Ex Parte 8206514 et al

Patent Trial and Appeal Board

May 6, 2016

95002087 (P.T.A.B. May. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
95/002,087 08/17/2012
25181 7590 05/09/2016
FOLEY HOAG, LLP
PA TENT GROUP, SEAPORT WEST
155 SEAPORT BL VD
BOSTON, MA 02210-2600
FIRST NAMED INVENTOR
8206514
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
TMF-00004 9427
EXAMINER
JASTRZAB, KRISANNE MARIE
ART UNIT PAPER NUMBER
3991
MAILDATE DELIVERY MODE
05/09/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
EXCELSIOR MEDICAL CORP.
Requester
v.
IVERA MEDICAL CORP.
Patent Owner and Appellant
Appeal2015-003760
Reexamination Control 95/002,087
Patent 8,206,514 B2
Technology Center 3900
Before MARK NAGUMO, JEFFREY B. ROBERTSON, and
RAEL YNN P. GUEST, Administrative Patent Judges.
ROBERTSON, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2015-003760
Reexamination Control 95/002,087
Patent 8,206,514 B2
Patent Owner Ivera Medical Corp. ("Patent Owner") appeals under
35 U.S.C. §§ 134(b) and 315(a) (pre-AIA) the Examiner's decision to reject
claims 1-37. 1 Third-Party Requester Excelsior Medical Corp. (hereinafter
"Requester") urges that the Examiner's decision must be affirmed. 2 We
have jurisdiction under 35 U.S.C. §§ 134(b) and 315(a) (pre-AIA). We
reverse the Examiner's decision to reject claims 1-37.
STATEMENT OF THE CASE
Requester requested inter partes reexamination of United States
Patent 8,206,514 B2 (hereinafter the "'514 Patent") on August 17, 2012.
The '514 Patent was filed as a continuation of U.S. Patent No. 7,985,302 Cl
(hereinafter the "'302 Patent"). The '302 Patent was subject to ex parte
reexamination (Control 90/009,950, filed on October 3, 2011), which
resulted in the patentability of original claims 1---6 and 8-17 being
confirmed, the patentability of claim 7 being confirmed as a result of an
amendment, and new claims 18-25 being added and determined to be
patentable. (See Ex Parte Reexamination Certificate Issued under 35 U.S.C.
§ 307, issued on May 22, 2012.) The '302 Patent is the subject of inter
partes reexamination Control No. 95/002,086, and also on appeal to PTAB
(Appeal No. 2015-004765) and was filed as a continuation of U.S. Patent
1 See Patent Owner's Appeal Brief 1 (filed August 5, 2014) (hereinafter
"App. Br."); Patent Owner's Rebuttal Brief (filed November 24, 2014)
(hereinafter "Reb. Br."); Examiner's Answer (mailed October 24, 2014)
(hereinafter "Ans."); Right of Appeal Notice (mailed April 4, 2014)
(hereinafter "RAN.").
2 See Requester's Respondent Brief (filed September 5, 2014) (hereinafter
"Resp 't Br.").
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7,780,794 Cl (hereinafter the "'794 Patent"). The '794 Patent was subject
to ex parte reexamination (Control 90/009,951, filed on October 3, 2011),
which resulted in the patentability of original claims 1-11 and 13-24 being
confirmed and the patentability of claim 12 being confirmed as a result of an
amendment. (See Ex Parte Reexamination Certificate Issued under
35 U.S.C. § 307, issued on June 26, 2012.) The '794 Patent is the subject of
inter partes reexamination Control No. 95/002,085, and is also on appeal to
PTAB (Appeal No. 2015-003842). (See App. Br. 1.) Decisions in Appeal
No. 2015-004765 and Appeal No. 2015-003842 are being mailed
concurrently herewith.
We heard oral argument from Patent Owner in the three above
mentioned inter partes reexamination appeals concurrently on July 8, 2015,
a transcript of which was entered into the electronic record on July 30, 2015.
We are also informed that the '514 Patent is related to or the subject
of the following proceedings styled: Ivera Medical Corporation v. Excelsior
Medical Corp.; Ivera Medical Corporation v. Hospira, Inc.; and Ivera
Medical Corporation v. Catheter Connections, Inc. (App. Br. 1.) We have
been informed that in a consolidated order dated April 29, 2014, the District
Court of the Southern District of California granted Defendants' Motion for
Summary Judgment of Invalidity of claims 12, 13, 15, 16, 18, 20, and 21 of
the '794 Patent, claims 1-21 of the '302 Patent, and claims 1-8, 11-18,
20-25, and 27 of the '514 Patent over similar prior art that is at issue in the
current reexamination. (See App. Br. (2015-003842), Ex. 25, at 3--4, and
15.)
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We observe that the Court of Appeal for the Federal Circuit reversed
the District Court's entry of summary judgment of invalidity and remanded
the proceeding to the District Court. Ivera Medical Corp. v. Hospira, Inc.,
801 F.3d 1336, 1346 (Fed. Cir. 2015).
The '514 Patent
The '514 Patent relates to a cleaning device, system, and method,
where the cleaning device includes a cap having an inner cavity and an
opening to receive a site of a medical device, the cap also including a
compressible material containing a cleaning agent. (Col. 2, 11. 15-26.) The
'514 Patent describes that the cap 10 includes a housing 4 having internal
threads 3, the internal threads being "sized and arranged to accommodate
luer threads, i.e. standardized male threads" and further describes that when
the cap is kept secured to a medical implement, "the cleaning agent in cap 10
will evaporate over time." (Col. 4, 11. 54---63, col. 6, 11. 5-15; Figs. 1-4.) In
some embodiments, the cap may either be configured with a threaded ring
106 that is adapted to receive the site of a medical implement, which
threaded ring may also include or create a small vent aperture or opening to
allow evaporation of a cleaning agent in the cap. (Col. 6, 11. 35--45; Figs.
5-11.) The '514 Patent discloses also that in an alternative embodiment,
holes can be included in the cleaning device to promote evaporation of the
cleaning agent. (Col. 8, 11. 13-24; Fig. 14.)
Claim 1, which is illustrative of the appealed subject matter, reads as
follows:
1. A cleaning device for a medical implement, the
cleaning device comprising:
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a cap having an opening to an inner cavity, the opening
for receiving a site of the medical implement;
one or more protrusions extending inwardly at least
partially around an inside surface of the cap near a periphery of
the opening to the inner cavity, the one or more protrusions to
engage an outer surface of the site of the medical implement to
maintain the cap on the site of the medical implement;
a cleaning agent that occupies at least some of the inner
cavity, the cleaning agent being formulated to clean the site
when the opening of the cap receives the site of the medical
implement;
at least one aperture to the inner cavity to allow venting
from the inner cavity when the opening of the cap receives the
site of the medical implement; and
a removable seal that covers the opening to maintain the
cleaning agent within the inner cavity prior to receipt of the site
of the medical implement.
(App. Br. Claims App'x.)
Patent Owner contests the Examiner's decision to reject the claims as
follows:
I. Claims 1-28 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hoang (US 2007/0112333 Al,
filed November 17, 2005, published May 17, 2007) in
view of Buchman (U.S. Pat. No. 7,922,701 B2, issued
April 12, 2011);
II. Claims 29-37 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hoang in view of Buchman, and
Lake (US 2004/0258560 Al, filed June 20, 2003,
published December 23, 2004);
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III. Claims 1-28 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hoang in view of Chin-Loy
(U.S. Patent No. 5,954,957, issued September 21, 1999);
and
IV. Claims 29-37 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hoang in view of Chin-Loy and
Lake.
Rejections I and II Hoang and Buchman
The Examiner rejected claims 1-28 as obvious over Hoang and
Buchman and claims 29-37 as obvious over Hoang, Buchman, and Lake.
ISSUE
The dispositive issue with respect to this rejection is:
Does Hoang in combination with Buchman render obvious the "at
least one aperture to the inner cavity to allow venting" recited in the claims?
DISCUSSION
The Examiner found that Hoang discloses an antiseptic capping
device having a pad that may be used to clean the access portion of a
catheter access valve. (RAN 3.) The Examiner found "[t]he cap has
threading on the interior thereof to connect with access valve threading and
the opening of the cap is sealed with a lid means 78a prior to use." (RAN 3.)
The Examiner found that "Hoang does not disclose any sort of venting, nor
does Hoang disclose a second opening or aperture to the interior of the cap
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device other than the single opening covered by the lid 78a. See Fig. 1 OB,
paragraphs 23, 27-30, 33, 37 and 43-46." (RAN 3.)
Hoang discloses a cap device for antiseptically maintaining a patient
fluid line access valve. (Hoang i-f 5.) An embodiment of a cap device
disclosed in Hoang is depicted in Figure 1 OB reproduced below:
78~
so
Figure 1 OB depicts a cap device 78 with lid 78a and pad 80. (Hoang
i-f 43.) The pad 80 may be a wet pad and as such the cap device 78 may be
used to clean medical devices by twisting the cap when the cap is placed on
the device or removed, or alternatively, by twisting in alternate directions for
a desired amount of time. (Hoang i-f 44.)
The Examiner found that Buchman discloses a catheter cleaning port
cap, which is configured for threaded connection with a male luer of a
catheter port. (RAN 3--4.) The Examiner found that Buchman discloses a
cap with threading, and apertures formed in the threading containing a
sponge material. (RAN 4.) The Examiner concluded that "[i]t would have
been obvious to add the apertures including the sponge material of Buchman
to the threads of Hoang because it would enhance cleaning of the catheter
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connection by scrubbing the threads and sides thereof in addition to the top
of the site." (RAN 4.)
Buchman discloses a catheter cleaning device. (Col. 3, 11. 12-21.)
Figure 1 of Buchman is reproduced below:
Figure 1 depicts a catheter cleaning cap including a body 10,
connector cap 20, mobile frit 30, open cell wiping foam or sponges 40,
0-ring 50, and spring 60. (Col. 3, 11. 24--30.) Frit 30 forms a reservoir 70 in
cavity of body 10. Id. The mobile frit 30 is designed to provide for slow
transfer of the cleaning solution from the reservoir to the foam or sponges
40. (Col. 5, 11. 20-24.) The wiping foam or sponges 40 are disclosed to
provide scrubbing surfaces in order to clean the port threads. (Col. 5, 11.
22-24.) 0-ring 50 is disclosed as providing a seal to seal the solution in the
reservoir 70 and spring 60 is included in order to push frit 30 distally when
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the device is not installed onto a port. (Col. 5, 11. 24--26.) The antimicrobial
cleaning solution resides in Reservoir 70. (Col. 5, 11. 26-28.)
In operation, the cap is screwed onto the luer fitting, which pushes the
mobile frit 30 up into reservoir 70, the increased pressure in the reservoir
forcing the solution through the frit 30 and into the foam or sponge 40,
bathing the port opening in the antimicrobial solution with a scrubbing
action on the luer top, injection port piston, and threads. (Col. 5, 11. 30-34.)
Buchman discloses that during removal of the device, the spring 60 pushes
the frit 30, creating a vacuum, which draws the solution back into the
reservoir and limits the amount of solution evaporation when the cap is not
installed onto a luer fitting. (Col. 5, 11. 37--41.)
Buchman discloses that vents may be included on the catheter
cleaning devices "to help transfer fluid from a reservoir to materials to be
contacted with the antimicrobial solution." (Col. 10, 11. 42--46.)
Patent Owner contends that Buchman requires a seal to be formed
between the cap and a medical implement, which is consistent with the
disclosure that Buchman discloses a reusable cap designed to prevent loss of
cleaning agent. (App. Br. 5---6.) Patent Owner argues that contrary to the
statements made by the Examiner, Buchman does not disclose apertures in
the cap threading. (App. Br. 6-8.) Patent Owner contends also that
Buchman does not disclose venting of disinfection solution from the inner
cavity of the cap. (App. Br. 8-9.) In this regard, Patent Owner argues that
when the medical device is mated to the cap, at least a portion of the sponge
present in the cap of Buchman would be compressed, and function as a
gasket, thus precluding any venting. (App. Br. 9-11.) Patent Owner argues
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that even accepting the Examiner's position that venting occurs through the
sponges present in the cap of Buchman, the language of the claims would
still not be satisfied because venting would occur only after the attachment
occurs. (App. Br. 11-12.)
Requester contends that Hoang discloses clearances between the
threading in the cap wall and the medical implement to allow for venting.
(Resp't Br. 2--4.) Requester argues that the Rice Declaration (Declaration of
James G. Rice, Ph.D., executed on August 16, 2012) provides evidence that
the cap disclosed in Hoang is made of polyethylene in a molding process,
which Dr. Rice, relying on his mechanical engineering experience, stated
would include clearances and would not provide an airtight seal. (Resp 't Br.
3--4.) Requester argues that Buchman does not require a seal in the
embodiments relied upon by the Examiner. (Resp't Br. 4.) Requester
contends that any desire expressed in Buchman to reduce venting, does not
diminish a disclosure and acknowledgment that venting occurs. (Resp 't Br.
5.) In this regard, Requester contends that the scrubbing sponge
configuration in Buchman facilitates some escape of fluid, which would
provide venting. (Resp't Br. 4--5, 6.) Requester agrees with the Examiner
that Buchman discloses a break in the threads where sponges reside. (Resp 't
Br. 5.) Requester argues that Buchman discloses venting in several contexts,
such as an escape of fluid in connection with receipt of a luer, the
embodiment in Figure 1 including an open cell sponge, and the disclosure of
vents in the catheter cleaning devices to help transfer fluid from a reservoir
to materials to be contacted with antimicrobial solution. (Resp 't Br. 5-7.)
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Initially, we address Requester's contention that Hoang inherently
provides venting. We observe that the Examiner did not rely on Hoang for
the venting aspect of the claims. (See RAN 3; Reb. Br. 5.)
We agree with Patent Owner (Reb. Br. 5-7) that the Rice Declaration
does not provide sufficient factual support for the statements made therein,
particularly when there is evidence in the record that directly contradicts
such statements. For example, although the Rice Declaration discusses an
increase in internal pressure in the cap upon attachment of the cap to the
medical device to support the position that Hoang inherently discloses
venting, the Rice Declaration does not persuasively evince that any internal
pressure would be of such a degree that such pressure necessarily would
have vented to the atmosphere. (Rice Deel. i-f 7.) In addition, the Rice
Declaration states that the arrangement of threads in Hoang inherently
allows for some escape of fluid between the threads or at the helical
interface. (Rice Deel. i-fi-1 6-10.)
In contrast, Anderson, which is of record in this reexamination (App.
Br. G, Evidence Appendix, Ex. 6), discloses that catheter connections
to catheter caps, which are used to seal the end of a catheter to
protect the sterility of the catheter and prevent fluid loss and/or
particle contamination, are most often made utilizing the
medical industry's standardized Luer taper fittings. These
fittings, which may either be male couplings or female
couplings, include a tapered end of standardized dimensions.
Coupling is made by the press-fit of mating parts. A threaded
lock-fit or other type of securing mechanism is commonly
utilized to ensure the integrity of the pressure fit of the Luer
fittings.
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(Anderson, 3 col. 1, 1. 59- col. 2, 1. 3.) In other words, the skilled artisan
would have understood that standard luer fittings generally are designed to
"prevent fluid loss," and thus would not have functioned properly if venting
was necessarily present in such a connection.
The Second Rice Declaration (Declaration of James G. Rice, executed
on February 1, 2013) states that in Figure lOB of Hoang, there are a limited
number of helical turns, an "unmistakable absence of thread tapering," and
that the ability of the cap to be twisted in two directions indicates a loose
connection (Second Rice Deel. i-f 9). We are not persuaded that Hoang's
catheter cap necessarily includes gaps in the threading sufficient for venting.
The Second Rice Declaration does not explain how Figure 1 OB,
unmistakably shows a lack of tapering. Moreover, the statements in the
Second Rice Declaration merely point out the alleged differences between
the threading disclosed in Hoang and "the threading that would ordinarily be
associated with an interference fit." (Second Rice Deel. i-f 9.) As such, an
absence of these features is not conclusive that venting is necessarily present
in Hoang's device.
The Examiner's reasoning relies on the finding that Buchman's
Figure 1 depicts breaks in the threading of the cap (apertures) that include
sponge material in order to advance the position that it would have been
obvious to include venting apertures in the cap of Hoang. We agree with
Patent Owner, that Buchman's disclosure does not support the Examiner's
position.
3 Anderson et al., US 8,167,847 B2, issued May 1, 2012 (hereinafter
Anderson")
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Buchman does not provide a detailed description of how the sponges
and threads interact. Thus, we agree that Figure 1 of Buchman and the
accompanying description in the Specification does not sufficiently convey
that there are breaks in the threading of the cap where the sponges 40 reside.
Further, we find insufficient evidence to show that the sponges would
necessarily have allowed evaporation or venting when the site is received,
such as having sufficient porosity, spacing, etc. Accordingly, we find that
the preponderance of the evidence supports Patent Owner's view that the
Examiner's determination of obviousness is not supported by sufficient
factual findings and rational underpinnings to provide sufficient basis for the
Examiner's obviousness combination and position that venting would occur
when the medical implement is received in the cleaning device cap.
As noted above, Buchman also discloses that vents may be included in
the cleaning devices. (Col. 10, 11. 42--46.) However, the vents disclosed in
Buchman are for the purpose of aiding transfer of antimicrobial solution
from a reservoir to the materials to be contacted. (Id.) As discussed above,
Buchman discloses that when the cap is screwed onto the luer fitting, the
mobile frit 30 is pushed up into reservoir 70, and the increased pressure in
the reservoir forces the solution through the frit 30 and into the foam or
sponge 40. (Col. 5, 11. 30-34.) Thus, Buchman contemplates the use of
vents to aid in fluid transfer from a reservoir to the sponge. Hoang does not
disclose a reservoir for cleaning fluid. Accordingly, there does not appear to
be a reason for one of ordinary skill in the art to have added the vents of
Buchman to the device of Hoang.
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As observed by Patent Owner, Lake is only relied upon for the
teaching of the packaging of a plurality of decontamination devices, and
does not make up for the deficiencies of Hoang in view of Buchman. (RAN
5-8; App. Br. 4--5.)
Therefore, we reverse the Examiner's rejection of claims 1-28 as
obvious over Hoang in view of Buchman and claims 29-37 as obvious over
Hoang in view of Buchman and Lake.
Rejection III and IV - Hoang and Chin-Loy
ISSUE
The issue with respect to this rejection is whether one of ordinary skill
in the art would have had a reason to have applied a venting channel, as
disclosed in Chin-Loy for venting the interior of a medical device during
sterilization to the cap/ cleaner device disclosed in Hoang?
DISCUSSION
The Examiner relied on Hoang in the same manner as discussed
above. (RAN 3, 7.)
The Examiner found that Chin-Loy discloses a cap for hydraulic ports
of a medical device, which preserves the sterile condition of the device until
time of use. (RAN 7-8.) The Examiner found that Chin-Loy "discloses an
embodiment having a channel in the cap to permit venting of the medical
device through the port while maintaining the internal condition of the
device until use of the device (column 2, lines 38-43)." (Id.) The Examiner
concluded:
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It would have been obvious to one of ordinary skill in the art to
including 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.
(RAN 8.)
Chin-Loy discloses a cap that is capable of being attached to a
hydraulic port that allows ingress and egress of liquids such as blood. The
cap is said to "maintain an internal condition (such as sterility or cleanliness)
of the medical device until time of use." (Col. 2, 11. 1-5.) Chin-Loy
discloses a channel, which may be included in the cap, which
permits venting of the interior of the medical device through the
blood port during sterilization of the medical device [and]
provides a "tortuous pathway" from the exterior to the interior
of the medical device serving to prevent incursion of
microorganisms from the external environment to the interior of
the medical device after the device has been sterilized.
(Col. 5, 11. 12-20.) Chin-Loy further discloses that "sterility of the medical
device is maintained even for long periods despite the presence of an air
pathway via the channel from the exterior to the interior of the device
whenever the caps are fully attached to the blood ports." (Col. 5, 11. 21-25.)
Patent Owner acknowledges that Chin-Loy discloses a vent, but
argues that Chin-Loy discloses a channel in the cap to provide a pathway to
the interior of the medical device rather than venting of a cleaning agent
from a cap during attachment of the cap to the device. (App. Br. 14.)
Accordingly, Patent Owner contends that the channel of Chin-Loy would be
provided for a fundamentally different function to satisfy the claim. (App.
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Br. 14--17.) That is, Patent Owner argues that the venting disclosed in
Chin-Loy is entirely distinct from the venting provided by the claimed
aperture. (App. Br. 15.) Patent Owner also argues that there is no reason in
the prior art for applying the channel of Chin-Loy to the cap of Hoang for an
entirely different purpose as disclosed in Chin-Loy. (App. Br. 18.) Patent
Owner also contends that Bousquet, 4 cited by Requester to show that it is
desirable to vent air from an antiseptic cap to relieve pressure, is distinct
from the claimed cap, because the cap in Bousquet is configured such that
cleaning agent is injected after attachment of the device, which is the reason
for the check valve disclosed therein. (App. Br. 19.)
Requester argues that modifying Hoang with the channel of Chin-Loy
is a combination of known methods yielding predictable results. (Resp 't Br.
7-10.) Initially, Requester contends that Chin-Loy is a cleaning cap and that
Chin-Loy is an acknowledgement that antiseptic caps can be provided for
the purpose of inhibiting pressure buildup without allowing undesirable
ingress of microorganisms. (Resp't Br. 8, 10.) Requester contends that
vents as disclosed in Chin-Loy can be formed in the cap of Hoang. (Resp 't
Br. 8-9.) Requester argues that the motivation for doing so can be found in
Patent Owner's admission that it is desirable in the art to allow the cleaning
agent to dry and that Chin-Loy provides a suggestion to modify the cap of
Hoang due to the ability of the vents to allow the escape of the sterilizing
agent to relieve the pressure of gas that may otherwise be compressed
without allowing microorganisms into the sterile environment. (Resp 't Br.
9-10.)
4 Bousquet, US 2005/0147524 Al, published July 7, 2005.
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Initially, we are mindful that the Supreme Court has instructed that "if
a technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417
(2007).
In addition, we are also mindful that in the related litigation, the
Federal Circuit, in reversing the District Court's grant of summary judgment
of invalidity, observed that Chin-Loy was related to blood ports of
hemodialysis machines, and that there was insufficient evidence or
explanation as to "whether disinfecting caps like the one described in Hoang
are sterilized or would benefit from venting during such a sterilization
procedure." Ivera Medical, 801 F.3d at 1345. With respect to the disclosure
in the '794 Patent related to effect of drying the site exposed to cleaning
solution in column 1, lines 51-55 (see '514 Patent, col. 1, 11. 48---62), our
reviewing court observed that this disclosure was related to manual
swabbing, and not disinfecting caps, where disinfecting caps are designed to
retain cleaning agent. Id. The Federal Circuit then stated: "the tradeoff
between the desire to retain the cleaning agent and the patents' disclosure
regarding drying is a factual matter left to the factfinder." Id.
The reasons offered for modifying Hoang with the channel of
Chin-Loy are based on the premise that the venting disclosed in Chin-Loy
relates to relieving pressure build-up during sterilization and which also
prevents the ingress of microorganisms into the cap after that process is
complete such that it would have been obvious to have provided a channel
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for similar relief of pressure build-up in cleaning caps such as disclosed in
Hoang. (RAN 8; Resp't Br. 7-8.) After consideration of the evidence of
record, we find that there is insufficient rational underpinnings to support the
reasoning offered for modifying the cap of Hoang with the channel disclosed
in Chin-Loy.
Even if we agree with Patent Owner that the channel of Chin-Loy is
used for a different purpose than the openings or apertures recited in the
claims of the '514 Patent, we do not view this alone as being dispositive.
The Supreme Court has emphasized the need to account for common sense
when considering whether a combination of references would have been
obvious: "[ c ]ommon sense teaches, however, that familiar items may have
obvious uses beyond their primary purposes, and in many cases a person of
ordinary skill will be able to fit the teachings of multiple patents together
like pieces of a puzzle." KSR, 550 U.S. at 420. In the instant case, the
inquiry turns on whether one of ordinary skill in the art would have had a
reason to provide vents in the cleaning caps of Hoang in view of the
disclosure in Chin-Loy.
We find insufficient evidence of record that there was a recognized
problem of pressure build-up in cleaning caps such as those disclosed in
Hoang, e.g., to the extent that cap were popping off, to have provided a
reason to have applied the channel of Chin-Loy, which is used to allow for
venting of gas during sterilization, to the cap of Hoang. Requester points to
alleged Patent Owner admissions that vents were known to prevent pop off
of the cleaning cap due to pressure build-up during evaporation (Resp 't Br.
10, Ex. B. pp. 12-13). However, as pointed out by Patent Owner, there are
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other ways to manage pressure build-up other than providing venting. (Reb.
Br. 3.) There is no indication that the prior art experienced a problem
regarding pressure build-up in a cleaning cap to a sufficient extent that
would have suggested a need for venting the cap. (See App. Br. 4.) In
addition, the Rice Declaration discusses an increase in internal pressure in
the cap upon attachment of the cap to the medical device, but does not opine
that the internal pressure was of such a degree that would require venting to
the atmosphere. (Rice Deel. i-f 7.) Further, while the '514 Patent
acknowledges that drying of the cleaning fluid is important to kill
microorganisms (col. 1, 11. 5 8---62), as discussed above, the prior art of record
at the time of the invention discloses the desire to maintain the amount of
cleaning fluid in cleaning caps, rather than to promote evaporation.
As discussed above, Chin-Loy discloses a channel to vent the interior
of the medical device during sterilization and during storage thereafter.
(App. Br. 15, 17, 18; Reb. Br. 11; Chin-Loy, col. 1, 11. 41--42, col. 5, 11. 13-
15.) Because we find that there is insufficient evidence on this record to
support the position that there was a reason to use the channel of Chin-Loy
for a purpose beyond its disclosed primary purpose of providing a pathway
during sterilization and storage of the device and insufficiently persuasive
evidence that such a structure is relevant to the cleaning cap of Hoang, there
are insufficient rational underpinnings to support the position that modifying
Hoang with Chin-Loy would have been obvious. 5
5 For similar reasons, we find Bousquet unpersuasive because the check
valve disclosed therein is to allow the escape of air during injection of liquid
sterilizing agent, which has not been shown persuasively to be relevant to
the cleaning cap of Hoang. (Bousquet, i-f 42.)
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Appeal2015-003760
Reexamination Control 95/002,087
Patent 8,206,514 B2
Accordingly, we are not persuaded by Requester's contentions that
modifying Hoang with Chin-Loy: is a combination of known methods
yielding predictable results; is a simple substitution of one known element
for another; is use of a known technique to alter a similar device; or that
there was a reason to modify Hoang disclosed in the prior art. (Resp 't Br. 7-
10.) As a result, any ability of the channel of Chin-Loy to maintain an
aseptic environment in preventing the incursion of microorganisms (RAN 8)
is irrelevant, as there is insufficient reasoning to include such channels in the
cap of Hoang in the first instance. We have not been directed to any other
rationale sufficient to support the combination of these references to render
the claims obvious.
As observed by Patent Owner, Lake is only relied upon for the
teaching of the packaging of a plurality of decontamination devices, and
does not make up for the deficiencies of Hoang in view of Chin-Loy. (RAN
9-10; App. Br. 14.)
Therefore, we reverse the Examiner's rejection of claims 1-28 as
obvious over Hoang in view of Chin-Loy and claims 29-37 as obvious over
Hoang in view of Chin-Loy and Lake.
DECISION
The Examiner's decision to reject claims 1-37 is reversed.
In accordance with 37 C.F.R. § 41.79(a)(l), the "[p]arties to the
appeal may file a request for rehearing of the decision within one month of
the date of: ... [t]he original decision of the Board under§ 41.77(a)." A
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b ).
20
Appeal2015-003760
Reexamination Control 95/002,087
Patent 8,206,514 B2
Comments in opposition to the request and additional requests for rehearing
must be in accordance with 37 C.F.R. § 41.79(c) & (d), respectively. Under
3 7 C.F .R. § 41. 79( e ), the times for requesting rehearing under paragraph (a)
of this section, for requesting further rehearing under paragraph ( d) of this
section, and for submitting comments under paragraph ( c) of this section
may not be extended.
An appeal to the United States Court of Appeals for the Federal
Circuit under 35 U.S.C. §§ 141-144 and 315 and 37 C.F.R. § 1.983 for an
inter partes reexamination proceeding "commenced" on or after November
2, 2002 may not be taken "until all parties' rights to request rehearing have
been exhausted, at which time the decision of the Board is final and
appealable by any party to the appeal to the Board." 37 C.F.R. § 41.81. See
also MPEP § 2682 (8th ed., Rev. 7, July 2008).
REVERSED
PATENT OWNER:
FOLEY HOAG, LLP
Patent Group, Seaport West
155 Seaport Blvd
Boston, MA 02210-2600
THIRD-PARTY REQUESTER:
MCCARTER & ENGLISH, LLP
Four Gateway Center
100 Mulberry Street
Newark, NJ 07102
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