Tuesday, September 08, 2015

Ivera wins reversal in Hospira case at CAFC

The bottom line in Ivera v. Hospira at the CAFC was a reversal of summary judgment of invalidity:

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.

Judge Reyna began the decision:

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.

As to the 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 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.

As to the district court's finding of obviousness:

Considering the differences between the prior art and
the claimed inventions, the court found that the “patentsin-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 benefit
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 sterilization.
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 CAFC noted

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, according
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 describes
benefits of venting a cap, which would have motivated
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 allegedly
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-
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.
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. I

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1613.Opinion.9-3-2015.1.PDF


Post a Comment

<< Home