Organovo, Inc.

Patent Trials and Appeals Board

Dec 13, 2021

IPR2021-01050 (P.T.A.B. Dec. 13, 2021)

Trials@uspto.gov Paper 8
571-272-7822 Entered: December 13, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

CELLINK AB,
Petitioner,
v.
ORGANOVO, INC.,
Patent Owner.

IPR2021-01050
Patent 9,855,369 B2

Before JEFFREY W. ABRAHAM, ELIZABETH M. ROESEL, and
MICHELLE N. ANKENBRAND, Administrative Patent Judges.
ROESEL, Administrative Patent Judge.
DECISION
Denying Institution of Inter Partes Review
35 U.S.C. § 314
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I. INTRODUCTION
A. Background and Summary
Cellink AB (“Petitioner”) filed a Petition (Paper 2, “Pet.”) seeking an
inter partes review of claims 1–15 (the “challenged claims”) of U.S. Patent
No. 9,855,369 B2 (Ex. 1001, “the ’369 Patent”). Organovo, Inc. (“Patent
Owner”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”).
We have authority to determine whether to institute an inter partes
review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). An inter
partes review may not be instituted “unless . . . the information presented in
the petition . . . and any response . . . shows that there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” 35 U.S.C. § 314(a). After considering
the parties’ arguments and evidence, we determine that the reasonable
likelihood standard is not met. Accordingly, we deny institution of inter
partes review.
B. Related Matters
Patent Owner indicates that the ’369 Patent is at issue in the following
district court action: Cellink AB v. Organovo, Inc., No. 21-cv-00832
(D. Del.). Paper 5, 1.
C. The ’369 Patent (Ex. 1001)
The ’369 Patent discloses a bioprinter for fabricating three-
dimensional (“3D”) tissues and organs. Ex. 1001, code (57), 1:56–58,
6:9–15, 7:22–28, 12:42–44, 18:34–35. The bioprinter includes a printer
head for receiving and holding at least one cartridge containing “bio-ink” or
support material; a means for calibrating the position of at least one
cartridge; and a means for dispensing the contents of at least one cartridge.
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Id. at code (57), 1:59–65, 6:16–24, 12:44–53. “[B]io-ink” is a “liquid, semi-
solid, or solid composition comprising a plurality of cells.” Id. at 7:14–15,
20:24–25. The “means for dispensing the contents of at least one cartridge”
may be “application of a piston, application of pressure, application of
compressed gas, hydraulics, or a combination thereof.” Id. at 2:16–19,
4:16–21, 13:19–23. The “means for calibrating the position of at least one
cartridge” may be “laser alignment, optical alignment, mechanical
alignment, piezoelectric alignment, magnetic alignment, electrical field or
capacitance alignment, ultrasound alignment, or a combination thereof.” Id.
at 2:9–14, 4:16–21, 13:10–15. The position of the cartridge may be
calibrated along the x-axis, the y-axis, and/or the z-axis. Id. at 2:48–54,
4:11–16, 6:32–37.
The ’369 Patent discloses a method for fabricating tissue constructs
wherein a “computer module” receives input of a visual representation of a
desired tissue construct and provides a series of commands to a bioprinter,
and the bioprinter deposits bio-ink and support material according to the
commands to form a construct with a defined geometry. Ex. 1001, 4:29–48,
6:38–47, 18:58–67. A “computer module” is “a software component
(including a section of code) that interacts with a larger computer system.”
Id. at 7:32–34, 19:22–24. Examples of bioprinting parameters that are
defined by user input and translated into computer code include print height,
pump speed, robot speed, and/or control of variable dispensing orifices. Id. at
12:4–7, 14:62–65, 18:50–54. According to the ’369 Patent, in some
embodiments, “computer code specifies the positioning of a printer head to
configure printer head height above a receiving surface.” Id. at 14:65–67.
“In further embodiments, computer code specifies the direction and speed of
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the motion of a printer head to configure dispensing characteristics for bio-
ink and/or support material.” Id. at 14:67–15:3.
The ’369 Patent discloses that “the bioprinter dispenses bio-ink or
support material in a specific pattern and at specific positions in order to form a
specific cellular construct, tissue, or organ.” Ex. 1001, 15:8–11, 16:65–17:1.
D. Illustrative Claim
Petitioner challenges claims 1–15 of the ’369 Patent. Pet. 1, 5.
Claims 1 and 4 are independent claims. Claim 1 is reproduced below.
1. A method of printing a three-dimensional (3D)
structure, the method comprising:
(a) providing a 3D printer, the printer comprising:
i. one or more printer heads, wherein a printer head
comprises a means for receiving and holding at least one
cartridge, wherein the cartridge comprises at least one
deposition orifice and contents comprising a bio-ink,
wherein the bio-ink comprises cell solutions, cells
suspensions, or cell concentrations;
ii. a means for dispensing the contents of at least one
cartridge;
iii. a receiving surface for receiving a first layer of the
materials dispensed from the at least one cartridge;
iv. a programmable computer processor communicatively
connected to the means for dispensing, the programmable
computer processor for positioning the one or more printer
heads in three dimensions and regulating the dispensing of
the contents of the at least one cartridge; and
v. a means for calibrating the position of the at least one
cartridge or the at least one deposition orifice;
(b) providing the materials to be dispensed;
(c) encoding the printer with a 3D structure to be printed, wherein
the 3D structure is a tissue construct;
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(d) dispensing from the deposition orifice the materials to be
dispensed, wherein the materials to be dispensed comprise cell
solutions, cells suspensions, or cell concentrations, wherein the
dispensing is by extrusion;
(e) depositing a first layer of the dispensed materials on the
receiving surface; and
(f) repeating the depositing step by depositing subsequent
dispensed material on the first and any subsequent layers of
deposited material, thereby depositing layer upon layer of
dispensed materials in a geometric arrangement according to the
3D structure.
Ex. 1001, 38:30–64.
Claim 4 is identical to claim 1, except that claim 4 does not recite
“v. a means for calibrating the position of the at least one cartridge or the at
least one deposition orifice.” Compare Ex. 1001, 38:30–64 (claim 1), with
id. at 39:6–40:7 (claim 4).
E. Asserted Grounds and Evidence
Petitioner asserts the following grounds of unpatentability under
35 U.S.C. § 103(a):1
Claim(s) Challenged Reference(s)
1, 2, 4–15 Lipson2
3 Lipson, Pasciak3

1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29,
125 Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
2013. Because the ’369 Patent has an effective filing date before this date,
the pre-AIA version of § 103 applies. Ex. 1001, code (63).
2 Ex. 1004, Lipson et al., US 2006/0156978 A1, published July 20, 2006.
3 Ex. 1009, Pasciak, US 4,808,000, issued February 28, 1989.
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Claim(s) Challenged Reference(s)
1, 2, 4–9, 11–15 Warren4
3 Warren, Pasciak
10 Warren, Lipson
Pet. 5. Petitioner relies on the Declaration of Dr. William Cimino to support
its challenges. Ex. 1002.
II. ANALYSIS
A. Legal Standards
“In an [inter partes review], the petitioner has the burden from the
onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
petitions to identify “with particularity . . . the evidence that supports the
grounds for the challenge to each claim”)); see also 37 C.F.R. § 42.104(b)
(requiring a petition for inter partes review to identify how the challenged
claim is to be construed and where each element of the claim is found in the
prior art patents or printed publications relied upon).
A patent 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 subject matter, as a whole, would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved based on underlying factual

4 Ex. 1005, Warren et al., US 2004/0253365 A1, published December 16,
2004.
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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 ordinary skill in the art; and (4) when presented, objective evidence of
nonobviousness, i.e., secondary considerations. Graham v. John Deere Co.,
383 U.S. 1, 17–18 (1966).
Additionally, the obviousness inquiry typically requires an analysis of
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In
re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness”)). Petitioner cannot satisfy its burden of proving obviousness
by employing “mere conclusory statements,” but “must instead articulate
specific reasoning, based on evidence of record, to support the legal
conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d
1364, 1380 (Fed. Cir. 2016).
B. Level of Ordinary Skill in the Art
Relying on Dr. Cimino’s testimony, Petitioner contends that a person
of ordinary skill in the art (“POSA”) would have had “a minimum of a
bachelor’s degree in mechanical engineering, electrical engineering,
biomedical engineering, or a related field, and approximately [five] years of
relevant experience or equivalent study in electromechanical systems,
regenerative medicine, tissue/organ engineering, and/or biologic and medical
research.” Pet. 13 (citing Ex. 1002 ¶¶ 10–12). Petitioner asserts that
“[a]dditional graduate education could substitute for professional
experience, or significant experience in the field could substitute for formal
education.” Id.
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For purposes of the Preliminary Response, Patent Owner does not
dispute Petitioner’s definition of a POSA. Prelim. Resp. 3.
We find that Petitioner’s definition of a POSA is consistent with the
scope and content of the ’369 Patent and the asserted prior art, and we apply
this definition for purposes of this Decision.
C. Claim Construction
In an inter partes review, we apply the same claim construction
standard as would be used by a district court to construe a claim in a civil
action involving the validity or infringement of a patent. 37 C.F.R.
§ 42.100(b). Under that standard, claim terms are given their ordinary and
customary meaning, as would have been understood by a person of ordinary
skill in the art at the time of the invention, in light of the language of the
claims, the specification, and the prosecution history of record. Id.; Phillips
v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner
v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012).
Petitioner provides proposed constructions for several claim terms,
including the means-plus-function claim terms. Pet. 14–17. For purposes of
the Preliminary Response, Patent Owner applies Petitioner’s constructions.
Prelim. Resp. 3.
We determine that we do not need to resolve any claim construction
disputes for purposes of this Decision. See Vivid Techs., Inc. v. Am. Sci. &
Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be
construed that are in controversy, and only to the extent necessary to resolve
the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean
Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in
the context of inter partes review).
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D. Petitioner’s Lipson-Led Grounds
Petitioner contends that claims 1, 2, and 4–15 are unpatentable as
obvious in view of Lipson and that claim 3 is unpatentable as obvious in
view of Lipson and Pasciak. Pet. 17–45. Patent Owner opposes these
challenges. Prelim. Resp. 5–32. We provide an overview of Lipson before
turning to the parties’ contentions and our analysis.
1. Lipson (Ex. 1004)
Lipson discloses a method and system for fabricating a living three-
dimensional structure. Ex. 1004, code (57), ¶ 10. Lipson depicts its system
in Figure 2, reproduced below.

Figure 2 shows a perspective view of Lipson’s material deposition device 2
and tool rack 4, wherein material deposition device 2 includes machine
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base 6, positioning system 8, substrate 16, and tool interface 20. Ex. 1004
¶¶ 48, 54. Material deposition tool 18 is mounted on tool interface 20 and
holds material cartridge 26. Id. ¶¶ 8, 51. Lipson teaches that “[i]n
operation, material deposition device 2 fabricates a product as positioning
system 8 moves material deposition tool 18 in a pathway along substrate 16
and material deposition tool 18 deposits material onto substrate 16 along the
pathway.” Id. ¶ 54. Lipson also discloses a system controller “operably
connected to the material deposition device to control operation of the
material deposition device.” Id. ¶ 8.
2. Independent claims 1 and 4
Our analysis focuses on the portion of independent claims 1 and 4 that
recites: “a 3D printer, the printer comprising: . . . a programmable computer
processor . . . the programmable computer processor for positioning the one
or more printer heads in three dimensions.” Ex. 1001, 38:32–43 (claim 1),
39:8–21 (claim 4).5
Petitioner contends that Lipson discloses a programmable computer
(system controller) and that the system controller is for positioning Lipson’s
printer head in three dimensions. Pet. 26–28. In the alternative, Petitioner
contends that three-dimensional positioning of the printer head would have
been obvious. Pet. 28. Petitioner provides an additional contention to cover
the contingency that the term “programmable computer processor” is
interpreted under § 112 ¶ 6. Pet. 28–29.

5 For the Lipson-led ground, Petitioner relies on the same contentions for
claim 4 as it presents for claim 1 (Pet. 34–37), and our analysis of
Petitioner’s contentions is the same for both claims.
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Patent Owner argues that Petitioner fails to demonstrate that Lipson
discloses “a 3D printer . . . comprising . . . a programmable computer
processor,” as claims 1 and 4 require. Prelim. Resp. 6–8. According to
Patent Owner, the Petition fails to show that Lipson’s system controller (the
alleged “programmable computer processor”) “is included in the
arrangement shown in FIG. 1 of Lipson,” which Petitioner identifies as the
claimed “3D printer.” Id. at 6–7 (emphasis omitted). In addition, Patent
Owner argues that Lipson does not disclose “a programmable computer
processor . . . for positioning the one or more printer heads in three
dimensions” and that Petitioner’s obviousness analysis for this claim
requirement is insufficient. Id. at 10–16.
After considering the parties’ arguments and evidence, we agree with
Patent Owner that Petitioner has not demonstrated sufficiently that Lipson
discloses or suggests a 3D printer comprising a programmable computer
processor, as claims 1 and 4 require. In addition, Petitioner has not
demonstrated sufficiently that Lipson discloses a programmable computer
processor for positioning one or more printer heads in three dimensions or
that it would have been obvious to modify Lipson to meet this claim
requirement. We address each of these claim requirements in turn below.
a) a 3D printer comprising a programmable computer processor
Petitioner contends that “Lipson discloses a programmable computer
processor (system controller).” Pet. 26 (emphasis omitted). As support for
that contention, Petitioner relies on the following two sentences from
Lipson: “System controller 104 is operated by fabrication system software
that automatically converts design data into a manufacturing plan.” Id.
(quoting Ex. 1004 ¶ 95). “The pattern is established by the system
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controller, which operates according to an electronic data file so that
changes to the product only require changes to the design data of the system
controller.” Pet. 27 (quoting Ex. 1004 ¶ 94).
Petitioner does not adequately address whether Lipson discloses a 3D
printer comprising a programmable computer processor. We find that
Lipson paragraphs 94 and 95 are not sufficient to support Petitioner’s
argument. At best, these paragraphs provide some support for Petitioner’s
contention that Lipson’s system controller is a programmable computer
processor. But these paragraphs do not address whether Lipson’s 3D printer
comprises a programmable computer processor, as claims 1 and 4 require.
Petitioner contends that Lipson discloses a 3D printer and directs us to
Lipson Figure 1, which shows a “fabrication system.” Pet. 20; Ex. 1004
¶ 17. Petitioner does not assert that Lipson’s fabrication system comprises a
system controller. By way of contrast, Petitioner explicitly maps the other
four elements of the claimed 3D printer to components of Lipson’s
fabrication system. Pet. 20–26, 29–30 (addressing the claimed printer heads,
means for dispensing, receiving surface, and means for calibrating).
More specifically, Petitioner maps the claimed “printer heads” to
Lipson’s material deposition tool 18 illustrated in Lipson Figures 1 and 2,
which show the fabrication system, and Lipson Figures 4 and 6, which show
the material deposition tool in more detail. Pet. 21–24; Ex. 1004 ¶¶ 47, 48,
51, 72, 76. Petitioner maps the claimed “means for dispensing” to Lipson’s
piston 70 and plunger 62, which force material out of cartridge 26, as
illustrated in Lipson Figure 8, which shows material deposition tool 18 of
the fabrication system. Pet. 24–25; Ex. 1004 ¶¶ 51, 76, 78. Petitioner maps
the claimed “receiving surface” to Lipson’s receptacle 306 of module 300
shown in Figure 15, which attaches to substrate 16 of the fabrication system,
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as shown in Figure 18. Pet. 25–26; Ex. 1004 ¶¶ 34, 111, 112, 125, Fig. 18.
Petitioner maps the claimed “means for calibrating” to Lipson’s calibration
sensor, including optical emitter/detector pairs 200A, B and 202A, B
illustrated in Lipson Figure 13, which shows calibration sensor device 44
mounted on substrate 16 of the fabrication system. Pet. 29–30; Ex. 1004
¶¶ 29, 108, Figs. 2, 13.
In contrast, however, Petitioner maps the claimed “programmable
computer processor” to Lipson’s system controller 104 (Pet. 26), which
Lipson illustrates and describes as an “external computer,” not a component
of the fabrication system. Ex. 1004 ¶¶ 26, 90, 91, 93, Fig. 10. More
specifically, Lipson Figure 10 depicts system controller 104 as a laptop
computer that is separate from the fabrication system that Petitioner
identifies as a 3D printer. Id. Fig. 10. Lipson describes the system
controller as an external computer in the following passages.
FIG. 10 is a perspective view of a fabrication system in
accordance with the present invention . . . . Also shown is the
electronic wiring of a fabrication system that connects to an
external computer.
Id. ¶ 26 (emphasis added).
Operation of the system of the present invention is
controlled by a system controller operably connected to the
material deposition device and the transfer device. . . . Figure 10
illustrates the system of the present invention with electrical
connections to system controller 104, which is an external
computer.
Id. ¶ 90 (emphasis added); see also id. ¶¶ 91, 93 (discussing external
computer 104).
Petitioner ignores the foregoing disclosures and fails to address
Lipson’s repeated description and illustration of the system controller as an
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external computer. Particularly in view of Lipson’s express disclosure that
the system controller (programmable computer processor) is external to the
fabrication system (3D printer), Petitioner had a duty to provide evidence
and argument, as part of its case-in-chief, sufficient to make a threshold
showing that Lipson discloses a 3D printer comprising a programmable
computer processor. Because Petitioner does not explain how or why
Lipson discloses or suggests this claim limitation, the Petition is deficient.
Although Petitioner relies on paragraphs 95–101 of Dr. Cimino’s
testimony as support for its contentions regarding a programmable computer
processor (Pet. 29), the cited testimony suffers from the same deficiencies as
the Petition. Dr. Cimino fails to explain how Lipson’s disclosure of a
system controller external to the fabrication system would have taught or
suggested a 3D printer comprising a programmable computer processor, as
claimed. Ex. 1002 ¶¶ 95–101.
Petitioner’s alternative contention based on a § 112 ¶ 6 construction
for “programmable computer processor” (Pet. 28–29) does nothing to
remedy the deficiencies in Petitioner’s showing that Lipson discloses or
suggests a 3D printer comprising a programmable computer processor.
b) “the programmable computer processor for positioning the
one or more printer heads in three dimensions”
Petitioner contends that Lipson’s system controller “is for positioning
the one or more printer heads (commanding positioning system 8 to move
material deposition tool 18 and the substrate).” Pet. 27 (citing Ex. 1004
¶¶ 9, 14, 83). Petitioner further contends that “Lipson discloses that the
printer head is positioned in three dimensions,” asserting that the printer
head is “moved in the X-Y plane” and “positioned in the Z-axis direction by
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moving the receiving surface relative to the printer head.” Pet. 28 (citing
Ex. 1004 ¶¶ 51, 53).
We agree with Patent Owner (Prelim. Resp. 10–11) that Petitioner
does not show sufficiently that Lipson discloses a programmable computer
processor “for positioning the one or more printer heads in three
dimensions,” as recited in claims 1 and 4. Petitioner maps the claimed “one
or more printer heads” to Lipson’s material deposition tool 18. Pet 20–21.
Petitioner does not, however, make a sufficient threshold showing that
Lipson’s material deposition tool 18 is positioned in three dimensions.
Petitioner asserts that Lipson discloses a printer head that moves in an X-Y
plane and a receiving surface that moves in the Z-axis direction. Pet. 28
(citing Ex. 1004 ¶¶ 51, 53). Petitioner contends that the claims do not
require moving the printer head relative to the receiving surface in all three
dimensions instead of moving the receiving surface (Pet. 19), but presents no
claim construction analysis or other reasoning to support that contention.
Petitioner does not show sufficiently for purposes of institution that
“positioning the one or more printer heads in three dimensions,” as recited in
claims 1 and 4, is broad enough to encompass positioning a printer head in
two dimensions and positioning a receiving surface in a third dimension.
Alternatively, Petitioner contends that “it would have been an obvious
design choice to move the printer head in the Z-axis direction instead of
moving the receiving surface.” Pet. 28. As an obviousness rationale,
Petitioner asserts “there were only two options (moving the printer head or
moving the receiving surface), both of which would have been obvious.”
Id.; see also Ex. 1002 ¶ 100 (same). Petitioner and Dr. Cimino provide no
further explanation or evidentiary support for their assertion.
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We agree with Patent Owner that Petitioner’s obviousness analysis is
conclusory and insufficiently supported. Prelim. Resp. 12–16. Essentially,
Petitioner and Dr. Cimino assert that “there were only two options,” one of
which is disclosed in the prior art, but not claimed, and the other of which is
claimed, but not disclosed in the prior art. Pet. 28; Ex. 1002 ¶ 100. That
naked assertion is inherently based on a hindsight view of the claims of the
challenged patent. Petitioner and Dr. Cimino provide no analysis supporting
their assertion that “moving the printer head or moving the receiving
surface” were the only two options. Pet. 28; Ex. 1002 ¶ 100. Petitioner and
Dr. Cimino fail to consider that there are three directions, namely the X-, Y-,
and Z-axis directions, in which the printer head or the receiving surface
could be moved.6 Under these circumstances, Petitioner’s and Dr. Cimino’s
“only two options” rationale does not meet the standard of “articulated
reasoning with some rational underpinning” sufficient to support institution
based on obviousness. In re Kahn, 441 F.3d at 988.
Furthermore, Petitioner and Dr. Cimino fail to explain sufficiently
how or why a POSA would have considered modifying Lipson’s system
controller to position material deposition tool 18 in the Z-axis direction

6 Assuming only one of these components moves in each direction, this leads
to eight possible combinations: (1) the printer head moves in the X-, Y-, and
Z- directions; (2) the receiving surface moves in the X-, Y-, and Z-
directions; (3) the printer head moves in the X-direction, and the receiving
surface moves in the Y- and Z-directions; (4) the receiving surface moves in
the X-direction, and the printer head moves in the Y- and Z-directions;
(5) the printer head moves in the Y-direction, and the receiving surface
moves in the X- and Z-directions; (6) the receiving surface moves in the Y-
direction, and the printer head moves in the X- and Z-directions; (7) the
printer head moves in the Z-direction, and the receiving surface moves in the
X- and Y-directions; (8) the receiving surface moves in the Z-direction, and
the printer head moves in the X- and Y-directions.
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instead of positioning substrate 16 in the Z-axis direction, as Lipson
discloses. Ex. 1004 ¶ 53. Petitioner and Dr. Cimino also fail to explain
sufficiently how or why a POSA would have modified Lipson’s fabrication
system to accomplish positioning material deposition tool 18 in three
dimensions as opposed to two, as Lipson discloses. Id.
Petitioner’s alternative contention based on a § 112 ¶ 6 construction
for “programmable computer processor” (Pet. 28–29) does nothing to
remedy the deficiencies in Petitioner’s showing that Lipson discloses or
suggests a “programmable computer processor for positioning the one or
more printer heads in three dimensions,” as recited in claims 1 and 4.
3. Dependent claims 2, 3, and 5–15
Claims 2 and 3 each depend directly or indirectly from claim 1, and
claims 5–15 each depend directly or indirectly from claim 4. Ex. 1001,
38:65–39:5, 40:8–32. Petitioner contends that claims 2 and 5–15 would
have been obvious in view of Lipson and that claim 3 would have been
obvious in view of Lipson and Pasciak. Pet. 34, 37–45. We find that
Petitioner’s arguments and evidence for dependent claims 2, 3, and 5–15 fail
to remedy the deficiencies in Petitioner’s arguments and evidence for
independent claims 1 and 4.
E. Petitioner’s Warren-Led Grounds
Petitioner contends that claims 1, 2, 4–9, and 11–15 are unpatentable
as obvious in view of Warren, that claim 3 is unpatentable as obvious in
view of Warren and Pasciak, and that claim 10 is unpatentable as obvious in
view of Warren and Lipson. Pet. 45–72. Patent Owner opposes these
challenges. Prelim. Resp. 32–60. We provide an overview of Warren
before turning to the parties’ contentions and our analysis.
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1. Warren (Ex. 1005)
Warren discloses “tools and methods for depositing materials
accurately on a selected substrate,” including “a tool for in vitro or in vivo
use in biological, tissue-engineering, and medical processes.” Ex. 1005 ¶¶ 3,
58. As one embodiment, Warren discloses “a direct-write patterning system
suitable for either fine-pattern microdispensing and/or fine-focused laser-
beam writing over flat or conformal surfaces.” Id. ¶ 10. Warren discloses
an integrated tool for “direct-write deposition” of material, i.e., an additive
process, which Warren refers to as “‘direct-write deposition technology’
(DWDT).” Id. ¶¶ 10, 11. According to Warren, the disclosed apparatus can
be used for “in vivo procedures” or for “in vitro applications in a tabletop
setting.” Id. ¶¶ 11, 12, 58–60, Figs. 1, 2.
Warren discloses that, “[f]or biological, medical, bioengineering, and
tissue-engineering embodiments of the DWDT, the apparatus may be
referred to herein as the ‘human architecture tool’ (HAT).” Ex. 1005 ¶ 14.
According to Warren, “[t]he in vitro and/or in vivo HAT technology . . . can
allow the user to ‘print’ biocompatible scaffolds, cells, growth factors,
therapeutics, enzymes, extracellular matrix (ECM) proteins, and the like
inside the human body using a microscale dispensing orifice (e.g., a
dispenser or stylus).” Id.; see also id. ¶¶ 320–323 (describing embodiments
of the biological HAT dispensing system for tissue engineering).
Warren discloses the DWDT/HAT includes material dispenser 100 for
performing additive procedures by which 3D engineered tissue constructs
are fabricated from biological, organic, or inorganic components. Ex. 1005
¶¶ 62, 94; see also id. ¶¶ 221–283, Figs. 5–7, 11–13, 23 (describing and
illustrating various embodiments of material dispenser 100). Warren also
discloses a system and method for controlling the position of one or more
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elements of a dispensing system using force feedback (id. ¶¶ 284–319,
Figs. 18–22), methods for depositing tissue engineering material at a
selected position on a substrate in vitro (id. ¶¶ 379–383), and methods for
depositing tissue engineering material at a target area within a subject’s body
(id. ¶¶ 384–472).
2. Independent claims 1 and 4
Our analysis focuses on the portion of independent claims 1 and 4 that
recites: “a programmable computer processor communicatively connected
to the means for dispensing.” Ex. 1001, 38:43–44 (claim 1), 39:21–22
(claim 4).7
Petitioner contends that Warren “discloses a programmable computer
processor (Windows based PC)” that is “communicatively connected to the
means for dispensing for regulating the dispensing of the contents of the at
least one cartridge (providing fine control over material dispensing by
operating the control valve on a pneumatic air cylinder).” Pet. 55.
Petitioner provides an additional contention to cover the contingency that
“programmable computer processor” is interpreted under § 112 ¶ 6. Pet. 56–
57.
Patent Owner argues that Petitioner fails to demonstrate that Warren
discloses a “programmable computer processor” as the challenged claims
require. Prelim. Resp. 33–38. Among other things, Patent Owner argues:
Petitioner’s assertions and cited portions of Warren do not
demonstrate how and where Warren discloses that the Windows
based PC in Warren (mapped to the claimed “programmable
computer processor”) . . . is “communicatively connected to” the

7 For the Warren-led grounds, Petitioner relies on the same contentions for
claim 4 as it presents for claim 1 (Pet. 62–65), and our analysis of
Petitioner’s contentions is the same for both claims.
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Patent 9,855,369 B2
20
“air pressure” aspects of Warren (which Petitioner maps to the
claimed “means for dispensing”[)] . . . .
Prelim. Resp. 37.
After considering the parties’ arguments and evidence, we agree with
Patent Owner that Petitioner has not adequately established that Warren
discloses or suggests a “programmable computer processor communicatively
connected to the means for dispensing,” as recited in claims 1 and 4.
Petitioner contends that Warren “discloses a means for dispensing the
contents of the cartridge (air pressure).” Pet. 54 (citing Ex. 1005 ¶¶ 280,
296). Petitioner further contends that “Warren discloses a programmable
computer processor (Windows based PC)” that is “communicatively
connected to the means for dispensing for regulating the dispensing.”
Pet. 55–56 (citing Ex. 1005 ¶¶ 227–229, 280, 413, 422). Petitioner does not,
however, show sufficiently that Warren’s “Windows based PC,” which
Petitioner identifies as the recited “programmable computer processor”
(Pet. 55) is communicatively connected to any mechanism for controlling air
pressure, which Petitioner identifies as the recited “means for dispensing the
contents of at least one cartridge” (Pet. 53–54).
To establish a communicative connection, Petitioner asserts that
Warren discloses “providing fine control over material dispensing by
operating the control valve on a pneumatic air cylinder.” Pet. 55. As further
discussed below, Petitioner’s assertion misstates Warren’s disclosure by
merging two unrelated snippets from Warren, the first related to a through-
nozzle dispenser and the second related to a capillary-based dispenser.
Petitioner’s first snippet, “providing fine control over material
dispensing,” is from Warren’s disclosure that “material dispenser 100 also
include[s] a means for selectively synchronizing the location control device
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Patent 9,855,369 B2
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800 with the actuator, to provide fine control over material dispensing.” Ex.
1005 ¶ 228. “[T]he actuator” is a reference to actuator 144, which “is
operatively coupled to the valve 130 for selectively moving the valve
between the open position and the closed position.” Id. ¶ 225, Fig. 11.
Valve 130 controls the flow of material through the dispenser. Id. Contrary
to Petitioner’s assertion, however, Warren’s valve 130 is not a “control valve
on a pneumatic air cylinder,” and actuator 144 does not operate a control
valve on a pneumatic air cylinder. Pet. 55.
Warren discloses that location control device 800 “can selectively
position the material dispenser 100 in xyz space (i.e., in three dimensions)”
and is synchronized with valve actuator 144, so that “the valving mechanism
may be synchronized with the xyz motion of the dispenser.” Ex. 1005
¶¶ 227–229, 232, 235, 236; see id. ¶ 54, Fig. 36 (schematically illustrating
“devices and methods for controlling and synchronizing the position of the
material dispenser and the position of the valve within the material
dispenser”). Petitioner does not, however, direct us to any disclosure or
suggestion in Warren that location control device 800 is synchronized with a
control valve on a pneumatic air cylinder or with any other mechanism for
controlling air pressure for dispensing the contents of a cartridge.
Petitioner’s second snippet, “by operating the control valve on a
pneumatic air cylinder,” is from Warren’s disclosure that “[t]he capillary
dispensers in the illustrated embodiment may be extended via a pneumatic
air cylinder with a proportional control valve controlling extension and
retraction speeds.” Ex. 1005 ¶ 280. “[T]he illustrated embodiment” is a
reference to Figure 23, which shows “four material dispensers, one through-
nozzle dispenser and three capillary-based dispensers.” Id. ¶ 279. Warren
discloses that “[t]he dispensers in the illustrated embodiment have been
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Patent 9,855,369 B2
22
designed to extend and retract, so that only one dispenser is writing at a
time.” Id.
By selectively quoting from Warren, Petitioner tries to suggest that a
control valve on a pneumatic air cylinder controls air pressure for dispensing
the contents of a cartridge. Pet. 54, 56. Warren does not support that
suggestion. Warren discloses “a pneumatic air cylinder with a proportional
control valve [for] controlling extension and retraction speeds.” Ex. 1005
¶ 280. The control valve controls extension and retraction of the capillary
dispenser, not the dispensing of material from the dispenser. Id. ¶¶ 279, 280.
Despite Petitioner’s assertion that Warren provides “fine control over
material dispensing by operating the control valve on a pneumatic air
cylinder” (Pet. 55), Petitioner does not direct us to any disclosure or
suggestion in Warren of a control valve for controlling air pressure for
material dispensing. Nor does Petitioner direct us to any disclosure or
suggestion in Warren that the “Windows based PC,” which Petitioner
identifies as the recited “programmable computer processor” (Pet. 55) is
communicatively connected to any mechanism for controlling air pressure,
which Petitioner identifies as the recited “means for dispensing the contents
of at least one cartridge” (Pet. 53–54).
For a through-nozzle dispenser, Warren discloses a communicative
connection between the Windows based PC and a valve for controlling the
flow of material from the dispenser. Ex. 1005 ¶¶ 54, 227–229, 232, 235,
236, Fig. 36. Petitioner does not, however, rely on Warren’s through-nozzle
dispenser or valve as teaching the “means for dispensing the contents of the
at least one cartridge.” Pet. 53–54. Instead, Petitioner relies on Warren’s
teachings related to capillary-based dispenser. Id. (citing Ex. 1005 ¶¶ 280,
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Patent 9,855,369 B2
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296).8 For the capillary-based dispenser, Petitioner does not direct us to any
communicative connection between the Windows based PC and air pressure,
which Petitioner relies upon as teaching a “means for dispensing the
contents of the cartridge.” Id.
Dr. Cimino testifies that, in Warren, “the application of pressure
causes the contents of the cartridge (the hydrogel or paste in reservoir 3850)
to be dispensed through the deposition orifice (tip 3840).” Ex. 1002 ¶ 171
(citing Ex. 1005 ¶ 196). When addressing the “programmable computer
processor” limitation (id. ¶¶ 176–181), however, Dr. Cimino does not
identify any disclosure or suggestion in Warren that any processor is
communicatively connected with “the application of pressure” that “causes
the contents of the cartridge . . . to be dispensed” (id. ¶ 171). Instead,
Dr. Cimino echoes the same unsupported characterization of Warren’s
disclosure as set forth in the Petition. Compare Pet. 55 (asserting that
Warren discloses “providing fine control over material dispensing by
operating the control valve on a pneumatic air cylinder”), with Ex. 1002
¶ 178 (same). For the reasons discussed above, Warren does not support this
characterization.
Petitioner’s alternative contention based on a § 112 ¶ 6 construction
for “programmable computer processor” (Pet. 56–57) does nothing to
remedy the deficiencies in Petitioner’s showing that Warren discloses or
suggests “a programmable computer processor communicatively connected
to the means for dispensing,” as recited in claims 1 and 4.

8 Petitioner’s citation to Warren paragraphs 224 and 380 without explanation
(Pet. 54) is not enough to convey that Petitioner relies on Warren’s through-
nozzle dispenser or valve as teaching the “means for dispensing the contents
of the at least one cartridge.”
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3. Dependent claims 2, 3, and 5–15
Petitioner contends that claims 2, 5–9, and 11–15 would have been
obvious in view of Warren, that claim 3 would have been obvious in view of
Warren and Pasciak, and that claim 10 would have been obvious in view of
Warren and Lipson. Pet. 61–62, 65–72. After reviewing Petitioner’s
contentions, we find that Petitioner’s arguments and evidence for dependent
claims 2, 3, and 5–15 fail to remedy the deficiencies in Petitioner’s
arguments and evidence for independent claims 1 and 4.
F. Discretion under 35 U.S.C. § 325(d)
Patent Owner argues that the Board should exercise its discretion to
deny the Petition under 35 U.S.C. § 325(d). Prelim. Resp. 60–62. In view
of our determination that Petitioner has not met the threshold for instituting
review on the merits, we need not consider Patent Owner’s arguments for a
discretionary denial of institution.
III. CONCLUSION
For the above reasons, we determine that Petitioner has not
established a reasonable likelihood that it would prevail in showing that
claims 1–15 of the ’369 Patent are unpatentable on the grounds asserted in
the Petition.
IV. ORDER
It is
ORDERED that, the Petition is denied, and no trial is instituted.
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Patent 9,855,369 B2
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FOR PETITIONER:
Scott A. McKeown
James L. Davis, Jr.
Christopher M. Bonny
ROPES & GRAY LLP
scott.mckeown@ropesgray.com
james.l.davis@ropesgray.com
christopher.bonny@ropesgray.com

FOR PATENT OWNER:

Naveen Modi
Joseph E. Palys
Elizabeth L. Brann
PAUL HASTINGS LLP
naveenmodi@paulhastings.com
josephpalys@paulhastings.com
elizabethbrann@paulhastings.com