have relevancy.” Graham, 383 U.S. at 17–18.
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. Rather, 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
IPR2019-01659
Patent 7,295,648 B2

9
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”).
“Although the KSR test is flexible, the Board ‘must still be careful not to
allow hindsight reconstruction of references . . . without any explanation as
to how or why the references would be combined to produce the claimed
invention.’” TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1066 (Fed. Cir.
2016) (citation omitted).
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)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed.
Cir. 2016) (stating that “‘conclusory statements’” amount to an “insufficient
articulation[] of motivation to combine”; “instead, the finding must be
supported by a ‘reasoned explanation’” (citation omitted)); 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.”).
The motivation to combine must be “accompanied by a reasonable
expectation of achieving what is claimed in the patent-at-issue.” Intelligent
Bio-Sys, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir.
2016). “The reasonable expectation of success requirement refers to the
IPR2019-01659
Patent 7,295,648 B2

10
likelihood of success in combining references to meet the limitations of the
claimed invention.” Id.
B. Level of Ordinary Skill in the Art
Petitioner relies on its expert, Dr. McCarthy, to contend:
A POSITA [person of ordinary skill in the art] at the time
of the claimed invention would have a bachelor’s degree in
mechanical engineering as well as at least five years of
experience in the industry working with mechanical systems
such as rotatable gantries, gyroscope gimbals and robotic
systems, including robot arms and wrists; or without an
undergraduate degree, a person of ordinary skill would have ten
years of experience designing, manufacturing, or overseeing
mechanical systems such as rotatable gantries, robotic systems,
such as robot arms, robotic surgery systems, and robotic
rehabilitation systems, all of which involve mechanical
positioning systems. See [McCarthy Decl.] ¶ 16.
Pet. 13.
Patent Owner’s expert, Dr. David Steidley, proposes:
[A] POSITA, at the time of the ’648 patent, would have an
undergraduate degree in science, math, physics, engineering, or
the like, and a graduate degree (M.S. or Ph.D.) in a similar field
that includes study of engineering, natural science, physics, radi-
ation physics or the like, together with at least five years of
experience working with radiation imaging and radiation therapy
systems beyond the completion of his or her degrees.
Steidley Decl. ¶ 52; Steidley 2nd Decl. ¶¶ 18, 45. Dr. Steidley testifies that
one of ordinary skill in the art must have at least five years of radiation
imaging and therapy experience, because the use of radiation to treat patients
creates a serious risk to the health and safety of human life, and a person
having less than five years’ experience would be unable to appreciate and
predict the medical risks encountered in the clinical practice of radiation
therapy. Steidley 2nd Decl. ¶ 51.
IPR2019-01659
Patent 7,295,648 B2

11
As stated in the “Field Of The Invention” of the ’648 patent:
This invention relates to a device for treating a patient with
ionising radiation. It is particularly suited to forms of radiosur-
gery and to certain forms of radiotherapy.
Ex. 1001, 1:6–8. The “Background Art” portion of the ’648 patent further
provides basic information about the treatment of pathological cells using
radiation, including the fact that radiation can be used to kill tumor cells, the
corresponding need to avoid damage to healthy cells, the use of radiation
imaging to assist in treatment, the need for “pinpoint accuracy” in focusing
the radiation beam when treating brain tumors, and characterizations of
several then-known approaches for radiation treatment. Id. at 1:12–2:23.
The background section also provides a high-level description of
linear accelerator (“linac”) devices used for treatment, including their use of
accelerated electrons to generate a collimated X-ray beam directed to the
patient from a variety of directions, to “minimise the dosage outside the
tumour and maximise it within the tumour.” Id. at 2:24–43. The ’648 patent
asserts that a disadvantage of using a linac is that they are “extremely
heavy,” due to the linac components themselves as well as the required
shielding to protect from radiation, and thus are hard to accurately position,
particularly if the linac is mounted on a robotic arm. Id. at 2:44–3:31.
Nonetheless, the’648 patent states that the use of linacs on robotic arms “can
be constructed and find application to bodily tumours, [although] they are
not sufficiently accurate for use with tumours of the brain.” Id. at 3:15–17.
Beyond this background section, the bulk of the ’648 patent is
directed to detailed description of a sturdy mechanical apparatus capable of
rotationally manipulating a linear accelerator in three dimensions oriented in
IPR2019-01659
Patent 7,295,648 B2

12
a variety of approach angles with high geometrical accuracy. Ex. 1001,
Figs. 1–17, 3:65–4:48, 5:36–9:36. In particular, the ’648 patent describes:
a support, on which is provided a mount, a radiation source
attached to the mount, the support being rotateable about an axis,
the source being attached to the mount via a rotateable union
having an axis of rotation which is non-parallel to the support
axis, wherein the axis of the mount passes through the axis of the
support and the radiation source is collimated so as to produce a
beam which passes through the coincidence of those axes.
Id. at 4:5–13. In other words, the ’648 patent is primarily directed to the
mechanical engineering aspects of designing an apparatus using a linac for
radiation treatment, not the details about the linac itself, or how such devices
are used in a clinical context.
Accordingly, we agree with Petitioner’s proposal requiring a person of
ordinary skill to have education and training in mechanical engineering.
Pet. 13. However, Petitioner’s proposal does not sufficiently take into
account the radiation imaging and radiation therapy environment of the
pertinent field, which Patent Owner emphasizes. PO Resp. 12–13. But
Patent Owner’s proposal omits the predominately mechanical engineering
aspects of the pertinent field, and disproportionately requires five years of
experience in radiation imaging and therapy. The person of ordinary skill in
the context of the ’648 patent is not the user of the radiation device, but the
designer of that device. We are not persuaded by Patent Owner’s expert Dr.
Steidley’s opinion that a mechanical engineer of ordinary skill would not
have been able to fully take into account the well-known dangers of
radiation in designing a radiation treatment device. Steidley 2nd Decl. ¶ 51.
Therefore, based on the preponderance of the evidence before us, we
determine that Petitioner’s proposal should be modified to add the
IPR2019-01659
Patent 7,295,648 B2

13
requirement that a person of ordinary skill in the art would also have several
years of experience designing radiation imaging and radiation therapy
systems. Alternatively, given that a person skilled in the art of mechanical
engineering would have been capable of applying engineering skills to a
wide variety of applications if given the necessary information and
specifications pertaining to such applications, it is sufficient for the person
of ordinary skill in the art of the ’648 patent to be skilled in the art of
mechanical engineering and to have access to sources of information (such
as collaborators in a development team) about the capabilities, constraints
and specifications of radiation imaging and radiation therapy systems, at
least to the extent of the general background information set forth in the ’648
patent. See In re Paulsen, 30 F.3d 1475, 1482 (Fed. Cir. 1994) (affirming
rejection of a laptop computer hinge as obvious over hinged cabinets, piano
lids, etc., because the “problem is not unique to portable computers”);
Pentec, Inc. v. Graphic Controls Corp., 776 F.2d 309, 314 (Fed. Cir.1985)
(affirming invalidation of a patent for a hinged pen arm because a person
skilled in pen art would have looked to hinge and fastener art for a way to
attach a pen to a pen arm); Sci. Plastic Prod., Inc. v. Biotage AB, 766 F.3d
1355, 1360 (Fed. Cir. 2014) (“[W]hen the problem an invention is designed
to solve is not unique to the specific field of the invention, it is not improper
for the trier of fact to consider whether a person of ordinary skill would
consult a different art in order to solve the problem.”).
Either of these articulations are consistent with the level of ordinary
skill in the art reflected by the prior art. See Okajima v. Bourdeau, 261 F.3d
1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir.
1995). They are also consistent with the evidence that actual radiation
IPR2019-01659
Patent 7,295,648 B2

14
therapy devices are developed by design teams that include mechanical
engineers with limited prior experience working specifically with radiation
treatment systems, who are able to consult with radiation therapists as
necessary. Asmerom Decl. ¶¶ 30–41.
C. Claim Construction
For petitions filed after November 13, 2018, as here, a claim “shall be
construed using the same claim construction standard that would be used to
construe the claim in a civil action under 35 U.S.C. 282(b).”
37 C.F.R. § 42.100(b) (2019). We apply the claim construction standard
from Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en
banc).
Under that standard, claim terms are generally given their ordinary
and customary meaning, as would be understood by one with ordinary skill
in the art in the context of the specification, the prosecution history, other
claims, and even extrinsic evidence including expert and inventor testimony,
dictionaries and learned treatises, although extrinsic evidence is less
significant than the intrinsic record. Phillips, 415 F.3d at 1312–17. Usually,
the specification is dispositive, and it is the single best guide to the meaning
of a disputed term. Id. at 1315.
“Importantly, the person of ordinary skill in the art is deemed to read
the claim term not only in the context of the particular claim in which the
disputed term appears, but in the context of the entire patent, including the
specification.” Id. at 1313. “In determining the meaning of the disputed
claim limitation, we look principally to the intrinsic evidence of record,
examining the claim language itself, the written description, and the
prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic
IPR2019-01659
Patent 7,295,648 B2

15
Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips,
415 F.3d at 1312–17). However, in construing the claims, care should be
taken to avoid improperly importing a limitation from the specification into
the claims. See Cont’l Circuits LLC v. Intel Corp., 915 F.3d 788, 797–98
(Fed. Cir. 2019) (“[U]se of the phrase ‘present invention’ or ‘this invention’
is not always . . . limiting, such as where . . . other portions of the intrinsic
evidence do not support applying the limitation to the entire patent.”
(citations omitted)). An inventor may provide a meaning for a term that is
different from its ordinary meaning by defining the term in the specification
with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994).
Claim terms need only be construed to the extent necessary to resolve
the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
(Fed. Cir. 2011).
1. claim 1: rotateable union
Petitioner proposes to construe the claim term “rotateable union” to
mean “a pivot between two components that provides rotating movement of
one component about the same axis along which the pivot itself rotates.”
Pet. 8.2 The term “rotateable union” was included in the original application
claims and specification. Ex. 1003 ¶¶ 341, 343, 352, 378. Although not
explicitly identified as such, we agree with Petitioner that, in the illustrative
embodiment of the claimed invention described in the ’648 patent, the two
“pivotal mounting point[s] 30,” illustrated in Figure 5 and described above,
which together establish that the rotation axis of the mount, correspond to

2 The record includes some instances of the United States spelling: “rotatable
union.” E.g., Ex. 1002, 18; Ex. 1008, 56.
IPR2019-01659
Patent 7,295,648 B2

16
the claimed rotatable union. Pet. 8–9; see Ex. 1001, Fig. 5, 7:16–28. The
“pivotal mounting point 30” is also referred to as merely a “pivot,” and also
as “pivot axis 30.” Ex. 1001, code(57), 8:47. Also, in the Great Britain
priority application, the claims were originally directed to a “pivot,” and
subsequently amended to “rotateable union.” Ex. 1007, 3, 157.
Therefore, we agree with Petitioner that, in the context of the
preferred embodiments of the ’648 patent, “a person of ordinary skill in the
art (‘POSITA’) would understand the term ‘rotateable union’ equates to a
physical ‘pivot,’” with the caveat that two such opposing pivots are required
to define the rotatable union. Pet. 9. However, we do not agree that it is
necessary or helpful to construe “rotatable union” as proposed. The term
“rotateable union” is clear in the context of the claims and specification, and
there is no need to instead revert to calling it a “pivot,” or “pivots.”
Moreover, the portion of the proposed construction, “the same axis along
which the pivot itself rotates,” is confusing, because a “pivot” itself does not
rotate, but rather establishes the axis about which something else rotates —
in this instance the “source.” See Ex. 1001, 12:10–12 (“the rotateable union
comprises a connection allowing rotation of the source around the mount”).
Patent Owner urges that “the term ‘rotateable union’ should not be
limited to a ‘pivot’ or any particular pivot.” PO Resp. 23. Patent Owner
also argues that Petitioner’s proposed construction of “rotatable union”
should be rejected. Id. at 26–27. As discussed above, we agree as to both of
these points.
2. rotation axis of the mount; support axis of the support
Petitioner points out that “rotation axis of the mount” in claim 1 has
no explicit antecedent, and proposes to resolve any uncertainty on that score
IPR2019-01659
Patent 7,295,648 B2

17
by construing the phrase to mean “the rotation axis of the rotateable union.”
Pet. 12-13. Patent Owner states that it “agrees with Petitioner that ‘the
rotation axis of the mount’ refers to the ‘axis of rotation’ in the claim
language.” PO Resp. 21. However, Patent Owner argues that “‘rotation axis
of the mount’ is best understood as ‘the rotation axis of the source relative to
the mount,’” and maintains that Petitioner’s construction “does not properly
capture the antecedent claim language.” Id.
Literally, the “rotation axis of the mount” in the fifth limitation of
claim 1 most closely corresponds to the “rotateable union having a [sic] an
axis of rotation axis [sic]” of the fourth limitation, which, after removing
obvious errors, reads “rotateable union having an axis of rotation.”3 Ex.
1001, 9:60–61. Thus, we agree with Petitioner’s interpretation, and we
adopt it for purposes of this decision. Although Patent Owner is correct that
the mount rotates about the rotation axis, the claim specifically states that it
is the “rotatable union” that has an “axis of rotation.” Ex. 1001, 9:60–61.
Petitioner’s construction more directly corresponds to the structure of the
claim — that the “rotation axis of the mount” is the “rotation axis of the
rotateable union.”
In addition, we note that the claimed “support axis of the support” in
the fifth limitation of claim 1 refers to the “axis coincident with the centre of
the ring” in the third limitation. Ex. 1001, 9:58–59. Petitioner does not

3 See Novo Industries, L.P. v. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed.
Cir. 2003) (correct on of errors in a claim is permitted if (1) the correction is
not subject to reasonable debate based on consideration of the claim
language and the specification and (2) the prosecution history does not
suggest a different interpretation of the claims); Fitbit, Inc. v. Valencell, Inc.,
964 F.3d 1112, 1119–20 (Fed. Cir. 2020) (re Board’s ability to correct
certain errors).
IPR2019-01659
Patent 7,295,648 B2

18
address this issue, and Patent Owner agrees with our interpretation. PO
Resp. 21.
In sum, there are two axes required by claim 1: a rotation axis and a
support axis. Examples of those axes are illustrated in the annotated figure
reproduced above at page 3. The rotation axis is referred to in the claim
language: “rotateable union having a [sic] an axis of rotation axis [sic],” and
“the rotation axis of the mount” (emphasis supplied). The radiation source
rotates about the rotation axis. The support axis is referred to in the claim
language: “an axis coincident with the centre of the ring,” and “the support
axis of the support” (emphasis supplied). The ring-shaped support rotates
about the support axis. See Ex. 1001, Fig. 1, 9:55–67.
3. ring-shaped support
Although not specifically raised as a claim construction issue, the
meaning of “ring-shaped support” in the claims is at issue, in connection
with the fifth ground asserted by Petitioner. Pet. 53. In particular, the
question arises as to whether a “C-shaped,” or semicircular, structure is ring-
shaped. Id. We conclude it is not: a ring-shaped support must encompass a
full, 360-degree circle, in accord with the plain meaning of “ring.” Patent
Owner agrees with this interpretation. PO Resp. 21–22. Our interpretation
is confirmed by the fact that the ’648 patent specifically distinguishes
between the ring-shaped support of the illustrative embodiment versus the
prior art that uses a “C-arm” or “U-arm” described in the background of the
invention:
Nakagawa et al [Ex. 2003] . . . proposes a system . . . in
which some flexibility of movement is sacrificed in favour of
greater accuracy. The linear accelerator is mounted on one end
of a C-arm, which is (in turn) held in a rotateable support. The
IPR2019-01659
Patent 7,295,648 B2

19
C-arm can move on its support; thus at its two extremities of mo-
tion it resembles more a U-arm or an inverted U. . . . [A]s the C-
arm moves, the centre of gravity of the apparatus will shift, caus-
ing errors. To counteract this, Nakagawa et al require a complex
system of retractable balance weights in order to prevent move-
ment; this is a potential weakness in the accuracy of the
apparatus.
* * *
[In the present invention, t]he rotation of the rotateable
support will be eased if this part of the apparatus is circular.
Ex. 1001, 3:18–31, 4:18–20 (emphasis added).
4. claim 18: rotatable union
Unlike claim 1, independent claim 18 does not recite a “mount” that is
“provided” by the “ring-shaped support,” and to which is “attached” a
“radiation source.” Ex. 1001, 10:63–11:9. Rather, the claim requires a
“ring-shaped support for the source,” where the support permits “rotation
about two axes,” the source rotates “about the two axes,” and the “rotation
takes place via a rotateable union of the source to the support.” We do not
understand by this that the claim requires a rotateable union that permits
rotation about two axes. We construe claim 18 as requiring a rotateable
union to permit rotation about one axis, with no explicit requirement as to
how the support permits rotation about the second axis. Patent Owner
agrees with this interpretation. PO Resp. 27–28. Petitioner does not address
this issue.
D. Objective Indicia of Non-Obviousness
Patent Owner submits evidence that it argues demonstrates the
presence of objective indicia of non-obviousness, applicable to
Petitioner’s asserted grounds of unpatentability — in particular, that
Petitioner’s sales of its “ZAP-X” product demonstrate commercial success of
IPR2019-01659
Patent 7,295,648 B2

20
claims of the ’648 patent, and that Petitioner copied the ’648 patent in
developing ZAP-X. PO Resp. 62–68, Sur-Reply 23–26.
Factual inquiries for an obviousness determination include
secondary considerations based on evaluation and crediting of objective
evidence of nonobviousness. Graham, 383 U.S. at 17. Notwithstanding
what the teachings of the prior art would have suggested to one with
ordinary skill in the art at the time of the invention, the totality of the
evidence submitted, including objective evidence of nonobviousness,
may lead to a conclusion that the claimed invention would not have been
obvious to one with ordinary skill in the art. In re Piasecki, 745 F.2d
1468, 1471–1472 (Fed. Cir. 1984).
“Commercial success is relevant because the law presumes an idea
would successfully have been brought to market sooner, in response to
market forces, had the idea been obvious to persons skilled in the art.”
Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir.
2005). But commercial success is relevant only when it is “due to
[something] disclosed in the patent . . . which was not readily available in
the prior art.” Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed.
Cir. 1983). That is, “[i]f commercial success is due to an element in the
prior art, no nexus exists” between the commercial success and the claimed
invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed.
Cir. 2011).
Patent Owner bears a burden of production with respect to evidence of
commercial success; it must show “significant sales in a relevant market,
and that the successful product is the invention disclosed and claimed in the
patent.” Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1377 (Fed.
IPR2019-01659
Patent 7,295,648 B2

21
Cir. 2000); see also Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324,
1332 (Fed. Cir. 2019) (nexus depends on the “correspondence between the
objective evidence and the claim scope”); Lectrosonics, Inc. v. Zaxcom, Inc.,
IPR2018-01129, Paper No. 33 at 32 (PTAB Jan. 24, 2020) (Precedential)
(noting rebuttable presumption). If a presumption of nexus is inappropriate,
the Patent Owner may yet prove nexus by showing the evidence of
secondary considerations is the “direct result of the unique characteristics of
the claimed invention.” See In re Huang, 100 F.3d 135, 140 (Fed. Cir.
1996). If Patent Owner makes such a showing, Petitioner may rebut the
evidence of commercial success by showing that “the commercial success
was instead due to other factors extraneous to the patented invention.”
Ecolochem, 227 F.3d at 1377.
Patent Owner asserts that ZAP-X embodies 15 of the 17 challenged
’648 claims, coextensive with ZAP-X, which is the only product of
Petitioner, and therefore nexus may be presumed. PO Resp. 63–64 (citing
Steidley 2nd Decl. ¶¶ 148–152, Ex. 2019).4 As evidence of commercial
success, Patent Owner cites FDA approval of ZAP-X, announcements of
third-parties investing in Petitioner, and actual showings of ZAP-X and the
installation of the ZAP-X at several medical facilities. Id. at 66–68 (citing
Ex. 2022 ¶¶ 9–20; Exs. 2027–2038).5 Patent Owner alleges that Petitioner

4 The cited paragraphs of the Steidley declaration in turn cite Exhibits 2014–
2018, and two videos relating to ZAP-X.
5 On January 15, 2021, we denied as untimely Patent Owner’s motion to
submit supplemental information consisting of three additional exhibits
regarding the use of ZAP-X to treat a patient, regulatory approvals, and a
ZAP-X presentation. Paper 40.
IPR2019-01659
Patent 7,295,648 B2

22
has sold “several” ZAP-X products that cost “millions of dollars.” Sur-
Reply 24.
Patent Owner also asserts, as an indicia of nonobviousness, that
Petitioner copied the subject matter of the ’648 patent, based on the fact that
Petitioner’s CEO, John Adler, is the named inventor of a patent application
that identified the ’648 patent in an information disclosure statement.
PO Resp. 64–65 (citing Ex. 2022 ¶¶ 4–7; Exs. 2020–2021). Patent Owner
further asserts that the Adler application copies the ‘648 patent, and in turn
that ZAP-X embodies the subject matter of that application. Id. at 65–66
(citing Steidley 2nd Decl. ¶¶ 153–154; Ex. 2022 ¶¶ 5–8; Exs. 2021, 2025,
2026).
Petitioner argues that Patent Owner has improperly attempted to
show nexus by incorporating by reference 25 pages of arguments in the
form of a claim chart comparing the ’648 patent claims to five
publications and two videos allegedly describing ZAP-X. Reply 22
(citing Steidley 2nd Decl. ¶¶ 148–152 (which in turn cites Exs. 2014–
2018); Ex. 2019). See 37 C.F.R. § 42.6(a)(3); Blackberry Corp. v.
MobileMedia Ideas LLC, Case No. IPR2013-00016, Paper 32 at 21
(P.T.A.B. Feb. 25, 2014).
Petitioner also submits that any presumption of nexus is rebutted
by the fact that ZAP-X uses subject matter of a patent directed to a “self-
shielded radiation treatment system,” which is a key feature that has
been the focus of the publicity surrounding ZAP-X. Reply 23–24 (citing
Ex. 1031, 4:34–40; Ex. 2037, 2; Ex. 1025, 155:10–156:2, 156:16–24,
157:13–158:7). Petitioner also points out that the handful of sales of
ZAP-X are insufficient evidence of commercial success. Id. at 24.
IPR2019-01659
Patent 7,295,648 B2

23
Petitioner also challenges Patent Owner’s evidence of copying as
insufficient, contrasting the facts here with cases involving evidence of
actual copying efforts. Reply 24–25.
Based on our review of the record we have considered the
secondary considerations of non-obviousness and accorded them
appropriate weight along with all of the Graham factors, and for the
reasons further set forth below we agree with the Petitioner that the
challenged claims would have been obvious in light of submitted
references. We are not prepared to accept Patent Owner’s conclusory
assertions of nexus, which are: supported only by attorney arguments
(not evidence); presented in the form of claim charts that are
incorporated by reference rather than being included on Patent Owner’s
Response; and dependent on hearsay descriptions of ZAP-X. In
addition, the record does not demonstrate that the alleged “millions of
dollars” of sales of ZAP-X (consisting of a few such items sold) are
attributable to the subject matter of the ’648 patent. For example, the
record shows that the use of linacs for radiation treatment preexisted the
invention of the ’648 patent. Ex. 1001, 2:24–62. There is no evidence
to differentiate the sales attributable to the invention from the sale of a
linac, together with the required shielding and control mechanisms
generally required for treatment irrespective of whether or not the
invention is used.
In addition, we find Patent Owner’s allegation of copying
speculative and not persuasive. The fact that the ’648 patent was cited
in an information disclosure statement during prosecution of a patent
IPR2019-01659
Patent 7,295,648 B2

24
application that named the CEO of Petitioner, without more, is not
sufficient evidence of copying.
E. Ground 1: Obviousness of Claims 1–4, 7–8, 11–12, 17–18, 20, and 23
Over Grady and Ruchala
Petitioner challenges claims 1–4, 7–8, 11–12, 17–18, 20, and 23 as
unpatentable under pre-AIA 35 U.S.C. § 103(a) over the combination of
Grady and Ruchala. Pet. 16–38. In support of this prior art combination,
Petitioner also relies on Winter, Schonberg, and Adler as evidence of the
pertinent prior art background. Pet. 20–21.
1. Grady
Grady, titled “Digital X-Ray Stand,” was filed January 30, 1984 and
issued March 10, 1987. Ex. 1009, codes (54), (22), (45). Because Grady
issued before the earliest priority date of the ’648 patent, this reference is
prior art to the ’648 patent under pre-AIA 35 U.S.C. § 102(a).
Grady discloses an X-ray tube mounted on sliding arm connected to a
rotating support. Id. at code (57). Figure 1 is reproduced below.
IPR2019-01659
Patent 7,295,648 B2

25

Figure 1 shows fixed outer ring 2, within which front ring 3 and rear ring 4
can rotate manually or via a motor drive. Id. at 1:46–49. Patient table T is
attached to rear ring 4, positioned along the axis of rotation A1 of the rings,
and longitudinally adjustable along that axis. Id. at 1:49–53. An arm
extends from sleeve 8 attached to front rotating ring 3, which arm can slide
in and out of the sleeve parallel to axis A1. Id. at 1:53–56. Carriage 10 is
attached to the arm via rotary bearing 11, and can rotate about axis A2. Id.
at 1:56–60. X-ray tube X is carried by carriage 10 and is aligned on
radiation axis A3 which intersects axes A1 and A2 at isocenter C. Id. at
1:61–66. As explained in Grady:
The present structure affords rotation of the radiation
source means X and receptor R about both the first axis Al and
second axis A2 for radiation of a subject from substantially
throughout spherical loci around the subject position at the
isocenter C.
IPR2019-01659
Patent 7,295,648 B2

26
Id. at 2:25–29. The X-ray device of Grady is used to obtain X-ray images
for examining patients. Id. at 1:27–28, 2:5–14.
2. Ruchala
The article by Ruchala, titled “Megavoltage CT image reconstruction
during tomotherapy treatments,” appears on its face to have been published
in the journal, “Phys. Med. Biol.,” in 2000. Ex. 1010. Although Petitioner
does not explicitly address publication date, the document itself indicates
that it was published in a professional journal and was copyrighted in 2000.
A copyright date in and of itself does not necessarily fix the exact date of
public accessibility. In-Depth Geophysical, Inc. v. Conocophillips Co.,
IPR2019-00849, Paper 14 at 4–13 (PTAB Sept. 6, 2019). However, the
article also includes a header with a conventional journal reference:
Phys. Med. Biol. 45 (2000) 3545-3562. Printed in the UK.6
Ex. 1010, 1. The occurrence of “2000” in the header of the article strongly
evidences publication as of that year or at least reasonably soon thereafter.
[I]ndicia on the face of a reference, such as printed dates and
stamps, are considered as part of the totality of the evidence.
* * *
The Board has often found a reasonable likelihood that a
reference is a printed publication for institution of an inter partes
review when the evidence relied on in a petition provides strong
indicia that an asserted reference was publicly accessible.
Hulu, LLC v Sound View Innovations, LLC, IPR2018-01039, Paper No. 29 at
17–18 (PTAB Dec. 20, 2019) (Precedential). Accordingly, we determine
that the preponderance of the evidence establishes that the referenced journal

6 A Google search indicates “Phys. Med. Biol.” refers to the journal, Physics
in Medicine & Biology.
IPR2019-01659
Patent 7,295,648 B2

27
containing this article was publically accessible prior to the earliest priority
date (October 23, 2003) of the ’648 patent. Ex. 1001, code (30).
Ruchala describes an “integrated tomotherapy system” that combines
CT imaging of a patient using a linac that is also used to treat tumors in the
patient. Ex. 1010, 3545, 3547. The linac is fitted with a “multileaf
collimator” to “allow for a highly conformal treatment that will deliver dose
to the tumour while sparing sensitive structures.” Id. at 3545. The CT
imaging capability ensures “properly positioning the patient’s body and
interior organs, [and] it is also vital to know that the treatment was delivered
as intended.” Id. In the system, “the patient remains still, but the linac and
detector rotate about the patient.” Id. at 3548.
3. The Combination of Grady and Ruchala
For the combination of Grady and Ruchala, Petitioner relies on its
expert Dr. McCarthy’s testimony that one of ordinary skill would have been
motivated to use the flexible targeting capabilities of Grady to treat tumors
with radiation sources, such as linacs, as described in Ruchala. Pet. 19–20
(citing McCarthy Decl. ¶ 74). The three-dimensional manipulation
capabilities of Grady adapted to use a radiation source for treatment of
tumors allows “therapy [to] be highly articulable and able to be directed to a
critical location from virtually any angle or direction.” Id.; Reply 18–20.
Dr. McCarthy further cites Ruchala as providing a motivation to adapt
Grady for use in treatment, because it teaches that the integration of imaging
and therapy delivery allows for more accurate delivery and verification of
dose delivery to the tumor, thus allowing imaging before, during, and after
therapy delivery, which provides benefits of potential increased patient
throughput, reductions in imaging dose, and visualization of the patient
IPR2019-01659
Patent 7,295,648 B2

28
during treatment. McCarthy Decl. ¶ 73 (citing Ex. 1010, Abstr., 3545);
Reply 18. Dr. McCarthy testifies that Ruchala shows that a “person of
ordinary skill would have known of the benefits of mounting a linear
accelerator with a collimator on a gantry both for treatment and imaging.”
Id.
Dr. McCarthy also cites Winter as evidence that a person of ordinary
skill would have been motivated to combine a CT scanner with a radiation
source to treat tumors, in order to “‘add a therapeutic dimension’ to . . .
existing imaging apparatus.” McCarthy Decl. ¶ 74; Ex. 1016, code (57), 1:65–
2:1.7 Winter teaches that this combination provides the benefit of “more
accurate positioning of the patient due to the fact that a single device having
diagnostic imaging capability is used for both imaging and therapy
purposes.” Ex. 1016, 2:41–45.
Relying in part on Adler, Dr. McCarthy further testifies that,
notwithstanding the assertions in the ’648 patent that the “great weight” of
linacs created problems that the patent solved (e.g., Ex. 1001, 3:3–17), it was
well known at the time of the priority date of the patent that “relatively light
weight” linacs were available, thus facilitating using technology such as
disclosed in Grady in combination with a linac as a therapeutic radiation
source, and confirming that a person of ordinary skill would be motivated to

7 Petitioner’s use of Winter (and Adler) as evidence of the state of the art, to
support why a POSITA would be motivated to combine Grady and Ruchala, is
appropriate. See Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d
1359, 1365 (Fed. Cir. 2015) (prior art references to show the state of the art
at the time of the invention “can legitimately serve to document the
knowledge that skilled artisans would bring to bear in reading the prior art
identified as producing obviousness”); Genzyme Therapeutic Prod. Ltd.
P’ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1369 (Fed. Cir. 2016).
IPR2019-01659
Patent 7,295,648 B2

29
arrive at the combination of Grady and Ruchala. Pet. 20–22 (citing
McCarthy Decl. ¶ 38; Ex. 1012, 1:8–10, 6:44–68.); see also Reply 3–5.8 Dr.
McCarthy testifies:
Given the identical purpose of the positioning system for
imaging and therapy and the availability and use of small,
lightweight portable linear accelerators by 2000, a person of
ordinary skill in the art would have been motivated to use a linear
accelerator as the X-ray radiation source of Grady to perform
radiotherapy in conjunction with imaging.
McCarthy Decl. ¶ 74.
As a threshold matter, Patent Owner challenges the testimony of Dr.
McCarthy.9 PO Resp. 2–3, 15–16, 18–20; Sur-Reply 6–9. Patent Owner
points out that Dr. McCarthy’s experience with Accuray, which developed
and sold the “CyberKnife” radiation treatment device, was primarily
supervisory, and not involved with the development of the CyberKnife. Id.
at 15 (citing Ex. 2010, 80:10–23, 81:1–9, 82:4–7, 82:8–13; 83:23–84:2);
Sur-Reply 7. In addition, Patent Owner cites the fact that Dr. McCarthy has
no experience in operating radiation therapy devices or creating treatment

8 Petitioner also relies on Schonberg for additional details of light-weight
linacs. Pet. 21, Ex. 1011. Unlike Ruchala, Schonberg appears to be a
document handed out at a meeting, and the record does not show that it was
publically accessible as of the priority date of the ‘648 patent. See
Medtronic, Inc. v. Barry, 891 F.3d 1368 (Fed. Cir. 2018). Therefore, we do
not consider it.
9 In the context of its revised motion to amend, Patent Owner also moves to
exclude Dr. McCarthy’s declarations submitted in support of Petitioner’s
Opposition to Patent Owner’s original motion to amend (Exhibit 1026), and
revised motion to amend (Exhibit 1036). Paper 37; Paper 41. This aspect of
Patent Owner’s challenges to Dr. McCarthy’s testimony is discussed further
below at Section V.
IPR2019-01659
Patent 7,295,648 B2

30
plans using such devices. Id. at 16 (citing Ex. 2010, 22:23–23:7; 24:8–9;
26:22–25, 27:8–18).
Patent Owner in particular alleges that Dr. McCarthy misunderstands
the teachings of Winter which, according to Dr. McCarthy, support his
testimony that one of ordinary skill in the art would have been aware of the
benefits of combining radiation therapy with imaging. See McCarthy Decl.
¶ 74. According to Patent Owner, the approach of Winter would not be
clinically acceptable for the types of treatments that Dr. McCarthy assumes
to be the case. PO Resp. 18–20 (citing Steidley Decl. ¶¶ 108–109; Steidley
2nd Decl. ¶¶ 54–56, 75).
In addition to challenging Petitioner’s reliance on its expert Dr.
McCarthy’s testimony, Patent Owner challenges Petitioner’s overall
rationale for making the combination, arguing that one of ordinary skill in
the art of radiation treatment devices would not consider diagnostic imaging
devices such as disclosed in Grady, because such devices serve a completely
different purpose, require “very different and completely separate training
and experience” to use, employ “orders of magnitude” lower radiation
energies, and use fan-shaped radiation beams that do not need to be narrowly
focused or shaped at specific distances and from different directions to treat
diseased tissue but avoid healthy tissue. PO Resp. 29–34 (citing Steidley 2nd
Decl. ¶¶ 59–82, 87–88; Beron Decl. ¶¶ 44–57, 73–77, 79–82, 90–91, 102,
105–117, 119–123).
Patent Owner submits that Grady discloses a diagnostic imaging
device and does not disclose anything about radiation treatment. Therefore,
Patent Owner argues, a person of ordinary skill in the art would not consider
it when designing a radiation treatment device, because it operated at an
IPR2019-01659
Patent 7,295,648 B2

31
unsuitable low radiation energy range, and was not engineered to accurately
carry and aim heavy linac radiation sources. PO Resp. 35–38 (citing
Steidley Decl. ¶¶ 80, 111–115; Steidley 2nd Decl. ¶¶ 61–66, 94–97; Beron
Decl. ¶¶ 114–116); see also Sur-Reply 4–6.
Patent Owner contrasts Grady with Ruchala and Adler, which use
linacs for radiation treatment, operate in the higher megavolt range, and
require more accurate aiming capability. PO Resp. 39–44 (citing Steidley
Decl. ¶¶ 97, 116–121, 146–150; Steidley 2nd Decl. ¶¶ 98, 118, 124–126;
Beron Decl. ¶ 45); Sur-Reply 19–20. Patent Owner argues that Grady’s
single extending arm is not designed to hold or properly aim a heavier, high
powered linac to deliver radiation treatment. In addition, Patent Owner
argues that Grady would need automated control capability to carry out the
required treatment, and therefore a person of ordinary skill in the art would
not have expected the structure of Grady to provide a viable solution for
focusing a therapeutic radiation source on the target. PO Resp. 44–46
(citing Steidley Decl. ¶¶ 125–126; Steidley 2nd Decl. ¶¶ 85, 102–108; Beron
Decl. ¶¶ 39–40, 74–77, 112–123, 124–129).
Patent Owner takes issue with Dr. McCarthy’s reliance on the
disclosures in Ruchala and Winter of combining CT scanning and radiation
treatment. PO Resp. 47–55. Patent Owner points out that the type of imaging
contemplated by those references uses different voltage ranges compared to
Grady, resulting in lower resolution images. PO Resp. 47–48 (citing Steidley
2nd Decl. ¶ 111). In addition, as discussed, Patent Owner argues that
incorporating the heavy linac of Ruchala would require substantial redesign
of the Grady apparatus. Id. at 48 (citing Steidley 2nd Decl. ¶ 112). Patent
Owner argues that even the lighter linac of Adler would be considerably
IPR2019-01659
Patent 7,295,648 B2

32
heavier than the X-ray device of Grady. Id. at 49 (citing Steidley 2nd Decl.
¶ 112). As discussed above in connection with Patent Owner’s challenge to
Dr. McCarthy’s testimony, Patent Owner argues that Winter discloses
practices that were outdated by the priority date of the ’648 patent, and that
Winter would not have worked as a therapeutic device. Id. at 51–53 (citing
Steidley Decl. ¶¶ 107–110; Steidley 2nd Decl. ¶¶ 54–56, 74–78, 107; Beron
Decl. ¶¶ 79, 83); Sur-Reply 21–22.
In response to Patent Owner’s arguments against Dr. McCarthy’s
testimony, Petitioner reiterates its position that the primary focus of the’648
patent claims is on the mechanical engineering aspects of a radiation therapy
device, not on the details of treatment of brain tumors. Reply 11–12.
Petitioner cites Dr. McCarthy’s experience in training mechanical engineers
to design radiation therapy devices in his position as Chief Technical Officer
of Accuray. Id. (citing McCarthy Reply Decl. ¶¶ 1–12, 39). Moreover,
Petitioner cites evidence that the design of radiation therapy devices
involves collaboration between mechanical engineers and persons with
clinical experience. Id. at 12 (citing Asmerom Decl. ¶¶ 8–22, 28–41, 51).
Petitioner further points out that during the prosecution of the ’648
patent, patents directed to imaging devices were cited, and were not
distinguished based on an argument that imaging devices were not relevant
art. Reply 1–2. Petitioner also submits the deposition testimony of Patent
Owner’s experts admitting that linacs were available at the pertinent time
period that weighed in the 100–175 kg range, which could be handled by
available industrial robot arms. Id. at 4–5 (citing Ex. 1025, 142:12–15,
144:17–19, 146:8–23; Ex. 1024, 36:23–38:23). Petitioner points out that,
IPR2019-01659
Patent 7,295,648 B2

33
notwithstanding the reference in the ’648 specification to heavy linacs, the
claims are not limited to any particular type of linac. Id. at 5.
Petitioner also argues that the preambles of independent claims 1 and
18, which recite “treating a patient,” are not limiting, and in any event the
claims do not require any particular form of treatment, such as treatment for
brain tumors, or any particular level of efficacy, precision, voltage level, or
pre-treatment planning. Reply 6–9. Petitioner also submits that Patent
Owner’s experts lack mechanical engineering experience, and therefore their
opinions regarding whether one of ordinary skill would be motivated to
combine Grady and Ruchala are not persuasive. Reply 13–14.
Regarding the imaging capabilities of Grady, Petitioner cites evidence
that Grady is designed for both kilovolt and megavolt energy ranges, and
thus does not have the resolution problems that Patent Owner alleges. Reply
15–16 (citing Ex. 2004, 1:13–16, 4:48–51). Petitioner also disputes Patent
Owner’s criticism of Winter, given that kilovolt-level radiation is suitable
for various type of treatments, and that irrespective of the suitability of using
“beam masks,” Winter nevertheless teaches the desirability of using a
radiation source for both imaging and treatment. Reply 16–17 (citing
Ex. 1024, 137:19–138: 3, 165:5–23).
We determine that the preponderance of the evidence demonstrates
that one of ordinary skill would have been motivated to combine the three-
dimensional flexible targeting capabilities of Grady to treat tumors with
radiation sources, such as linacs, as described in Ruchala, to arrive at a
radiation therapeutic device that meets the challenged claims of the ’648
patent. Obviousness entails an inquiry that is “expansive and flexible” and
takes into account “the inferences and creative steps a person of ordinary
IPR2019-01659
Patent 7,295,648 B2

34
skill in the art would employ” when presented with the teachings of the prior
art. KSR, 550 U.S. at 415–18. “[I]n many cases a person of ordinary skill
will be able to fit the teachings of multiple patents together like pieces of a
puzzle. . . . A person of ordinary skill is also a person of ordinary creativity,
not an automaton.” Id. at 420–421. Also, “[t]he test for obviousness is not
whether the features of a secondary reference may be bodily incorporated
into the structure of the primary reference . . . . ‘Rather, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.’” In re Keller, 642 F.2d 413, 425 (CCPA 1981).
“Combining the teachings of references does not involve an ability to
combine their specific structures.” In re Nievelt, 482 F.2d 965, 968 (CCPA
1973).
As discussed above in Section III.B, the pertinent field of the
invention includes the engineering design of sturdy mechanical apparatus
capable of rotationally manipulating heavy devices in three dimensions
oriented in a variety of approach angles with high geometrical accuracy, in
the context of the radiation imaging and radiation therapy environment. One
of ordinary skill in the art would have been a mechanical engineer, either
with experience in radiation therapy devices or with access to information
concerning such devices. We credit Petitioner’s expert Dr. McCarthy as
qualified to testify about the mechanical engineering aspects of radiation
therapy devices, which is the principal focus of the ’648 patent claims. The
record shows that Dr. McCarthy has extensive experience and knowledge of
mechanical engineering design, including sufficient experience with
radiation imaging and radiation therapy devices. McCarthy Decl. ¶¶ 3–10;
Ex. 1004. In addition, he has reviewed and analyzed the art of radiation
IPR2019-01659
Patent 7,295,648 B2

35
imaging and radiation therapy systems pertinent to the invalidity issues
raised by Petitioner. McCarthy Decl. ¶¶ 12–13, 32–43, 74, 77. We are not
persuaded that Dr. McCarthy’s testimony should be disregarded.
We acknowledge that there are differences between lower voltage X-
Ray devices used for imaging, and higher voltage linacs used for treatment.
But we are not persuaded by Patent Owner’s expert’s testimony that,
because Grady is an X-ray imaging apparatus used as a diagnostic device for
imaging soft tissue, one of ordinary skill in the art of radiation treatment
devices would not consider diagnostic imaging devices such as disclosed in
Grady. Indeed, we find that Patent Owner’s experts’ testimony on this score
lacks credibility — persons of ordinary skill in the applicable art would have
readily understood the advantages of the three-dimensional manipulation
capabilities of the Grady approach, would have appreciated their
applicability to radiation treatment, and would have not have been dissuaded
from making the combination despite the various differences between
imaging and treatment that Patent Owner’s experts rely on. The Patent
Owner’s experts’ arguments directed to the need for high degree of precision
required for treatment of brain tumors are not commensurate with the scope
of the claims, which do not require any particular degree of precision and are
not limited to the treatment of brain tumors. Likewise, Patent Owner’s
experts’ testimony regarding orders of magnitude difference in radiation
energies, fan-shaped versus narrow beams, difficulty in accommodating
heavy linacs, and differences in efficacy, precision, and pre-treatment
planning are not factors which would dissuade one of ordinary skill from
making the combination.
IPR2019-01659
Patent 7,295,648 B2

36
In sum, the preponderance of the evidence establishes that a person of
ordinary skill would have been motivated to use the flexible targeting
capabilities of Grady to treat tumors with radiation sources, such as linacs,
as taught by Ruchala.
4. Independent Claim 1
The preamble of claim 1 requires, “A device for treating a patient with
ionising radiation.”10 Ex. 1001, 9:54–55. Petitioner relies on the
combination of Grady and Ruchala as teaching or suggesting such a device,
and in particular the disclosure in Ruchala of the use of a linac for
radiotherapy. Pet. 23–24 (citing McCarthy Decl. ¶¶ 72–75; Ex. 1010, 3545,
3547).
The first limitation of claim 1 requires, “a ring-shaped support, on
which is provided a mount, a radiation source attached to the mount.”
Ex. 1001, 9:56–57. Petitioner identifies front ring 4 of Grady as the ring-
shaped support, sleeve 8 with its sliding arm as the mount, to which is
attached carriage 10 which holds the radiation source, which in the
combination is the linac of Ruchala. Pet. 24–25 (citing Ex. 1009, Fig. 1,
1:46-60).
The second limitation of claim 1 requires, “the support being
rotateable about an axis coincident with the centre of the ring.” Ex. 1001,

10 The petition apparently assumes the preamble is limiting, but Petitioner
argues in the Reply that it is not limiting. Pet. 23–24; Reply 6–7. Patent
Owner argues otherwise. Sur-Reply 10–13. Because the record has shown
that the recitation in the preamble is satisfied by the prior art, there is no
need to determine whether the preamble is limiting. See Vivid Techs., Inc. v.
Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
IPR2019-01659
Patent 7,295,648 B2

37
9:58–59. Petitioner relies on the fact that front ring 4 rotates about axis A1.
Pet. 25 (citing McCarthy Decl. ¶ 72; Ex. 1009, Fig. 1, 2:18–24).
The third limitation of claim 1 requires, “the source being attached to
the mount via a rotateable union having a [sic] an axis of rotation axis [sic]
which is non-parallel to the support axis.” Ex. 1001, 9:60–62. Petitioner
relies on the fact that carriage 10 rotates on rotary bearing 11 about axis A2,
which is perpendicular to axis A1. Pet. 25–26 (citing Ex. 1009, Fig. 2, 1:56–
66).
The fourth limitation of claim 1 requires, “wherein the rotation axis of
the mount passes through the support axis of the support and the radiation
source is collimated so as to produce a beam which passes through the co-
incidence of the rotation and support axes.” Ex. 1001, 9:63–67. Petitioner
relies on the fact that the isocenter C is defined by the intersection of axes
A1, A2, and the radiation axis A3. Petitioner also relies on the disclosure in
Ruchala that the linac beam is equipped with a collimator. Pet. 26–27
(citing Ex. 1009, Fig. 1, 1:56–66; Ex. 1010 at 3547).
Other than arguing that Petitioner’s combination of Grady and
Ruchala is improper, and that objective indicia require a conclusion of
nonobviousness (which arguments, for the reasons discussed above, we find
unpersuasive), Patent Owner does not have any specific arguments refuting
Petitioner’s comparison of the combination to the requirements of claim 1.
Having considered both the evidence of obviousness and Patent
Owner’s submitted evidence of nonobviousness, and weighed the entirety of
the evidence, we determine that Petitioner has proved by a preponderance of
the evidence that claim 1 would have been obvious over the combination of
Grady and Ruchala.
IPR2019-01659
Patent 7,295,648 B2

38
5. Independent Claim 18
The preamble of claim 18 requires, “A method of treating a patient
with a source that emits a beam of radiation in a direction emanating
therefrom.” Ex. 1001, 10:63–65. Petitioner relies on its analysis of the
preamble of claim 1 for the claim 18 preamble. Pet. 33.
The first limitation of claim 18 requires, “providing a ring-shaped
support for the source, the support permitting rotation about two axes each
offset from the source, with both axes and the beam direction all being co-
incident at a single isocentre.” Ex. 1001, 10:66–11:2. For this claim
requirement, Petitioner relies on the same features of Grady identified for
claim 1. Pet. 33–35.
The second and third limitations of claim 18 require, “positioning the
patient such that a diseased area of tissue is located at the isocentre” and
“activating the source.” Ex. 1001, 11:3–5. Petitioner relies on the
combination of Grady and Ruchala for these requirements, including the
Grady Figure 2 disclosure of a patient P positioned on table T at isocenter C,
which is the target of the radiation beam, which in the combination is the
linac used to treat the patient’s tumor. Pet. 35–36 (citing McCarthy Decl.
¶¶ 155–158; Ex. 1009, Fig. 2; Ex. 1010, 3551, 3560).
The fourth limitation of claim 18 requires, “causing rotation of the
source about the two axes to achieve a greater dosage at the isocentre than
around the isocentre, wherein the rotation takes place via a rotateable union
of the source to the support.”11 Ex. 1001, 11:6–9. Petitioner relies on the

11 We note that, unlike claim 1, claim 18 does not recite a “mount” that is
“provided” by the “ring-shaped support,” and to which is “attached” a
“radiation source.” Rather, the claim requires a “ring-shaped support for the
source,” where the support permits “rotation about two axes,” the source
IPR2019-01659
Patent 7,295,648 B2

39
ability of Grady to rotate the source about axes A1 and A2, together with the
description in Ruchala of “deliver[ing] doses to the tumour while sparing
sensitive structures.” Pet. 36–37 (citing McCarthy Decl. ¶¶ 155–157;
Ex. 1009, 2:25–29; Ex. 1010, 3545).
Other than arguing that Petitioner’s combination of Grady and
Ruchala is improper, and that objective indicia require a conclusion of
nonobviousness (which arguments, for the reasons discussed above, we find
unpersuasive), Patent Owner does not have any specific arguments refuting
Petitioner’s comparison of the combination to the requirements of claim 18.
Having considered both the evidence of obviousness and Patent
Owner’s submitted evidence of nonobviousness, and weighed the entirety of
the evidence, we determine that Petitioner has proved by a preponderance of
the evidence that claim 18 would have been obvious over the combination of
Grady and Ruchala.
6. Dependent Claims 2–4, 7–8, 11–12, 17, 20, and 23
Claims 2–4, 7, and 23 depend from claim 1, and add the limitations,
respectively, “the support is disposed in an upright disposition”; “the support
and rotation axes are transverse”; “the mount extends transverse to the
support”; “the beam direction is perpendicular to the rotation axis of the
mount”; and “the rotateable union comprises a connection allowing rotation
of the source around the mount.” Ex. 1001, 10:1–9, 10:16–18, 12:10–12.
Petitioner relies on the disclosed orientation of the components and axes of

rotates “about the two axes,” and the “rotation takes place via a rotateable
union of the source to the support.” As discussed in Section III.C.4 above,
we construe this claim as requiring a rotateable union to permit rotation
about one axis.
IPR2019-01659
Patent 7,295,648 B2

40
the embodiment shown in Figure 1 of Grady as discussed above in
connection with claim 1. Pet. 28–31, 37 (citing McCarthy Decl. ¶¶ 90–95;
Ex. 1009, Fig. 1, 2:25–29).
Claim 8 depends from claim 1, and adds the limitation, “the radiation
source is a linear accelerator.” Ex. 1001, 10:19–21. Petitioner relies on the
disclosed linac of Ruchala, in combination with Grady. Pet. 31–32 (citing
McCarthy Decl. ¶¶ 101–105; Ex. 1010, 3547–48).
Claim 11 depends from claim 1, and adds the limitation, “including a
patient support,” and claim 12 depends from claim 11, and adds the
limitation, “a position of the patient support is adjustable.” Ex. 1001, 10:31–
34. Petitioner relies on patient table T described in Grady, which is
longitudinally adjustable parallel to the rotation axis A1. Pet. 32 (citing Ex.
1009, 1:49–53.)
Claim 17 depends from claim 1, and adds the limitation, “an integral
imaging device is used to determine a position of the patient.” Ex. 1001,
10:60–62. Petitioner relies on the description in Ruchala on the use of a
linac for both treatment as well as scanning capabilities at low energy levels,
used to properly position the patient’s body, in combination with the
apparatus of Grady, including table T. Pet. 32–37 (citing McCarthy Decl.
¶¶ 147–148; Ex. 1010, 3545, 3548).
Claim 20 depends from claim 18, and adds the limitation, “the source
is de-activated when the source is in specific positions relative to the two
axes.” Ex. 1001, 11:13–15. Petitioner argues that a person of ordinary skill
would know that the source is activated only when properly focused on the
target region, and is normally otherwise not activated. Pet. 32–33 (citing
McCarthy Decl. ¶¶ 170–171).
IPR2019-01659
Patent 7,295,648 B2

41
Other than arguing that Petitioner’s combination of Grady and
Ruchala is improper, and that objective indicia require a conclusion of
nonobviousness (which arguments, for the reasons discussed above, we find
unpersuasive), Patent Owner does not have any specific arguments refuting
Petitioner’s comparison of the combination to the requirements of these
claims.
Having considered both the evidence of obviousness and Patent
Owner’s submitted evidence of nonobviousness, and weighed the entirety of
the evidence, we determine that Petitioner has proved by a preponderance of
the evidence that claims 2–4, 7–8, 11–12, 17, 20, and 23 would have been
obvious over the combination of Grady and Ruchala.
F. Ground 2: Obviousness of Claims 9, 10, 13, 16, and 22
Over Grady, Ruchala, and Lam
Petitioner challenges claims 9, 10, 13, 16, and 22 as unpatentable
under pre-AIA 35 U.S.C. § 103(a) over the combination of Grady, Ruchala,
and Lam. Pet. 38–46.
Lam, titled “Computer Controlled Collimator Changer,” was filed
September 5, 1997 and issued August 31, 1999. Ex. 1013, codes (54), (22),
(45). Because Lam issued before the earliest priority date of the ’648 patent,
this reference is prior art to the ’648 patent under pre-AIA 35 U.S.C.
§ 102(a). Lam discloses controlling radiation doses from a linac mounted on
a gantry using a computer that controls the beam position and intensity, the
collimators that shape the beam, and the orientation and position of the
assembly supporting the patient. Ex. 1013, code (57), Fig. 4, 4:17–29, 53–
61.
IPR2019-01659
Patent 7,295,648 B2

42
Claims 9 and 10 depend from claim 1, and claims 13, 16, and 22
depend from claim 10, and add the limitations, respectively:
“the collimation of the radiation source is adjustable”
(claim 9);
“a control means for programmably controlling the
collimation of the radiation source in a manner correlated with a
movement of the radiation source” (claim 10);
“a patient table having a position which is adjustable under
the control of the control means, the control means being adapted
to adjust the position of the patient table in a manner correlated
with the movement of the radiation source” (claims 13 and 22);
“at least one rotation speed of the radiation source is
controllable by the control means, the control means being
adapted to adjust the at least one rotation speed in a manner
correlated with at least one of the movement of the radiation
source, the collimation of the radiation source, and the position
of a patient table” (claim 16).
Ex. 1001, 10:23–29, 10:36–41, 10:53–59, 12:3–9. Petitioner summarizes
these claims as “relating to adjustment of the collimation of the radiation,
and ‘a control means for programmably controlling’ the collimation of the
radiation source, position of the patient table, [and] rotation speed of the
rotation source in relation to various parameters.” Pet. 38–39. Petitioner
cites the admission in the ’648 patent that much of this claimed functionality
is commonplace and well known:
[T]he use of a linear accelerator allows dynamic changes to the
intensity of the beam or its temporary interruption. . . . it is well
known that to conform to irregular distributions of pathological
tissue that combinations of beams collimated to different sizes
are often required. As this device only has a single source a
programmable collimator such as a multileaf collimator or
selection of different sized collimators can be provided. The size
of the collimator can be programmed to change at certain times
in the treatment.
IPR2019-01659
Patent 7,295,648 B2

43
Pet. 39 (citing Ex. 1001, 8:1–17).
In support of the combination of Grady, Ruchala, and Lam, Petitioner
refers to its arguments discussed above for the combination of Grady and
Ruchala, and supplements them by arguing that a person of ordinary skill in
the art would have been further motivated to implement the computer
control of Lam, given that each of Lam, Grady, and Ruchala relate to the use
of radiation sources mounted on a gantry, that Ruchala discloses that the
treatment beam is modulated with collimators controlled by software, and
that Lam provides a more detailed teaching of such control. Pet. 42–43
(citing McCarthy Decl. ¶¶ 106–121, 132–144, 172–176; Ex. 1009, 1:23–37;
Ex. 1010, 3545, 3547, 3548, 3552; Ex. 1013, Fig. 4, 4:17–29, 53–61).
Other than arguing that Petitioner’s combination of Grady and
Ruchala is improper, and that objective indicia require a conclusion of
nonobviousness (which arguments, for the reasons discussed above, we find
unpersuasive), Patent Owner does not have any specific arguments refuting
Petitioner’s reliance on the combination of Grady, Ruchala, and Lam for this
ground. Accordingly, the preponderance of the evidence establishes that a
person of ordinary skill would have been motivated to combine Grady,
Ruchala, and Lam as argued by Petitioner.
For the claims 9 and 10, Petitioner relies on the disclosure in Lam of
the use of collimators to adjust the shale of the beam, controlled by a
computer as a function of beam position. Pet. 44 (citing Ex. 1013, 3:28–35,
5:35–39).
For claims 13, 16, and 22, Petitioner relies on the disclosure in Lam of
a computer that controls the beam position and intensity, the collimators that
shape the beam, and the orientation and position of the assembly supporting
IPR2019-01659
Patent 7,295,648 B2

44
the patient, with such adjustments correlated with each other. Pet. 44–46
(citing Ex. 1013, 4:53–61).
Other than arguing that Petitioner’s combination of Grady and
Ruchala is improper, and that objective indicia require a conclusion of
nonobviousness (which arguments, for the reasons discussed above, we find
unpersuasive), Patent Owner does not have any specific arguments refuting
Petitioner’s Ground 2 challenge.
Having considered both the evidence of obviousness and Patent
Owner’s submitted evidence of nonobviousness, and weighed the entirety of
the evidence, we determine that Petitioner has proved by a preponderance of
the evidence that claims 9, 10, 13, 16, and 22 would have been obvious over
the combination of Grady, Ruchala, and Lam.
G. Grounds 3 and 4: Obviousness of Claims 1–4, 7–8, 11–12, 17–18, 20,
and 23 Over Adler and Grady, and of Claims 9, 10, 13, 16,
and 22 Over Adler, Grady, and Lam
Petitioner challenges claims 1–4, 7–8, 11–12, 17–18, 20, and 23 as
unpatentable under pre-AIA 35 U.S.C. § 103(a) over the combination of
Adler and Grady, and of Claims 9, 10, 13, 16, and 22 Over Adler, Grady,
and Lam. Pet. 46–52.
Adler, titled “Apparatus For And Method Of Performing Stereotaxic
Surgery,” was filed October 19, 1990 and issued May 4, 1993. Ex. 1012,
codes (54), (22), (45). Because Adler issued before the earliest priority date
of the ’648 patent, this reference is prior art to the ’648 patent under pre-AIA
35 U.S.C. § 102(a). Adler discloses using a linac mounted on a robotic arm,
using collimators to treat tumors. Ex. 1012, 1:6–12. Figure 3 of Adler is
reproduced below.
IPR2019-01659
Patent 7,295,648 B2

45

Figure 3 depicts beaming apparatus 120 supported and positioned by
processor controllable robotic arm 46 which has six axes of motion to target
the patient from multiple angles. Id. at 7:66–8:4. A disclosed example of
apparatus 120 is a “relatively small size and relatively light weight” linac.
Id. at 6:65–67. The beam is collimated and focused on the target region,
controlled by a microprocessor. Id. at 8:26–31. Diagnostic x-ray beams 126
and 128 are directed at the target to generate images use to control the
treatment. Id. at 8:14–31.
Petitioner’s arguments in support of Grounds 3 and 4 are substantially
the same as its arguments for Grounds 1 and 2, except that the combinations
involve Adler in place of Ruchala, and the claim requirements argued to be
satisfied by Ruchala for Grounds 1 and 2 are argued to be satisfied by
corresponding disclosures in Adler for Grounds 3 and 4. Pet. 48–52.
IPR2019-01659
Patent 7,295,648 B2

46
Likewise, Patent Owner’s arguments refuting Petitioner’s Grounds 3 and 4
track those for Grounds 1 and 2. PO Resp. 41–44, 50–51.12
For substantially the same reasons as discussed above for Grounds 1
and 2, and having considered both the evidence of obviousness and Patent
Owner’s submitted evidence of nonobviousness, and weighed the entirety of
the evidence, we determine that Petitioner has proved by a preponderance of
the evidence that claims 1–4, 7–8, 11–12, 17–18, 20, and 23 would have
been obvious over the combination of Adler and Grady, and that claims 9,
10, 13, 16, and 22 would have been obvious over the combination of Adler,
Grady, and Lam.
H. Grounds 5 and 6: Obviousness of Claims 1–4, 7–8, 11–12, 17–18, 20,
and 23 Over Valentin and Roder, and of Claims 9, 10, 13, 16, and 22
Over Valentin, Roder, and Lam
Petitioner challenges claims 1–4, 7–8, 11–12, 17–18, 20, and 23 as
unpatentable under pre-AIA 35 U.S.C. § 103(a) over the combination of
Valentin and Roder, and claims 9, 10, 13, 16, and 22 over the combination
of Valentin, Roder, and Lam. Pet. 52–77.
Valentin, titled “Device For Stereotactic Radiotherapy,” was filed
August 8, 2000 and published February 22, 2001. Ex. 1014, codes (54),

12 Patent Owner also objects to the fact that Petitioner argues for Ground 3
both that it would have been obvious to place Adler’s LINAC in the Grady
device, and to place Grady’s gantry in the Adler device. Sur-Reply 22–23.
This objection is without merit. See In re Bush, 296 F.2d 491, 496 (CCPA
1961) (where obviousness “is predicated on two references each containing
pertinent disclosure . . . we deem it to be of no significance, but merely a
matter of exposition, that the rejection is stated to be on A in view of B
instead of on B in view of A, or to term one reference primary and the other
secondary”).

IPR2019-01659
Patent 7,295,648 B2

47
(22), (43). Because Valentin published before the earliest priority date of
the ’648 patent, this reference is prior art to the ’648 patent under pre-AIA
35 U.S.C. § 102(a). Figure 1 of Valentin is reproduced below.

Figure 1 depicts patient table 2 aligned along axis h, with the position of the
table remotely controlled “with micrometric precision.” Ex. 1014, 11–12.
Semicircular opening 3 is formed around transversal axis s. Id. Guide rail 4
is coaxial to opening 3, and carriage 5 is attached to guide rail 4 so that it
can move along the rail in a circular trajectory around axis S. Id. at 12.
Carriage 5 carries support arm 6 of head 7 and is pivotally mounted about
axis h which intersects the axis s. Id. Head 7 includes two radiation
sources, a collimated linac for treatment, and a low dose X-ray source for
imaging. Id. at 13. The point of intersection of the axes h and s is the
isocenter of the device. Id. at 12. The beams from head 7 are directed along
axis f which intersects the isocenter. Id. at 13.
Roder, titled “Apparatus For Examination Or Treatment Of A Patient
By Means Of Penetrating Radiation,” was filed June 9, 1983 and published
IPR2019-01659
Patent 7,295,648 B2

48
Dec. 13, 1984. Ex. 1015, codes (54), (22), (43). Because Roder published
before the earliest priority date of the ’648 patent, this reference is prior art
to the ’648 patent under pre-AIA 35 U.S.C. § 102(a). Figure 1 of Roder is
reproduced below.

Figure 1 shows adjustable patient table 11 centered within circular raceway
13 mounted within ring 14, within which raceway 13 can rotate. Id. at 5.
Radiation source 17 is attached to raceway 13. Id. at 6.
Petitioner admits that Valentin does not disclose a “ring-shaped
support,” as required by the claims, assuming that term is construed “to
require a full, 360-degree ring” (which as discussed above, is the
construction we adopt). Pet. 53. Under that assumption, Petitioner argues
one of ordinary skill would combine Valentin with Roder, modifying the
semicircular guide rail of Valentin to form a ring in the manner of the
circular raceway of Roder. Pet. 55–57. Petitioner argues that, given the
teachings of Roder, a person of ordinary skill would have recognized the
structural deficiencies of a C-shaped structure such as disclosed in Valentin,
and thus modified Valentin accordingly. Pet. 55–56 (citing Ex. 1015, 5:4–
16.) However, Petitioner recognizes that such modification would not work
IPR2019-01659
Patent 7,295,648 B2

49
if patient table 2 of Valentin remained aligned along axis h, and instead
argues the combination would be implemented to realign the table along
axis S. Pet. 56–57 (citing McCarthy Decl. ¶¶ 82, 165.)
Patent Owner argues that the proposed modification of the orientation
of the patient table would not have been adopted by a person of ordinary
skill in the art, because even with the modification the mobility of the head
around the patient would still be limited to the same extent as would have
been the case without the modification, and therefore one of ordinary skill
would have had no reason to make the modification that Petitioner urges.
PO Resp. 55–59 (citing Steidley Decl. ¶¶ 171–193; Steidley 2nd Decl. ¶¶
135–146).
Petitioner does not respond to this argument in the Reply, and based
on our review of the record we agree with Patent Owner’s arguments.
Therefore, we determine Petitioner has not established by a preponderance
of the evidence that a person of ordinary skill in the art would have been
motivated to combine the teachings of Valentin and Roder as proposed by
Petitioner. In particular, the alignment of the patient table in Valentin,
whether or not rearranged, is incompatible with a ring-shaped support.
Accordingly, we determine that Petitioner has not demonstrated by a
preponderance of the evidence that claims 1–4, 7–8, 11–12, 17–18, 20, and
23 would have been obvious over the combination of Valentin and Roder.
The addition of Lam to the combination does not remedy the deficiencies
discussed above, and accordingly we also determine that Petitioner has not
demonstrated by a preponderance of the evidence that claims 9, 10, 13, 16,
and 22 would have been obvious over the combination of Valentin, Roder,
and Lam.
IPR2019-01659
Patent 7,295,648 B2

50
IV. REVISED MOTION TO AMEND
Because we conclude that all of the challenged claims are
unpatentable, we consider Patent Owner’s Revised Motion to Amend. See
RMTA 1 (stating that “[i]f the Board finds independent claim 1 and/or 18
unpatentable, Elekta requests that the Board grant this revised Motion to
Amend and issue the appropriate corresponding substitute claims as
presented herein”).
“Before considering the patentability of any substitute claims, . . . the
Board first must determine whether the motion to amend meets the statutory
and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R.
§ 42.121.” Lectrosonics, Paper 15 at 4 (PTAB Feb. 25, 2019) (precedential).
Accordingly, a patent owner must provide a claim listing reproducing each
proposed substitute claim, and must make an initial showing to demonstrate
the following: (1) the amendment proposes a reasonable number of
substitute claims; (2) the proposed claims are supported in the original
disclosure (and any earlier filed disclosure for which the benefit of the
earlier filing date is sought); (3) the amendment responds to a ground of
unpatentability involved in the trial; and (4) the amendment does not seek to
enlarge the scope of the claims of the patent or introduce new subject matter.
See 35 U.S.C. § 326(d); 37 C.F.R. § 42.121.
The Board also must assess the patentability of proposed substitute
claims “without placing the burden of persuasion on the patent owner.”
Aqua Prods., 872 F.3d at 1328; see Lectrosonics, Paper 15 at 3‒4
(discussing Aqua Products and the burden of persuasion). After Aqua
Products, the Federal Circuit further clarified the burden of persuasion in
Bosch Automotive Service Solutions, LLC v. Matal, 878 F.3d 1027 (Fed. Cir.
IPR2019-01659
Patent 7,295,648 B2

51
2017), amended by Bosch Automotive Service Solutions, LLC v. Iancu,
No. 2015-1928 (Fed. Cir. Mar. 15, 2018). According to Aqua Products,
Bosch, and Lectrosonics, a patent owner does not bear the burden of
persuasion to show that the proposed substitute claims are patentable.
Rather, ordinarily “the petitioner bears the burden of proving that the
proposed amended claims are unpatentable by a preponderance of the
evidence.” Bosch, 878 F.3d at 1040 (as amended on rehearing);
Lectrosonics, Paper 15 at 3–4. To determine whether a petitioner has proven
the substitute claims are unpatentable, the Board focuses on “arguments and
theories raised by the petitioner in its petition or opposition to the motion to
amend.” Nike, Inc. v. Adidas AG, 955 F.3d 45, 51 (Fed. Cir. 2020). The
Board itself also may justify any finding of unpatentability by referring to
evidence of record in the proceeding. Lectrosonics, Paper 15 at 4 (citing
Aqua Products, 872 F.3d at 1311 (O’Malley, J.)).
A. Proposed Substitute Claims
Patent Owner proposes a set of substitute claims in one-to-one
correspondence with the set of original claims. RMTA App’x A. That is,
proposed claim 24 substitutes for original claim 1; proposed claim 25
substitutes for original claim 4; proposed claim 26 substitutes for original
claim 3; proposed claim 27 substitutes for original claim 2; proposed claims
28–34 substitute for original claims 7–13, respectively; proposed claims 35–
37 substitute for original claims 16–18, respectively; proposed claim 38
substitutes for original claim 20; and proposed claims 39 and 40 substitute
IPR2019-01659
Patent 7,295,648 B2

52
for original claims 22 and 23, respectively.13 Id. Of the proposed substitute
claims, claims 24 and 37 are independent. Id.
Proposed substitute claim 24 is illustrative, and is reproduced below
with underlining to indicate text added to original claim 1 and strike-outs to
indicate text removed from original claim 1.
24. A device for treating a patient with ionising radiation
comprising:
a ring-shaped support, on which is provided a mount,
a therapeutic radiation source attached to the mount to
provide the ionizing radiation to treat the patient;
the ring-shaped support being rotateable about an axis a
support axis, the support axis being coincident with the centre
of the ring ring-shaped support;
the therapeutic radiation source being attached to the
mount via a rotateable union having a an axis of rotation axis
which is non-parallel to the support axis;
wherein the rotation axis of the mount passes through the
support axis of the support and the therapeutic radiation source
is collimated so as to produce a therapeutic beam which passes
through the co-incidence of the rotation and support axes to
treat the patient with the ionising radiation.
RMTA App’x 1.
Patent Owner submits that, given that there is a one-to-one
correspondence between the challenged claims and the proposed substitute
claims, its proposal is presumptively reasonable. RMTA 3 (citing 37 C.F.R.
§ 42.121(a)(3); Lectrosonics, IPR2018-01129, Paper 33 at 45).

13 In the Appendix, proposed substitute claim 25 is worded as a substitute for
claim 2. RMTA App’x A, 1. At the hearing, Patent Owner corrected that to
refer to claim 4. Paper 47, 31:23–32:10. We accept that correction.
IPR2019-01659
Patent 7,295,648 B2

53
Petitioner disagrees as to proposed substitute claims 32 and 33,
arguing that in effect, “Patent Owner both cancels claim 12 by striking its
original limitation and amending it to be substitute claim 33 while also
amending claim 11 in order to recreate and retain claim 12 as substitute
claim 32.” Opp. RMTA 2. Petitioner argues “this results in an unreasonable
number of proposed substitute claims.” Id.
However, because proposed substitute claim 32 depends from
proposed substitute claim 25 rather than challenged claim 1, it is not a
recreated version of claim 12. See Reply RMTA 16. We agree with Patent
Owner that because there is only one proposed substitute claim per original
challenged claim, Patent Owner proposes a reasonable number of substitute
claims.
B. Support for Proposed Substitute Claims
New subject matter is any addition to the claims that lacks sufficient
support in the subject patent’s original disclosure. See TurboCare Div. of
Demag Delaval Turbomach. v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed.
Cir. 2001) (“When [an] applicant adds a claim . . . , the new claim[] must . . .
find support in the original specification.”). The Board requires that a patent
owner show in a motion to amend that there is written-description support in
the originally filed disclosure of the subject patent for each proposed
substitute claim, and also set forth support in an earlier-filed disclosure for
each claim for which the patent owner seeks the benefit of the earlier-filed
disclosure’s filing date. See 37 C.F.R. §§ 42.121(b)(1), 42.121(b)(2).
To support its contention that the proposed substitute claims have
sufficient support, Patent Owner provides a chart that identifies support for
the proposed substitute claims in the ’648 Patent. RMTA 6–17. Patent
IPR2019-01659
Patent 7,295,648 B2

54
Owner submits that a “person of ordinary skill in the art . . . would
understand the ’648 Patent and its corresponding application ‘as describing
with sufficient particularity the material to be incorporated.’”14 RMTA 17.
Petitioner contends that the original ’648 disclosure does not support
proposed substitute claim 34’s requirement of “a shielding enclosure which
encloses at least the linear accelerator, the collimator, and the beam stop.”
Opp. RMTA 3–4. As support for this limitation, Patent Owner cites the
following disclosure in the ’648 patent:
[A] shielding can be provided more easily and more
inexpensively since only the main source needs to be shielded as
opposed to the shielding of a large number of sources. This
shielding is achieved by the enclosure 34, the beam stop 42 and
the collimator 43 which will be formed of a material which is
generally radiopaque so as to limit unnecessary exposure of staff
and patients outside the device. The weight of such a reduced
amount of shielding will also be significantly less.
RMTA 13–14 (citing Ex. 1001 at 7:59–67) (emphasis supplied). This is
illustrated in Figure 9 of the ’648 patent set forth below.

14 Our review of the prosecution history of the ’648 patent indicates that
there were no substantive amendments to the specification during
prosecution. Ex. 1002. In this particular instance, we deem that fact that
Patent Owner does not explicitly compare the proposed substitute claims to
the October 21, 2004 application to be harmless error.
IPR2019-01659
Patent 7,295,648 B2

55

Figure 9 is a view of the radiation treatment device showing the general
geometry of the device relative to patient 18, including linac 44 with
enclosure 34, beam stop 42 and collimator 43. Ex. 1001, Figs. 9, 12–15,
7:59–66, 8:53–60.
Petitioner argues that enclosure 34 “does not ‘enclose’ the linear
accelerator, collimator and beam stop.” Opp. RMTA 4 (citing McCarthy
RMTA Decl. ¶ 84). Indeed, as shown in Figure 9, as well as Figures 12–15,
enclosure 34 at most encloses the linac. Confirming this, the ’648 patent
emphasizes that this arrangement reduces the amount of shielding to
minimize the weight of the apparatus. Ex. 1001, 7:62–67, 8:58–60.
In response, Patent Owner asserts that, according to Figures 5–10 of
the ’648 patent, linac housing 34 surrounds the linac, beam stop, and
collimator. Reply RMTA 17. However, that statement is not supported by
the above-cited figures and excerpts from the specification, which explicitly
differentiates between “enclosure 34,” versus “beam stop 42” and
IPR2019-01659
Patent 7,295,648 B2

56
“collimator 43.” Ex. 1001, 7:62–63. The only “enclosure” disclosed in the
’648 patent that encloses a larger area of the device is specifically described
as “radio-transparent so as to allow transmission of the therapeutic beam into
the enclosure,” and thus is not part of any shielding. Id. at Fig.3, 6:56–64.
Therefore, we agree with Petitioner that proposed substitute claim 34
is not supported by the original disclosure. Petitioner does not raise
disclosure issues as to the other proposed substitute claims, and based on our
review of the record, we conclude that Patent Owner has made a sufficient
showing that identifies adequate written-description support for the
remaining proposed substitute claims.
C. Responsiveness to a Ground of Unpatentability Involved in the Trial
Patent Owner submits that each proposed substitute claim is
responsive to one or more grounds of patentability raised for independent
claims 1 and 18. RMTA 3 (citing 37 C.F.R. § 42.121(a)(2)(i)). In
particular, Patent Owner’s proposed substitute independent claims 24 and 37
add a requirements for use of therapeutic radiation source for treating a
patient with ionizing radiation, in order to render moot any argument that the
preambles are not limiting, and in an attempt to further distinguish the
asserted combination involving Grady. Reply RMTA 3.
Patent Owner also includes: (i) in proposed substitute claims 25 and
40, a limitation requiring “a single isocentre at a plurality of approach angles
relative to the patient,” with the location of one axis “fixed relative to” the
other; (ii) in proposed substitute claims 26 and 39, a limitation specifying
“the radiation source is moveable” or “causing rotation of the therapeutic
radiation source,” with a requirement “to achieve a greater dosage of
therapeutic radiation at the isocentre than around the isocentre to treat the
IPR2019-01659
Patent 7,295,648 B2

57
patient”; (iii) in proposed substitute claim 27, a limitation requiring “the
therapeutic radiation source is rotateable about the rotation axis”; and (iv) in
proposed substitute claims 29 and 33–35, various limitations requiring
shielding and a shielding enclosure. RMTA 4–5. Patent Owner asserts
these amendments further distinguish the asserted combination involving
Grady. Id. In addition, the proposed substitute claims include clarifying
amendments and amendments to provide appropriate antecedents.15 Id.
Petitioner alleges that proposed substitute claims 32 and 33 do not
respond to any ground of unpatentability, arguing that substitute claim 32
would be of identical scope to claim 12. Opp. RMTA 2. However, as
discussed above in addressing Petitioner’s argument that Patent Owner does
not propose a reasonable number of substitute claims, this argument fails
because proposed substitute claim 32 depends from proposed substitute
claim 25, rather than from claim 1, and proposed substitute claim 25 has
different limitations than claim 1. Petitioner does not make this assertion for
any of the other proposed substitute claims. Accordingly, we conclude that

15 It is not required “that every word added to or removed from a claim in a
motion to amend be solely for the purpose of overcoming an instituted
ground.” Lectrosonics, Paper 15 at 5. Even though challenges for inter
partes reviews may be based only on “ground[s] that could be raised under
section 102 or 103,” a patent owner “also may include additional limitations
[in proposing a claim amendment] to address potential § 101 or § 112
issues” once the proposed claim “includes amendments to address a prior art
ground in the trial.” 35 U.S.C. § 311(b); Lectrosonics, Paper 15 at 6.
“Allowing an amendment to address such issues . . . serves the public
interest by helping to ensure the patentability of amended claims.”
Lectrosonics, Paper 15 at 6 (citing Veeam Software Corp. v. Veritas Techs.,
LLC, IPR2014-00090, Paper 48 at 26–29 (PTAB July 17, 2017)).
IPR2019-01659
Patent 7,295,648 B2

58
Patent Owner has made a sufficient showing that the proposed amendments
are responsive to a ground of unpatentability involved in the trial.
D. Scope of Proposed Substitute Claims
Patent Owner submits that none of the proposed substitute claims
seeks to enlarge the scope of the original patent claims. RMTA 5 (citing
37 C.F.R. § 42.121(a)(2)(ii)). However, Petitioner argues proposed
substitute claim 24 broadens the scope of challenged claim 1 by eliminating
the “ring” limitation from the claims. Opp. RMTA 3. Given that proposed
substitute claims 25–34 and 36, depend from claim 24, Petitioner argues that
those claims also enlarge the scope of the claims. Id.
Comparing challenged claim 1 to proposed substitute claim 24, and
considering the claims as a whole, we conclude that amending “ring” to
“ring-shaped support” is clarifying, by providing a clear antecedent
relationship to the previous occurrence of that phrase, rather than
broadening. See Reply RMTA 16. Therefore, based on our review of the
record we conclude that Patent Owner has made a sufficient showing that
the proposed substitute claims do not enlarge the scope of the claims.
E. Patentability of the Proposed Substitute Claims
1. Obviousness of proposed substitute Claims 24 and 37 over the
combination of Grady and Ruchala and of Grady and Adler
Petitioner argues that proposed substitute claims 24 and 37 are
obvious over the combination of Grady with Ruchala or Adler. Opp. RMTA
5–8. As Petitioner points out, the amended claims make “treatment . . . with
ionizing radiation” an express limitation as opposed to part of the preamble,
and require the radiation source to be “therapeutic.” Id. Petitioner submits
that its arguments and evidence for obviousness of challenged claims 1
and 18 apply equally to proposed substitute claims 24 and 37. Id. Petitioner
IPR2019-01659
Patent 7,295,648 B2

59
argues that, although Grady discloses an imaging radiation source rather
than a therapeutic source, and does not treat a patient, but rather is used for
imaging, the combination of Grady with Ruchala or Adler does meet those
requirements, because the latter two references disclose therapeutic
treatment with ionizing radiation. Id.
Patent Owner responds with, in substance, the same arguments and
evidence that it offers for the original invalidity Grounds 1–4 raised in the
Petition. RMTA 18–19; Reply RMTA 2–5. As argued against Grounds 1–
4, Patent Owner points out that Grady only discloses the use of radiation for
imaging, that it entails much different requirements for voltages and
precision compared with therapeutic radiation devices, and that linacs used
for therapeutic treatment are heavier than X-ray sources and impose much
more rigorous safety and treatment concerns. Id. As discussed in
connection with Grounds 1–4 asserted against the challenged original
claims, we are not persuaded by these arguments, and in particular reject the
assertion that a person of ordinary skill would not have considered the three-
dimensional manipulation capabilities of Grady as applicable to radiation
therapy devices such as disclosed in Ruchala or Adler. We therefore have
determined that the preponderance of the evidence supports the asserted
combination of Grady with Ruchala or Adler, and that those combinations
render obvious claims 1 and 18, and those determinations apply equally to
our consideration of proposed substitute claims 24 and 37.
Patent Owner asserts that Petitioner “does not identify a prior art
device having the features of claim 24 that acts ‘to treat the patient with the
ionising radiation,’ or a method ‘to treat the patient’ with a device as recited
in claim 37.” Reply RMTA 3. However, as we determined for Grounds
IPR2019-01659
Patent 7,295,648 B2

60
1 and 3 (Sections III.E, III.G above), Ruchala and Adler disclose linacs that
treat patients with ionising radiation, and the combination of Grady with
Ruchala or Adler satisfy the additional requirements of claims 1 and 18 that
are common to proposed substitute claims 24 and 37. See Sur-Reply
RMTA 2–6.
Therefore, having considered both the evidence of obviousness and
Patent Owner’s submitted evidence of nonobviousness, and weighed the
entirety of the evidence, we determine that Petitioner has proved by a
preponderance of the evidence that proposed substitute claims 24 and 37
would have been obvious over the combination of Grady and Ruchala, and
also would have been obvious over the combination of Adler and Grady.
2. Obviousness of proposed substitute Claims 24 and 37 over the
combination of Lajus and Ruchala and of Lajus and Adler
In the alternative, Petitioner argues that proposed substitute claims 24
and 37 are obvious over the combination of Lajus with Ruchala or Adler.
Opp. RMTA 5–8.
Lajus, titled “Radiological Examination Apparatus,” was filed July 6,
1980 and issued June 13, 1972. Ex. 1022, codes (54), (22), (45). Because
Lajus issued before the earliest priority date of the ’648 patent, this reference
is prior art to the ’648 patent under pre-AIA 35 U.S.C. § 102(a). Figure 1 of
Lajus is reproduced below.
IPR2019-01659
Patent 7,295,648 B2

61

Figure 1 is a front view of the apparatus, depicting patient P positioned so
that his head is at point O, in the path of an X-ray beam passing form X-ray
source 2 to X-ray image pickup 3. Ex. 1022, 1:66–75. The X-ray devices
are supported on carrying arm 1, which rotates about shaft axis 4. Id. at 2:2–
5. Shaft 4 is mounted in gimbal 5, which rotates about an axis defined by
shafts 6. Id. at 2:5–8. Shafts 6 are mounted on arms 10, which in turn are
mounted on ring-shaped support 9. Id. at 2:9–11. Ring 9 rotates in the
vertical plane about an axis passing through point O. Id. at 2:33–42. Point
O defines the intersection of axis 4 and the axis defined by shafts 6. Id. at
2:11–15.
Petitioner argues that Lajus serves essentially the same role in the
patentability analysis as Grady, disclosing a gantry arrangement including a
ring shaped support (ring 9) which rotates about an axis, a mount attached to
the ring shaped support (arms 10), an X-ray source attached to the mount via
IPR2019-01659
Patent 7,295,648 B2

62
a rotatable union (shafts 6), each of these components having the same
physical relationships as Grady. Opp. RMTA 8–10 (citing Paper 18, 14–19;
McCarthy Suppl. Decl. ¶¶ 37–44). Petitioner marshals essentially the same
rationale for why a person of ordinary skill would have combined Lajus with
Ruchala or Adler, and thus arrived at the subject matter of proposed
substitute claims 24 and 37. Id.; see also Sur-Reply RMTA 9.
Similarly, Patent Owner’s arguments challenging the combination of
Lajus with Ruchala or Adler are for the most part essentially the same as for
the Grady/Ruchala and Grady/Adler combinations. RMTA 18–19; Reply
RMTA 6–7. Additional arguments raised by Patent Owner are that Lajus’
patient support apparatus 7 can be rotated in the vertical plane, which would
be undesirable for radiation therapy, and that the X-Ray source is not
attached to the mount, but rather attached to carrying arm 1. Reply
RMTA 6. In response, Petitioner cites evidence that the ability to move the
patient during radiation treatment was an acceptable practice, and argues that
the additional degree of freedom introduced by axis of rotation 4 is not
excluded by the claims. Sur-Reply RMTA 9–10.
We agree with Petitioner’s analysis for the same reasons as discussed
above in connection with Grounds 1–4, and we agree that Patent Owner’s
additional arguments are unpersuasive for the reasons stated by Petitioner.
Therefore, having considered both the evidence of obviousness and Patent
Owner’s submitted evidence of nonobviousness, and weighed the entirety of
the evidence, we determine that Petitioner has proved by a preponderance of
the evidence that proposed substitute claims 24 and 37 would have been
IPR2019-01659
Patent 7,295,648 B2

63
obvious over the combination of Lajus and Ruchala, and also would have
been obvious over the combination of Lajus and Adler.16
3. Proposed Substitute Claims 25, 26, 39, and 40
Proposed substitute claim 25 depends from independent proposed
substitute 24 and additionally requires “the rotation axis is fixed relative to
the support axis, and the therapeutic beam, the rotation axis, and the support
axis are co-incident at a single isocentre for a plurality of approach angles of
the therapeutic beam relative to the patient.” RMTA App’x 1. Proposed
substitute claim 26 depends from claim 25 and additionally requires “the
therapeutic radiation source is movable to provide the therapeutic beam at
the plurality of approach angles relative to the patient to achieve a greater
dosage of therapeutic radiation at the isocentre than around the isocentre to
treat the patient with the ionising radiation.” Id.
Proposed substitute claim 39 depends from independent proposed
substitute claim 37, and additionally requires “causing rotation of the
therapeutic radiation source about the two axes provides the therapeutic
beam at a plurality of approach angles relative to the patient to treat the
patient with the therapeutic beam.” RMTA App’x 4. Proposed substitute
claim 40 depends from claim 39 and additionally requires “the therapeutic
beam and the two axes are co-incident at a single isocentre for the plurality

16 Petitioner also argues additional combinations of references render
obvious proposed substitute claims 24 and 37 — viz., (i) Grady and Ruchala
further in view of Lajus; (ii) Adler and Grady further in view of Lajus;
(iii) Brown (Ex. 1023) and Lajus; and (iv) Nafstadius (Ex. 1037). Opp.
RMTA 8–13. Given our determination regarding the combinations
involving Grady, Lajus, Ruchala, and Adler, it is unnecessary to consider
these alternative arguments.
IPR2019-01659
Patent 7,295,648 B2

64
of approach angles, the location of one of the two axes being fixed relative
to the location of the other of the two axes.” Id.
Petitioner relies, inter alia, on the combination of Lajus and Ruchala
or Lajus and Adler as rendering these claims obvious. In addition to
rendering obvious the limitations of proposed substitute claims 24 and 37,
discussed above, Petitioner argues that the combination of Lajus with
Ruchala or Adler would have taught all the additional limitations of these
proposed substitute claims. Opp. RMTA 13–17. In particular, Petitioner
relies on Lajus as disclosing: (i) for proposed substitute claims 25 and 40,
that the rotation axis is fixed relative to the support axis, and the radiation
beam, the rotation axis, and the support axis are co-incident at a single
isocentre for a plurality of approach angles; and (ii) for proposed substitute
claims 26 and 39, that the radiation source is movable, or can be rotated
about the two axes, to provide the beam at the plurality of approach angles.
Id. Petitioner additionally relies on the teachings of Ruchala and Adler for
the claim requirements of treating a patient with a therapeutic beam, which
is manipulated to achieve a greater dosage of therapeutic radiation at the
isocentre than around the isocentre. Id.
For example, Petitioner cites Ruchala’s teaching that “a highly
conformal treatment that will deliver dose to the tumour while sparing
sensitive structures” and Adler’s teaching of selective irradiation of the
target region where the collimated beam is “continuously focused on the
target region while the healthy tissue through which the collimated beam
passes is changed.” Opp. RMTA 16 (citing Ex. 1010, 3545; Ex. 1012, 7:54–
57).
IPR2019-01659
Patent 7,295,648 B2

65
Patent Owner repeats its arguments that Lajus is confined to radiation
imaging and that one of ordinary skill would not have been motivated to
apply the three-dimensional rotation capabilities of that reference to the
therapeutic applications described in Ruchala and Adler. Reply RMTA 6–7.
As discussed above, we are not persuaded by these arguments. In addition,
Patent Owner argues that Petitioner has failed to address the requirement of
proposed substitute claim 25 that the “rotation axis is fixed relative to the
support axis,” and the commensurate requirement of proposed substitute
claim 40. Id. at 12. To the contrary, Petitioner cites to Lajus as disclosing
this aspect of the claims, and our review of that reference confirms that
Lajus discloses the fixed axes relationship.17 Ex. 1022, Figs. 1, 2; Opp.
RMTA 13–14; Sur-Reply RMTA 14.
Therefore, having considered both the evidence of obviousness and
Patent Owner’s submitted evidence of nonobviousness, and weighed the
entirety of the evidence, we determine that Petitioner has proved by a
preponderance of the evidence that proposed substitute claims 25, 26, 39,
and 40 would have been obvious over the combination of Lajus and
Ruchala, and also would have been obvious over the combination of Lajus
and Adler.
4. Proposed Substitute Claim 27
Proposed substitute claim 27 depends from proposed substitute claim
24, and additionally requires “the therapeutic radiation source is attached to
the mount such that the therapeutic radiation source is rotateable about the

17 Petitioner also argues that the fixed axes requirement of proposed
substitute claim 25 would have been obvious over the combination of Grady
and Ruchala or Adler. Opp. RMTA 13–14. We need not consider that
argument, given our determination with respect to Lajus.
IPR2019-01659
Patent 7,295,648 B2

66
rotation axis.” RMTA App’x 2. Petitioner cites the fact that the radiation
source of Grady is attached to carriage 10, which rotates about axis A2, and
relies on the combination of Grady with Ruchala or Adler to teach the use of
a therapeutic radiation source. Opp. RMTA 18. Petitioner propounds
similar arguments relying on the combination of Lajus with Ruchala or
Adler. Id.
In this context, Patent Owner raises the issue, discussed above,
regarding the construction of rotateable union. RMTA 22–23. However,
Patent Owner’s only substantive argument addressing obviousness of
proposed substitute claim 27 is a reiteration of its arguments that Grady and
Lajus are not therapeutic devices and that one of ordinary skill would not
have been motivated to combine Grady or Lajus with Ruchala or Adler. Id.
For the reasons discussed above, we are not persuaded by these
arguments. Therefore, having considered both the evidence of obviousness
and Patent Owner’s submitted evidence of nonobviousness, and weighed the
entirety of the evidence, we determine that Petitioner has proved by a
preponderance of the evidence that proposed substitute claim 27 would have
been obvious over the combination of Grady and Ruchala, Grady and Adler,
Lajus and Ruchala, and Lajus and Adler.
5. Proposed Substitute Claims 33 and 35
Proposed substitute claim 33 depends from proposed substitute claim
29, and additionally requires “collimator, a beam stop, and shielding, the
linear accelerator, the collimator, the beam stop, and the shielding forming a
linear accelerator structure, the linear accelerator structure being attached to
the mount via the rotateable union.” RMTA App’x 2. Proposed substitute
IPR2019-01659
Patent 7,295,648 B2

67
claim 35, which depends from proposed substitute claim 37, adds a
commensurate requirement. RMTA App’x 3.
Petitioner contends that these limitations would have been obvious
over the combination of Grady with Ruchala or Adler, and in particular that
one of ordinary skill would have known that shielding material is necessary
when treating a patient with a linac, and would also have known that beam
stops would be part of such devices. Opp. RMTA 19–21. Again, Patent
Owner relies on the arguments that Grady and Lajus are not therapeutic
devices, and that one of ordinary skill would not have been motivated to
combine Grady or Lajus with Ruchala or Adler. Reply RMTA 14.
For the reasons discussed above, we are not persuaded by these
arguments. Therefore, having considered both the evidence of obviousness
and Patent Owner’s submitted evidence of nonobviousness, and weighed the
entirety of the evidence, we determine that Petitioner has proved by a
preponderance of the evidence that proposed substitute claims 33 and 35
would have been obvious over the combination of Grady and Ruchala,
Grady and Adler, Lajus and Ruchala, and Lajus and Adler.18
6. Proposed Substitute Claims 28–32, 36, and 38
Proposed substitute claims 28–32, 36, and 38 depend from one of the
proposed substitute claims discussed above. RMTA App’x 2–3. These
claims raise no additional issues that have not been resolved in the above

18 Proposed substitute claim 34 depends from claim 33, and additionally
requires “a shielding enclosure which encloses at least the linear accelerator,
the collimator, and the beam stop.” RMTA App’x 2. As discussed above,
we have determined that this claim is not supported by the original
disclosure of the ’648 patent. Therefore, it is not necessary to consider
Petitioner’s invalidity arguments with respect to this claim.
IPR2019-01659
Patent 7,295,648 B2

68
analyses of the claims from which they depend, or in connection with our
analysis of Grounds 1–4. RMTA 25; Opp. RMTA 24–25. Therefore,
having considered both the evidence of obviousness and Patent Owner’s
submitted evidence of nonobviousness, and weighed the entirety of the
evidence, we determine that Petitioner has proved by a preponderance of the
evidence that proposed substitute claims 28–32, 36, and 38 would have been
obvious over the combination of Lajus and Ruchala, and also would have
been obvious over the combination of Lajus and Adler.
Also, proposed substitute claims 30, 36 and 38 do not depend from
claim 25, and therefore do not require the fixed axes relationship of that
claim. Therefore, we determine that Petitioner has proved by a
preponderance of the evidence that claims 30, 36 and 38 would have been
obvious over the combination of Grady and Ruchala, and also would have
been obvious over the combination of Grady and Adler.
F. Summary
Because we have determined that Patent Owner has not demonstrated
that proposed substitute claim 34 is supported by the original disclosure, and
because Petitioner has demonstrated by a preponderance of the evidence that
proposed substitute claims 24–33 and 35–40 are unpatentable, we deny
Patent Owner’s revised motion to amend.
V. PATENT OWNER’S MOTION TO EXCLUDE
Patent Owner requests that we exclude portions of Dr. McCarthy’s
testimony in support of Petitioner’s opposition to the revised motion to
amend, set forth in his declarations filed as Exhibits 1026 and 1036. Paper
37, 1. As discussed above, Patent Owner argues that Dr. McCarthy is not
IPR2019-01659
Patent 7,295,648 B2

69
qualified as an expert in this case, because he has not had sufficient
experience with radiation imaging and treatment devices. Id. at 4–8.
For the reasons discussed above, we are not persuaded that Dr.
McCarthy is unqualified to render opinions in this case. To be qualified as
an expert, Dr. McCarthy does not necessarily need to be a person of ordinary
skill in the art as to the precise subject matter of the patent at issue. Rather,
a witness may qualify as an expert if he or she has “knowledge, skill,
experience, training, or education” of a “scientific, technical, or other
specialized” nature that is likely to help the Board “to understand the
evidence or to determine a fact in issue.” Fed. R. Evid. 702; see also PTAB
Consolidated Trial Practice Guide, 34 (Nov. 2019), https://go.usa.gov/xpvPF
(“CTPG”) (“There is . . . no requirement of a perfect match between the
expert’s experience and the relevant field.” (citing SEB S.A. v. Montgomery
Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010))).
We consider the admissibility of Dr. McCarthy’s testimony in light of
this standard. We have found Dr. McCarthy’s testimony helpful, and deny
Patent Owner’s motion to exclude it.
Patent Owner also moves to exclude references — Exhibit 1022
(Lajus), Exhibit 1023 (Brown), and Exhibit 1037 (Nafstadius) — submitted
by Petitioner in opposition to the revised motion to amend, on the ground
that those references are not responsive to the proposed amendments, but
rather are submitted as alternative grounds of unpatentability of the
originally challenged claims. Paper 37, 1–2. With respect to Brown and
Nafstadius, we have not considered these references in our analysis, and
therefore the motion to exclude is moot. We have considered Lajus in
connection with the new fixed axes relationship requirement introduced by
IPR2019-01659
Patent 7,295,648 B2

70
proposed substitute claims 25 and 40. Therefore, Patent Owner’s premise
that Lajus is not directed to the proposed amendments is without merit.
Accordingly, we deny Patent Owner’s Motion to Exclude.
VI. CONCLUSION19
For the reasons above, Petitioner has shown by a preponderance of the
evidence that claims 1–4, 7–13, 16–18, 20, 22, and 23 of the ’648 patent are
unpatentable, as summarized in the following table.
Claims 35 U.S.C. § References/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1–4, 7–8, 11,
12, 17, 18,
20, 23
103(a) Grady,
Ruchala
1–4, 7–8, 11,
12, 17, 18, 20,
23

9, 10, 13, 16,
22
103(a) Grady,
Ruchala,
Lam
9, 10, 13, 16,
22

1–4, 7–8, 11,
12, 17, 18,
20, 23
103(a) Adler, Grady 1–4, 7–8, 11,
12, 17, 18, 20,
23

9, 10, 13, 16,
22
103(a) Adler,
Grady, Lam
9, 10, 13, 16,
22

1–4, 7–8, 11,
12, 17, 18,
20, 23
103(a) Valentin,
Roder
1–4, 7–8, 11,
12, 17, 18, 20,
23
9, 10, 13, 16, 103(a) Valentin, 9, 10, 13, 16,

19 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
IPR2019-01659
Patent 7,295,648 B2

71
Claims 35 U.S.C. § References/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
22 Roder, Lam 22
Overall
Outcome
1–4, 7–13,
16–18, 20, 22,
23

The table below summarizes our conclusions as to Patent Owner’s
Revised Motion to Amend the claims.
Motion to Amend Outcome Claims
Original Claims Canceled by Amendment
Substitute Claims Proposed in the Amendment 24–40
Substitute Claims: Motion to Amend Granted
Substitute Claims: Motion to Amend Denied 24–40
Substitute Claims: Not Reached

VII. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that, based on a preponderance of the evidence, claims 1–
4, 7–13, 16–18, 20, 22, and 23 of U.S. Patent No. 7,295,648 B2 are held to
be unpatentable;
FURTHER ORDERED that Patent Owner’s Revised Motion to
Amend (Paper 24) is denied;
FURTHER ORDERED that Patent Owner’s Motion to Exclude
(Paper 25) is denied; and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of our decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

IPR2019-01659
Patent 7,295,648 B2

72
PETITIONER
James Isbester
John Alemanni
KILPATRICK TOWNSEND & STOCKTON LLP
jisbester@kilpatricktownsend.com
jalemanni@kilpatricktownsend.com

PATENT OWNER

Frank Bernstein
Tamara Fraizer
David Prueter
SQUIRE PATTON BOGGS
Frank.bernstein@squirepb.com
Tamara.fraizer@squirepb.com
David.prueter@squirepb.com