Truinject Corp.

Patent Trials and Appeals Board

Nov 15, 2021

IPR2020-00937 (P.T.A.B. Nov. 15, 2021)

trials@uspto.gov Paper 28
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.
____________

IPR2020-00937
Patent 10,290,232 B2
____________

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

COCKS, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining No 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, 6–16, and 20–26 (“the challenged claims”) of U.S. Patent
No. 10,290,232 B2 (Ex. 1001, “the ’232 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, 6–13, 15, 16, 20,
21, 24–26
103 Lampotang,2 Mukherjee 2014,3
Mukherjee 20124,5
4, 22, 23 103 Lampotang, Mukherjee 2014,
Mukherjee 2012, Dawson6

1 Petitioner relies on the Declaration of Biswarup Mukherjee, Ph.D.
(Ex. 1002) in support of the Petition.
2 US Patent Application Publication No. 2012/0280988 A1 published Nov.
8, 2012 (Ex. 1008, “Lampotang”).
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 US Patent Application Publication No. 2004/0234933 A1 published Nov.
25, 2004 (Ex. 1038, “Dawson”).
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Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
14 103 Lampotang, Mukherjee 2014,
Mukherjee 2012, Samosky7
Paper 11 (“Dec. on Inst.”).
Truinject Corp. (“Patent Owner” or “Truinject”) timely filed a Patent
Owner Response. Paper 14 (“PO Resp.”).8 Petitioner filed a Reply (Paper
18, “Pet. Reply”) to which Patent Owner filed a Sur-reply (Paper 20, “PO
Sur-reply”).
Oral argument was conducted on August 18, 2021. A transcript of the
oral argument appears in the record. Paper 27.9
For the reasons set forth below, we determine that Petitioner has not
shown by a preponderance of the evidence that any of the challenged claims
are unpatentable based on the grounds of unpatentability proposed by
Petitioner as a part of this proceeding. See 35 U.S.C. § 316(e).
B. Related Matters
The parties contend that the ’232 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 5, 1. The parties also reference

7 US Patent Application Publication No. 2013/0323700 A1 published Dec. 5,
2013 (Ex. 1004, “Samosky”).
8 Patent Owner relies on the Declaration of Dr. Carla M. Pugh (Ex. 2005) in
support of its Patent Owner Response.
9 A consolidated oral argument was held for both the present proceeding and
related proceeding IPR2020-00935 (“the ’935 IPR”).
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IPR2020-00042 involving U.S. Patent No. 9,792,836 (“the ’836 patent”) and
the ’935 IPR involving U.S. Patent No. 10,290,231 (“the ’231 patent”).10
Pet. 2; Paper 5, 1. Petitioner states that the ’836 patent and the ’231 patent
have been asserted in the Delaware Action. Pet. 2.
C. The ’232 Patent
The ’232 patent is titled “Automated Detection of Performance
Characteristics in an Injection Training System.” Ex. 1001, code (54). The
’232 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 1:36–38. 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 1:39–58. The ’232 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 2:6–28. The ’232 patent postulates that there is a need for
“effective, efficient, and extensible training injection systems, methods, and
devices.” Id. at 2:59–62. The Abstract of the ’232 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

10 Institution of inter partes review was denied in IPR2020-00042 on April
14, 2020. See IPR2020-00042, Paper 7. A Final Written Decision in
IPR2020-00935 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 ’232 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 Claim
Of the challenged claims, claims 1 and 20 are independent. Claim 1 is
illustrative and is reproduced below:
1. [i] An injection training system configured for training
of a facial injection technique, the system comprising:
[ii] a syringe having a syringe body and a plunger, the
plunger configured to move relative to the syringe body, the
syringe body comprising a proximal end and a distal end, the
syringe further comprising a flange portion disposed at or near
the proximal end, and a needle coupled to the distal end;
[iii] a training apparatus in the form of an anatomical
model of a human head configured to receive a facial training
injection performed by a user using the syringe, the training
apparatus comprising a layer of synthetic or simulated tissue, the
needle of the syringe configured to penetrate the layer of tissue;
[iv] a location sensing system including a first portion and
a second portion, the first portion and the second portion working
together to determine a position and orientation of the syringe
needle, the first portion coupled to the syringe and configured to
move with the syringe, the second portion being stationary
relative to the training apparatus, wherein at least one of the first
or second portion is at least configured to measure information
corresponding to characteristics of a magnetic field; and
[v] a processing unit in electrical communication with the
location sensing system, wherein the location sensing system is
configured to determine and transmit to the processing unit
information related to the position and orientation of the syringe
needle,
[vi] the processing unit configured to calculate the position
and orientation of the syringe needle relative to the training
apparatus, the determined position and orientation including at
least a depth and location of the injection associated with the
layer of tissue of the training apparatus, and
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[vii] the processing unit further configured to cause a
display device to display feedback on how the user performed in
the facial training injection, wherein the feedback comprises a
three-dimensional graphical depiction of the training injection
based at least in part on the calculated position and orientation of
the syringe relative to the training apparatus,
[viii] wherein the three-dimensional graphical depiction
comprises a digital model of the syringe and the digital model of
the training apparatus, the digital model of the training apparatus
comprising a plurality of different anatomical layers, [ix] the
three-dimensional graphical depiction further comprising a
simulated delivery of therapeutic agent to the digital model of the
training apparatus and a dynamic position of the plunger in real-
time.
Id. at 33:41–34:26 (with the Roman numerals i–ix added for ease of
discussion (see Pet. 31–32)).
II. ANALYSIS
A. Claim Construction
In the Petition, Petitioner did not offer any particular construction for
any claim term of the ’232 patent, and stated that we do not need to
expressly construe any claim term. See Pet. 18–19 (“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
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controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
Dec. on Inst. 16.
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 20), and (2) “a simulated
delivery of therapeutic agent to the digital three-dimensional model of the
anatomically-shaped apparatus” (claim 1). PO Resp. 17–21. In its Reply,
Petitioner offers its own views on the meaning of the above-noted claim
phrases. Pet. Reply 1–5. We address the noted claim phrases to the extent
necessary.
1. “three-dimensional graphical depiction of the training
injection”(claims 1 and 20)
At the outset, we note that the phrase “graphical depiction of the
training injection” is at issue in the related ’935 IPR, and in both that
proceeding and here, Patent Owner takes the view that such phrase excludes
mathematical graphs.11 In the ’935 IPR, the potential exclusion of
mathematical graphs merited discussion as the question of whether
Samosky’s mathematical graphs (Figures 14A and 14B) constituted
“graphical depictions” was potentially material to the outcome of that
proceeding. See IPR2020-00935, Paper 30, 8–11 (concluding that
“graphical depiction” does not exclude mathematical graphs). Here,

11 We note that the Specification in ’232 patent involved in this proceeding
is substantively identical to the Specification of the ’231 patent involved in
the ’935 IPR.
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however, we do not discern that the outcome of this proceeding depends on
whether or not a “graphical depiction” excludes mathematical graphs.
Accordingly, we consider it unnecessary to further address the above-noted
limitation as a part of this proceeding. See 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))).
2. “a simulated delivery of the therapeutic agent to the digital three-
dimensional model of the anatomically-shaped apparatus”
(claim 1)
Patent Owner represents the following:
As shown in the Joint Claim Construction Chart in the related
district court litigation, Petitioner and Truinject have agreed that
“a simulated delivery of therapeutic agent to the digital model of
the training apparatus” in the ’232 Patent should be given its
plain and ordinary meaning of “a simulated flow of therapeutic
agent delivered from the digital model of the syringe to the
digital model of the training apparatus.” Ex. 1011 at 7. Truinject
respectfully asks that the Board apply the same construction.
PO Resp. 21.
Thus, Patent Owner proposes a construction of the above-noted phrase
as “a simulated flow of therapeutic agent delivered from the digital model of
the syringe to the digital model of the training apparatus.” Petitioner
acknowledges that “the parties agreed to the construction of this term in the
Delaware Action. No further construction of the term is required.” Pet.
Reply 5.
In light of the parties’ mutually acknowledged agreement of the
meaning of the noted-term, and given that we do not see reason on the
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record before us to deviate from that meaning, we apply the same meaning
of “a simulated flow of therapeutic agent delivered from the digital model of
the syringe to the digital model of the training apparatus” to the noted claim
phrase and consider no further construction to be necessary.
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
’232 patent: (1) claims 1, 3, 6–13, 15, 16, 20, 21, and 24–26 as unpatentable
over Lampotang, Mukherjee 2014, and Mukherjee 2012; (2) claims 4, 22,
and 23 as unpatentable over Lampotang, Mukherjee 2014, Mukherjee 2012,
and Dawson; and (3) claim 14 as unpatentable over Lampotang, Mukherjee
2014, Mukherjee 2012, and Samosky.
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 said 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
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nonobviousness, i.e., secondary considerations. See Graham v. John Deere
Co., 383 U.S. 1, 17–18 (1966).
2. Level of Ordinary Skill in the Art
Petitioner offers the following assessment with respect to the level of
ordinary skill in the art:
The prior art discussed below and the declaration of Dr.
Mukherjee (EX1002) demonstrate that a person of ordinary skill
in the art (“POSITA”) as of the earliest claimed priority date of
March 13, 2014[,] would have had at least a master’s degree in
electrical engineering, robotics engineering, mechatronics, or a
similar field. EX1002, ¶21. Alternatively, a POSITA may have
had a lesser degree in one of those fields, but accompanied by
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., ¶22. 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. 17–18.
Patent Owner offers the following assessment of the level of ordinary
skill in the art:
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A person of ordinary skill in the art at the time of the
effective filing date of the application that led to the ’232 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.
PO Resp. 16.
Although noting that its assessment of the level of skill in the art
“differs from that proposed by Petitioner, Patent Owner believes the
difference is immaterial to deciding the issues raised by the Petition.” Id.
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) 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
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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).
Lampotang also describes that its system is an “interactive combined
physical and virtual (i.e., mixed) system,” and incorporates “a patient
mannequin, a tool and/or instrument to interact with the patient mannequin,
and a virtual model of internal anatomy that can be associated with the
patient mannequin and instantiated on a display.” Id. ¶¶ 12, 15.
Lampotang’s Figure 2 is reproduced below:

Figure 2 above “shows a representation of an interactive mixed simulator
system that can be used for the simulation of inserting a needle into a proper
vessel.” Id. ¶ 78. The system includes “physical model 201,”
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“instrument 202,” “display 203,” “virtual model 204,” and “virtual
instrument 222.” Id.
Lampotang’s Figure 3 is reproduced below:

Figure 3 above “shows a syringe instrument according to one embodiment of
the invention.” Syringe 300 can include electromagnetic tracking sensor 40
at needle 301. Id. ¶ 91. One or more LEDs 45 that are, for example, red or
blue can be included on the plunger. Id. Lampotang describes:
During conducting of a central venous access a user is
usually pulling back on the plunger of a syringe. If the needle tip
is in tissue, the plunger cannot be pulled back. If the needle tip
is in the artery or vein, the plunger can be pulled back and red
(oxygenated) or blue (de-oxygenated) blood is aspirated
respectively. . . . The red or blue blood flashback can be
simulated with red or blue LEDs that light up or by allowing red
or blue colored water to enter the syringe.
Id. ¶ 89.
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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.
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
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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.
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 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) Dawson
Dawson is titled “Medical Procedure Training System.” Ex. 1038,
code (54). Dawson’s Abstract is reproduced below:
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A medical procedure training system includes a
mannequin having internal and external anatomical
characteristics, such as body contour and organs, derived from
medical imaging of an actual patient. The system can includes
[sic] an instrument tracking system for monitoring the position
of an instrument in relation to the mannequin anatomical
components, which can be registered in relation to a reference
point.
Id. at code (57).
e) 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.
4. Ground Based on Lampotang, Mukherjee 2014, Mukherjee 2012
Petitioner contends that claims 1, 3, 6–13, 15, 16, 20, 21, and 24–26
of the ’232 patent are unpatentable based on the combined teachings of
Lampotang, Mukherjee 2014, and Mukherjee 2012. See Pet. 33–65.
Petitioner also reasons that a person of ordinary skill in the art would have
had adequate reason to combine the teachings of the above-noted references.
Id. at 28–31. Patent Owner disagrees with Petitioner. Patent Owner argues
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that the cited prior art is missing certain features of the challenged claims,
focusing particularly on independent claims 1 and 20. PO Resp. 23–33, 37–
40; PO Sur-reply 5–9, 13–16. Patent Owner additionally contends that
features required by claim 9 are also absent from the prior art. PO Resp. 45–
47; PO Sur-reply 16–18. Patent Owner also disputes that a skilled artisan
would have had reason to combine Lampotang and the Mukherjee articles.
PO Resp. 33–37, 40–45; PO Sur-reply 9–13.
a) Claim 1
As to the proposed missing features of claim 1, Patent Owner focuses
its arguments on the following features: “the three-dimensional graphical
depiction further comprising a simulated delivery of therapeutic agent to the
digital model of the training apparatus and a dynamic position of the plunger
in real-time.”12 PO Resp. 23. More specifically, Patent Owner contends that
none of the cited references includes (1) “a simulated delivery of therapeutic
agent to the digital model of the training apparatus” (PO Resp. 37–40; PO
Sur-reply 13–16) (claim 1), or (2) “a dynamic position of the plunger in real
time” (PO Resp. 25–33; PO Sur-reply 7–13) (claims 1 and 20).
(1) “a simulated delivery of therapeutic agent to the
digital model of the training apparatus.”
We consider first whether the prior art that has been relied upon by
Petitioner in this proceeding in urging the unpatentability of claim 1
discloses “a three-dimensional graphical depiction” that comprises “a
simulated delivery of therapeutic agent to the digital model of the training

12 These features are identified as a part of Roman numeral [ix] in this
Decision.
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apparatus.” As noted above the parties agree that the above-noted claim
phrase means “a simulated flow of therapeutic agent delivered from the
digital model of the syringe to the digital model of the training apparatus.”
Thus, claim 1 requires a three-dimensional graphical depiction of a
simulated flow of therapeutic agent from a digital model of a syringe to a
digital model of a training apparatus.
For this limitation, Petitioner relies initially on the disclosure of
Lampotang, and, specifically, its Figure 2 (reproduced supra) and
paragraph 89. Pet. 48–49. Petitioner states the following:
As shown above, Fig. 2 of Lampotang illustrates a virtual
syringe used for injection in relation to the virtual model and
illustrates a simulated delivery of a therapeutic agent to a digital
model of the training apparatus. For example, Lampotang
indicates that the system of Fig. 2 can be used for simulated
injection into a central venous line (CVL), in which application
the tool comprises a syringe with a needle and plunger that
simulates aspiration into an artery or vein. Lampotang, ¶89; see
EX1002, ¶132.
Id.
Thus, it is clear that a central tenet of the Petition in accounting for the
noted limitation pertaining to simulated delivery of therapeutic agent is the
illustration of Lampotang’s Figure 2 coupled with disclosure at Lampotang’s
paragraph 89, which is stated to describe simulated aspiration into an artery
or vein.
Patent Owner challenges Petitioner’s above-noted reliance on
Lampotang’s disclosure on several fronts. Patent Owner first disputes that
Lampotang’s Figure 2 illustrates any display of a therapeutic agent, or any
simulated delivery of therapeutic agent to a training apparatus. PO Resp.
38–39 (citing Ex. 1008 ¶ 78; Ex. 2021, 126:1–8). Patent Owner also
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contends that Lampotang’s paragraph 89 is limited to “describing physically
simulating withdrawal of blood in a physical syringe.” Id. at 39. In that
respect, Patent Owner expresses that “Lampotang does not disclose a digital
model of the syringe delivering a flow of therapeutic agent to a digital model
of a training apparatus.” Id.
We conclude that Patent Owner has identified inconsistencies in
Petitioner’s characterization of Lampotang’s disclosure in the Petition as
compared with Lampotang’s actual disclosure. Although Lampotang’s
Figure 2 does appear to illustrate virtual syringe 222 associated with display
203, there is nothing in that figure or its associated description that conveys
disclosure of a simulated depiction of a therapeutic agent, or simulated
delivery of that agent. See Ex. 1008 ¶ 78. Rather, Lampotang simply
characterizes Figure 2 as showing “a representation of an interactive mixed
simulator system that can be used for the simulation of inserting a needle
into a proper vessel.” Id. We also are mindful of the deposition testimony
of Petitioner’s declarant, Dr. Mukherjee, in which he acknowledged that
Lampotang’s Figure 2 does not shown an illustration of therapeutic agent.
See Ex. 1021, 136:1–8; PO Resp. 10. We further take note of the
Declaration testimony of Patent Owner’s declarant, Dr. Pugh, who testifies
as follows:
Lampotang’s disclosure with reference to Figure 2 focuses
on the CVL technique, which involves withdrawing blood from
a blood vessel rather than injecting medication into the patient’s
body. Ex. 1008 ¶¶ 89-90. The CVL technique is not concerned
with visualizing a simulated flow of therapeutic agent delivered
from a digital model of the syringe to the digital model of the
training apparatus.
Ex. 2005 ¶ 102; see PO Resp. 41.
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We credit Dr. Pugh’s testimony on this matter, as we find it consistent
with Lampotang’s disclosure as to the content of its Figure 2 and
Lampotang’s description of the CVL technique. See, e.g., Ex. 1008 ¶¶ 78,
89–90.
In light of the record that has developed during trial, we conclude that
Patent Owner correctly contends that Lampotang’s paragraph 89 describes
aspects of a physical syringe that is operated by a user, rather than any three-
dimensional digital depiction of a syringe. The discussion of “simulation”
as a part of that paragraph pertains to simulation components such as red and
blue light emitting diodes (LEDs) or red and blue colored water that are
physically associated with an actual syringe and not a digital display of the
syringe. See Ex. 1008 ¶ 89. Such a physical syringe is shown, for instance,
at Lampotang’s Figure 3, in which syringe 300 that is operated by a user
includes red and blue LEDs 45 for providing the noted “simulation.” See id.
¶ 91. It is not apparent that such “simulation” is directed to the delivery of
therapeutic agent. Nevertheless, even if it is, Petitioner does not explain
persuasively how providing for simulation features as a part of an actual,
physical syringe, teaches or suggests providing a simulated flow of
therapeutic agent from a digital model of a syringe that is part of a three-
dimensional graphical depiction, as required by claim 1. Simply put, a
physical syringe and a three-dimensional model of such a syringe are not the
same.
Perhaps recognizing the apparent deficiency in the Petition’s reliance
on Lampotang’s paragraph 89, Petitioner attempts to expand its proposed
ground, and uses the Petitioner Reply to do so. To that end, Petitioner turns
to specific disclosure of Samosky at paragraph 67 as providing an
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evidentiary basis to conclude that depiction of a simulated delivery of a
therapeutic agent “would have been obvious.” Pet. Reply 14.
A reply provides an opportunity for a party to respond to arguments
made, for instance, in a patent owner response. 37 C.F.R. § 42.23(b). A
reply, however, is not an appropriate vehicle to reconfigure a proposed
ground based on new or additional evidence that is not reasonably tied to a
ground advanced in the Petition, which is what Petitioner seeks to do here.
The Petition does not set forth an adequate basis to conclude that Petitioner
relied on Samosky’s teachings to account for features of claim 1 of the ’232
patent. As Patent Owner points out (PO Sur-reply 13–14), it is
impermissible and untimely for Petitioner to now attempt to do so as a part
of the Reply. See, e.g., Henny Penny Corp. v. Frymaster LLC, 938 F.3d
1324, 1330–31 (Fed. Cir. 2019) (“[A]n [inter partes review] petitioner may
not raise in reply ‘an entirely new rationale’ for why a claim would have
been obvious.”) (citing Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
821 F.3d 1359, 1370 (Fed. Cir. 2016)).
In the Reply, Petitioner also seeks to rely on additional content of
Lampotang stated to be part of Lampotang’s “background section” and
appearing at paragraph 9 of that reference. Here, too, the Petition did not
rely on content of Lampotang that the reference describes as constituting
material that is “background” to Lampotang’s own disclosed invention.
Petitioner additionally attempts to connect Lampotang’s background
discussion of paragraph 9 with Lampotang’s paragraph 60. Pet.
Reply 15–16. The referenced portion of paragraph 60 reads “[w]hen the
needle nicks an artery or vein, the virtual representation can indicate a
flashback of blood or warning to simulate the damage.” Ex. 1008 ¶ 60.
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Petitioner, however, does not provide adequate or meaningful explanation as
to why that disclosure amounts to the required three-dimensional graphical
depiction of the simulated delivery of therapeutic agent from a digital model
of the syringe to a digital model of the training apparatus as is required by
claim 1.
We are cognizant that Petitioner also relies on the Mukherjee articles
as a part of its discussion pertaining to the limitation of claim 1 that
encompasses the “simulated delivery of therapeutic agent” feature. See Pet.
49–51. For instance, Petitioner points to Mukherjee 2014’s disclosure of
“[a] Lab VIEW[22]-based VI with an intuitive GUI provides the trainee with
real-time feedback on the proximity and touch of syringe needle to the
[extraocular muscles (EOM)] and the rate of injection of anesthetic fluid.”
Pet. 49 (quoting Ex. 1005, 2). Petitioner also points to Mukherjee 2012’s
disclosure at Figure 5 of a “Virtual Instrument” display that shows a “piston
position and Aspiration indicators in real-time.” Id. (quoting Ex. 1006, 452).
Petitioner, however, does not explain adequately why those identified
teachings in the Mukherjee articles themselves give rise to teachings of
presenting a three-dimensional graphical depiction for a simulated delivery
of a therapeutic agent from a digital model of a syringe to a digital model of
a training apparatus. Rather, the principle basis of Petitioner’s reliance on
the Mukherjee articles appears rooted in accounting for other aspects of
claim 1, in particular, the dynamic display of a plunger in real-time.
Petitioner also does not rely on the content of the Mukherjee articles to
make-up for Petitioner’s inaccurate assessments of Lampotang’s disclosure,
which are noted above.
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Accordingly, in view of the record that is before us in this proceeding,
we conclude that, as a part of its proposed ground in the Petition, Petitioner
has not accounted adequately for the requirement in claim 1 directed to a
“three-dimensional graphical depiction” that shows “a simulated delivery of
therapeutic agent to the digital model of the training apparatus,” as that
phrase is understood in the context of the ’232 patent.
(2) Remaining Limitations of Claim 1
Because we determine that the Petition does not account adequately
for the above-discussed limitation required by claim 1, we conclude that it is
unnecessary to further consider the Petition’s assessment of other features of
claim 1, including the requirement of a three-dimensional depiction showing
a “dynamic position of the plunger in real-time.” Whether or not those
features have been shown to be present in the prior art does not remedy the
deficiencies noted above when it comes to the requirements surrounding the
“simulated delivery of therapeutic agent” feature of claim 1.
(3) Conclusion—Claim 1
Because Petitioner has not accounted adequately in this proceeding
for all the features required by claim 1, we conclude that Petitioner has not
shown by a preponderance of the evidence that claim 1 would have been
unpatentable based on Lampotang, Mukherjee 2014, and Mukherjee 2012.
b) Claims 3, 6–12, 15, and 16
Each of claims 3, 6–12, 15, and 16 ultimately depends from
independent claim 1, and thus each dependent claim requires all the features
of that independent claim. We also conclude that Petitioner has not shown
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by a preponderance of the evidence that claims 3, 6–12, 15, and 16 would
have been unpatentable based on Lampotang, Mukherjee 2014, and
Mukherjee 2012.
c) Claim 20
Similar to claim 1, independent claim 20 is drawn to “[a]n injection
training system configured for training of a facial injection technique.” Ex.
1001, 35:29–30. Among other limitations, claim 20 requires a “three-
dimensional graphical depiction” comprising a digital model of a syringe
with “the digital model of the syringe comprising a digital model of the
plunger moving in real-time relative to the digital model of the syringe
needle based on the dynamic position of the plunger relative to the syringe
needle during the facial training injection.” Id. at 36:16–21. Patent Owner
argues that those features are not accounted for in Petitioner’s proposed
ground of unpatentability for claim 20. See PO Resp. 25–37; PO Sur-reply
7–13.13
The Petition sets forth only the following in accounting for the above-
noted requirement of claim 20: “See Sections IX.A.1 and IX.A.2.ix. See
EX1002, ¶ 170.” Pet. 64. Section “IX.A.1” is a portion of the Petition that
spans pages 19 to 31 and constitutes Petitioner’s summary of the disclosures
of Lampotang and the Mukherjee articles as well as arguments that it would
have been obvious to combine those disclosures. Id. at 19–31. That section
provides only generalized discussion of each reference as a whole and does

13 In the noted sections of the Patent Owner Response and the Sur-reply,
Patent Owner also submits arguments tied to features required by claim 1.
Here, however, we focus on features required by claim 20.
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not provide specific or directed discussion reasonably viewed as being
focused on the above-noted feature of claim 20.
Section “IX.A.2.ix” is a portion of the Petition spanning pages 48
to 51 and addresses element “[ix]” of claim 1. As discussed above, that
element reads “the three-dimensional graphical depiction further comprising
a simulated delivery of therapeutic agent to the digital model of the training
apparatus and a dynamic position of the plunger in real-time.” Id. at 48. As
claim 20 does not require features pertaining to a simulated delivery of
therapeutic agent, it is clear that, in referencing section “IX.A.2.ix,”
Petitioner is drawing attention to the discussion in that section as to
requirements in claim 1 of a three-dimensional graphical depiction that
comprises “a dynamic position of the plunger in real time.” Id. at 50–51.
The referenced paragraph 170 of Dr. Mukherjee’s testimony recites
simply that, with respect to the pertinent of claim 20, “[t]hese features would
have been obvious, as I discussed regarding claim 1.” Ex. 1002 ¶ 170.
At the outset, we note that claim 1 and claim 20 include different
phrasing as to the particular, noted feature in each claim. In that regard,
where claim 1 only generally recites that its three-dimensional graphical
depiction comprises “a dynamic position of the plunger in real-time”
(Ex. 1001, 34:25–26), claim 20 is decidedly more detailed in reciting that its
three-dimensional graphical depiction comprises “a digital model of the
plunger moving in real-time relative to the digital model of the syringe
needle based on the dynamic position of the plunger relative to the syringe
needle during the facial training injection” (id. at 36:16–21). Although the
Petition evidently equates the pertinent requirement of each of those claims,
the Petition provides no explanation as to why, despite the clear differences
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in the language of the claims, there is, nevertheless, no distinction in the
scope of the claims.
In our view, the different expressions in claim 1 and claim 20 as to the
three-dimensional depiction of plunger position gives rise to different
requirements as between those two claims. It is clear that claim 20 is
explicit in its requirement of a three-dimensional graphical depiction that
shows movement of a digital model of the plunger in real-time relative to a
syringe needle of a digital model of a syringe, and also further specifies that
such movement is based on the dynamic position of the plunger relative to
the syringe needle. Those are not requirements in claim 1. Patent Owner
contends that “[n]owhere does Lampotang disclose a three-dimensional
graphical depiction of a dynamic position of the plunger in real-time or a
digital model of the plunger moving in real-time.” PO Resp. 25–26. In
response, Petitioner expresses that “[i]t is undisputed that Lampotang’s
system provides for a three-dimensional graphical depiction of the entire
syringe, including the plunger, and the syringe needle as shown, for example
in Figure 2.” Pet. Reply 6 (citing Ex. 1008 ¶ 12; Ex. 1002 ¶ 128).
Petitioner’s representation that the noted matter is “undisputed” is, in
our view, not entirely accurate. We discern that disclosure of Lampotang as
to aspects of a digital plunger is clearly in dispute, as is apparent from Patent
Owner’s Response as well as its Sur-reply. See, e.g., PO Resp. 25–26; PO
Sur-reply 7–8. Lampotang’s Figure 2 does illustrate a digital model of a
syringe, however, neither that figure nor its description shows or describes a
plunger or associates motion of a digital model of a plunger relative to a
digital model of a syringe and syringe needle. In support of its position of
unpatentability, Petitioner now cites to Lampotang’s paragraph 12 in its
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Petitioner Reply. Pet. Reply 6. That paragraph is part of a brief summary of
Lampotang’s invention and only generally describes that a “3D virtual
model is registered invisibly and/or internally to a physical model,” and that
a user may interact with the physical model using “a physical tool or
implement that may be tracked in a 3D space.” Ex. 1008 ¶ 12. There is no
discussion in paragraph 12 of a three-dimensional depiction of a model of a
syringe and syringe plunger in which the syringe plunger is shown moving
relative to a syringe needle. The testimony of Dr. Mukherjee at paragraph
128 of his declaration (Ex. 1002) that Petitioner references in its Reply (Pet.
Reply 6) only describes Lampotang’s Figure 2. As noted above, however,
that figure also does not describe or show real-time motion of a digital
model of a plunger with respect to a digital model of a syringe and syringe
needle.
Petitioner additionally relies on the Mukherjee articles as a part of its
Petition addressing the pertinent feature of claim 1. See Pet. 49–51. It is
apparent that at least Mukherjee 2012 describes that a virtual display may
show the position of a syringe piston, i.e., a plunger, in real-time. In
particular, Mukherjee 2012’s Figure 5 shows a two-dimensional virtual
display in which plunger position is shown in real-time in connection with a
graph of the position (left side of Figure 5) as well as numerical values
indicative of that position (right side of Figure 5). See Ex. 1006, 452. We
do not discern, however, any disclosure in the Mukherjee articles, and
Petitioner points to none, which establishes an association of that plunger
position with a three-dimensional depiction in which the real-time
movement of a digital model of a plunger is specifically depicted relative to
a digital model of a syringe and a syringe needle.
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As discussed above, claim 20 requires “a three-dimensional graphical
depiction” showing “a digital model of the plunger moving in real-time
relative to the digital model of the syringe needle based on the dynamic
position of the plunger relative to the syringe needle during the facial
training injection.” The Petition is silent as to those particular requirements.
The Petition’s silence on those requirements is a substantial impediment to
Petitioner’s view that claim 20 is unpatentable based on the teachings of
Lampotang, Mukherjee 2014, and Mukherjee 2012.14 The burden is on
Petitioner to demonstrate unpatentability. See Dynamic Drinkware,
800 F.3d at 1378. In light of the record that is now before us, we conclude
that Petitioner has not accounted adequately in its Petition for all of the
features required by claim 20, and thus has not met its burden. Accordingly,
we conclude that, on the record of this proceeding, Petitioner has not shown
by a preponderance of the evidence that claim 20 would have been
unpatentable over Lampotang, Mukherjee 2014, and Mukherjee 2012.

14 It is apparent from Patent Owner’s briefing that Patent Owner is of the
view that the features in each of claim 1 and 20 pertaining to the movement
of the plunger in real time are not satisfied by the combined teachings
Lampotang, Mukherjee 2014, and Mukherjee 2012. See, e.g., PO Resp. 25–
33; PO Sur-reply 7–13. As noted above, claims 1 and 20 include different
recitations pertaining to that feature. Because, as discussed above, we
conclude that Petitioner has not accounted adequately for other limitations
required by claim 1, we find it unnecessary to also assess claim 1’s more
general recitation of simply depiction of “a dynamic position of the plunger
in real-time” in connection with either that recitation’s scope or its presence
in the prior art.
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d) Claims 21 and 24–26
Claims 21 and 24–26 depend from claim 20. Claims 21 and 24–26,
thus, include all the limitations required by claim 20. As discussed above,
Petitioner has not accounted adequately for all the features required by claim
20. Accordingly, we conclude that Petitioner has not shown that claims 21
and 24–26 are unpatentable based on Lampotang, Mukherjee 2014, and
Mukherjee 2012.
5. Other Grounds
Petitioner also challenges the patentability of (1) claim 4, 22, and 23
based on Lampotang, Mukherjee 2014, Mukherjee 2012, and Dawson, and
(2) claim 14 based on Lampotang, Mukherjee 2014, Mukherjee 2012, and
Samosky. Pet. 65–68.
a) Claims 4, 22, and 23
Claim 4 depends from claim 1. Claim 22 depends from claim 20.
Claim 23 depends from claim 22. As noted above, Petitioner contends that
claims 4, 22, and 23 are unpatentable over Lampotang, Mukherjee 2014,
Mukherjee 2012, and Dawson. Petitioner does not rely on Dawson to
overcome any of the deficiencies that we have noted when it comes to
claims 1 and 20. Accordingly, we also conclude that Petitioner has not
shown by a preponderance of the evidence that claims 4, 22, and 23 are
unpatentable over Lampotang, Mukherjee 2014, Mukherjee 2012, and
Dawson.
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b) Claim 14
Claim 14 depends from claim 1. Petitioner contends that claim 14 is
unpatentable over Lampotang, Mukherjee 2014, Mukherjee 2012, and
Samosky. Thus, the ground applied to claim 14 includes application of
some teachings of Samosky.15 Pet. 67–68. We, however, do not discern
that, with respect to claim 14, the Petition addresses the shortcomings that
we identify above when it comes to claim 1, namely, the shortcomings in
connection with the requirement of “a three-dimensional graphical
depiction” that comprises “a simulated delivery of therapeutic agent to the
digital model of the training apparatus.” Accordingly, we conclude that on
the record of this proceeding, Petitioner has not met its burden to show by a
preponderance of the evidence that claim 14 is unpatentable.
III. CONCLUSION
For the foregoing reasons, we conclude that Petitioner has not met its
burden to show by a preponderance of the evidence that claims 1, 3, 4, 6–16,
and 20–26 are unpatentable based on the grounds that were presented in the
Petition.
In summary,
Claims
35
U.S.C. §
Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1, 3, 6–16,
21, 24–26 103
Lampotang,
Mukherjee 2014,
Mukherjee 2012
1, 3, 6–16, 21, 24–26

15 Samosky is the reference that Petitioner, in its Reply, belatedly seeks to
incorporate into its ground of unpatentability applied to claim 1.
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Claims
35
U.S.C. §
Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
4, 22, 23 103
Lampotang,
Mukherjee 2014,
Mukherjee 2012,
Dawson
4, 22, 23
14 103
Lampotang,
Mukherjee 2014,
Mukherjee 2012,
Samosky
14
Overall Outcome 1, 3, 4, 6–16, 20–26

IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioner has not shown by a preponderance of the
evidence that claims 1, 3, 4, 6–16, and 20–26 of the ’232 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.
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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