Ivera – The Circuit reverses the grant of summary judgement of invalidity, ruling that issues of fact remain as to the teachings of the prior art and whether one with ordinary skill would have been motivated to combine the references.

Ivera Medical Corp. v. Hospira, Inc., Fed. Cir. Case 2014-1613, -1614 (September 8, 2015)

The three patents in suit share the same written description and explain that medical implements, such as catheters and luer ports, are common sites for transmissions of pathogens into patients. To prevent these types of transmissions, medical staff traditionally swabbed a site before making connections to medical implements. After swabbing, the site is allowed to dry, killing any pathogens. In practice, these swabbing procedures were often overlooked or poorly executed. 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 shows a cleaning device that includes a cap 102 with threads 105 adapted to receive a medical implement and first and second cleaning materials 107 and 108. When the 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.

Central to the parties’ arguments 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. Second, in FIG. 14 holes 164 are formed in housing 162, which “can promote evaporation of the cleaning agent, particularly when the housing covers a site of a medical implement to be disinfected.”

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.

The Asserted Prior Art and the Prosecution of the Patents

The prior art Hoang application describes a device for antiseptically maintaining a patient fluid line access valve. Hoang includes a cap that has a lid and a pad that may be impregnated with a cleaning agent and an antimicrobial agent. The pad can thus clean the valve as the cap device is twisted on to the valve.

The prior art Chin-Loy patent describes a cap adapted to cover blood ports for devices such as hemodialysis machines. Chin-Loy includes a cap with a first end defining a female portion, which receives a male blood port. The cap can be twisted onto a blood port when the port is threaded or can “snap on” for unthreaded ports. The cap includes a channel so that when the cap is attached to a blood port, the channel permits “venting of the medical device through the male blood nipple while maintaining an internal condition of the medical device until time of use.”

The prior art White patent describes a catheter assembly with an outer protective cap that contains a sponge that is saturated with an antiseptic. When the outer protective cap is twisted, the antiseptic from the sponge can “bathe the exterior surfaces” of the assembly.

In response to a rejection based on Hoang and various secondary references, the applicant amended the claims to recite vents that allow for evaporation or drying of the cleaning agent. The examiner then allowed the application stating 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 while in use.”

Inter Partes Reexamination

Hospira later requested inter partes reexamination of the patents-in-suit, which was granted. After the examiner rejected the claims, Ivera attempted to enter declarations, including one from an inventor of the Hoang reference and another from Dr. Buchman, the inventor of another reference relied on during the inter partes reexaminations. 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.

Assessing the merits, the examiner rejected all of the challenged claims, concluding that it would have been obvious 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.” The examiner also concluded that 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. Ivera informs us that it is appealing the rejections to the PTAB.

Back in the district court, Hospira’s summary judgment of invalidity was granted, and Ivera appealed.

Issues of Fact as to the Teachings of the Prior Art and as to Whether One in the Art Would Have Been Motivated to Add a Vent Preclude Summary Judgment of Invalidity

Ivera argues that a person of ordinary skill in the art would not have been motivated to add a vent to Hoang’s cap. Instead, according to Ivera, that the conventional wisdom among those skilled in the art was that disinfecting caps should be fluid tight. Hospira responds that Chin-Loy describes benefits of venting a cap, which would have motivated one of ordinary skill to add a vent to Hoang’s cap. Hospira also cites the written description of the patents-in-suit as encouraging evaporation of cleaning agents. A person of ordinary skill would also have, according to Hospira, seen the benefit of bathing the exterior of a cap, as allegedly described in White.

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. The declarations that were submitted in the inter partes reexamination indicate that a person of ordinary skill would have desired fluid-tight disinfecting caps to retain the cleaning agent included within the cap. Referring 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.” 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. 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.”

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 bathe the surface of the injection port entrance in the antimicrobial solution to obtain the best possible disinfection” and that “establishing and maintaining a fluid tight seal over the injection port was an important aspect of my design.” It was “commonly understood,” according to Dr. Buchman, that effective disinfection of the surface of the injection port “required that it be continuously bathed in the antimicrobial fluid.”

Hospira argues that Chin-Loy describes a channel that permits venting during sterilization. Chin-Loy, however, relates to blood ports of hemodialysis machines. Hospira cites no evidence explaining how this description is relevant to disinfecting caps. Chin-Loy thus does not foreclose a genuine dispute over whether one of ordinary skill would have been motivated to add a vent to Hoang’s cap.

Finally, Hospira points to White’s disclosure of bathing “the exterior surfaces.” The parties dispute whether this disclosure means that the antiseptic bathes only his threaded shoulder (as Ivera asserts) or if the antiseptic drips down the outside of the distal member (as Hospira asserts). This dispute over the content of White is a factual dispute that we must resolve in Ivera’s favor at the summary judgment stage. 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.

For the foregoing reasons, we hold that Ivera established 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.

Comment: The fact that Ivera is appealing the rejection of the claims in the inter partes reexamination is significant because if it had not appealed that rejection, that would be the end of the matter. Remember that under the ePlus v. Lawson, 790 F. 3d 1307 (Fed. Cir. 2015) and Fresenius v Baxter, 733 F.3d 1369 (Fed. Cir. 2013) line of cases, if the PTO decides in a reexamination or AIA proceeding that patent claims are invalid, the claims are invalid for all purposes, even if court litigation is continuing. Therefore, if the PTAB affirms the determination of invalidity, Ivera would have to appeal to the Circuit or its infringement case would be dismissed since all of the patent claims being asserted would have been found invalid. In that appeal, the Circuit would apply the preponderance of the evidence standard to the obviousness issue rather than simply looking to see if genuine issues of fact exist, as it did in this decision.

If, on the other hand, the PTAB decides that the examiner should have ‎considered the declarations and, based on the declarations, reverses the determination of ‎invalidity, Hospira would presumably want to, but would not have to, appeal that determination to the Circuit. Hospira would want to have its invalidity argument heard by the Circuit applying the preponderance of the evidence standard, rather than go to trial where it would have to prove invalidity by clear and convincing evidence, with the jury knowing that it had been unsuccessful in its arguments to the PTO in the inter partes reexamination. ‎But, because its inter partes reexamination was pre-AIA, it would not be precluded from arguing invalidity in court, even based on the same references.