Court Opinion

ID: 2897983
Source: CourtListenerOpinion
Date Created: 2015-09-08 15:01:13.242742+00
Date Added: 2024-06-11T15:15:47.140383
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

         IVERA MEDICAL CORPORATION,
                Plaintiff-Appellant

                           v.

                  HOSPIRA, INC.,
                  Defendant-Appellee

                ______________________

                 2014-1613, 2014-1614
                ______________________

   Appeals from the United States District Court for the
Southern District of California in Nos. 3:11-cv-01246-H-
RBB, 3:12-cv-01582-H-RBB, Judge Marilyn L. Huff.
                ______________________

              Decided: September 8, 2015
                ______________________

    DAVID J.F. GROSS, Faegre Baker Daniels LLP, Minne-
apolis, MN, argued for plaintiff-appellant. Also repre-
sented by THEODORE MICHAEL BUDD, CHAD DROWN, EVA
BETH STENSVAD.

    ADAM R. HESS, Venable LLP, Washington, DC, argued
for defendant-appellee. Also represented by MEAGHAN
KENT, MARTIN LYNN SAAD; PAUL F. STRAIN, Baltimore,
MD.
                ______________________
2                IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

    Before NEWMAN, REYNA, and TARANTO, Circuit Judges.
REYNA, Circuit Judge.
    Ivera Medical Corp. (“Ivera”) sued Hospira, Inc.
(“Hospira”) in the Southern District of California alleging
infringement of U.S. Patent Nos. 7,780,794 (the ’794
patent), 7,985,302 (the ’302 patent), and 8,206,514 (the
’514 patent). The district court granted summary judg-
ment of invalidity, finding the asserted patent claims
obvious under 35 U.S.C. § 103. Ivera appeals. For the
reasons that follow, we reverse and remand.
                        BACKGROUND
                 A. The Patents-in-Suit.
    The ’514 patent is a continuation of ’302 patent, which
is a continuation of the ’794 patent. All three patents
share the same written description. 1 The patents explain
that medical implements, such as catheters and luer
ports, are common sites for transmissions of pathogens
into patients. ’794 patent col. 1 ll. 32–35. To prevent
these types of transmissions, medical staff traditionally
swabbed a site before making connections to medical
implements. Id. col. 1 ll. 41–45. The swabs came in a
small pad of cotton gauze soaked in a cleaning agent (e.g.,
isopropyl alcohol) and packed in a foil package to prevent
evaporation. Id. col. 1 ll. 45–47. After swabbing, the site
is allowed to dry, killing any pathogens. Id. col. 1 ll. 48–
55.
    In practice, these swabbing procedures were often
“overlooked” or “poorly executed.” Id. col. 1 ll. 56–58. To
overcome this problem, the inventors provided a cleaning
device that includes a cap that, when used, reliably disin-

     1  For simplicity, we refer below to the written de-
scription of the ’794 patent.
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.            3

fects a medical implement. For example, FIG. 6, provided
below, shows a cross-sectional diagram of a cleaning
device 100 that includes a cap 102. Id. col. 6 ll. 19–20.
Cap 102 includes threads 105 adapted to receive a medi-
cal implement, and first and second cleaning materials
107 and 108. Id. col. 6 ll. 26–30 and 49-52. When the
medical implement is twisted into cap 102, first cleaning
material 107 compresses radially, cleansing the sides of
the implement, and second cleaning material 108 com-
presses axially, cleansing the foremost surface of the
implement. See id. col. 7 ll. 27–33.

    Central to the parties’ arguments on summary judg-
ment are openings that permit venting of the interior of
the cap. The patents describe two embodiments of these
openings. First, in FIG. 6, threaded ring 106 can create
“a small vent aperture or opening” relative to the inner
wall of cap 102 to allow evaporation of the cleaning agent
in cap 102. Id. col. 6 ll. 37–43. Second, in FIG. 14 (pro-
vided below), holes 164 are formed in housing 162 of the
cap. Holes 164 “can promote evaporation of the cleaning
4                 IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

agent, particularly when the housing covers a site of a
medical implement to be disinfected.” Id. col. 8 ll. 15–17.

    The asserted claims of the patents-in-suit recite clean-
ing devices that include a “second opening,” “aperture,” or
“means for venting” that inhibit pressure buildup and
allow for evaporation. 2 For example, claim 13 of the ’794
patent recites:
    13. A cleaning device for a medical implement, the
    cleaning device comprising:
    a cap having a first opening to an inner cavity, an
    inner surface of the first opening including one or

    2      We refer to these limitations collectively as
“vents.”
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.                5

   more threads adapted to receive a site of the med-
   ical implement;
   a cleaning material formed of a compressible ma-
   terial that is at least partially secured in the inner
   cavity, the cleaning material containing a clean-
   ing agent;
   a second opening in the cap to allow evaporation of
   the cleaning agent from the inner cavity and to
   inhibit a buildup of pressure in the cap when the
   cleaning material is compressed by the site of the
   medical implement and a removable covering that
   covers the first opening and the second opening to
   the inner cavity prior to coupling the threads of
   the cap with the site of the medical implement via
   the first opening.
’794 patent col. 10 ll. 1–17 (emphasis added).
                    B. The Prior Art.
                        1. Hoang.
    U.S. Patent Application Publication No. 2007/0112333
(“Hoang”) describes a “device for antiseptically maintain-
ing a patient fluid line access valve.” Hoang, ¶ 5. The
parties focus their attention on FIG. 10b of Hoang, which
is provided below. FIG. 10b shows a cap device 78 that
has a lid 78a and a pad 80. Id. ¶ 43. Cap device 78 can be
twisted onto a patient’s valve using its threads (not nu-
merically referenced in FIG. 10b). Id. ¶ 44. Pad 80 can be
used as a “dry” pad or a “wet” pad. Id. ¶ 43. When used
as a “dry” pad, pad 80 is impregnated with an antimicro-
bial agent that maintains antiseptic conditions on the
access portion of a valve. Id. ¶ 23. When used as a wet
pad, pad 80 is impregnated with a cleaning agent and,
optionally, an antimicrobial agent. Id. ¶ 27. In this latter
example, pad 80 can clean the valve as cap device 78 is
twisted on to the valve. Id. ¶ 44.
6               IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

                      2. Chin-Loy.
     U.S. Patent No. 5,954,957 (“Chin-Loy”) describes a
cap adapted to cover blood ports or other hydraulic con-
nection ports for medical devices such as hemodialysis
machines. Chin-Loy col. 3 ll. 19–23. FIG. 1 of Chin-Loy,
provided below, shows a cap 10 with a first end 12 defin-
ing a female portion 16, which receives a male blood port.
Id. col. 3 ll. 54–57. Side wall 22 and end wall 24 together
define a receptacle 34 that receives the male nipple. Id.
col. 4 ll. 5–7. Cap 10 can be twisted onto a blood port
when the port is threaded or can “snap on” for unthreaded
ports. Id. col. 4 ll. 32–35, col. 4 ll. 46–49. Cap 10 also
includes a channel 66 defined by interior surface 28. Id.
col. 5 ll. 1–2. When cap 10 is attached to a blood port,
channel 66 permits “venting of the medical device through
the male blood nipple while maintaining an internal
condition of the medical device until time of use.” Id. col.
2 ll. 41-43 and col. 5 ll. 12–15.
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.              7

                        3. White.
    U.S. Patent No. 5,242,425 (“White”) describes a cathe-
ter assembly that includes a distal member and a proxi-
mal member. 3 FIG. 7 of White, provided below, shows an
example catheter assembly that includes a distal member
70 having a finger grip 72. White col. 7 ll. 23–25. Distal
member 70 is connected to flexible catheter tubing 18 and
proximal member 82. Id. col. 7 ll. 29–32. Proximal mem-
ber 82 has a self-sealing septum 84 through which a
needle can be inserted to introduce liquids into catheter
tubing 18. Id. col. 7 ll. 1–6.
    Distal member 70 has an externally threaded shoul-
der 74 that is adapted to receive internal threads of outer
protective cap 78. Id. col. 7 ll. 26–27. Outer protective
cap 78 contains a sponge 80 that is saturated with an

   3    In White, the “distal end” is the end closest to the
patient and “proximal end” is the end exposed to the
outside world. White col. 2 ll. 45–50.
8               IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

antiseptic. Id. col. 7 ll. 27–29. When outer protective cap
78 is twisted onto externally threaded shoulder 74, the
antiseptic from sponge 80 can “bathe the exterior surfaces
of distal member 70, proximal member 82, and self-
sealing septum 84.” Id. col. 7 ll. 29–35.

                 C. Prosecution History.
     In February 2007, Bobby Rogers and Paul DiPerna
filed non-provisional application no. 11/705,805 (the “’805
application”), which led to the ’794 patent. In response to
a September 2009 Office Action, which rejected all of the
claims as either anticipated by Hoang or obvious over
Hoang and various secondary references, the applicant
amended the claims to recite, inter alia, vents that allow
for evaporation or drying of the cleaning agent. J.A.
5412–18. In response, the examiner allowed the applica-
tion. J.A. 5029–33. In the Notice of Allowance, the exam-
iner stated that “the reviewed prior art does not disclose
or render obvious a medical implement cleaning device
comprising a cap having holes or openings for venting the
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.             9

device while in use,” J.A. 5033, and that Hoang does not
disclose “vent holes, apertures, or additional openings to
inhibit vacuum [sic] in the cap cleaning device.” J.A.
5034. The ’794 patent issued thereafter in August 2010.
    The ’794 and ’302 patents were each subject to ex
parte reexamination. In each of these proceedings, the
examiner initially rejected the claims over various refer-
ences. In at least the reexamination of the ’794 patent,
the examiner considered the Hoang reference. J.A. 5097–
98. The examiner determined that the challenged claims
of the ’794 and ’302 patents were patentable over the cited
prior art based at least partially on the vent limitations.
J.A. 38; J.A. 54; J.A. 5097–98; J.A. 5161–62.
    Hospira later requested inter partes reexamination of
the patents-in-suit, which the United States Patent and
Trademark Office granted. After the examiner rejected
claims in an Action Closing Prosecution (“ACP”), Ivera
attempted to enter seven declarations, including one from
an inventor of the Hoang reference, Minh Hoang, and
another from Dr. Alan Buchman, the sole inventor of a
prior art reference relied on during the inter partes reex-
aminations, but not at issue here. J.A. 5473. In the Right
of Appeal Notice (“RAN”), the examiner determined that
these declarations would not be considered because Ivera
had not explained why this evidence was not presented
earlier in the proceedings. J.A. 5473.
    Assessing the merits, the examiner rejected all of the
challenged claims as obvious over the combination of
Hoang and Chin-Loy (among other rejections). J.A. 5467–
68, 5513–14, 5553–54. The examiner concluded that it
would have been obvious to one of ordinary skill to include
“the venting channel of Chin-Loy in the cap housing of
Hoang because it would allow for venting from the cap
interior while preventing the infiltration of microorgan-
isms to maintain the sterile condition of the catheter
access site.” J.A. 5468. The examiner also concluded that
10               IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

because threaded luer connections are not fluid-tight, a
threaded opening (such as the ones disclosed in Hoang
and White) can meet the vent limitations. See J.A. 5521.
Ivera informs us that it is appealing the rejections to the
Patent Trial and Appeal Board. Appellant’s Br. 18.
                  D. Procedural Posture.
      Ivera sued Hospira for infringement of the ’794 and
’302 patents in 2011 and for infringement of the ’514
patent in 2012. In October 2013, the district court issued
its claim constructions for the disputed terms of all of the
patents-in-suit. Relevant here, the district court con-
strued the term “opening” or “first opening” to mean “an
entrance or exit to the inner cavity of the cap,” “second
opening” to mean “a second, distinct channel or pathway
that extends from the interior to the exterior of the cap,”
and “aperture” to mean “a channel, pathway, hole, gap, or
split.” J.A. 5433, 5435, 5437. The district court also
construed “means for venting” under 35 U.S.C. § 112, ¶
6, 4 to mean “the following combination of proposed terms:
(a) a threaded ring that fits into a groove that is formed in
the inside edge surface of the cap near the opening, where
the threaded ring includes or creates with the cap wall a
small vent aperture or opening; (b) holes in the housing of
the cap; and (c) permitted equivalents of (a) and (b).” J.A.
5439. The parties do not challenge these constructions
before us.

     4  Paragraph 6 of 35 U.S.C. § 112 was replaced with
newly designated § 112(f) when § 4(c) of the America
Invents Act (AIA), Pub. L. No. 112-29, took effect on
September 16, 2012. Because the applications resulting
in the patents-in-suit were filed before that date, we refer
to the pre-AIA version of § 112.
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.              11

    In April 2014, the district court granted Hospira’s mo-
tion for summary judgment of invalidity. J.A. 9. The
district court found that the scope of the prior art included
Hoang, Chin-Loy, and White. J.A. 13. The court further
found that the level of ordinary skill is a person with “a
bachelor’s degree in mechanical engineering, biomedical
engineering, or a comparable field with anywhere from
two to five years’ work in the disposable medical device
industry.” J.A. 16.
     Considering the differences between the prior art and
the claimed inventions, the court found that the “patents-
in-suit contain the same elements that perform the same
functions they had been known to perform in the prior
art,” J.A. 16, and that the “arrangement of elements in
the asserted claims do[es] not yield anything other than
predictable results,” J.A. 18. The court noted, however,
that Hoang does not disclose the vent limitations. J.A. 19.
Still, a person of ordinary skill would not “need the bene-
fit of hindsight to realize that adding a vent would relieve
possible pressure on the inside of the cap.” J.A. 19.
According to the court, a person of ordinary skill would
recognize the benefits of adding a vent as allegedly taught
in Chin-Loy, i.e., it would allow venting of the interior of
the medical device through a blood port during steriliza-
tion. J.A. 19 (citing Chin-Loy col. 5 ll. 1–20). A person of
ordinary skill would also recognize that adding a second
opening would allow the cleaning agent to “vent onto the
exterior of the medical implement, sterilizing a larger
portion of it,” as allegedly described in White. J.A. 19
(citing White col. 7 ll. 23–35). Thus, the district court
determined that “the record demonstrates no triable issue
of material fact on obviousness for the asserted claims of
the patents-in-suit.” J.A. 20. The district court further
found that Ivera’s evidence of secondary indicia of non-
obviousness did not rebut this conclusion, stating that
“[t]he asserted claims encompassed obvious subject mat-
12               IVERA MEDICAL CORPORATION    v. HOSPIRA, INC.

ter regardless of evidence of secondary factors, and as a
result fail to meet the requirement of § 103.” J.A. 21.
   Ivera timely appealed. We have jurisdiction under 28
U.S.C. § 1295(a)(1).
                        DISCUSSION
    Summary judgment is appropriate if “the movant
shows that there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of
law.” Fed. R. Civ. P. 56(a). We review a grant or denial of
summary judgment under the law of the regional circuit,
which in this case is the Ninth Circuit. Aristocrat Techs.
Austl. Pty Ltd. v. Int’l Game Tech., 709 F.3d 1348, 1361
(Fed. Cir. 2013). The Ninth Circuit reviews such a deci-
sion de novo. Humane Soc’y of the U.S. v. Locke, 626 F.3d
1040, 1047 (9th Cir. 2010). That is, we apply the same
standard applied by the district court. Lew v. Kona Hosp.,
754 F.2d 1420, 1423 (9th Cir. 1985). In doing so, we
resolve factual disputes against the movant. Gen. Elec.
Co. v. Joiner, 522 U.S. 136, 143 (1997). We must also
take into account that invalidity of a patent must be
shown by clear and convincing evidence. Microsoft Corp.
v. i4i Ltd. P'ship, 131 S. Ct. 2238, 2243 (2011); see also
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
     Under 35 U.S.C. § 103, a patent may not be obtained
“if the differences between the subject matter sought to be
patented 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.” 5 Obvi-
ousness is a legal question based on the following under-
lying factual inquiries: (1) the scope and content of the
prior art; (2) the level of ordinary skill in the art; (3) the

     5   Again, we refer to the pre-AIA version of § 103.
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.             13

differences between the claimed invention and the prior
art; and (4) secondary evidence of nonobviousness. Gra-
ham v. John Deere Co., 383 U.S. 1, 17–18 (1966). “A party
seeking to invalidate a patent on obviousness grounds
must demonstrate by clear and convincing evidence that a
skilled artisan would have been motivated to combine the
teachings of the prior art references to achieve the
claimed invention, and that the skilled artisan would
have had a reasonable expectation of success in doing so.”
InTouch Techs., Inc. v. VGO Commc'ns, Inc., 751 F.3d
1327, 1347 (Fed. Cir. 2014) (internal citations and quota-
tion marks omitted). Determining whether one of ordi-
nary skill in the art would have been motivated to
combine the teachings of different references is a flexible
inquiry, and the motivation is not required to be found in
any particular prior art reference. KSR Int'l Co. v. Tele-
flex Inc., 550 U.S. 398, 415 (2007).
    Ivera argues that a person of ordinary skill in the art
would not have been motivated to add a vent to Hoang’s
cap. Appellant’s Br. 33. Instead, the record shows, ac-
cording to Ivera, that the conventional wisdom among
those skilled in the art was that disinfecting caps should
be fluid tight. Id. Hospira responds that Chin-Loy de-
scribes benefits of venting a cap, which would have moti-
vated a person of ordinary skill to add a similar vent to
Hoang’s cap. Appellee’s Br. 29. Hospira also cites the
written description of the patents-in-suit as encouraging
evaporation of cleaning agents. Id. A person of ordinary
skill in the art would also have, according to Hospira,
seen the benefit of bathing the exterior of a cap, as alleg-
edly described in White. Id. at 31.
    We agree with Ivera that record evidence establishes
a genuine dispute over whether a person of ordinary skill
would have been motivated to add a vent to Hoang’s
disinfecting cap. During the inter partes reexaminations,
Ivera submitted multiple expert declarations. As noted
above, the examiner decided not to consider these declara-
14              IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

tions because Ivera did not establish why it had not
submitted them earlier. Hospira does not, however,
challenge Ivera’s reference to these declarations at the
summary judgment stage before the district court. The
declarations indicate that a person of ordinary skill would
have desired fluid-tight disinfecting caps to retain the
cleaning agent included within the cap. For example,
Ivera relies on a declaration from an inventor of the
Hoang reference, Minh Hoang. In his declaration, Minh
Hoang states that “[a]t the time of my invention, it was
the understanding and belief of persons of ordinary skill
in the art, such as myself, that such a cap should seal over
the access portion of the access valve and retain the
cleaning solution contained in the cap.” J.A. 5652. Refer-
ring to the cap described in the Hoang reference, Minh
Hoang explains the cap “avoided using any pathways or
channels out of the housing of the cap during placement
or use on the access valve, because doing so would allow
an exit of the cleaning solution from the cap, which I
believed would reduce the effectiveness of the cap.” J.A.
5653. Although the statements of an inventor are not
controlling as to the content of a patent application,
Hospira does not challenge Minh Hoang’s assertion that
he is a person of ordinary skill. Ivera’s expert, Karl
Leinsing, agreed with Minh Hoang that one of ordinary
skill in the art would not seek to add a vent to Hoang’s
cap because doing so would cause the loss of cleaning
solution. J.A. 5618. Karl Leinsing added that, in his
opinion, fluid-line connections are generally presumed to
be “fluid-tight to avoid leakage of any such fluid into the
hospital environment.” J.A. 5585.
    Ivera also submitted a declaration from Dr. Alan
Buchman, the sole inventor of a prior art patent cited in
the inter partes reexaminations. In his declaration, Dr.
Buchman states that his goal in creating a catheter
cleaning device was to “create a device that would form a
fluid-tight seal over the injection port and continuously
IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.             15

bathe the surface of the injection port entrance in the
antimicrobial solution to obtain the best possible disinfec-
tion” and that “[e]stablishing and maintaining a fluid-
tight seal over the injection port was an important aspect
of my design.” J.A. 5293. It was “commonly understood,”
according to Dr. Buchman, that effective disinfection of
the surface of the injection port “required that it be con-
tinuously bathed in the antimicrobial fluid.” J.A. 5293-94.
    Hospira argues that the prior art provides reasons to
add a vent to Hoang’s cap. Appellee’s Br. 29. For exam-
ple, Chin-Loy describes a channel that permits venting of
the medical device during sterilization. Chin-Loy col. 5 ll.
13–15. Chin-Loy, however, relates to blood ports of he-
modialysis machines. Id. col. 3 ll. 19–23. Hospira cites no
evidence explaining how this description is relevant to
disinfecting caps. Hospira has not explained, for example,
whether disinfecting caps like the one described in Hoang
are sterilized or would benefit from venting during such a
sterilization procedure. Chin-Loy thus does not foreclose
a genuine dispute over whether a person of ordinary skill
would have been motivated to add a vent to Hoang’s cap.
    Hospira also cites the following passage of the ’794
patent’s written description as indicating that a person of
ordinary skill in the art would not seek to retain the
cleaning solution, but rather seek to have the cleaning
solution evaporate:
   The site should be allowed to dry, usually twenty
   to thirty seconds, immediately prior to making
   any connection. This ‘drying’ period is important:
   when alcohol dries, it breaks open the cellular
   walls of microorganisms, thereby killing them.
’794 patent col. 1 ll. 51–55. This passage, however, re-
lates to manual swabbing of a site, and Hospira presents
no evidence relating these teachings to the use of disin-
fecting caps. In fact, earlier in the same paragraph, the
patents explain that caps are designed to retain the
16               IVERA MEDICAL CORPORATION   v. HOSPIRA, INC.

cleaning agent, explaining that the swabs are packed
individually in a foil package to “retain the alcohol within
the package and to prevent evaporation.” Id. col. 1 ll. 45–
47. In any event, the tradeoff between the desire to retain
the cleaning agent and the patents’ disclosure regarding
drying is a factual matter left to the factfinder.
    Finally, Hospira points to White’s disclosure of bath-
ing “the exterior surfaces of distal member 70, proximal
member 82, and self-sealing septum 84.” White col. 7 ll.
29–35. The parties dispute whether this disclosure means
that the antiseptic bathes only threaded shoulder 74 of
distal member 70 (as Ivera asserts), or if the antiseptic
drips down the outside of distal member 70 (as Hospira
asserts). Appellant’s Br. 28; Appellee’s Br. 31. White is
not clear on which interpretation is correct, and neither
side points to any other evidence favoring one interpreta-
tion. This dispute over the content of White is a factual
dispute that we must resolve in Ivera’s favor at the sum-
mary judgment stage. Plantronics, Inc. v. Aliph, Inc., 724
F.3d 1343, 1356-57 (Fed. Cir. 2013); Gen. Elec. Co., 522
U.S. at 143. The cited passage from White does not,
therefore, indicate that one of ordinary skill in the art
would have sought to add a vent to Hoang’s cap.
                       CONCLUSION
     For the foregoing reasons, we hold that Ivera estab-
lished a genuine dispute over whether one of ordinary
skill in the art would have been motivated to add a vent
to the disinfecting cap described in Hoang. Accordingly,
we reverse the district court’s entry of summary judgment
of invalidity.
            REVERSED AND REMANDED
                          COSTS
     No Costs.