TRUINJECT Corp.

Patent Trials and Appeals Board

Nov 15, 2021

IPR2020-00935 (P.T.A.B. Nov. 15, 2021)

trials@uspto.gov Paper 30
571-272-7822 Date: November 15, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

SHDS, INC. and GALDERMA LABORATORIES, L.P.,
Petitioner,

v.

TRUINJECT CORP.,
Patent Owner.
____________

IPR2020-00935
Patent 10,290,231 B2
____________

Before JOSIAH C. COCKS, MITCHELL G. WEATHERLY, and
JAMES J. MAYBERRY, Administrative Patent Judges.

COCKS, Administrative Patent Judge.

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

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I. INTRODUCTION
A. Background
SHDS, Inc. and Galderma Laboratories, L.P. (collectively
“Petitioner”) filed a Petition (Paper 1, “Pet.”) to institute inter partes review
of claims 1, 3, 4, 6, 10–12, 15–19, and 21–24 (“the challenged claims”) of
U.S. Patent No. 10, 290,231 B2 (Ex. 1001, “the ’231 patent”).1 See
35 U.S.C. § 311 (2018). We instituted trial to determine whether the
challenged claims were unpatentable as follows:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1, 3, 4, 6, 10, 11, 15, 17, 18,
21–24
103 Samosky,2 Mukherjee
2014,3 Mukherjee 20124,5
12 103 Samosky, Mukherjee 2014,
Mukherjee 2012, Toly6

1 Petitioner relies on the Declaration of Biswarup Mukherjee, Ph.D. (Ex.
1002) in support of the Petition.
2 U.S. Patent Application Publication No. 2013/0323700 A1 published Dec.
5, 2013 (Ex. 1004, “Samosky”).
3 B. Mukherjee; B. George; M. Sivapraksam, An Opthamalic Anesthesia
Training System Using Integrated Capacitive and Hall Effect Sensors, IEEE
TRANS. INSTRUMENT AND MEASUREMENT (2014) (Ex. 1005, “Mukherjee
2014”).
4 B. Mukherjee; B. George; M. Sivapraksam, A Hall Effect Sensor Based
Syringe Injection Rate Detector, IEEE 2012 SIXTH INT’L CONF. ON SENSING
TECHNOL. (ICST) (2012) (Ex. 1006, “Mukherjee 2012”).
5 In this Decision, we also reference Mukherjee 2014 and Mukherjee 2012
together as “the Mukherjee articles.”
6 U.S. Patent Application Publication No. 2005/0181342 A1 published Aug.
18, 2005 (Ex. 1007, “Toly”).
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Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
16, 19 103 Samosky, Mukherjee 2014,
Mukherjee 2012,
Lampotang,7 Sinclair8
Paper 12 (“Dec. on Inst.”).
Truinject Corp. (“Patent Owner” or “Truinject”) timely filed a Patent
Owner Response. Paper 15 (“PO Resp.”).9 Petitioner filed a Reply (Paper
20, “Pet. Reply”), to which Patent Owner filed a Sur-reply (Paper 22, “PO
Sur-reply”).
Oral argument was conducted on August 18, 2021.10 A transcript of
the oral argument appears in the record. Paper 29.
For the reasons set forth below, we determine that Petitioner has
shown, by a preponderance of the evidence, that all of the challenged claims
are unpatentable. See 35 U.S.C. § 316(e).
B. Related Matters
The parties contend that the ’231 patent is the subject of Truinject
Corp. v. Nestlé Skin Health, S.A., et al., No. 1:19-cv-00592 (D. Del.) (filed
March 28, 2019) (“the Delaware Action”), which is a related matter under
37 C.F.R. § 42.8(b)(2). Pet. 2; Paper 6, 1. The parties also reference

7 US Patent Application Publication No. 2012/0280988 A1 published Nov.
8, 2012 (Ex. 1008, “Lampotang”).
8 US Patent No. 5,766,016 issued Jun. 16, 1998 (Ex. 1016, “Sinclair”).
9 Patent Owner relies on the Declaration of Dr. Carla M. Pugh (Ex. 2005) in
support of its Patent Owner Response.
10 Oral argument in this proceeding was consolidated with the oral argument
in IPR2020-00937.
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IPR2020-00042 involving U.S. Patent No. 9,792,836 (“the ’836 patent”) and
IPR2020-000937 involving U.S. Patent No. 10,290,232 (“the ’232
patent”).11 Pet. 2; Paper 6, 1. Petitioner states that the ’836 patent and the
’232 patent have been asserted in the Delaware Action. Pet. 2.
C. The ’231 Patent
The ’231 patent is titled “Automated Detection of Performance
Characteristics in an Injection Training System.” Ex. 1001, code (54). The
’231 patent characterizes its disclosure as relating “generally to cosmetic and
therapeutic training, and more specifically to systems, devices, and methods
for cosmetic and therapeutic training.” Id. at 1:34–36. Generally, cosmetic
and therapeutic treatments can involve injections in various locations on the
body to treat medical conditions, address aesthetic imperfections, or perform
restorative cosmetic procedures. Id. at 1:37–56. The ’231 patent sets forth
that problems in the relevant field include a lack of official certification or
training processes directed to administering injections, and that current
training options are generally limited to hands-on training performed on live
models. Id. at 2:4–26. The ’231 patent postulates that there is a need for
“effective, efficient, and extensible training injection systems, methods, and
devices.” Id. at 2:58–61. The Abstract of the ’231 patent is reproduced
below:
Various systems and methods are provided for injection training
by collecting, processing, analyzing and displaying measured
information associated with the delivery of an injection. Sensor-
based measurements of a syringe’s position and orientation in

11 Institution of inter partes review was denied in IPR2020-00042 on April
14, 2020. See IPR2020-00042, Paper 7. A Final Written Decision in
IPR2020-00937 is issued concurrently with the present Decision.
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three-dimensional space are obtained and processed to provide
metrics of a trainee’s injection performance. The measurements
can be combined with a digital model of a training apparatus to
deliver a computer generated, graphical depiction of the training
injection, enabling visualization of the injection from
perspectives unavailable in the physical world. The training
injection execution, as reflected in the measured sensor-based
data, can be reviewed and analyzed at times after, and in
locations different than, the time and location of the training
injection. Additionally, injection training data associated with
multiple training injections can be aggregated and analyzed for,
among other things, trends in performance.
Id. at code (57).
Figure 1 of the ’231 patent is reproduced below.

Figure 1 above shows “an example of an injection training system in which
aspects of the present disclosure may be employed.” Id. at 12:53–55.
Training system 100 includes training apparatus 200 that is configured to
receive a training injection delivered by syringe 210. Id. at 14:59–63.
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Training apparatus 200 is configured to communicate with local display
device 106 via network 104. Id. at 15:6–8.
D. Illustrative Claims
Of the challenged claims, claims 1 and 6 are independent. Claim 1 is
illustrative and is reproduced below:
1. [i] A method to improve performance of an injection
technique using one or more signal processors of an injection
training system having an anatomically-shaped apparatus and a
syringe, the method comprising:
[ii] providing the anatomically-shaped apparatus, the
anatomically-shaped apparatus configured to receive a training
injection of the injection technique performed by a user;
[iii] providing the syringe having a needle, a barrel, and a
plunger and configured to deliver the training injection to the
anatomically-shaped apparatus, [iv] the syringe further
comprising at least one syringe sensor on the syringe;
[v] receiving, by the one or more signal processors of the
injection training system, sensor-based injection information
associated with the training injection of the injection technique,
the sensor-based injection information comprising information
indicative of the position and use characteristics of the syringe
detected by the at least one syringe sensor;
[vi] analyzing electronically, using the one or more signal
processors, the sensor-based injection information;
[vii] evaluating electronically, using the one or more
signal processors, the analyzed sensor-based injection
information relative to at least one evaluation criterion; and
[viii] comparing electronically, using the one or more
signal processors, the analyzed sensor-based injection
information with at least one performance requirement to
determine whether the training injection met the at least one
performance requirement;
[ix] outputting by the one or more signal processors, for
displaying on a display device during and/or after the training
injection, a graphical depiction of the training injection, [x]
wherein the graphic depiction includes a digital three-
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dimensional model of the anatomically-shaped apparatus [xi] a
location of the needle relative to the digital three-dimensional
model of the anatomically-shaped apparatus, and [xii] a dynamic
position of the plunger in real time, [xiii] the digital three-
dimensional model of the anatomically-shaped apparatus
comprising facial anatomical features, [xiv] wherein the one or
more signal processors are configured to alter a view of the
graphical depiction to better visualize the training injection; and
[xv] outputting electronically, using the one or more signal
processors, based on the analyzed sensor-based injection
information, a recommended action to improve injection
technique.
Id. at 33:41–34:22 (with the Roman numerals i–xv added for ease of
discussion (see Pet. 29–30)).
II. ANALYSIS
A. Claim Construction
In the Petition, Petitioner did not expressly construe any claim term of
the ’231 patent and contended that we need not either. See Pet. 13
(“Petitioners submit that the Board need not specially construe any terms of
the challenged claims in this proceeding.”). In our Decision on Institution,
we expressed the following:
At this time, we give all terms their “ordinary and customary
meaning” and determine that it is unnecessary to make explicit
that meaning for any term. See, e.g., Phillips v. AWH Corp., 415
F.3d 1303 (Fed. Cir. 2005) (en banc); see also Nidec Motor Corp.
v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
(Fed. Cir. 2017) (noting that “we need only construe terms ‘that
are in controversy, and only to the extent necessary to resolve the
controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
Dec. on Inst. 16.
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Patent Owner does not disagree that all the claim terms should be
given their ordinary meaning. In its Patent Owner Response, Patent Owner
discusses that ordinary meaning for two claim phrases (1) “a graphical
depiction of the training injection” (claims 1 and 6), and (2) “a simulated
delivery of therapeutic agent to the digital three-dimensional model of the
anatomically-shaped apparatus.” PO Resp. 22–28. In its Reply, Petitioner
offers its own views on the meaning of the above-noted claim phrases. Pet.
Reply 1–5.
It is clear that there is some disagreement between the parties as to the
meaning of those claim phrases. Accordingly, we discuss them below.
1. “graphical depiction of the training injection”(claims 1 and 6)
According to Patent Owner, the ordinary meaning of the above-noted
phrase is “a computer-generated portrayal or likeness of the training
injection.” PO Resp. 22. In offering that meaning, Patent Owner also
contends that, in the context of the ’231 patent, the term “graphical” means
“of or relating to visual art of computer graphics,” and points to portions of
the ’231 patent that are said to support Patent Owner’s contention. See id. at
23 (citing Ex. 1001, 3:6–18). Patent Owner also relies on dictionary
definitions of the term “depiction” as allegedly meaning “a portrayal or
likeness.” Id. (citing Ex. 2008, 4; Ex. 2007, 4). In Patent Owner’s view,
“[a]ll the descriptions of graphical depictions of the training injection in the
’231 Patent are computer-generated portrayals or likenesses of the training
injection and are not mathematical graphs showing data on a coordinate
system.” Id. at 24. Patent Owner further attempts to support that view on
the basis that, during prosecution of the application that became the
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’231 patent, Patent Owner represented to the Examiner examining the
application that the claims of the ’231 patent exclude such mathematical
graphs from being graphical depictions. Id. at 25–26.12
Petitioner disagrees with Patent Owner. At the outset, Petitioner
expresses that “[n]o construction of this term was found to be necessary in
the Delaware Action and none is required here.” Pet. Reply 2. Petitioner is
of the view that none of the evidence of record, including the ’231 patent,
the cited dictionary definitions, and the prosecution history, supports the
meaning of “graphical depiction of the training injection” offered by Patent
Owner, specifically that such phrase excludes “‘mathematical graphs’
showing the position of a needle tip relative to the model of the apparatus.”
Id. at 2–4. Petitioner also indicates that “the Examiner never accepted
[Patent Owner’s] arguments” that “graphical depiction” excludes
mathematical graphs, such as those shown in Figures 14A and 14B of
Samosky. Id. at 4 (citing Ex. 1010, 388–391, 404–405). Rather, Petitioner
represents that “the Examiner found that ‘a graphical depiction of the
training injection encompasses the 4D graph shown in Figures 14A-B of
Samosky.” Id. (citing Ex. 1010, 386–408).
Petitioner makes the better case. We do not discern from the
’231 patent any express indication that “graphical depiction” should be read
to exclude a type of display recognized as a “graph,” mathematical or

12 Patent Owner made those representations in the context of discussing
Figures 14A and 14B of Samosky, which was a reference applied by the
Examiner during examination, and is also a reference on which Petitioner
relies in this proceeding.
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otherwise.13 We share Petitioner’s view that Patent Owner does not make a
colorable case that “depiction” must be something limited to a “portrayal or
likeness.” We do not discern that the ’231 patent limits “depiction” to such
a restricted meaning. The dictionary definitions on which Patent Owner
relies (Exs. 2007, 2008) do not limit “depiction” to a portrayal, or, as
Petitioner notes, even use the term “likeness.” See Pet. Reply 3; Ex. 2007, 4;
Ex. 2008, 4. We also do not discern that the ’231 patent presents a basis for
concluding that a “depiction” is restricted to a “portrayal or likeness.”
Additionally, it is difficult to reconcile Patent Owner’s view that,
simply because it represented to the Examiner during prosecution that
“graphical depiction” excludes mathematical graphs, like those shown in
Samosky’s 14A and 14B, such exclusion must be true. Patent Owner does
not direct our attention to any portion of the record indicating that the
Examiner agreed with Patent Owner’s representations. Instead, the record
reflects that the Examiner held an opposing view in maintaining that “a
graphical depiction of the training injection” is accounted for by Figures

13 As noted above, Patent Owner seeks to connect the requirement of
“computer-generated” with the claim term “graphical depiction.” We
discern that the portions of the ’231 patent that Patent Owner cites for that
premise, qualify, in every instance, the term “graphical depiction” with the
leading descriptor “computer-generated.” See, e.g., Ex. 1001, 3:6–18. That
the ’231 patent specifically sees its necessary to add the term “computer-
generated” to describe a “graphical depiction” does not lend itself favorably
to a conclusion that the term “graphical depiction” unaccompanied by the
term “computer-generated,” nevertheless still requires a graphical depiction
that is “computer-generated.” The issue, however, is immaterial with
respect to Petitioner’s unpatentability challenges, as there is no dispute
before us that the prior art on which Petitioner relies presents images that are
understood to be computer-generated.
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14A and 14B of Samosky. See, e.g., Ex. 1010, 390 (“a graphical depiction
of the training injection (see figures 14A and 14B [of Samosky], showing a
graph of the training injection and its location).”).
We are cognizant that the Examiner ultimately allowed the claims of
the ’231 patent over the teachings of Samosky. That, however, only
occurred after Patent Owner accepted amendments proposed to the claims
by the Examiner that are not directed to the particular aspects of a “graphical
depiction” that are the focus here. See Ex. 1010, 21–25.14 That such
amendments were proposed by the Examiner and accepted by Patent Owner
does not indicate that the Examiner retreated from a position that a
“graphical depiction of the training injection” encompasses the mathematical
graphs of Samosky’s Figures 14A and 14B.
We have considered the parties’ positions as to what is encompassed
by the claim phrase “graphical depiction of the training injection.” On the
record at hand, we do not find Patent Owner’s position availing that it has
offered a suitable basis to regard that phrase as categorically excluding
displays of mathematical graphs. Instead, we agree with Petitioner that the
record does not establish that mathematical graphs, such as those shown in
Figures 14A and 14B of Samosky, are outside of consideration as a
“graphical depiction.”

14 Patent Owner indicates that it “agreed” to the amendments proposed by
the Examiner “in the interest of obtaining allowance.” PO Resp. 10.
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2. “a simulated delivery of the therapeutic agent to the digital three-
dimensional model of the anatomically-shaped apparatus” (claims
23 and 24)
Claim 23 depends from independent claim 1, and claim 24 depends
from independent claim 6. Each of claims 23 and 24 adds to their respective
independent claim the above-noted claim phrase. Here, Patent Owner
contends that the above-noted claim phrase means “a simulated flow of
therapeutic agent delivered from a digital model of the syringe to a digital
model of the anatomically-shaped apparatus.” Thus, what Patent Owner
attempts to emphasize is the premise that the claim phrase requires that the
simulated flow of therapeutic agent is delivered from “a digital model of the
syringe.” According to Patent Owner, in the Delaware Action, the parties
agreed to the above-noted meaning in the context of claims of the related
’232 patent.15 PO Resp. 27–28.
Petitioner contends the following:
With respect to claim 23, Truinject’s construction (Resp.
26–28) is improper. No digital model of the syringe is recited in
claim 23 or claim 1 from which it depends. In contrast, the claims
of the ’232 patent that recite “simulated delivery” also recite a
“digital model of the syringe.”
As with the ’232 patent claims, claim 24 does require a
digital three-dimensional model of the syringe by virtue of its
incorporation of claim 6.
Accordingly, as used in claim 24, this term would be
understood to mean “a simulated flow of therapeutic agent
delivered from the digital three-dimensional model of the

15 The ’232 patent is the subject patent of related proceeding IPR2020-
00937.
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syringe to the digital three-dimensional model of the
anatomically shaped apparatus.”
Pet. Reply 4–5.
Thus, with respect to claim 24, the parties are in apparent agreement
that the claim requires a three-dimensional digital model of the syringe
because of the recitation in independent claim 6 of “a digital three-
dimensional model of the syringe.” See Ex. 1001, 35:35–36. As Petitioner
notes, however, and as we also discern, claim 1 includes no such
corresponding limitation directed to a digital model of a syringe. It is
apparent from the record that the agreement between the parties in the
Delaware Action as to the requirement of a three-dimensional digital model
of a syringe is premised on the explicit recitation in the claims of the ’232
patent of a three-dimensional digital model of a syringe.
Patent Owner appears to suggest that a separate limitation of claim 1
gives rise to the requirement of a digital model of the syringe. Specifically,
Patent Owner advances the following:
Although Claim 1, from which Claim 23 depends, does not
explicitly recite a digital model of the syringe, Claim 1 requires
that the graphical depiction include “a location of the needle
relative to the digital three-dimensional model of the
anatomically-shaped apparatus, and a dynamic position of the
plunger in real time,” which amounts to a digital model of the
syringe.
PO Resp. 28 (citing Ex. 1001, 34:9–12; Ex. 2005 ¶ 55).
Patent Owner, however, does not articulate meaningfully why the
above-quoted feature pertaining to the “location of the needle” and a
“dynamic position of the plunger” necessarily “amounts” to a digital model
of the syringe. In its Sur-reply, Patent Owner again references the above-
noted feature of claim 1, but simply expresses that “[n]o special construction
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of this term is required” and provides no further elaboration as to why the
feature gives rise to a “digital model of the syringe” where no such recitation
appears in either claim 1 or claim 23. Patent Owner simply does not explain
adequately why, despite the absence of an express limitation directed to a
three-dimensional model of a syringe in either claim 1 or claim 23 of the
’231 patent, those claims should, nevertheless, be regarded as including such
a requirement.
On the record before us, we note that the parties are in agreement that
claim 24 explicitly requires a three-dimensional model of a syringe that
provides the simulated flow of therapeutic agent because claim 24
incorporates the recitation of “a digital three-dimensional model of the
syringe” from its independent claim 6. In light of the parties’ mutually
acknowledged agreement, and given that we do not see reason to deviate
from it on the record before us, we apply the same agreed-to meaning and
conclude that claim 24 has such a requirement. By contrast, neither claim 23
nor its independent claim 1 explicitly recites any type of digital model of the
syringe. Thus, we conclude that claim 23 does not require a three-
dimensional digital model of a syringe.
3. Remaining Claim Terms
We discern that no other term needs an express construction to resolve
the parties’ dispute. See Nidec, 868 F.3d at 1017.
B. Grounds of Unpatentability
Petitioner proposes three grounds of unpatentability to claims of the
’231 patent: (1) claims 1, 3, 4, 6, 10, 11, 15, 17, 18, 21–24 as unpatentable
over Samosky, Mukherjee 2014, and Mukherjee 2012; (2) claim 12 as
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unpatentable over Samosky, Mukherjee 2014, Mukherjee 2012, and Toly;
and (3) claims 16 and 19 as unpatentable over Samosky, Mukherjee 2014,
Mukherjee 2012, Lampotang, and Sinclair.
1. Principles of Law
A claim is unpatentable under 35 U.S.C. § 103 if the differences
between the claimed subject matter and the prior art are “such that the
claimed invention as a whole would have been obvious before the effective
filing date of the claimed invention to a person having ordinary skill in the
art to which such subject matter pertains.” 35 U.S.C. § 103 (2018). The
question of obviousness under 35 U.S.C. § 103 is resolved on the basis of
underlying factual determinations, including: (1) the scope and content of
the prior art; (2) any differences between the claimed subject matter and the
prior art; (3) the level of skill in the art; and (4) objective evidence of
nonobviousness, i.e., secondary considerations. See Graham v. John Deere
Co., 383 U.S. 1, 17–18 (1966).16
2. Level of Ordinary Skill in the Art
Petitioner offers the following assessment in conjunction with the
level of ordinary skill in the art:
The prior art discussed below and Dr. Mukherjee’s
Declaration (EX1002) demonstrate that a person of ordinary skill
in the art (“POSITA”) as of the effective filing date of the
‘231 patent would have had at least a master’s degree in
electrical engineering, robotics engineering, mechatronics, or a
similar field. EX1002, ¶22. Alternatively, a POSITA may have
had a lesser degree in one of those fields, but accompanied by

16 Neither party presents any objective indicia of non-obviousness as a part
of this proceeding.
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practical experience in designing medical training or similar
systems. Id. The POSITA would have an in-depth working
knowledge of machine vision, three-dimensional tracking
systems, microprocessors, signal processing, sensors, computer
programming, or a combination thereof. Id.
In addition to the aforementioned technical skills, the
POSITA would have experience in designing and producing
realistic anatomical models or life-like mannequins and would
have a strong working knowledge of mannequin design,
computer-aided design and manufacturing (CAD/CAM),
materials selection, human anatomy, related special effects, and
known software for collecting, analyzing, and displaying three-
dimensional models of training procedures using such models.
Id., ¶23. To the extent necessary, the POSITA may have
collaborated with other skilled artisans, such that the individual
and/or team collectively would have had experience and/or
knowledge of particular injection metrics and procedures to be
practiced and/or evaluated. Id.
Pet. 12–13.
Patent Owner offers the following assessment of the level of ordinary
skill in the art:
A person of ordinary skill in the art at the time of the effective
filing date of the application that led to the ’231 Patent would
have had a B.S. in Electrical Engineering, Biomedical
Engineering, or any similar type of engineering or biomedical
degree and at least one year experience in designing sensor-based
motion tracking and simulators for evaluating clinical
performances. Ex. 2005 ¶ 30. For individuals with different
educational backgrounds, a person could still be of ordinary skill
in the art provided that person’s additional experience
compensates for any differences in that person’s education as
stated above. Id.
PO Resp. 20–21.
Although noting that its assessment of the level of skill in the art
“differs from that proposed by Petitioner, Patent Owner believes the
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difference is immaterial to deciding the issues raised by the Petition.” Id.
at 21. Petitioner does not dispute Patent Owner’s contention in that regard,
and we also agree that the outcome of this proceeding would be the same
under either of the Petitioner’s and Patent Owner’s proposed level of
ordinary skill in the art. Nevertheless, for completeness, we adopt Patent
Owner’s assessment of the level of ordinary skill. We also note that the
applied prior art reflects the appropriate level of skill at the time of the
claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
Cir. 2001).
3. Scope and Content of the Prior Art
a) Samosky
Samosky is titled “Hybrid Physical-Virtual Reality Simulation for
Clinical Training Capable of Providing Feedback to a Physical Anatomic
Model.” Ex. 1004, code (54). Samosky characterizes its disclosure as
follows:
The subject innovation relates generally to simulation
based training (SBT), and in aspects, the innovation can simulate
a clinical procedure utilizing a mixed-reality approach that can
incorporate one or more of a physical model, a virtual model
(e.g., which can be a 3D model derived from a medical imaging
scan (e.g., magnetic resonance imaging (MRI), computed
tomography (CT) data, or 3D ultrasound date, etc.) isomorphic
to the physical model, etc.), mechatronics and spatial tracking.
Id. ¶ 31.
Samosky further describes the following:
The innovation disclosed and claimed therein, in one
aspect thereof, comprises a system that facilitates training in
clinical procedures via mixed reality simulations are disclosed.
Such a system can comprise a physical model of an anatomic
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region that can be associated with the clinical procedure and a
virtual model of the anatomic region, wherein the virtual model
that can associate a tissue type with each location in the physical
model. The system can also include a tracking component that
can track at least one location of at least one clinical instrument
relative to the physical model and the virtual model, and a
feedback component that can provide feedback based at least in
part on at least one location in the physical model associated with
the at least one location of the at least one clinical instrument.
Id. ¶ 7.
Samosky’s Figure 1 is reproduced below:

Figure 1 above illustrates “system 100 that can simulate a clinical procedure
via a hybrid physical-virtual model.” Id. ¶ 39. “Physical anatomic model
102 and virtual anatomic model 104 can model an anatomic region
associated with the clinical procedure (e.g., limb, neck, back, or substantially
any other anatomic region).” Id. Samosky further discloses the following:
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The two anatomic models can be co-registered such that the
virtual anatomic model 104 can associate tissue types with
corresponding locations of the physical anatomic model 102. In
various aspects, as described further herein, virtual anatomic
model 104 can correspond to real anatomy (e.g., as derived from
segmented medical imaging data, from any of a plurality of
person, or can corresponding to modifications or simplifications
thereof (e.g., for training purposes, etc.).
Id.
Samosky further incorporates a “tracking component that tracks
locations of at least one clinical instrument relative to the models.” Id. at
code (57). Samosky’s Figures 5–8 show example displays of a “hybrid
physical-virtual model” according to Samosky’s invention. Id. ¶¶ 14–17.
Samosky’s Figure 5 is reproduced below:

Figure 5 above shows an “example prototype of a hybrid physical-virtual
model.” Id. ¶ 14. The model includes “cylindrical phantom ‘limb’” 502 and
a corresponding virtual model that a trainer can perform a simulated
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procedure on. Id. ¶ 65. The model further includes instruments 506 for
interacting with the model, syringe simulation subsystem 508, anesthetic
syringe 510, display 512 for a trainee, and display 514 for an instructor. Id.
Samosky’s Figure 8 is reproduced below:

Figure 8 above “illustrates an example display of a prototype instructor
interface in accordance with the system shown in” Figure 5. Id. at ¶ 17. The
instructor interface “can provide indicators identifying the anatomical
feature (e.g., tissue type or structure, etc.) at the needle tip location,” “needle
to nerve distance, current tissue type the needle tip is located in (air, tissue,
vessel, nerve, bone),” and presents “a ‘bull’s-eye’ visualization of the needle
tip approaching the nerve.” Id. ¶¶ 66–67.
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Samosky’s Figures 14A and 14B are reproduced below:

Figures 14A and 14B above show “a pair of 4D graphs of needle tip
trajectories 1402 [on left] and 1404 [on right] recorded with a prototype
system in accordance with the subject innovation, as measured with an
electromagnetic tracking system.” Id. ¶ 74.
b) Mukherjee 2014
Mukherjee 2014 is an article titled “An Ophthalmic Anesthesia
Training System Using Integrated Capacitive and Hall Effect Sensors.”
Ex. 1005, Title. The training system incorporates a training manikin and
training is accomplished through use of a “virtual instrument” (VI) that
measures the output from capacitive sensing electrodes and Hall-effect
sensors and displays the output to the trainee through a graphical user
interface (GUI). Id. at Abstract.
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Mukherjee 2014’s Figure 2 is reproduced below:

Figure 2 above is a “[c]onceptual diagram of the ophthalmic regional
anesthesia training system showing the trainee with a modified syringe
administering a block on the manikin.” Id. at 1. “A VI shows real-time
feedback of the needle proximity and touch of muscles, rate of injection
along with a qualitative score based on the trainee’s performance.” Id.
c) Mukherjee 2012
Mukherjee 2012 is an article titled “A Hall Effect Sensor based
Syringe Injection Rate Detector.” Ex. 1006, Title. Mukherjee 2012
describes a “training system based on a suitably modified syringe equipped
with a simple measurement system where a trainee can observe the rate of
injection, prior to practicing on live patients.” Id. at Abstract.
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Mukherjee 2012 also explains that a “Hall Effect sensor along with a
permanent magnet senses the position of the syringe piston relative to the
syringe body.” Id.
Mukherjee 2012’s Figure 5 is reproduced below:

Figure 5 above is described as showing a “LabVIEW based Virtual
Instrument front panel showing the rate of injection, piston position and
Aspiration indicators in real-time.” Id. at 452.
d) Toly
Toly is titled “Medical Training Simulator Including Contact-Less
Sensors.” Ex. 1007, code (54). Toly’s Abstract is reproduced below:
A medical training simulator includes contact-less sensors and
corresponding detection objects, configured to enable sensor
data collected during a training exercise to be used to evaluate
the performance of the training exercise. The simulator includes
a simulated anatomical structure, at least one contact-less sensor,
and at least one detection object. During a training exercise, a
spatial relationship between the contact-less sensor and the
detection object produces data for evaluating performance of the
training exercise. Either the contact-less sensor or the detection
object is embedded in the simulated physiological structure,
while the other is included in either a support for the simulated
physiological structure, or as part of a tool used during the
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training exercise. Many types of contact-less sensors can be
employed, including capacitance sensors, impedance sensors,
inductive sensors, and magnetic sensors.
Id. at code (57).
e) Lampotang
Lampotang is titled “Interactive Mixed Reality System and Uses
Thereof.” Ex. 1008, code (54). Lampotang’s Abstract is reproduced below:
An interactive mixed reality simulator is provided that includes
a virtual 3D model of internal or hidden features of an object; a
physical model or object being interacted with; and a tracked
instrument used to interact with the physical object. The tracked
instrument can be used to simulate or visualize interactions with
internal features of the physical object represented by the
physical model. In certain embodiments, one or more of the
internal features can be present in the physical model. In another
embodiment, some internal features do not have a physical
presence within the physical model.
Id. at code (57).
f) Sinclair
Sinclair is titled “Surgical Simulator and Method for Simulating
Surgical Procedure.” Ex. 1016, code [54]. Sinclair’s Abstract is reproduced
below:
A surgical simulator provides both visual and tactile feedback in
order to realistically portray an actual surgical procedure. The
visual feedback is provided through an SGI graphics computer
which drives a monitor to display two images of an eye at slightly
different perspectives. A set of optics, which preferably mimics
an actual surgical microscope, combines the two images to form
a stereo image of the eye. An instrument for simulating a surgical
tool is connected through three sets of levers and hinges to three
servo-motors which collectively generate a resistive force along
any direction. The forces provided to the instrument are modeled
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after forces measured during an actual procedure and therefore
accurately simulate the feel of a surgical procedure. The position
and orientation of the instrument is transmitted to the SGI
graphics computer which manipulates the eye based upon the
position and motion of the instrument and updates the image of
the eye to display a manipulated eye. The position of the
instrument is also relayed to a second processing unit which
provides the tactile feedback based upon the state of the
instrument.
Id. at code [57].
4. Ground Based on Samosky, Mukherjee 2014, Mukherjee 2012
Petitioner contends that claims 1, 3, 4, 6, 10, 11, 15, 17, 18, and 21–24
of the ’231 patent are unpatentable based on the combined teachings of
Samosky, Mukherjee 2014, and Mukherjee 2012. Petitioner lays out in
detail where it believes all the features of those claims reside in the prior art.
Pet. 29–65. Petitioner also reasons that a person of ordinary skill in the art
would have had adequate reasons to combine the teachings of the above-
noted references. Id. at 25–28. Patent Owner disagrees with Petitioner.
Patent Owner argues that the cited prior art is missing certain features of the
challenged claims, focusing particularly on independent claims 1 and 6. PO
Resp. 30–50, 57–62; PO Sur-reply 9–21. Patent Owner additionally
contends that features required by claims 17, 23, and 24 are also absent from
the prior art. PO Resp. 62–69; PO Sur-reply 21–26. Patent Owner further
disputes that a skilled artisan would have had reason to combine Samosky
and the Mukherjee articles, or a reasonable expectation of success in doing
so. PO Resp. 50–57.
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a) Claim 1
As to the alleged missing features of claim 1, Patent Owner focuses its
arguments on an “outputting” step (that we designate in this Decision as
beginning with limitation [ix]) required by claim 1.17 That outputting step
requires a “graphical depiction” or “graphic depiction” that includes certain
displayed content. Patent Owner contends that limitations associated with
[ix], [x], [xi], and [xii] of the “outputting” step are not disclosed in the prior
art. We evaluate whether those features are disclosed in Samosky and the
Mukherjee articles.
(1) Limitation [ix]: “graphical depiction of the training
injection”
Petitioner contends that the requirement of a “graphical depiction of
the training injection” is satisfied by the “‘4D’ depiction of a needle
trajectory from a training session” that appears in Figures 14A and 14B of
Samosky. Pet. 40. Although Patent Owner disagrees with Petitioner, that
disagreement is predicated on its construction of “graphical depiction” as
being a “portrayal or likeness” of the injection that excludes displays of
mathematical graphs, which we reject (see supra, § II.A.1). PO Resp. 33–
35. Patent Owner’s general assertion, for instance that Samosky’s Figures
14A and 14B do not show a graphical depiction of the training injection
because they “merely show graphs of needle trajectories,” is unavailing. See
id. at 34.
Samosky’s Figures 14A and 14B are described as “4D graphs” of two
examples of needle tip trajectories 1402 and 1404 tracking movement of a

17 Claim 6 requires a similar outputting step.
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needle tip in three-dimensional space over a period of time from starting
point “O” to target “T.” Ex. 1004 ¶ 74. Samosky also discloses that its
system is associated with a “virtual anatomic model” that “can model an
anatomic region associated with the clinical procedure” and is applicable to
“training” a variety of medical procedures, including those involving needle
injection. Id. at ¶¶ 38–39. We conclude that Petitioner has shown
adequately that Samosky discloses “a graphical depiction of the training
injection” as is required by claim 1. See Pet. 40–41.
(2) Limitation [x]: “wherein the graphic depiction
includes a digital three-dimensional model of the
anatomically-shaped apparatus”
Petitioner relies on Samosky as showing the required graphic
depiction that may include a digital three-dimensional model of the
anatomically-shaped apparatus. In particular, Petitioner points to various
parts of Samosky’s disclosure including Figures 14A and 14B and
Samosky’s description of its “virtual model” as being a “3D model derived
from a medical imaging scan (e.g., magnetic resonance imaging (MRI),
computed tomography (CT) data, or 3D ultrasound date, etc.) isomorphic to
the physical model, etc.” Pet. 41–42 (quoting Ex. 1004 ¶ 31). As we noted
above, Samosky also clearly provides that its “virtual anatomic model 104
can model an anatomic region associated with the clinical procedure.”
Ex. 1004 ¶ 39.
Patent Owner discounts Samosky’s disclosure in accounting for the
above-noted feature, arguing that neither Petitioner nor its declarant,
Dr. Mukherjee, explains how the graphs of Samosky’s Figures 14A and 14B
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are associated with Samosky’s disclosure of a virtual model. See, e.g., PO
Resp. 34–35.
We find unavailing the basis for Patent Owner’s discounting of
Samosky’s teachings. In that respect, we determine that Patent Owner has
not accounted adequately for what a person of ordinary skill in the art would
have understood from Samosky’s teachings. “[A] prior art reference” stands
for “all that it teaches to those of ordinary skill in the art.” In re Fritch, 972
F.2d 1260, 1264–65 (Fed. Cir. 1992). Furthermore, a person of ordinary
skill in the art is also a person of ordinary creativity. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 421 (2007).
Samosky clearly sets forth that its system contemplates use of a “3D”
“virtual model” of an “anatomic region” that is “isomorphic” to a physical
model, and used during the course of training for medical procedures. See,
e.g., Ex. 1004 ¶¶ 31, 38, 39. Samosky’s “4D” graphs of Figures 14A and
14B are described as being associated with a “prototype system in
accordance with the subject innovation” used to assist with “tutoring,”
“coaching” and providing “feedback” to a user of Samosky’s system. See,
e.g., id. ¶ 74. It follows from Samosky’s explicit teachings that one of
ordinary skill and creativity in the art would have appreciated that the graphs
of Samosky’s Figures 14A and 14B would be associated with a virtual
model of an anatomic region on which a user is training for a medical
procedure. We credit the testimony of Dr. Mukherjee in that respect as it is
consistent with Samosky’s own disclosure. See, e.g., Ex. 1002 ¶ 130. We
credit Dr. Mukherjee’s testimony over the countervailing testimony of
Dr. Pugh (see, e.g., Ex. 2005 ¶ 87), as we conclude that Dr. Pugh’s
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testimony does not adequately reflect what a skilled artisan would have
gleaned from Samosky’s clear teachings.
Accordingly, we determine that Petitioner has shown how Samosky’s
teachings convey to a person of ordinary skill in the art a “graphic depiction”
that “includes a digital three-dimensional model of the anatomically-shaped
apparatus” as recited in claim 1.
(3) Limitation [xi]: “a location of the needle relative to
the digital three-dimensional model of the anatomically
shaped apparatus”
In accounting for limitation [xi], Petitioner points to Samosky’s
Figure 8 and its description as showing “an instructional component that
displays the location of a needle relative to the model of the anatomically-
shaped apparatus.” Pet. 42 (citing Ex. 1004 ¶ 66 (“As can be seen, the
instructor interface can provide indicators identifying the anatomical feature
(e.g., tissue type of structure, etc.) at the current needle tip location (the
color-coded indicators to the left in FIG. 8).”)). Petitioner also refers to
Samosky’s paragraph 74 and its description of the 4D graphs illustrated in
Figures 14A and 14B. Id. As noted above, Samosky describes Figures 14A
and 14B as showing graphs of “needle tip trajectories.” Ex 1004 ¶ 74.
Patent Owner argues that the graphs of Figures 14A and 14B do not
themselves show the location of a needle that is relative to the digital three-
dimensional model of an anatomically-shaped apparatus. PO Resp. 35–36.
As a part of that argument, Patent Owner also expresses that “Samosky does
not explain how the needle trajectory graphs shown in Figures 14A and 14B
could be combined with a medical imaging scan.” Id. Patent Owner further
contends that the indicators of Figure 8 are not displayed relative to any
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digital three-dimensional model of an anatomically shaped apparatus. Id.
at 36–38.
As discussed above, Samosky describes its “virtual model” as being a
“3D model derived from a medical imaging scan (e.g., magnetic resonance
imaging (MRI), computed tomography (CT) data, or 3D ultrasound date,
etc.),” and which depicts an anatomic region that simulates a physical
model. See, e.g., Ex. 1004 ¶¶ 31, 39. Figures 14A and 14B show, in three
dimensions, the trajectories or locations of a needle during a period of time.
All of Samosky’s “virtual model” disclosures and its disclosures as to three-
dimensional display of needle trajectories are associated with a system
designed to provide medical procedure training for a user. Although
Samosky does not show expressly the graphs of Figures 14A and 14B
associated or overlaid with a virtual model of an anatomic region, such an
understanding flows logically and directly from Samosky’s teachings.
We also do not find persuasive Patent Owner’s arguments that the
location of a needle relative to a three-dimensional anatomically shaped
apparatus is absent from Samosky’s teachings, including those of Samosky’s
Figure 8. That figure shows an “instructor interface” that “can provide
indicators identifying the anatomical feature (e.g., tissue type or structure,
etc.) at the current needle tip location (the color-coded indicators to the left
in FIG. 8”). Ex. 1004 ¶ 66. Although Samosky may not directly associate
the content of its Figure 8 with a three-dimensional model of an
anatomically shaped apparatus, that is not dispositive where, as here, the
question is one of obviousness. Indeed, in an obviousness analysis, it is not
necessary to find precise teachings in the prior art directed to the specific
subject matter claimed because inferences and creative steps that a person of
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ordinary skill in the art would have employed can be taken into account.
KSR, 550 U.S. at 418 (2007). Samosky is clear that its disclosed system as a
whole “facilitates training in clinical procedures via mixed reality
simulations” and contemplates a virtual model that is a three-dimensional
representation of an anatomic region. See, e.g., Ex. 1004 ¶¶ 7, 31. A person
of ordinary skill and creativity in the art would have reasonably inferred
from Samosky’s disclosure that one aspect of its training system, such as the
instructor interface of Figure 8 showing needle tip location in connection
with an anatomical feature, is associated with a three-dimensional display of
needle tip location associated with an anatomically-shaped apparatus. We
find persuasive Petitioner’s argument to that effect (see, e.g., Pet. 42), and
credit the testimony of Petitioner’s declarant, Dr. Mukherjee (Ex. 1002
¶¶ 131–132), in part, because it is consistent with Samosky’s express
disclosure.
We have considered Patent Owner’s arguments as to feature [xi], but
find them unavailing. We are persuaded by Petitioner that Samosky’s
disclosure, including its Figures 8, 14A, and 14B and their associated
descriptions, accounts for limitation [xi].
(4) Limitation [xii]: “a dynamic position of the plunger
in real time”
For limitation [xii], Petitioner relies on the disclosure of Samosky and
the Mukherjee articles. Pet. 42–44. Figure 5 of Mukherjee 2012 describes
that a “Virtual Instrument” display may show, among other things, “piston
position and Aspiration indicators in real-time.” See Ex. 1006, 452.
Mukherjee 2014 states that “[a] Lab VIEW[22]-based VI with an intuitive
GUI provides the trainee with real-time feedback on the proximity and touch
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of syringe to the EOM [extraocular muscles] and the rate of injection of
anesthetic fluid.” Ex. 1005, 2. Petitioner contends that “Samosky teaches
the benefits of providing a depiction of the needle position as well as
information on ‘whether the user is pushing or pulling back on a plunger,
amount of fluid injected into various tissue, etc.’” Pet. 43 (citing Ex. 1004
¶¶ 50, 74). Petitioner concludes that:
[i]n view of these teachings and Mukherjee 2014 and Mukherjee
2012’s teachings of a sensor detecting syringe position, a
POSITA would have found it obvious to provide a three-
dimensional graphical depiction of a dynamic position of a
plunger in real time, and would have had a reasonable
expectation of success in making such modifications.
Id. at 43–44 (citing Ex. 1002 ¶¶ 82, 133–135).
Patent Owner contests Petitioner’s view that the prior art accounts for
the graphical depiction of a dynamic position of the plunger in real time.
See PO Resp. 43–50. According to Patent Owner, Petitioner relies only on
the teachings of the Mukherjee articles for that requirement, and none of the
figures in the Mukherjee articles displays a syringe plunger in real time. See
id. Central to Patent Owner’s argument appears to be the premise that
claim 1 requires that a “graphical depiction” that includes a “dynamic
position of the plunger in real time” must constitute a computer-generated
portrayal of likeness of a syringe that displays an image of a plunger moving
in real time. See id.
As discussed above in connection with claim construction, we observe
that claim 1 does not require a digital three-dimensional model of a syringe.
Yet, that is what Patent Owner contends must be present in order to provide
a depiction of a dynamic position of a plunger in real time. Petitioner points
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to Figure 5 of Mukherjee 2012 as depicting a display of a syringe piston or
plunger that is described as being shown in “real-time.” See Ex. 1006, 452.
Figure 5 of Mukherjee 2012 is reproduced below:

Figure 5 above shows a “LabVIEW based Virtual Instrument front panel
showing the rate of injection, piston position and Aspiration indicators in
real-time.” Id. at 452 (emphasis added). The left side of Figure 5 shows a
“Graph of Position and Rate of Injection.” It is clear from that graph that the
position of a syringe “piston,” i.e., plunger, is charted over a defined period
of time. See, e.g., Ex. 1002 ¶ 83. The middle portion of Figure 5 also
includes an indicator of “Position/Volume (ml),” which is understood to
reflect movement of the syringe position in real-time. See id. Mukherjee
2012 further describes its system as including a “Hall effect sensor along
with a permanent magnet” that “sense the position of the syringe piston
relative to the syringe body.” Id. at 450 (Abstract). Additionally,
Mukherjee 2012 explains the following:
As the piston is moved, the distance between the Hall sensor and
the magnets change. Thus the magnetic field strength
experienced by the Hall sensor changes according to the position
of the piston in relation to the syringe body. As a result the output
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of the Hall sensor is a function of the piston position and in turn,
the volume of liquid expelled in ml.
Id. at 452 (Measurement Scheme).
We also take note of Dr. Mukherjee’s credible testimony, for
example, that “displaying the dynamic position of the syringe plunger in real
time as taught by Mukherjee 2012 would provide the trainee with feedback
as to the trainee’s injection technique, particularly as to the rate of
injection.” Ex. 1002 ¶ 135. It further is clear from the record at hand,
including Samosky’s Figures 14A and 14B, that real-time digital display of
syringe components, such as needle tip position, during an injection
procedure was known. See also id. (“Samosky illustrates the benefits of
providing a depiction of the needle position, as well as the utility of
monitoring whether the plunger of a syringe has been pulled back or
pushed” (citing Ex. 1004 ¶¶ 50, 74)).
Patent Owner characterizes Figure 5 of Mukjherjee 2012 as simply
being a “mathematical graph” that “does not provide a computer-generated
portrayal or likeness of the plunger.” PO Resp. 46. It is apparent from such
characterization that Patent Owner largely bases its argument on its claim
construction position that a “graphical depiction” must be a computer-
generated portrayal or likeness that excludes mathematical graphs. See, e.g.,
PO Resp. 46–47. As we have discussed above, however, that is a position
with which we do not agree.
Having reviewed the record, we conclude that Samosky’s teachings
along with those of the Mukherjee articles reasonably would have conveyed
to a skilled artisan that a virtual graphical display of a training injection
exercise shows the syringe’s plunger position in real-time. We, thus, are
persuaded that Petitioner, in relying on the teachings of Samosky and the
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Mukherjee articles, in particular Mukherjee 2012, demonstrates that a
graphical depiction that displays a dynamic position of a syringe plunger in
real-time does not distinguish claim 1 from the teachings of the prior art.
(5) Remaining Limitations of Claim 1
Petitioner persuasively explains where all of the limitations of claim 1
are found in the prior art, including those that have been discussed
specifically above. Pet. 29–65. Other than the limitations addressed above,
Patent Owner does not argue that any of the remaining limitations of claim 1
are absent from the prior art. In light of the record before us, we conclude
that Petitioner has demonstrated where all of the limitations of claim 1 are
found in the prior art.
(6) Reasons to Combine
Petitioner contends that one of ordinary skill in the art “would have
been motivated and had reason to combine the relevant teachings of
Samosky, Mukherjee 2014, and Mukherjee 2012 to arrive at the features of
the challenged claims.” Pet. 25. Petitioner characterizes the three references
as “analogous art” to the ’231 patent and that “[e]ach reference, like the
’231 patent, is directed to the same problem of providing a simulated
injection training system to reduce human error by practitioners.” Id.
Petitioner also contends that “a POSITA would have been motivated to
employ a simulated syringe in Samosky’s simulation-based training system
based on Mukherjee 2014 and Mukherjee 2012 in order to provide feedback
as to the rate of anesthesia being injected as a particular target site.” Id.
at 26 (citing Ex. 1002 ¶¶ 99–101, 111–112). Petitioner offers the following
additional reasoning:
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Further, a POSITA would have found it obvious to have
included with Samosky’s system a display of dynamic position
of the plunger in real time during a training exercise. See
EX1002, ¶¶102-104. For example, as shown above, Samosky,
Mukherjee 2012, and Mukherjee 2014 teach that it was well
known to display to a trainee information relating to injection
parameters, such as flow rate, to assist with training in real time
and to evaluate the trainee after conclusion of a training session.
Further, Mukherjee 2012 and Mukherjee 2014 each show that it
was known to display the dynamic position of the plunger
(specifically, the piston portion of the plunger) during an
injection exercise. Mukherjee 2014, p. 1; Mukherjee 2012,
p. 450.
Thus, displaying position of the plunger over time would
simply have involved the use of known techniques to improve a
known device to yield predictable results. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416-419 (2007); see EX1002,
¶¶94-104, 133-135. Notably, nothing in the ‘231 patent suggests
that there is any new or unexpected result associated with display
of plunger position in real time. In fact, the ‘231 patent fails to
describe how this result is achieved or even to illustrate that
feature in the drawings.
Samosky and Mukherjee 2014 show that it would have
been obvious to apply Samosky’s teachings to an application
involving a model of human facial features. As set forth above,
Samosky expressly states that its system and method may be used
for other procedures. See, e.g., Samosky, ¶¶34, 36, 38, 61, 63,
64. Mukherjee 2014 describes the benefits of a simulation based
training system for ocular anesthetic injection. Mukherjee 2014,
p. 1. Accordingly, a POSITA would have found it obvious to
apply Samosky’s position detection and training feedback
techniques to training procedures involving facial injection, and
would have had a reasonable expectation of success in doing so.
See EX1002, ¶¶94-104, 133-135.
Id. at 27–28.
Patent Owner initially focuses on the claim feature of “a dynamic
position of the plunger in real time,” and contends that one of ordinary skill
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in the art “would not have been motivated to modify Samosky in view of
Mukherjee 2014 and Mukherjee 2012 to arrive at this feature.” PO
Resp. 50. Pointing to a statement at page 44 of the Petition, Patent Owner
contends that “Petitioner merely relies on the claim limitation itself to allege
motivation to combine the asserted references.” Id. at 50–51 (quoting Paper
1, 44 (“[A] POSITA would have been motivated to display ‘a dynamic
position of the plunger in real time’ in order to provide this information to a
user during a training injection.”)). That contention, in our view, does not
adequately consider Petitioner’s expressed reasoning for combining the
teachings of the prior art. Patent Owner’s myopic focus on a single
statement in the Petition does not address adequately Petitioner’s analysis
(for instance, that which is reproduced above) that a person of ordinary skill
in the art would have had multiple reasons to combine the teachings of
Samosky and the Mukherjee articles.
Patent Owner also generally is of the view that the deposition
testimony of Dr. Mukherjee is inadequate to provide suitable reasons to
modify Samosky based on the teachings of the Mukherjee articles. PO
Resp. 51–53 (citing Ex. 2020, 92:18–93:22, 63:22–64:12, 76:2–73:11).
According to Patent Owner, “[n]either Petitioner nor its expert explain why
the proposed modification would provide better feedback to the user than
Samosky’s display.” PO Resp. 51. Patent Owner also contends Samosky
and Mukherjee 2014 have aspirator indicators that are “simple” or “easily
interpretable” and that “[a] person of skill would have no motivation to
convert this easy to interpret indicator to a graphical depiction of a dynamic
position of the plunger in real time.” Id. at 51–53.
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We find Patent Owner’s arguments unavailing. That Samosky’s and
Mukherjee 2014’s indicators may be “simple” or “easily interpretable” does
not mean that any modification is precluded. The prior art clearly sets forth
that it was known in the art that providing “real-time feedback” in
dispensing a therapeutic agent during a training exercise is desirable “[t]o
give the trainee a realistic training environment.” See, e.g., Ex. 1005, 1;
Ex. 1006, 450. It is also clear that one known mechanism for providing that
feedback is through real-time indication of the position of a syringe piston or
plunger during a training exercise. See Ex. 1006, 452, Fig. 5. We find
sufficiently persuasive and credible Petitioner’s and Dr. Mukherjee’s views
that the desire to provide that feedback provides adequate reason to
implement display of the dynamic position of a syringe plunger in real-time
into other types of known virtual training simulations, such as that of
Samosky, so as to enhance the training experience. See Pet. 25–28 (citing
various paragraphs of Ex. 1002 (Mukherjee Declaration)).
We find that Patent Owner’s arguments and Dr. Pugh’s testimony
(e.g., PO Resp. 50–55; Ex. 2005 ¶¶ 34–36, 97–105, 108) do not
appropriately take into account what a skilled artisan would have regarded as
clear and adequate reason to combine the teachings of the prior art, and
specifically to implement the display of a dynamic position of a plunger into
a virtual training simulation. We conclude that the record conveys adequate
reason to combine the teachings of Samosky, Mukherjee 2014, and
Mukherjee 2012.
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(7) Reasonable Expectation of Success
Patent Owner contends that a person of ordinary skill in the art
“would not have had a reasonable expectation of success in combining
Samosky, Mukherjee 2014, and Mukherjee 2012 to display a graphical
depiction including ‘a dynamic position of the plunger in real time.’” PO
Resp. 55. Patent Owner bases that contention on the theory that Dr.
Mukherjee has offered insufficient evidence “that a person of skill would
have been able to turn the two-dimensional graphs, such as shown in
Figure 5 in Mukherjee 2012, into a three-dimensional display of a dynamic
position of a syringe plunger in combination with a three-dimensional model
of the anatomically-shaped apparatus.” Id. at 55–56. We discern, however,
that Dr. Mukherjee bases his testimony concerning the “dynamic position of
the plunger in real time” claim feature on disclosure in each of Samosky,
Mukherjee 2012, and Mukherjee 2014. See Ex. 1002 ¶¶ 133–135 (citing
Mukherjee 2014 (Ex. 1005) § II, p. 2; Mukherjee 2012 (Ex. 1006) Fig. 5,
452; Samosky (Ex. 1004) ¶¶ 50, 74).
Taken together, those references describe, among other things:
(1) displaying a syringe plunger position in real time (e.g., Ex. 1005 § II, 2;
Ex. 1006, Fig. 5, 452); (2) tracking of syringe needle trajectory as a part of a
three-dimensional display (see, e.g., Ex. 1004, Figs. 14A, 14B, ¶ 74); and
(3) simulation based training for medical procedures that incorporates a
physical model and an associated three-dimensional virtual model (see, e.g.,
Ex. 1004 ¶¶ 31, 38, 39). Moreover, in connection with a discussion of “a
digital three-dimensional model of the syringe,” Dr. Mukherjee also points
to disclosure of Samosky at Figs. 15, 16A, and 16B, and paragraph 83.
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Ex. 1002 ¶ 167.18 Paragraph 83 of Samosky describes, in part, the
following:
A laryngoscope was fitted with the tracking sensor attached via
a custom-made adapter to the end of the hand, and a 3D model
of the laryngoscope was generated, as can be seen in the display
in FIG. 15. The system was able to display a “target” position for
the laryngoscope—set, for example, by a clinical teacher. As
seen in FIG.16, a learner or user of the system can see both the
fixed, target laryngoscope position, rendered as a 3D virtual
laryngoscope on a computer display, and a current, “live”
laryngoscope position. As the live laryngoscope is aligned to the
target position, positional error metrics can be displayed as visual
cues (e.g., color coded, etc.) to guide the user. When the
positional error drops below a preset threshold, a visual alert and
audio tone can signal the user that he or she has successfully
targeted the reference position. Although this prototype related
specifically to a laryngoscope, this technique can be applied to
any tool or device and can permit both quantification of proper
manipulation and visual feedback to guide a learner to achieving
correct target positioning.
Ex. 1004 ¶ 83.
Thus, Samosky describes a system in which a “user of the system can
see a fixed, target laryngoscope, rendered as a 3D virtual laryngoscope on a
computer display and a current ‘live’ laryngoscope position.” Id. Samosky
also describes that the disclosed “technique” may be applied to any tool or
device to facilitate the goal of providing “proper manipulation and visual
feedback.” Id. It follows readily from the teachings of the prior art that a
skilled artisan would have recognized a syringe as the type of device ripe for
application of the noted technique in connection with an injection procedure
to harness the state benefits of “proper manipulation and visual feedback.”

18 Referenced on page 58 of the Petition.
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Relying on the testimony of Dr. Pugh, Patent Owner argues that “it
was not well-known for simulation-based medical training systems to
display a three-dimensional real time animation of an interaction of a syringe
and an anatomical model, in which the plunger of the digital three-
dimensional model of the syringe moves according to the dynamic position
of the plunger in real time.” PO Resp. 56 (citing Ex. 2005 ¶ 109). That
argument is misplaced, however, because, even accepting Dr. Pugh’s
testimony as true, claim 1 does not require an “animation” or a “digital
three-dimensional model of the syringe.” Furthermore, Dr. Pugh offers no
more than general and unsupported statements as to what was well-known.
Dr. Pugh does not cite to any tangible or credible evidence that substantiates
this testimony. See Ex. 2005 ¶ 109.
Dr. Pugh also opines, without citing supporting evidence, that the
“LabVIEW . . . virtual instrument GUI” of the Mukherjee articles would be
incapable of a “three-dimensional rendering of the dynamic movement of
the syringe plunger” that is displayed in real time. See Ex. 2005 ¶ 110; see
also PO Resp. 56–57 (relying solely on Ex. 2005 ¶ 110). Yet, even if true,
claim 1 does not require a “three-dimensional rendering” of the dynamic
movement of the syringe plunger.
Moreover, Patent Owner’s own assessment of the level of ordinary
skill in the art conveys that such person has a degree in “Electrical
Engineering, Biomedical Engineering, or any similar type of engineering or
biomedical degree” and also has “at least one year experience in designing
sensor-based motion tracking and simulators for evaluating clinical
performances.” See PO Resp. 20–21. It is difficult to reconcile Patent
Owner’s and Dr. Pugh’s view that a skilled artisan with such a background
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would have found it beyond their skill to implement an approach of
displaying real-time data as a part of a three-dimensional rendering,
particularly given the evidentiary record at hand that includes the teachings
of Samosky, Mukherjee 2012, and Mukherjee 2014.
We have considered Patent Owner’s arguments suggesting that a
person of ordinary skill in the art would not have had a reasonable
expectation of success in combining the teachings of the prior art, including
Samosky, Mukherjee 2012, and Mukherjee 2014. We, however, find them
unavailing.
(8) Conclusion—Claim 1
In light of the record that has been developed during trial, including
the parties’ filings and the underlying supporting evidence, we conclude that
Petitioner has shown: (1) where all the features of claim 1 are found in the
prior art, specifically Samosky, Mukherjee 2012, and Mukherjee 2014; (2)
that a person of ordinary skill in the art would have had adequate reasons to
combine the teachings of Samosky, Mukherjee 2012, and Mukherjee 2014;
and (3) a person of ordinary skill in the art would have had a reasonable
expectation of success in so combining those teachings. Accordingly, we
conclude that Petitioner has shown by a preponderance of the evidence that
claim 1 would have been unpatentable over the combined teachings of
Samosky, Mukherjee 2014, and Mukherjee 2012.
b) Claim 6
Petitioner also contends that claim 6 is unpatentable over Samosky,
Mukherjee 2014, and Mukherjee 2012. Pet. 49–59. Claim 6 is drawn to a
“method to analyze a collection of injection training data using one or more
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signal processors of an injection training system having an anatomically-
shaped apparatus and a syringe[.]” Claim 6 includes many of the same or
similar features as claim 1 including an “outputting” step. That outputting
step is reproduced below:
outputting from the one or more signal processors, for displaying
on a display device during and/or after the training injection, a
graphical depiction of the training injection, wherein the graphic
depiction includes a digital three-dimensional model of the
anatomically-shaped apparatus, a digital three-dimensional
model of the syringe, a dynamic position of the plunger in real
time, and a location of the needle relative to the digital three-
dimensional model of the anatomically-shaped apparatus, the
digital three-dimensional model of the anatomically-shaped
apparatus comprising a plurality of anatomical layers.
Ex. 1001, 35:30–41.
Thus, claim 6, like claim 1, requires: (1) “a graphical depiction of the
training injection” (corresponding to limitation [ix] of claim 1); (2) “wherein
the graphic depiction includes a digital three-dimensional model of the
anatomically-shaped apparatus” (corresponding to limitation [x] of claim 1);
(3) “a location of the needle relative to the digital three-dimensional model
of the anatomically-shaped apparatus” (corresponding to limitation [xi] of
claim 1; and (4) “a dynamic position of the plunger in real time”
(corresponding to limitation [xii] of claim 1). For the same reasons
discussed above with respect to claim 1, we conclude that Petitioner has
accounted adequately for those features in the prior art.
Unlike claim 1, the outputting step of claim 6 expressly recites a
“three-dimensional model of the syringe.” Patent Owner disputes that the
requirement is described or suggested by the prior art teachings of Samosky,
Mukherjee 2014, and Mukherjee 2012.
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With respect to the above-noted requirement, Petitioner focuses on
disclosure in Samosky as to discussion, in the context of a virtual training
procedure, of providing a laryngoscope position “rendered as a 3D virtual
laryngoscope,” and also providing such rendering for other devices. Pet.
58–59 (citing Ex. 1004 ¶ 83). Petitioner reasons the following:
A POSITA would have understood that the “virtual” instrument
would be based on a virtual model of an actual instrument,
utilizing known techniques, such as described by Samosky with
respect to the virtual model of the training apparatus. See
[Ex. 1004 ¶ 83], ¶¶ 31, 32; see also EX1002 ¶167. A POSITA
would have recognized the benefit of displaying other types of
virtual instruments, such as an injection syringe. See EX1002
¶¶ 40, 167.
Pet. 58.
We find Petitioner’s reasoning persuasive. We also credit
Dr. Mukherjee’s testimony in that regard (e.g., Ex. 1002 ¶¶ 40, 167). It is
clear from record evidence, including, for instance, Samosky’s paragraph 83,
that it was known in the art to display “virtual” instruments in the form of a
three-dimensional rendering of the instrument. It also is abundantly clear
that an injection syringe is a known device employed in training simulations.
See, e.g., Ex. 1004 ¶¶ 66–67; Ex. 1005, Fig. 2; Ex. 1006, 450. Whether any
of the prior art references expressly discloses a three-dimensional model of a
syringe is not dispositive, where, as here, the question is one of obviousness.
Indeed, in an obviousness analysis, it is not necessary to find precise
teachings in the prior art directed to the specific subject matter claimed
because inferences and creative steps that a person of ordinary skill in the art
would employ can be taken into account. KSR, 550 U.S. 418 (2007). In this
case, it is a ready inference from the record that an injection syringe is the
type of device contemplated by Samosky as being suitable to be displayed as
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a virtual instrument via three-dimensional rendering in a training simulation.
See, e.g., Ex. 1004 ¶ 83, ¶¶ 31, 32; Ex. 1002 ¶¶ 40, 167.
Furthermore, we agree with Petitioner that although claim 6 recites
each of “a dynamic position of the plunger” and a “three-dimensional model
of the syringe,” there is no requirement of “a three-dimensional depiction
that shows both a syringe and movement of the plunger.” Pet. Reply 14.
With respect to what claim 6 does require, the record includes ample
evidence that providing and displaying real-time information to a user
during a training procedure (see generally Exs. 1004, 1005, 1006) and also
presenting virtual three-dimensional images as a part of such training (see,
e.g., Ex. 1004, Figs 14A, 14B ¶¶ 31, 39, 74, 83) were known in the art. The
record reasonably conveys that a skilled artisan would have contemplated
providing such real-time information in connection with a dynamic three-
dimensional image. See, e.g., Ex. 1002 ¶¶ 135–137. The record suggests
that such is true even if the implementation is “difficult and computationally
complex” as is urged by Patent Owner. See, e.g., PO Sur-reply 20 (citing
Ex. 2005 ¶ 119). We share Petitioner’s view that it is notable that, despite
what Patent Owner and Dr. Pugh characterize as “difficult” in nature, the
’231 patent itself provides little, if any, explanation or guidance as to the
specifics of overcoming such difficulty. See Pet. Reply 12–14. That such
explanation is omitted as being unnecessary in the ’231 patent does not lend
itself to a conclusion that addressing such issues would have been outside of,
or beyond, the skill of a person of ordinary skill in the art.
For the reasons set forth above, we conclude that Petitioner has
accounted adequately in the prior art for the recitation in claim 6 of a “three-
dimensional model of the syringe.” We further conclude that Petitioner has
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shown adequately where all other features of claim 6 are found in the prior
art. See Pet. 49–59.
Accordingly, as with claim 1, we conclude that Petitioner has shown:
(1) where all the features of claim 6 are found in the prior art, specifically
Samosky, Mukherjee 2012, and Mukherjee 2014; (2) that a person of
ordinary skill in the art would have had adequate reasons to combine the
teachings of Samosky, Mukherjee 2012, and Mukherjee 2014; and (3) a
person of ordinary skill in the art would have had a reasonable expectation
of success in so combining those teachings. Accordingly, we conclude that
Petitioner has shown by a preponderance of the evidence that claim 6 would
have been unpatentable over the combined teachings of Samosky,
Mukherjee 2014, and Mukerjee 2012.
c) Claim 17
Claim 17 depends from claim 6. Claim 6 includes a requirement that
the three-dimensional model of the anatomically-shaped apparatus includes
“a plurality of anatomic layers.” Ex. 1001, 35:39–41. Claim 17 adds the
following “[w]herein altering the view of the training injection comprises
causing to be displayed different ones of the plurality of anatomical layers as
a needle tip of the syringe penetrates each one of the anatomical layers.” Id.
at 37:8–12.
With respect to claim 6 and its “anatomical layers” requirement, the
Petition set forth the following:
In particular, Samosky discloses that “[t]he virtual anatomic
model 104 can be a 3D model and can virtually represent the
anatomical region corresponding to the physical anatomic model
102, and can comprise information associating or co-registering
anatomical features or tissue types (e.g., blood vessels, nerves,
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etc.) with locations in the physical anatomic model 102.”
[Ex. 1004], ¶40. Samosky further discloses “showing an internal
view of the four layers of the physical model of the arm—skin at
1102, fat at 1104, fascia [connective tissue] at 1106, and soft
tissue (muscle) at 1108—along with the bone structure 1110.”
Id., ¶70. Samosky further discloses simulating a nerve-block
procedure with a model that “utilized a translucent cylindrical
silicone phantom cylindrical phantom ‘limb’ 502 and
corresponding virtual model.” Id., ¶65. Thus, Samosky
demonstrates that it was known to create a virtual model that
includes various anatomical layers. See also EX1002, ¶172.
Pet. 60.19
Thus, Petitioner relies on Samosky’s disclosure that its virtual model
may be a three-dimensional model that corresponds to a physical model.
Petitioner also points to Samosky’s disclosure that the physical model may
incorporate multiple “layers” and that the virtual model is “co-register[ed]”
to the physical model. Id.; see also Ex. 1004 ¶ 70 (“Nerves, blood vessels,
fascia, skin, and other relevant anatomy were segmented . . . to create a
virtual model that was registered to the physical model to track needle
distance.”).
With respect to claim 17, the Petition expresses the following:
Samosky discloses that “details of both the physical
anatomic model 102 and the virtual anatomic model 104 will
vary.” Samosky, ¶40. Samosky further discloses that a
determined “response of the physical anatomic model 102,
virtual anatomic model 104, or clinical instruments 106” can
include “changes in the virtual anatomic model 104.” Id., ¶45.
Samosky further discloses that an instructor interface
shows the “current tissue type the needle is located in (air, tissue,
vessel, nerve, bone).” Samosky, ¶67. Samosky discloses

19 The quoted portion comes from the Petition addressing claim 11, but is
referenced in connection with the corresponding feature of claim 6. See
Pet. 59.
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providing “indicators identifying the anatomical feature (e.g.,
tissue type or structure, etc.) at the current needle tip location (the
color-coded indicators to the left in FIG. 8)” and that “other
indicators can display the volume of fluid that has been injected
into each tissue type (shown in FIG. 8 via the gray indicators).”
Id., ¶66. At least because the interface depicts the “current” tissue
type that a needle is located in, Samosky teaches display of the
anatomical layer as the needle penetrates that layer during
training injection. See EX1002, ¶¶175-176.
Pet. 61–62.
Thus, Petitioner points to Samosky’s teachings concerning a virtual
model coupled with other of Samosky’s teachings pertaining to “indicators
identifying the anatomical feature (e.g., tissue type or structure, etc.) at the
current needle tip location (the color-coded indicators to the left in FIG.
8).” Id.
Patent Owner disputes that Samosky’s teachings account for the
requirements of claim 17. According to Patent Owner, Petitioner is
combining multiple embodiments of Samosky and has not explained
adequately how those embodiments are being combined. See PO
Resp. 62–65; PO Sur-reply 13–14.
We are not satisfied that Patent Owner accounts adequately for what
Samosky’s teachings would have suggested to one of ordinary skill in the
art. Samosky is clear in its teachings of a virtual model that is structured to
mimic a physical model that includes multiple anatomical “layers,” e.g.,
tissue, blood vessels, nerves, and bones. Samosky is also clear in its
teachings of using “indicators” to convey real-time information to a user
engaged in a training exercise as to the “current” location of a needle tip in
relation to a given layer. See Ex. 1004 ¶ 66. Although Samosky discusses
those “indicators” in the context of the instructor interface panel of Figure 8,
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which is not itself a virtual model of an anatomic region (see Ex. 1004 ¶ 66),
Samosky does not limit its teachings pertaining to needle tip location solely
to Figure 8. Given Samosky’s disclosures of a “virtual model” of anatomic
layers of a physical model and the recognized usefulness of providing
current needle tip location with respect to those layers, a person of ordinary
skill and creativity would have reasonably inferred that information of the
needle tip location is associated with the virtual model. See, e.g., Ex. 1002
¶ 176.
We agree with Petitioner that Patent Owner does not appropriately
consider the full nature of Samosky’s teachings when it comes to the
technological disclosure of a physical-virtual model based training system.
See Pet. Reply 9–10. A prior art reference must be considered for
everything it teaches by way of technology. See EWP Corp. v. Reliance
Universal Inc., 755 F.2d 898, 907 (Fed. Cir. 1985). In our view, Petitioner’s
position is better aligned with what a person of ordinary skill in the art
would have understood from the full nature of Samosky’s teachings. We
further agree with the following assessment offered by Petitioner:
Samosky explains that “FIGS. 5 through 8 tracked the replica
ultrasound probe and the needle tip, and the student or trainee
interface or application was capable of displaying the virtual
ultrasound image that corresponds to the cylindrical phantom
anatomy and calculating the needle to nearest target nerve
distance (which was also displayed on the screen).” EX1004,
¶67. If the phantom anatomy data is “cylindrical”—i.e., three
dimensional—the virtual ultrasound image is also
cylindrical/three-dimensional. This is consistent with Samosky’s
indication that the virtual ultrasound image may be derived from
“3D ultrasound data.” See, id., ¶¶31, 67. Nerves and tissue are
three-dimensional structures. Thus, to provide “needle to nerve
distance” and “current tissue type the needle tip is located in,”
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the location of the needle in Samosky must be tracked relative to
the digital three-dimensional model of the anatomically-shaped
apparatus, e.g., as shown in Figure 14. Id., ¶74. Thus, contrary to
Truinject’s assertions, there is no need to “explain how the
indicators shown in Figure 8 of Samosky could be combined with
a three-dimensional model of the anatomically shaped
apparatus.” Samosky already does this.
Pet. Reply 9–10.
Accordingly, we conclude that Petitioner has shown by a
preponderance of the evidence that claim 17 would have been unpatentable
over Samosky, Mukherjee 2014, and Mukherjee 2012.
d) Claims 23 and 24
Claim 23 depends from claim 1 and claim 24 depends from claim 6.
Each of claim 23 and claim 24 adds the following feature: “wherein the
graphical depiction further comprises a simulated delivery of therapeutic
agent to the digital three-dimensional model of the anatomically-shaped
apparatus.” Ex. 1001, 38:14–21. The Petition sets forth the following with
respect to that feature:
Samosky teaches “provid[ing] a ‘bull’s-eye’ visualization
of the needle tip approaching the nerve.” Samosky, ¶67.
Samosky further discloses providing indicators to “display the
volume of fluid that has been injected into each tissue type” (id.,
¶66.), and Figs. 7-8 depict example displays including a distance
to nerve (id., Figs. 7-8) and whether a plunger is pulled or pushed
back (id., Fig. 8). These portions of Samosky thus teach “the
graphical depiction further comprises a simulated delivery of
therapeutic agent to the digital three-dimensional model of the
anatomically-shaped apparatus.” See EX1002, ¶180.
Further, Mukherjee 2014 shows, in Fig. 12, a graphical
user interface depicting a syringe being inserted into an eyeball
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for a simulated delivery. Mukherjee 2014, Fig. 12; see EX1002,
¶181.
Pet. 64.
Thus, Petitioner points to disclosure in Samosky as to displaying:
(1) fluid volume that has been injected; (2) distance to nerve information;
and (3) the positioning of a plunger, i.e. pulled or pushed back. In its
Petitioner Reply, Petitioner additionally expresses that “[t]hese three
parameters—volume of injected fluid, distance from needle tip to nerve, and
whether the plunger is pulled or pushed back—sufficiently define a
simulated delivery of therapeutic agent.” Pet. 24 (citing Ex. 1002 ¶ 180).
Petitioner and Dr. Mukherjee (Ex. 1002 ¶ 181) also characterize Mukherjee
2014’s Figure 12 as showing a syringe inserted into an eyeball for simulated
delivery. Id.
Patent Owner contends that Petitioner has mischaracterized
Samosky’s Figures 7 and 8 and its teachings with respect to those figures.
PO Resp. 65; see PO Sur-reply 24–25. According to Patent Owner, neither
of those figures “shows a computer generated portrayal or likeness of a
therapeutic agent.” PO Resp. 65; PO Sur-reply 25. Patent Owner also
argues that neither figure shows a three-dimensional image of a virtual
model (each being allegedly limited to a “two dimensional image”), and thus
cannot convey “a simulated delivery of therapeutic agent to the digital three-
dimensional model of the anatomically-shaped apparatus.” PO Resp. 66–67;
see PO Sur-reply 25–26 (citing Ex. 2005 ¶ 130) (emphasis omitted). Lastly,
Patent Owner discounts Petitioner’s and Dr. Mukherjee’s assessment as to
what is shown in Figure 12 of Mukherjee 2014. Id. at 67–69.
Initially, we note that Patent Owner appears, in part, to premise its
argument on the requirement that a “graphical depiction” be a “computer
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generated portrayal or likeness.” That is a premise with which we do not
agree. See supra, § II.A.1. In any event, as we have discussed above, we
do not conclude that Samosky limits its teachings, or any of its figures,
strictly to two-dimensional images. See, e.g., supra, § II.B.4.c. We, thus, do
not find persuasive Patent Owner’s arguments and Dr. Pugh’s testimony
(e.g., Ex. 2005 ¶ 130) that attempts to minimize aspects of Samosky’s
teachings as being limited to two-dimensional images. Rather, the record
establishes that Samosky contemplates a three-dimensional virtual model,
and also three-dimensional simulated devices, as a part of its physical-virtual
training simulation. See, e.g., Ex. 1004 ¶¶ 31, 39, 83.
Samosky also clearly provides that “indicators can display the volume
of fluid that has been injected into each tissue type.” Id. ¶ 66. In the
Petitioner Reply, Petitioner additionally notes the following:
Samosky states, with reference to Figure 8, “[v]olume and
location of fluid injected was displayed on the instructor
interface, although in other embodiments, the measured injected
fluid volume can be used to provide feedback in other manners,
such as using it as a real-time input parameter to model a
visible bolus of fluid in the vicinity of the needle tip on the
simulated ultrasound display.
Pet. Reply 24 (quoting Ex. 1004 ¶ 67).
Thus, Samosky clearly contemplates modeling of injected fluid as a
part of a simulated display. It follows readily that a skilled artisan would
have regarded simulated delivery of a therapeutic agent as being
encompassed as a part of Samosky’s disclosed physical-virtual training
simulation. Also, as discussed above, we conclude that a person of ordinary
skill in the art would have recognized that such simulation incorporates
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delivery of therapeutic agent as a part of a three-dimensional virtual model
including a three-dimensional model of a syringe.20
We are cognizant of Patent Owner’s contention that, with respect to
page 24 of the Reply, “Petitioner did not present the argument in the
Petition,” and that it is “newly raised argument.” PO Sur-reply 25–26. We,
however, view it as a permissible reply argument (see 37 C.F.R. § 42.23(b))
made in response to Patent Owner’s contentions in the Patent Owner
Response as to proposed inadequacies in Samosky’s teachings, because the
argument points to teachings of Samosky that are consistent with disclosures
that Petitioner relied on in the Petition. Indeed, as generally discussed in this
Decision, throughout the Petition, Petitioner relies on Samosky’s teachings
pertaining to its physical-virtual simulation based training that encompasses
a three-dimensional model of anatomy derived from a medical imaging scan
and three-dimensional modeling of devices or tools, which includes injection
syringes. See, e.g., Pet. 14–18 (citing, among other content, Ex. 1004 ¶¶ 7,
31, 55, 65 66, 67, 74); id. at 41–42 (citing Ex. 1004 ¶ 31); id. at 58 (citing
Ex. 1004 ¶¶ 31, 32, 83); id. at 61–62 (citing Ex. 1004 ¶¶ 40, 45, 66, 67).
Furthermore, Patent Owner had opportunity to address Petitioner’s
Reply Brief as a part of its Sur-reply, and did so. According to Patent
Owner, “even if considered,” the content of Samosky identified at page 24
of the Reply does not establish that Samosky’s Figure 7 discloses the
requirements of claims 23 and 24 including a “digital three-dimensional
model of the anatomically-shaped apparatus” or “a simulated delivery of the

20 We note, however, that when it comes to claim 23, as we discussed in
connection with claim construction, there is no requirement of a “three-
dimensional syringe.”
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therapeutic agent to the digital three-dimensional model of the anatomically-
shaped apparatus.” PO Sur-reply 25–26. Yet, as discussed above, we
conclude that Petitioner does not rely solely on Samosky’s Figure 7 in that
respect. Instead, Petitioner’s reliance is more broadly premised on that
figure taken in the context of Samosky’s overall disclosure as to its physical-
virtual simulation device, and also in combination with the teachings of the
Mukherjee articles.
In our view, given the extent of the evidentiary record, and what a
person of ordinary skill in the art would have reasonably understood from
that record, we cannot conclude that a “graphical depiction” of “a simulated
delivery of therapeutic agent to the digital three-dimensional model of the
anatomically-shaped apparatus” establishes a distinction over the prior art.
We credit Dr. Mukherjee’s testimony to that effect (Ex. 1002 ¶¶ 180, 181),
as it is consistent with what a skilled artisan would have understood from the
full extent of the teachings of the prior art, including Samosky’s teachings.
We conclude that Petitioner has shown by a preponderance of the
evidence that claims 23 and 24 would have been unpatentable over
Samosky, Mukherjee2014, and Mukherjee 2012.
e) Claims 3, 4, 10, 11, 15, 18, 21, and 22
We have reviewed the Petition with respect to all the limitations
required by claims 3, 4, 10, 11, 15, 18, 21, and 22. See Pet. 46–49, 59–64.
Patent Owner does not offer any arguments directed specifically to those
claims. We determine that Petitioner has shown where all the limitations of
those claims are found in Samosky and the Mukherjee articles. See id. We
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also conclude that Petitioner has shown by a preponderance of the evidence
that those claims are unpatentable.
5. Other Grounds
Petitioner also challenges the patentability of (1) claim 12 based on
Samosky, Mukherjee 2014, Mukherjee 2012, and Toly, and (2) claims 16
and 19 based on Samosky, Mukherjee 2014, Mukherjee 2012, Lampotang,
and Sinclair. Pet. 65–69. Patent Owner does not present any arguments
directed specifically to either of those grounds, or any of claims 12, 16,
and 19.21 Rather, Patent Owner simply references its arguments as to
claims 1 and 6. See PO Resp. 69–70. As discussed above, we do not find
those arguments availing. In considering the record before us, we find
Petitioner’s showing for both of the noted grounds to be persuasive. See Pet.
65–69. Accordingly, we conclude that Petitioner has shown by a
preponderance of the evidence that claims 12, 16, and 19 are unpatentable.

21 Claims 12 and 16 depend from claim 6. Claim 19 depends from claim 1.
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III. CONCLUSION22
For the foregoing reasons, we conclude that Petitioner has met its
burden to show by a preponderance of the evidence that claims 1, 3, 4, 6,
10–12, 15–19, and 21–24 are unpatentable over the prior art.
In summary,
Claims
35
U.S.C. §
Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1, 3, 4, 6,
10, 11, 15,
17, 18,
21–24
103
Samosky,
Mukherjee 2014,
Mukherjee 2012
1, 3, 4, 6, 10,
11, 15, 17, 18,
21–24

12 103
Samosky,
Mukherjee 2014,
Mukherjee 2012,
Toly
12
16, 19 103
Samosky,
Mukherjee 2014,
Mukherjee 2012.
Lampotang,
Sinclair
16, 19

22 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).
IPR2020-00935
Patent 10,290,231 B2

57
Claims
35
U.S.C. §
Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
Overall Outcome
1, 3, 4, 6,
10–12, 15–19,
21–24

IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioner has shown by a preponderance of the
evidence that claims 1, 3, 4, 6, 10–12, 15–19, and 21–24 of the ’231 patent
are unpatentable; and
FURTHER ORDERED because this is a final written decision, the
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.
IPR2020-00935
Patent 10,290,231 B2

58
PETITIONER:
George C. Beck
Stephen B. Maebius
Chase J. Brill
FOLEY & LARDNER LLP
gbeck@foley.com
smaebius@foley.com
cbrill@foley.com

PATENT OWNER:

Benjamin Everton
Shannon Lam
KNOBBE, MARTENS, OLSON & BEAR, LLP
2bje@knobbe.com
2sxl@knobbe.com