Truinject Corp. v. Nestle Skin Health, S.A., et al

Filing 224

REPORT AND RECOMMENDATIONS re: Markman Hearing and Claim Construction. Please note that when filing Objections pursuant to Federal Rule of Civil Procedure 72(b)(2), briefing consists solely of the Objections (no longer than ten (10) pages) and the Response to the Objections (no longer than ten (10) pages). No further briefing shall be permitted with respect to objections without leave of the Court. (*Objections to R&R due by 7/2/2020). Signed by Judge Jennifer L. Hall on 6/18/2020. (ceg)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
TRUINJECT CORP.,
Plaintiff,
v.
GALDERMA, S.A., GALDERMA
LABORATORIES, L.P., and NESTLÉ SKIN
HEALTH, INC.,
Defendants.

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C.A. No. 19-592-LPS-JLH

REPORT AND RECOMMENDATION
Presently pending before the Court are the parties’ claim construction disputes related to
terms in United States Patent Nos. 9,792,836 (the “’836 Patent”), 10,290,231 (the “’231 Patent”),
and 10,290,232 (the “’232 Patent”). The Court held a Markman hearing on June 8, 2020. I
recommend that the Court adopt the constructions as set forth below.
The parties agreed on the constructions of a number of terms in the ’836, ’231, and ’232
Patents. (D.I. 218 at 5-7.) In accordance with the parties’ agreement, I RECOMMEND that those
terms be construed as follows:

1

Term
“[clear layer of] elastomer coating”

Court
“a clear layer of elastic material that simulates
skin or muscle”

“[clear layer of] elastomer”

2

(’836 Patent, Claim 1)
“a base layer”
(’836 Patent, Claim 1)

“a top layer or surface of the base”

3

“a three-dimensional (3D) tracking system “a tracking system contained inside the base
positioned inside the base and configured that tracks the location in three dimensions of
to determine a location of a needle inserted the needle inserted into the clear layer”
into the clear layer”

4

(’836 Patent, Claim 1)
“injection measurement data”

5

(’836 Patent, Claim 16)
“a recommended action”

6

(’231 Patent, Claim 1)
“use characteristics of the syringe”

7

8

9

“data indicative of the depth, angle, pressure
or accuracy of the injection”
“training resources or materials directed at an
aspect of the injection technique”

“two or more pieces of information about use
of the syringe as the syringe delivers the
(’231 Patent, Claim 1)
training injection, but excluding information
indicative of the position of the syringe”
“[a/the] collection of injection training “data associated with previous training
data”
injections”
(’231 Patent, Claim 6)
“A simulated delivery of therapeutic agent “a simulated flow of therapeutic agent
to the digital model of the training delivered from the digital model of the syringe
apparatus”
to the digital model of the training apparatus”
(’232 Patent, Claim 1)
Location sensing system

A location tracking system

(’232 Patent, Claim 1)
10 “[the
three-dimensional
graphical “[the three-dimensional graphical depiction
depiction comprises] a digital model of the comprises] a/the three-dimensional digital
syringe”
model of the syringe”
“the digital model of the syringe”
(’232 Patent, Claims 1, 20, 27)
11 “first location sensing means”

Means-plus-function:

(’232 Patent, Claim 27)

Function: sensing location
Structure: the syringe sensor [4:40–5:6],
defined as a position sensor, accelerometer,
3D position sensor, orientation sensor, inertial
measurement unit, pressure sensor, antenna to
detect radio waves, or a microphone to detect
sound.

2

12 “second location sensing means”

Means-plus-function:

(’232 Patent, Claim 27)

Function: sensing location
Structure: the apparatus sensor [206], defined
as an optical measurement and tracking
system (4:25–28), at least two stereoscopic
cameras (4:28–31), a three-dimensional
tracking system (a camera, two cameras or an
array of light sensors) (7:27–31), a camera
(17:6–7), or magnetometer (17:14–15)

Further, as announced at the hearing on June 8, 2020, I RECOMMEND that the following
disputed claim terms of the ’836 and ’231 patents be construed as follows:
Term
1

2

Court

“[partially hollow] base configured to “an apparatus with a cavity or space that is
provide structural support”
used to provide structural support for the clear
layer and opaque layer”
(’836 Patent, Claim 1)
“the base, clear layer, and opaque layer “the base, clear layer, and opaque layer
form an anatomical shape”
together form an anatomical shape”

3

(’836 Patent, Claim 1)
“at least one evaluation criterion”

4

(’231 Patent, Claim 1)
“at least one performance requirement”

5

(’231 Patent, Claim 1)
“the information set”

7

“one or more standards used to measure
injection performance”

describing

the

“the data collected during the injection
training from the syringe or training
apparatus, but must include data collected
from at least one syringe sensor”
training Indefinite

(’231 Patent, Claim 6)
“information describing
session”

the

training Indefinite for lack of antecedent basis

(’231 Patent, Claim 6)
6

“one or more standards used to assess an
injection”

“information
injection”

(’231 Patent, Claim 12)

3

I.

LEGAL STANDARDS
A.

Claim Construction

The purpose of the claim construction process is to “determin[e] the meaning and scope of
the patent claims asserted to be infringed.” Markman v. Westview Instruments, Inc., 52 F.3d 967,
976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996). When the parties have an actual dispute
regarding the proper scope of claim terms, their dispute must be resolved by the judge, not the
jury. Id. at 979. The Court only needs to construe a claim term if there is a dispute over its
meaning, and it only needs to be construed to the extent necessary to resolve the dispute. Vivid
Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
“[T]here is no magic formula or catechism for conducting claim construction.” Phillips v.
AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005). But there are guiding principles. Id.
“The inquiry into how a person of ordinary skill in the art understands a claim term provides
an objective baseline from which to begin claim interpretation.” Id. at 1313. In some cases, the
ordinary meaning of a claim term, as understood by a person of ordinary skill in the art, is readily
apparent even to a lay person and requires “little more than the application of the widely accepted
meaning of commonly understood words.” Id. at 1314. Where the meaning is not readily apparent,
however, the court may look to “those sources available to the public that show what a person of
skill in the art would have understood disputed claim language to mean.” Innova/Pure Water, Inc.
v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004). Those sources include
“the words of the claims themselves, the remainder of the specification, the prosecution history,
and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms,
and the state of the art.” Id.

4

“The claims themselves provide substantial guidance as to the meaning of particular claim
terms.” Phillips, 415 F.3d at 1314. For example, “the context in which a term is used in the
asserted claim can be highly instructive.” Id. Considering other, unasserted, claims can also be
helpful. Id. “For example, the presence of a dependent claim that adds a particular limitation
gives rise to a presumption that the limitation in question is not present in the independent claim.”
Id. at 1314-15.
In addition, the “claims must be read in view of the specification, of which they are a part.”
Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)).
The specification “is always highly relevant to the claim construction analysis.” Id. (quoting
Vitronics, 90 F.3d at 1582). The specification may contain a special definition given to a claim
term by the patentee, in which case, the patentee’s lexicography governs. Id. at 1316. The
specification may also reveal an intentional disclaimer or disavowal of claim scope. Id. However,
“even when the specification describes only a single embodiment, the claims of the patent will not
be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
using words or expressions of manifest exclusion or restriction.” Hill-Rom Servs., Inc. v. Stryker
Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (internal marks omitted).
Courts should also consider the patent’s prosecution history. Phillips, 415 F.3d at 1317.
It may inform “the meaning of the claim language by demonstrating how the inventor understood
the invention and whether the inventor limited the invention in the course of prosecution, making
the claim scope narrower than it would otherwise be.” Id. Statements made by a patentee or patent
owner during inter partes review may also be considered. Aylus Networks, Inc. v. Apple Inc., 856
F.3d 1353, 1362 (Fed. Cir. 2017).

5

In appropriate cases, courts may also consider extrinsic evidence, which “consists of all
evidence external to the patent and prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises.” Markman, 52 F.3d at 980.

For example, dictionaries,

especially technical dictionaries, can be helpful resources during claim construction by providing
insight into commonly accepted meanings of a term to those of skill in the art. Phillips, 415 F.3d
at 1318. Expert testimony can also be useful “to ensure that the court’s understanding of the
technical aspects of the patent is consistent with that of a person of skill in the art, or to establish
that a particular term in the patent or the prior art has a particular meaning in the pertinent field.”
Id.; see also Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 331-32 (2015).
B.

Indefiniteness

Section 112 of Title 35 imposes a definiteness requirement on patent claims. 35 U.S.C.
§ 112(b) (requiring that the claims “particularly point[] out and distinctly claim[] the subject matter
which the inventor . . . regards as the invention”). “The primary purpose of the definiteness
requirement is to ensure that the claims are written in such a way that they give notice to the public
of the extent of the legal protection afforded by the patent, so that interested members of the public,
e.g., competitors of the patent owner, can determine whether or not they infringe.” All Dental
Prodx, LLC v. Advantage Dental Prod., Inc., 309 F.3d 774, 779-80 (Fed. Cir. 2002).
“A patent is invalid for indefiniteness if its claims, read in light of the specification
delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those
skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572
U.S. 898, 901 (2014). Definiteness, like claim construction, should be assessed from the viewpoint
of a person of ordinary skill in the art at the time the patent was filed, and it should be considered
in view of the patent’s specification and prosecution history. Id. at 908.

6

The party asserting indefiniteness has the burden to prove it by clear and convincing
evidence. BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017).
II.

THE COURT’S RULING
My Report and Recommendation regarding the disputed claim terms of the ’836 and ’231

Patents was announced from the bench at the conclusion of the hearing as follows:
At issue in this case are three patents. U.S. Patent No.
9,792,836 is titled “Injection Training Apparatus Using 3D Position
Sensor.” The ’836 patent has two related terms in dispute. U.S.
Patent No. 10,290,231 is titled “Automatic Detection of
Performance Characteristics in an Injection Training System.” The
’231 patent has five terms in dispute. And U.S. Patent No.
10,290,232 is titled “Automated Detection of Performance
Characteristics in an Injection Training System.” The ’232 patent,
per the parties’ agreement last week, no longer has any terms in
dispute.
I’m prepared to rule on all of the disputed claim terms today.
I will not be issuing a separate written Report and Recommendation
but I will issue a written Report and Recommendation that
incorporates my ruling today.
And I want to emphasize before I announce my decisions
that while I am not issuing a separate opinion, we have followed a
full and thorough process before making the decisions I’m about to
state. We’ve reviewed the patents-in-suit. There was full briefing
on each of the disputed terms. The parties submitted their briefing
in accordance with my procedures, so each side had the opportunity
to submit two briefs and they were combined into one joint claim
construction brief incorporating all arguments.
The parties’ joint claim construction brief also attached
several exhibits. Those exhibits included portions of the prosecution
history relied on by the parties, a post-grant review document, and
expert declarations. An expert declaration from Dr. Blake
Hannaford was submitted in support of Truinject’s positions and
two expert declarations from Dr. Gianluca De Novi were submitted
in support of SHDS’s positions.
Plaintiff also submitted a technology tutorial. Neither party
elected to put on live expert testimony, but the Court did permit

7

lengthy oral argument here today, and all of that has been carefully
considered.
To be clear, while my oral ruling will cite to the intrinsic and
extrinsic evidence that I conclude best support my recommended
constructions, my failure to cite to other evidence provided by the
parties does not mean that I ignored or failed to consider it. As I
stated, I have considered all of the arguments and evidence cited by
the parties.
Now as to my rulings.
As an initial matter, I’m not going to read into the record my
understanding of the general legal principles of claim construction
and indefiniteness. I set forth those standards in my opinion in
3Shape [A/S v. Align Technology, Inc., C.A. No. 18-886, 2020 WL
2188857, at *1-2 (D. Del. May 6, 2020)], and I incorporate that
articulation by reference.
A claim term is supposed to be given the meaning that the
term would have to a person of ordinary skill in the art at the time
of the invention. And I note here that neither side has argued that
any differences the parties may have in defining one of ordinary skill
in the art for any of the three patents is material to resolving the
disputes before me today. In other words, neither side is saying not
to credit the other side’s expert because they’re not a person of skill
in the art.
Defendant has also argued that a number of the disputed
terms are indefinite, and, again, I incorporate by reference my
understanding of the law of indefiniteness as set forth in 3Shape,
[2020 WL 2188857, at *2].
I understand that the parties agree on constructions for a
number of terms and I will recommend to Chief Judge Stark that he
adopt the agreed-upon constructions.
As to the disputed terms, I will start with the ’836 patent. As
I mentioned, it has two related terms in dispute. Claim 1 recites, in
pertinent part:
[1.] An anatomically shaped injection training
apparatus comprising:
an at least partially hollow base configured to
provide structural support;
8

a clear layer of elastomer coating at least partially
covering a base layer; [and]
an opaque layer at least partially covering the clear
layer, wherein the base, clear layer, and
opaque layer form an anatomical shape. . . .
The primary dispute for these terms is about which portion
or portions of the training apparatus need to be anatomically shaped.
I will start with the phrase “[partially hollow] base configured to
provide structural support.”
Truinject argues that the term should be construed as “an
apparatus with a cavity or space that is used to provide support for
the training device.” According to Truinject, the base is required to
provide support and be partially hollow, but it doesn’t have to be
anatomically shaped. Truinject points to the use of the word “may”
in the specification to support its argument, for example, at column
3, lines 55 to 57. [’836 Patent at 3:55–57 (“In some embodiments,
the base layer of the apparatus may be a clear plastic shell simulating
a human or animal body part, such as, for example, a human or
animal head.”).]
SHDS argues that the base must be anatomically shaped. It
argues that the specification only teaches one way in which the base
is configured to provide structural support and that is because it is
anatomically shaped. SHDS also argues that the PTAB’s recent
denial of IPR institution further supports its construction.
Starting with the claims, there is nothing in the claims
suggesting that the base is required to be anatomically shaped. Nor
does the specification suggest that the base must be anatomically
shaped, and the specification does not criticize prior art on the basis
that it’s not.
As for SHDS’s argument that all of the examples in the
patent show anatomically shaped bases, the Federal Circuit has
made clear that it is improper to import limitations into claims from
examples or embodiments appearing only in a patent’s written
description, even when a specification describes very specific
embodiments of the invention or even describes only a single
embodiment, unless the specification makes clear that the patentee
intends for the claims and the embodiments in the specification to
be strictly coextensive. [See Phillips, 415 F.3d at 1323.]

9

I don’t think the ICU case cited by SHDS during argument
today is particularly informative. [ICU Med., Inc. v. Alaris Med.
Sys., Inc., 558 F.3d 1368, 1374-76 (Fed. Cir. 2009).] In that case,
the Federal Circuit held that the term “spike” had to be pointed. The
specification examples were consistent with the common
understanding that a spike has to be pointy.
That case falls on the side of construing the claims in light
of the specification. SHDS’s argument here falls on the side of
improperly importing limitations from the specification into the
claims.
Turning to the prosecution history, I do not find SHDS’s
argument regarding the PTAB’s decision persuasive. To the extent
that particular PTAB decision denying IPR is even relevant to claim
construction, I don’t think it is informative on the issue here. I read
that decision. The PTAB was assessing a piece of prior art that
looked like a breast sitting on top of a giant hinged base that was in
the shape of the letter Z. The PTAB stated that the prior art “does
not describe explicitly a base that forms part of the anatomical
shape” as was claimed in the ’836 Patent. [D.I. 211, Ex. A at JA 14,
17-18.]
I don’t take that statement to mean that the PTAB believed
that the base claimed in the ’836 patent itself had to be in an
anatomical shape. At best, it means that the base must form part of
the anatomical shape.
There is a secondary dispute about whether the base has to
support the layers. I think that dispute was largely resolved during
the hearing today in light of Truinject’s agreement that it would
modify its proposed construction.
Accordingly, I construe the phrase “[partially hollow] base
configured to provide structural support” as “an apparatus with a
cavity or space that is used to provide structural support for the clear
layer and opaque layer.”
Moving now to the phrase “the base, clear layer, and opaque
layer form an anatomical shape.”
For the same reasons, I agree with Truinject that this
limitation does not require that each of the base, clear layer, and
opaque layer have an anatomical shape.

10

There is nothing in the claims, specification, or prosecution
history that requires that. Moreover, I do not think that construing
the claim in accordance with Truinject’s proposal makes the
preamble redundant. The preamble tells us that the apparatus is
anatomically shaped, and this claim phrase lets us know that it is
these three components that give the apparatus its anatomical shape.
Accordingly, I construe this phrase as “the base, clear layer,
and opaque layer together form an anatomical shape.”
Now I’ll move on to the ’231 Patent. As I stated earlier, the
’231 patent has five terms in dispute, the first two of which are
related.
The terms “at least one evaluation criterion” and “at least one
performance requirement” are found in Claim 1. Claim 1 provides,
in pertinent part:
[1.] A method to improve performance of an
injection technique . . . comprising:
. . . evaluating electronically . . . the analyzed sensorbased injection information relative to at least
one evaluation criterion; and
comparing electronically, . . . the analyzed sensorbased injection information with at least one
performance requirement to determine
whether the training injection met the at least
one performance requirement. . . .
Truinject argues that “at least one evaluation criterion”
means “one or more injection standards used to assess an injection.”
Truinject points out that the phrase is used in the specification, and
that the specification provides multiple examples of what the
evaluation criterion could be, for example, whether the injection hit
the target location. I’m looking at column 7, lines 51 through 64.
[’231 Patent, 7:51–64.]
Truinject argues that “at least one performance requirement”
means “one or more injection standards used to measure injection
performance.” That phrase is also used in the specification. For
example, at column 7, line 64 through column 8, line 2, it states:
“Evaluating the injection information relative to at least one
evaluation criterion can comprise comparing the obtained injection
information with at least one performance requirement to determine
11

whether the training injection met the at least one performance
requirement.” [’231 Patent, 7:64–8:2.]
SHDS argues that the terms are indefinite. SHDS offers the
declarations of Dr. De Novi in support of its argument that a person
of skill in the art would not understand the scope of those terms.
I have carefully studied the relevant portions of Dr. De
Novi’s declarations, which are at paragraphs 19 through 29 of his
first declaration and 3 through 13 of his second declaration. [D.I.
211, Ex. B ¶¶ 19-29, Ex. E ¶¶ 3-13.] Essentially, his opinion is, one,
that the disputed phrases are broad because they cover all possible
evaluation criteria and performance requirements. Two, that a
person of skill in the art would want to know what subset of all
evaluation criteria and performance requirements are covered by the
claim. And, three, there is no basis in the patent to define a subset.
I make no finding about Dr. De Novi’s opinion as a matter
of science. But as a matter of patent law, claims are not indefinite
just because they are broad. In paragraph 22 of Dr. De Novi’s
declaration, he opines that if the term “evaluation criteri[a]” were
read broadly -- i.e., to cover all evaluation criteria -- that the claim
is not enabled. [D.I. 211, Ex. B ¶ 22.] That conflates definiteness
with the question of enablement, which is a distinct inquiry.
The definiteness inquiry looks to see whether the claims,
read in light of the specification and the prosecution history, inform
with reasonable certainty those skilled in the art about the scope of
the invention. The disputed phrases are broad -- and Truinject’s
construction is broad. I believe that a person of skill in the art
would understand them to be broad. In other words, they reasonably
inform those of skill in the art that the claims cover all standards
used to assess an injection and all standards used to measure
injection performance.
The declaration from Truinject’s expert, Dr. Hannaford,
supports that understanding. [D.I. 211, Ex. C ¶¶ 22-31.]
Accordingly, I find that SHDS has not met its burden to show by
clear and convincing evidence that the disputed phrases are
indefinite.
Because SHDS has not proposed alternative constructions
for either term, I will recommend that the court adopt most of
Truinject’s constructions. However, I do agree with SHDS to the
extent it argued that introduction of the phrase “injection standards”
into the construction is not helpful.
12

Accordingly, I construe the phrase “at least one evaluation
criterion” to mean “one or more standards used to assess an
injection.” And I construe “at least one performance requirement”
to mean “one or more standards used to measure injection
performance.”
The next term is “the information set.” That term can be
found in Claim 6. Claim 6 states in relevant part:
[6.] A method to analyze a collection of injection
training data . . . comprising:
. . . receiving, by the one or more signal processors
of the injection training system, the collection
of injection training data, the collection of
injection
training
data
comprising
information sets, wherein an information set
comprises data collected during the injection
training from the at least one syringe sensor,
the information set comprising:
information describing dynamic motion of
the syringe relative to the
anatomically-shaped apparatus as the
syringe delivers the training injection
to the anatomically-shaped apparatus;
information describing the anatomicallyshaped apparatus; and
information describing the training injection.
...
The parties’ dispute over this term is about whether the data
in the information set can include data from the training apparatus
in addition to the data from the syringe sensor. Truinject says it can.
SHDS says it can’t.
I agree with Truinject that there is no requirement in the
claim that requires the data to be obtained solely from the at least
one syringe sensor. The claim language says the information set
comprises data collected from the syringe sensor. As the Federal
Circuit has recognized, the term “comprising” is a term of art which
means that the named elements are essential, but other elements may
be added and still form a construct within the scope of the claim.
13

[See Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir.
1997).]
I reject SHDS’s argument that the applicant limited the
scope of this term during prosecution. I have carefully reviewed the
cited prosecution history and I do not agree with SHDS that the
applicant narrowed its claims in such a way to surrender coverage
of information sets that contain data from the training apparatus.
[D.I. 194-1, Ex. 4.] Therefore, the term “the information set” is
properly construed so that it must contain data collected from the
syringe sensor, but it can also contain other data.
Accordingly, I construe “the information set” as “the data
collected during the injection training from the syringe or training
apparatus, but must include data collected from at least one syringe
sensor.”
The next term is “information describing the training
injection,” which is found in Claim 6 of the ’231 patent. The
relevant portion of Claim 6 is, again:
receiving, by the one or more signal processors of the
injection training system, the collection of injection
training data, the collection of injection training data
comprising information sets, wherein an information
set comprises data collected during the injection
training from the at least one syringe sensor, the
information set comprising:
[1] information describing dynamic motion of the
syringe relative to the anatomically-shaped
apparatus as the syringe delivers the training
injection to the anatomically-shaped
apparatus;
[2] information describing the anatomically-shaped
apparatus; and
[3] information describing the training injection. . . .
The phrase “information describing the training injection”
was amended during prosecution. The term originally read:
“information describing the training session.” That is a phrase used
in the specification, for example, at column 10, lines 47 to 61, and
column 12, lines 13 through 17. [’231 Patent, 10:47–61, 12:13–17.]
The latter states that information describing the training session
14

“includes, without limitation, a training date and time; a training
location; a trainee identity; a training session duration; a training
score; an injection time; and a pass/fail determination.”
The phrase “information describing the training injection”
appears nowhere in the specification.
Truinject’s opening brief suggested that I should construe
“information describing the training injection” coextensive with
“information describing the training session.” In its reply brief,
however, it argued that “information describing the training
injection is . . . different from information describing the training
session, which includes the date, time location, duration, score, or
pass/fail determination.” [D.I. 210 at 57.] And it argues that
“information describing the training injection” means “data
describing the training syringe or training apparatus during the
training injection.”
Truinject offered the opinion of its expert, Dr. Hannaford, in
support of its construction of this term. [D.I. 211 ¶¶ 32–37.] I make
no conclusions about Dr. Hannaford’s opinion as a matter of
science. But Dr. Hannaford does not resolve the linguistic and legal
conflict pointed out by SHDS. As SHDS points out, the claim
requires the information set to contain, in addition to information
describing the training injection, information describing dynamic
motion of the syringe and information describing the anatomically
shaped apparatus.
Truinject’s proposed construction of “information
describing the training injection” would encompass information
describing the dynamic motion of the syringe and information
describing the apparatus, which would render those requirements
superfluous.
Truinject and its expert, as far as I can understand them,
respond that a person of skill in the art would therefore understand
“information describing the training injection” to mean all data
describing the training syringe or training apparatus during the
training session except what the patent considers “information
describing the training session” and except information describing
the anatomically shaped apparatus and the dynamic motion of the
syringe, both of which are already required by the claim.
The problem is that Truinject’s proposed construction
captures what Truinject itself agrees cannot be included in the scope
of the term. Truinject has not proposed a reasoned basis or
15

construction to resolve this problem, and I agree with SHDS and its
expert that it cannot be done. For that reason, I agree with SHDS
that the term “information describing the training injection” is
indefinite.
And I want to be clear about why I find this term indefinite
but I didn’t find the disputed terms in the ʼ836 Patent indefinite. As
an initial matter, the disputed ’836 Patent terms were actually used
in the specification and the specification informed their meaning.
Here, in contrast, the specification does not use the disputed phrase.
Moreover, standing alone, the “information describing the
training injection” term could be broadly construed as all
information that describes the training injection, and that is the
approach I took with the disputed terms in the ’836 Patent. But
unlike the disputed terms in the ’836 Patent, claim 6 of the ’231
Patent contains two other claim terms that inform the scope of the
“information describing the training injection” term. An analysis of
the claim language and specification reveals no principled basis or
guidance as to how to construe it less broadly so that it does not
overlap with or encompass information already captured by the two
other terms.
Truinject’s proposed construction does not resolve the issue.
Nor have Truinject or its expert explained what category of
information this term would capture in a way that would inform with
reasonable certainty those skilled in the art about the scope of the
invention. [Nautilus, 572 U.S. at 901.] Accordingly, it is indefinite.
Finally, the term “the information describing the training
session” appears in claim 12, a dependent claim to claim 6. Claim
12 recites: “The method of claim 6, wherein the information
describing the training session comprises” various things.
I find this claim indefinite for lack of an antecedent basis.
As I mentioned, the application claim that became claim 6 originally
required “information describing the training session.” And the
dependent application claim added the additional limitation as to
what that information describing the training session must be. When
the independent claim was amended to change information
describing the training session to information describing the training
injection, the dependent claim was not amended. And now it refers
back to a term that is no longer there.
As the Court found in the RetailMeNot case, the amended
claim’s lack of an antecedent basis renders it invalid. [RetailMeNot,
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Inc. v. Honey Sci. Corp., No. 18-937, 2019 WL 6337719, *23 (D.
Del. Nov. 27, 2019).]
In a footnote in its reply brief, Truinject says that the Court
can correct the patent by replacing “training session” in claim 12
with “training injection” because the substitution is not subject to a
“reasonable debate.” The problem with that is that the information
comprising the training session in dependent claim 12 is information
that Truinject itself argues is different information than what is
covered by the phrase “information describing the training
injection.” In light of that, and in view of the circumstances
surrounding the patentee’s amendment of the term in claim 6 during
prosecution, it’s clear that the issue is subject to debate.
The Energizer Holdings case cited by Truinject is not to the
contrary. That case held that the phrase “said zinc anode” was not
indefinite for lack of an antecedent basis because another claim
phrase contained the limitation “anode gel comprised of zinc.”
[Energizer Holdings, Inc. v. Int’l Trade Comm’n, 435 F.3d 1366,
1369–71 (Fed. Cir. 2006).] Here, there is no phrase that “the
information describing the training session” could be referring to,
since Truinject itself agrees that the information describing the
training session is different than the information describing the
training injection.
Given the lack of an antecedent basis for the term “the
information describing the training session,” I find that it is
indefinite.
That concludes my claim construction rulings today.
This Report and Recommendation is filed pursuant to 28 U.S.C. § 636(b)(1)(B),(C),
Federal Rule of Civil Procedure 72(b)(1), and District of Delaware Local Rule 72.1. Any
objections to the Report and Recommendation shall be filed within fourteen days and limited to
ten pages. Any response shall be filed within fourteen days thereafter and limited to ten pages.
The failure of a party to object to legal conclusions may result in the loss of the right to de novo
review in the district court.

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The parties are directed to the Court’s “Standing Order for Objections Filed Under Fed. R.
Civ. P. 72,” dated October 9, 2013, a copy of which can be found on the Court’s website.

Dated: June 18, 2020

___________________________________
The Honorable Jennifer L. Hall
United States Magistrate Judge

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