Ivera Med. Corp. v. Hospira, Inc.

• Decision Date: 08 September 2015
• Docket Number: Nos. 2014–1613,2014–1614.,s. 2014–1613
• Citation: 116 U.S.P.Q.2d 1400,801 F.3d 1336
• Parties: IVERA MEDICAL CORPORATION, Plaintiff–Appellant v. HOSPIRA, INC., Defendant–Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

801 F.3d 1336

116 U.S.P.Q.2d 1400

IVERA MEDICAL CORPORATION, Plaintiff–Appellant

v.HOSPIRA, INC., Defendant–Appellee.

Nos. 2014–1613

2014–1614.

United States Court of Appeals, Federal Circuit.

Sept. 8, 2015.

David J.F. Gross, Faegre Baker Daniels LLP, Minneapolis, MN, argued for plaintiff-appellant. Also represented 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.

Before NEWMAN, REYNA, and TARANTO, Circuit Judges.

Opinion

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 judgment 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 disinfects 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 medical 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 compresses axially, cleansing the foremost surface of the implement. See id. col. 7 ll. 27–33.

Central to the parties' arguments on summary judgment 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 (provided below), holes 164 are formed in housing 162 of the cap. Holes 164 “can promote evaporation of the cleaning 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 cleaning 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 more threads adapted to receive a site of the medical implement;

a cleaning material formed of a compressible material that is at least partially secured in the inner cavity, the cleaning material containing a cleaning 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 maintaining 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 numerically 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 antimicrobial 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.

2. Chin–Loy.

U.S. Patent No. 5,954,957 (“Chin–Loy”) describes a cap adapted to cover blood ports or other hydraulic connection 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 defining 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.

3. White.

U.S. Patent No. 5,242,425 (“White”) describes a catheter assembly that includes a distal member and a proximal 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 member 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 shoulder 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 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 application. J.A. 5029–33. In the Notice of Allowance, the examiner 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 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 references. 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 reexaminations, 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 microorganisms to maintain the sterile condition of the catheter access site.” J.A. 5468. The examiner also concluded that because threaded luer connections are...