Hologic, Inc. v. Smith & Nephew, Inc. , 884 F.3d 1357 ( 2018 )

United States Court of Appeals
for the Federal Circuit
______________________
HOLOGIC, INC.,
Appellant
v.
SMITH & NEPHEW, INC., COVIDIEN LP,
Appellees
______________________
2017-1389
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 95/002,058.
______________________
Decided: March 14, 2018
______________________
MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
Washington, DC, argued for appellant. Also represented
by MARC A. COHN; JENNIFER SKLENAR, Los Angeles, CA.
MICHAEL A. ALBERT, Wolf Greenfield & Sacks, PC,
Boston, MA, argued for appellees. Appellee Smith &
Nephew, Inc. also represented by RICHARD GIUNTA.
NAVEEN MODI, Paul Hastings LLP, Washington, DC,
for appellee Covidien LP.
______________________
Before NEWMAN, WALLACH, and STOLL, Circuit Judges.
2 HOLOGIC, INC. v. SMITH & NEPHEW, INC.
STOLL, Circuit Judge.
Appellant Hologic, Inc. initiated an inter partes reex-
amination of U.S. Patent No. 8,061,359, which is owned
by Appellees Smith & Nephew, Inc. and Covidien LP
(together, “S&N”). S&N’s ’359 patent claims priority to
an earlier-filed PCT application by the same inventor
with a nearly identical specification. The U.S. Patent and
Trademark Office’s Patent Trial and Appeal Board found
that S&N’s earlier-filed PCT application has sufficient
written description to make it a priority document instead
of an invalidating obviousness reference. Hologic, Inc. v.
Smith & Nephew, Inc., No. 2016-006894, 2016 WL
6216657 (P.T.A.B. Oct. 21, 2016) (“Board Decision”).
Hologic appeals. We affirm.
BACKGROUND
The ’359 patent relates to an endoscope and method to
remove uterine tissue. Claims 1–3 and 5–7 are at issue in
this appeal, and independent claim 1 is representative.
Claim 1, partially reproduced below, recites a method of
using an endoscope, which includes a “permanently
affixed” “light guide” in one of two channels:
1. A method for removal of tissue from a uterus,
comprising:
inserting a distal region of an endoscope
into said uterus, the endoscope including a
valve and an elongated member defining
discrete first and second channels extend-
ing from a proximal region of the elongat-
ed member to the distal region, the second
channel having a proximal end in commu-
nication with the valve such that fluid
from the valve is able to flow into and
through the second channel to the uterus,
and the first channel having a light guide
permanently affixed therein and being
HOLOGIC, INC. v. SMITH & NEPHEW, INC. 3
sealed from the second channel to prevent
fluid from the valve from entering the
uterus through the first channel . . . .
’359 patent, claim 1 (emphasis added).
The figures in the ’359 patent are relevant to under-
standing the disputed claim term “light guide.” Figure 2,
reproduced below, shows the full device, including the two
claimed channels 5 and 6, one of which must have a light
guide permanently fixed inside. According to the specifi-
cation, viewing channel 6 has a lens 13 and can be con-
nected to a light source 8.
Figure 3, reproduced below, shows a cut-away of Fig-
ure 2, including viewing channel 6 and lens 13, and
depicts light going from the lens into the viewing channel.
4 HOLOGIC, INC. v. SMITH & NEPHEW, INC.
Finally, Figure 1a, reproduced below, illustrates a
cross section of the endoscope shaft, including the two
channels from Figure 2: viewing channel 6 and main
channel 5.
The ’359 patent specification text and figures are
nearly identical to PCT International Publication No. WO
99/11184 (“Emanuel PCT”), to which the ’359 patent
claims priority. 1 After entering the national stage with
the Emanuel PCT application in a parent application,
S&N filed a divisional application that later issued as the
’359 patent. An examiner objected to the application’s
drawings for not showing the “light guide” required by
then-pending claim 1 (discussed above). After an inter-
view with the examiner, S&N addressed the objection by
amending the specification to state: “A connection 8 for a
light source is also present, for connection to a light guide,
such as a fibre optics bundle which provides for lighting at
the end of lens 13.” J.A. 486 (amendment underlined),
J.A. 493 (Applicant’s Remarks in Amendment). Compare
’359 patent col. 3 ll. 56–58, with Emanuel PCT at 4:34–36.
1 The ’359 patent claims priority to Emanuel PCT
via U.S. Patent No. 7,249,602, which issued from the
national stage application of Emanuel PCT. The disclo-
sures of the ’602 patent and Emanuel PCT are the same
for our purposes, so we focus on Emanuel PCT and its role
in the ’359 patent’s prosecution history.
HOLOGIC, INC. v. SMITH & NEPHEW, INC. 5
With that amendment, the examiner issued the applica-
tion as the ’359 patent.
After the ’359 patent issued, Hologic requested inter
partes reexamination of the patent, which the PTO grant-
ed. During reexamination, the examiner found that the
’359 patent could not claim priority to Emanuel PCT
because Emanuel PCT did not provide adequate written
description for the ’359 patent’s claims. Specifically, the
examiner reasoned that the disclosure in Emanuel PCT of
only a “fibre optics bundle” did not provide adequate
written description for the broad genus of “light guides.”
Thus, the examiner determined that the effective priority
date was no earlier than July 20, 2007, and Emanuel
PCT, which was published on March 11, 1999, constituted
prior art to the ’359 patent’s claims under pre-AIA
§ 102(b). Therefore, the examiner rejected claims 1–3 and
5–7 as obvious over Emanuel PCT in view of a secondary
reference. S&N appealed to the Board.
The issue before the Board—and before us on ap-
peal—is whether Emanuel PCT, which discloses a “con-
nection to a fibre optics bundle which provides for lighting
at the end of lens 13,” provides sufficient written descrip-
tion to support the “light guide” “permanently affixed” in
the “first channel” of the ’359 patent’s claims. See Eman-
uel PCT at 4:34–36. If it does, then the ’359 patent
properly claims priority based on Emanuel PCT. If it does
not, then Emanuel PCT is prior art to the ’359 patent and
invalidates it as obvious. The Board, after briefing and
review of expert testimony, found that the disclosure in
Emanuel PCT provides sufficient written description
support for the claimed “light guide,” entitling the ’359
patent to the priority date of Emanuel PCT. Accordingly,
the Board reversed the examiner’s rejections of the ’359
patent’s claims.
Hologic appeals the Board’s decision. We have juris-
diction pursuant to 28 U.S.C. § 1295(a)(4)(A).
6 HOLOGIC, INC. v. SMITH & NEPHEW, INC.
DISCUSSION
On appeal, Hologic challenges the Board’s priority
date determination and urges this court to reinstate the
examiner’s obviousness determination. Obviousness
under 35 U.S.C. § 103 is a mixed question of law and
fact. 2 We review the Board’s ultimate obviousness deter-
mination de novo and underlying fact-findings for sub-
stantial evidence. Harmonic Inc. v. Avid Tech., Inc.,
815 F.3d 1356, 1363 (Fed. Cir. 2016). Whether an earlier-
filed application possesses sufficient written description to
qualify it as a priority document or is instead invalidating
prior art is a fact-finding we review for substantial evi-
dence. See 35 U.S.C. §§ 112, 120; Yeda Research & Dev.
Co. v. Abbott GmbH & Co. KG, 837 F.3d 1341, 1344–45
(Fed. Cir. 2016).
I.
To be entitled to the priority date of the earlier-filed
Emanuel PCT, S&N must show that Emanuel PCT dis-
closes what the ’359 patent claims, according to the writ-
ten description requirement of pre-AIA 35 U.S.C. § 112
¶ 1. 3 See In re Katz Interactive Call Processing Patent
2 Congress amended § 103 when it enacted the
Leahy-Smith America Invents Act (“AIA”). Pub. L.
No. 112-29, § 3(c), 125 Stat. 284, 287 (2011). However,
because the application that led to the ’359 patent has
never contained (1) a claim having an effective filing date
on or after March 16, 2013, or (2) a reference under
35 U.S.C. §§ 120, 121, or 365(c) to any patent or applica-
tion that ever contained such a claim, the pre-AIA § 103
applies. See id. § 3(n)(1), 125 Stat. at 293.
3 Congress also amended § 112 when it enacted the
AIA. AIA § 4(c), 125 Stat. at 296−97. However, the
amended version of § 112 applies only to patent applica-
tions “filed on or after” September 16, 2012. See AIA
HOLOGIC, INC. v. SMITH & NEPHEW, INC. 7
Litig., 639 F.3d 1303, 1322 (Fed. Cir. 2011). Specifically,
based on “an objective inquiry into the four corners of the
specification from the perspective of a person of ordinary
skill in the art . . . , the specification must describe an
invention understandable to that skilled artisan and show
that the inventor actually invented the invention
claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc). “In other words,
the test for sufficiency is whether the disclosure of the
[earlier] application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of
the claimed subject matter” as of that earlier filing date.
Id. As discussed further below, we find that this standard
is satisfied here.
As a preliminary matter, the parties do not dispute
the Board’s definition of a person of ordinary skill in the
art as a “degreed engineer having at least 5 years of
experience designing and developing devices used in
minimally invasive surgery (endoscopes, resectoscopes,
shavers, tissue removal devices, etc.).” Board Decision,
2016 WL 6216657, at *8. We agree with the Board’s
finding that the field of this invention is a predictable art,
such that a lower level of detail is required to satisfy the
written description requirement than for unpredictable
arts. See id. at *13; Ariad, 598 F.3d at 1351.
II.
We affirm the Board’s reversal of the examiner’s re-
jection because we find substantial evidence supports the
Board’s finding that the ’359 patent is entitled to claim
priority to Emanuel PCT. Specifically, substantial evi-
dence supports the Board’s finding that Emanuel PCT
§ 4(e), 125 Stat. at 297. Because the application that led
to the ’359 patent was filed before that date, pre-AIA
§ 112 applies here.
8 HOLOGIC, INC. v. SMITH & NEPHEW, INC.
reasonably conveys to a person of ordinary skill that the
inventor had possession of the “first channel having a
light guide permanently affixed therein.” See ’359 patent,
claim 1. We address the substantial evidence supporting
each element.
First, Hologic argues that substantial evidence does
not support the Board’s conclusion that the Emanuel PCT
disclosure reasonably conveys to a person of ordinary skill
that the inventor had possession of a “light guide.” While
Emanuel PCT explicitly discloses a “fibre optics bundle,”
it does not explicitly disclose a “light guide.” Emanuel
PCT at 4:34–36. In finding that Emanuel PCT also
discloses a “light guide,” however, the Board properly
relied on the fact that the parties do not dispute that a
“fibre optic bundle” is a type of light guide. Board Deci-
sion, 2016 WL 6216657, at *13. Nor did the parties
dispute that various types of light guides were well-
known in the art. Indeed, the Board correctly found that
the declarations of Hologic’s own experts did not dispute
either point in discussing how one of ordinary skill would
interpret Emanuel PCT. See id. (citing Dominicis Decl.
¶ 12 (J.A. 2290), Walbrink Decl. ¶¶ 10(c), 30 (J.A. 2648)).
Accordingly, we conclude that substantial evidence sup-
ports the Board’s finding that Emanuel PCT reasonably
conveys to a person of ordinary skill that the inventor had
possession of a “light guide.”
Second, Hologic argues that substantial evidence does
not support the Board’s conclusion that the Emanuel PCT
disclosure reasonably conveys to a person of ordinary skill
that the inventor had possession of a light guide perma-
nently affixed in the “first channel.” Hologic’s argument
rings hollow. The first channel is depicted in Figures 2
and 3 as element 6 and is described in Emanuel PCT as a
“light channel” or “viewing channel.” See Emanuel PCT
at 3:24–25, 4:30–36 (emphases added). Channel 6 is
further described as terminating in lens 13 at one end and
viewing tube 7, which is an eyepiece or camera connec-
HOLOGIC, INC. v. SMITH & NEPHEW, INC. 9
tion, at the other end. Furthermore, the specification
makes clear that the viewing channel is element 6 in
Figure 2. Element 6 is next to connection 8 for the light
source. Additionally, the specification explains that “[a]
connection 8 for a light source is also present, for connec-
tion to a fibre optics bundle, which provides for lighting at
the end of lens 13.” Id. at 4:34–36.
Taken together, these statements in the specification
support the Board’s finding that Emanuel PCT contem-
plated a distinct channel for light or viewing, separate
from cutting tools. Accordingly, we find that substantial
evidence supports the Board’s conclusion that a person of
ordinary skill, reviewing the Emanuel PCT figures and
specification, would have understood that the inventor
had possession of a light guide affixed in the “first chan-
nel.”
We must also address Hologic’s argument that Fig-
ure 1a, which it alleges does not show illumination com-
ponents, evidences that the inventor was not in
possession of a “first channel having a light guide perma-
nently affixed therein” at the relevant time. We disagree
with Hologic’s contention for at least two reasons. First,
that the viewing channel does not depict a light guide or
fibre optics is not dispositive. The written description
does not require that every claimed element be illustrated
in the figures, particularly in predictable arts and where
the element not depicted is conventional and not “neces-
sary for the understanding of the subject matter sought to
be patented.” 35 U.S.C. § 113 (requiring only that the
“applicant shall furnish a drawing where necessary for
the understanding of the subject matter sought to be
patented”); see also 37 C.F.R. § 1.81(a) (“The applicant for
a patent is required to furnish a drawing of the invention
where necessary for the understanding of the subject
matter sought to be patented.”); In re Hayes Microcomput-
er Prods., Inc. Patent Litig., 982 F.2d 1527, 1536 (Fed. Cir.
1992) (concluding substantial evidence supports the
10 HOLOGIC, INC. v. SMITH & NEPHEW, INC.
finding that a “microprocessor” illustrated in a figure was
sufficient written description support for claimed timing
means and other claim elements not depicted in figures).
Moreover, the lack of an illumination component in Fig-
ure 1a does not undermine the strong evidence noted
above that supports the Board’s finding that Emanuel
PCT discloses a light guide in channel 6.
Finally, Hologic argues that the Board’s finding that
Emanuel PCT reasonably conveys to a person of ordinary
skill that the inventor had possession of a “permanently
affixed” light guide lacks the support of substantial evi-
dence. We disagree. Figure 1 of Emanuel PCT illustrates
a cutting device 1 that may be assembled from multiple
parts. Emanuel PCT at 4:15–16 (“Fig. 1 shows the endo-
scopic cutting device according to the invention in the
assembled state.”) Specifically, cutting device 1 is assem-
bled from three primary parts: (a) viewing/receiving
part 3 (illustrated in Figure 2), (b) cutting part 2 (illus-
trated in Figures 4 and 5), and (c) insertion mandrel 40
(illustrated in Figure 6). Id. at 4:17–29. Emanuel PCT
explains that cutting part 2 is removable. Id. at 8:3–8
(“Surgical endoscopic cutting device (1) . . . provided with
a receiving part (5) . . . for receiving cutting means (2)
. . . .”). Similarly, insertion mandrel 40 is removable. Id.
at 5:38–6:1 (“Mandrel 42 is then removed. . . .”). No-
where, however, does Emanuel PCT suggest that the fibre
optics bundle of viewing/receiving part 3 is removable.
See id. at 4:26–36. Indeed the specification explains that
viewing/receiving part 3 is composed of an outer tube 4 in
which a main channel 5 and viewing channel 6 are de-
fined. Id. at Fig. 2, 4:30–32. At no point does the specifi-
cation describe the fibre optics bundle component of the
viewing/receiving part 3 as removable. It is connection 8
that enables addition or removal of a light source in
conjunction with the fibre optics bundle. Id. at 4:34–36.
Further, viewing channel 6 ends at one side in a lens 13
and at the other side in a viewing tube 7, on which an
HOLOGIC, INC. v. SMITH & NEPHEW, INC. 11
eyepiece or camera connection is placed. Id. at Fig. 2,
4:30–37. The fact that viewing channel 6 is bookended by
lens 13 and viewing tube 7 is evidence that these compo-
nents form a unitary part that is not removable. The
specification also describes a connection 8 for a light
source, for connection to a fibre optics bundle that pro-
vides for lighting at the end of the lens 13. Id. at Fig. 2,
4:30–37. Indeed, Figure 2 shows connection 8 is integral
with the viewing/receiving part 3. Id. at Fig. 2. Taken
together, these disclosures in Emanuel PCT support the
Board’s finding that Emanuel PCT contemplated a “per-
manently affixed” light guide. Accordingly, we find that
substantial evidence supports the Board’s conclusion that
a person of ordinary skill, reviewing Emanuel PCT, would
have understood that the inventor had possession of a
“permanently affixed” light guide.
In addition to the intrinsic evidence discussed above,
prior patents reflecting the state of the art at the time of
the invention and expert testimony regarding that evi-
dence further support the Board’s findings. The
’359 patent on its face lists several pieces of prior art,
including U.S. Patent No. 4,606,330 (“Bonnet”) and U.S.
Patent No. 4,706,656 (“Kuboto”). Bonnet and Kuboto both
describe endoscopes with permanently affixed light
guides. S&N’s experts, Dr. Keith B. Isaacson and
Mr. Richard J. Apley, each testified that the figures in
Emanuel PCT look more like the figures in Bonnet and
Kuboto than figures in several prior art patents directed
to removable light guides. Specifically, Dr. Isaacson
testified that, as of at least September 1998, a person of
ordinary skill in the art would have known that there
were two types of endoscopic systems generally available
for use in surgical procedures: a removable “telescope,” or
a unitary integrated device—like Bonnet and Kuboto.
Dr. Isaacson further testified that the two types of devices
were readily distinguishable merely by looking at pictures
of the devices. Continuing, Dr. Isaacson explained that,
12 HOLOGIC, INC. v. SMITH & NEPHEW, INC.
in looking at the Emanuel PCT figures, a person of skill in
the art would recognize that they have permanently
affixed light guides and lenses, similar to those shown in
Bonnet and Kuboto. Mr. Apley provided similar testimo-
ny.
Hologic argues that the Board improperly relied on
prior art to supply missing claim elements. We do not
agree. The Board simply considered what the specifica-
tion reasonably conveys to the skilled artisan who has
knowledge of the prior art. See Ariad, 598 F.3d at 1351.
The Board did not err in this regard.
Hologic likewise argues that the Board did not proper-
ly limit its consideration to the four corners of Emanuel
PCT because the endoscope in Emanuel PCT does not
expressly or “necessarily include a light guide permanent-
ly affixed in a first channel.” Appellant Br. 38 (emphasis
added). Hologic’s understanding of our written descrip-
tion law is incorrect. Rather, we agree with the Board
that the proper test is the one we articulated in Ariad:
“whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as
of the filing date.” Board Decision, 2016 WL 6216657,
at *6 (citing Ariad, 598 F.3d at 1351).
For the above reasons, we are satisfied that the Board
applied the correct law and that substantial evidence
supports the Board’s finding that Emanuel PCT provides
sufficient written description disclosure of the claimed
“first channel having a light guide permanently affixed
therein.”
CONCLUSION
We have reviewed Hologic’s remaining arguments and
find them unpersuasive. For the reasons above, we affirm
the Board’s finding that Emanuel PCT provides written
description support for claims 1–3 and 5–7 of the
HOLOGIC, INC. v. SMITH & NEPHEW, INC. 13
’359 patent and that the ’359 patent is entitled to claim
priority to Emanuel PCT. Accordingly, we affirm the
Board’s finding that Emanuel PCT is not prior art to the
’359 patent under pre-AIA Section 102(b). We also affirm
the Board’s reversal of the examiner’s corresponding
obviousness rejection.
AFFIRMED
COSTS
Costs to Appellees.