Ex Parte 7985302 et al

Patent Trial and Appeal Board

May 6, 2016

95002086 (P.T.A.B. May. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
95/002,086 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
7985302
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-00005 4374
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
Appeal2015-004765
Reexamination Control 95/002,086
Patent 7 ,985,302 C 1
Technology Center 3900
Before MARK NAGUMO, JEFFREY B. ROBERTSON, and
RAEL YNN P. GUEST, Administrative Patent Judges.
ROBERTSON, Administrative Patent Judge.
DECISION ON APPEAL
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Patent Owner Ivera Medical Corp. ("Patent Owner") appeals under
35 U.S.C. §§ 134(b) and 3 l 5(a) (pre-AIA) the Examiner's decision to reject
claims 1-25. 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 1-25.
STATEMENT OF THE CASE
Requester requested inter partes reexamination of United States
Patent 7,985,302 Cl (hereinafter the "'302 Patent"), on August 17, 2012.
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
was filed as a continuation of U.S. Patent 7,780,794 Cl (hereinafter the
"'794 Patent"), which was subject to ex parte reexamination (Control
90/009,951, filed on October 3, 2011), and 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
1 See Patent Owner's Appeal Brief 1 (filed August 5, 2014) (hereinafter
"App. Br."), PO Rebuttal Brief, filed December 5, 2014, "Reb. Br.";
Examiner's Answer (mailed November 7, 2014) (hereinafter "Ans."); Right
of Appeal Notice (mailed April 3, 2014) (hereinafter "RAN.").
2 See Requester's Respondent Brief (filed October 16, 2014) (hereinafter
"Resp 't Br.").
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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
95/002,085, and also on appeal to PTAB (Appeal No. 2015-003842). U.S.
Patent No. 8,206,514 B2, which was filed as a continuation of the '302
Patent, is the subject of inter partes reexamination Control No. 95/002,087,
and also on appeal to PTAB (Appeal No. 2015-003760). (See App. Br. 1.)
Decisions in Appeal No. 2015-003842 and Appeal No. 2015-003760 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 '794 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. (App. Br. (2015-003842), Ex. 25, at 3--4, and 15.)
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).
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The '302 Patent
The '3 02 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. 10-21.) The
'3 02 Patent describes that the cap 10 includes a housing 4 having internal
threads 3, the internal threads being "sized and arranged to accommodate
[l]uer 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. 56-60, col. 6, 11. 7-13; 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. 26-
43; Figs. 5-11.) The '302 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. 11-21; 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:
a cap having an opening to an inner cavity, the opening
for receiving a site of the medical implement;
threading at least partially around an inside surface of the
cap near a periphery of the opening to the inner cavity, the
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threading to engage corresponding threads on the site of the
medical implement;
a compressible cleaning material in the inner cavity and
containing a cleaning agent, the compressible cleaning material
adapted to swab and clean the site with the cleaning agent;
at least one aperture to the inner cavity to allow venting
from the inner cavity when the opening receives the site of the
medical implement; and
a removable seal attached to the cap at the opening to
cover the opening and to maintain the compressible cleaning
material and 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 1-21 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Wnite (U.S. Patent No.
5,242,425, issued September 7, 1993) in view of Hoang
(US 2007/0112333 Al, filed Nov. 17, 2005, published
May 17, 2007) as evidenced by the Rice Declaration
(Declaration of James G. Rice, Ph.D. in Support of Inter
Partes Request for Reexamination of U.S. Patent No.
7,780,794, executed on August 16, 2012) (Ground 1);
II. Claims 1-21 are rejected under 35 U.S.C. § 102(e) as
being anticipated by Anderson (U.S. Patent No.
8,167,847 B2, issued May 1, 2012) (Ground 2);
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III. Claims 1-21 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Anderson in view of White
(Ground 4);
IV. Claims 1-21 are rejected under 35 U.S.C. § 102(e) as
being anticipated by Hoang as evidenced by the Rice
Declaration (Ground 5);
V. Claims 1-21 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Tennican (WO 2007/137056 A2,
published November 29, 2007) in view of ISO Luer
(International Standard, Conical fittings with 6% (Luer)
taper for syringes, needles and certain other medical
equipment - Part 2: Lock fittings, Reference number ISO
594-2: 1998(E) (International Organization for
Standardization) (1998)) (Ground 7);
VI. Claims 1-25 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hoang in view of Buchman
(U.S. Patent No. 7,922,701 B2, issued April 12, 2011)
(Ground 8); and
VII. Claims 1-25 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)
(Ground 9).
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Rejections I and IV (Grounds 1 and 5) White, Hoang, and Rice
Declaration
Because Rejections I and IV rely on similar combinations of
references, positions, and arguments, we address these two rejections
together. (RAN 3---6, 9-11; App. Br. 5-11; Resp't Br. 11-13.)
ISSUE
The dispositive issue with respect to these rejections is:
Does Hoang alone or in combination with White disclose or render
obvious the "at least one aperture to the inner cavity to allow venting from
the inner cavity" recited in the claims?
DISCUSSION
In rejecting claims 1-21, the Examiner found that White discloses an
antiseptic coupler system for a catheter assembly including an outer
protective cap containing a sponge material saturated with antiseptic to
contact a self-sealing portion of a male connector of the catheter assembly.
(RAN 3.)
White discloses a catheter assembly with an outer protective cap
containing an absorbent material saturated with an antiseptic. (Col. 2,
11. 59-64.)
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Figure 7 of White is reproduced below:
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Figure 7 depicts an embodiment of the capped catheter assembly
including outer protective cap 78 containing sponge 80 and internal threads
7 6 which are received by externally threaded shoulder 7 4 of distal member
70. (Col. 7, 11. 23-29.) Distal member 70 also includes finger grip 72. (Col.
7, 11. 23-24.) White discloses that the outer protective cap 78 is spaced from
proximal member or injection cap 82 "to permit antiseptic to bathe the
exterior surfaces of distal member 70, proximal member 82, and self-sealing
septum 84." (Col. 7, 11. 29-32.) White discloses that as a result of this
configuration, self-sealing septum 84, proximal member 82, and the
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interconnection between proximal member 82 and distal member are
maintained in aseptic conditions. (Col. 7, 11. 32-35.)
The Examiner found that the inner surface of the cap is spaced from
the outer surface of the connector so that the outer surface of the connector
is bathed with antiseptic when the cap is in place with the sponge to contact
the connector portion. (RAN 3.) The Examiner further found that the cap of
White is provided with threads to interact with the threads of the connector,
where the connection formed is a luer connection. (RAN 3--4.)
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 4.)
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~ 78a
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
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the device or removed, or alternatively, by twisting in alternate directions for
a desired amount of time. (Hoang i-f 44.)
The Examiner stated that "Hoang does not disclose any sort of venting
nor does Hoang disclose a second opening or aperture to the interior of the
cap device other than the single opening covered by the lid 78a." (RAN 4.)
The Examiner found that neither White nor Hoang acknowledge
venting the cleaning agent as claimed, but that "neither reference discloses
means to seal the connection between the catheter connection and [the] cap
means preventing such venting." (RAN 4.) The Examiner relied on the
Rice Declaration (Declaration of James G. Rice, Ph.D., executed on August
16, 2012) for the principle that a threaded connection does not provide an
airtight connection absent some type of sealing component such as an 0-ring
or gasket. (RAN 5.) The Examiner found that because White and Hoang
were both silent as to the presence of either a sealing component or sealed
connection, "it would have been intrinsic to the configuration that some
venting would occur through a gap formed by the incomplete seal in the
threaded connection thereby meeting all limitations of claims 1-21." (RAN
5.)
Patent Owner contends that there is no teaching in White or Hoang
that threaded connections allow venting. (App. Br. 5.) Patent Owner
contends that the Rice Declaration fails to set forth any evidentiary or
analytical support that the threads as disclosed in White or Hoang would be
manufactured with significant clearance. (App. Br. 5-7.) Patent Owner
cites to additional evidence that allegedly shows that threaded connections
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form a fluid tight seal without the use of a separate sealing component. 3
(App. Br. 7-9.) Patent Owner contends that White and Hoang fail to teach
or suggest that the threaded connection between the cap and a medical
implement will necessarily vent, and that one skilled in the art would have
understood that the threaded connections in White and Hoang were fluid
tight. (App. Br. 9-11.) Patent Owner contends that the space between the
cap 78 and the medical implement 82 disclosed in White (see figure 7) is an
internal gap that is formed after the cap is threaded onto the distal member,
which does not vent as recited in the claims. (Reb. Br. 13-14.)
Requester argues that the Rice Declaration is anchored in the
disclosure of Hoang and specifically, that the cap disclosed therein 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. 11-12.) Requester contends
that Hoang implicitly discloses venting and White expressly teaches venting.
(Resp't Br. 12-13.)
We are not persuaded that the threading disclosed in Hoang or White
between the caps and the medical implements disclosed in each reference
necessarily would allow for venting as required by the claims. As discussed
3 We observe that there is a disagreement as to whether certain evidence
offered by Patent Owner, namely Exhibits 19-22 and 24 attached to Patent
Owner's Appeal Brief has been entered into the record. (Resp't Br. 4--5;
Reb. Br. 4--5.) The Examiner indicated that some evidence had not been
entered, but did not specifically comment on whether the disputed evidence
had been entered. (See RAN 18-21.) Because we resolve this appeal in
Patent Owner's favor based on evidence that was clearly made of record, we
find it unnecessary to discuss the additional evidence in dispute.
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above, the Examiner found that both Hoang and White are silent as to the
aspect of venting. The Examiner relied on the Rice Declaration for this
missing teaching in Hoang or White.
However, the Rice Declaration does not provide sufficient factual
support for the statements made therein, and there is evidence in the record
that directly contradicts such statements. 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-16-10.)
In contrast, Anderson, which is of record in this reexamination,
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.
(Anderson, 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
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"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 Decl.i-f 9). We are not persuaded Hoang's
catheter cap necessarily include gaps in the threading sufficient for venting.
The Second Rice Declaration does not explain why a person skilled in the art
would have relied on Figure 1 OB for details such as the structure of threads.
Nor does the Second Rice Declaration explain how Figure lOB
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. i19.) As such, an
absence of these features is not conclusive that venting is necessarily present
in Hoang's device.
With respect to White, we disagree with Requester that White
discloses venting. Requester's position relies on White's Figure 7
embodiment, and the accompanying disclosure of a space between the outer
protective cap 78 and the proximal member 82 in order to "bathe the
exterior surfaces of distal member 70." (Resp't Br. 12-13, quoting White,
col. 7, 11. 29-32.) We disagree with Requester that White discloses a "means
for venting" as recited in the claims. That is, in describing distal member
70, White discloses that distal member 70 is provided with "externally"
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threaded shoulder 7 4, which is adapted to receive internal threads 7 6 of
protective cap 78. (Col. 7, 11. 24--28.) We are of the opinion that when
White refers to bathing the "exterior surfaces of distal member 70," White is
referring to the exposed area of the distal member that is proximate to the
member 82 above the threads on shoulder 74, inside the inner cavity of cap
78. (See Fig. 7.) We disagree that this teaching in White describes venting
from the inner cavity.
As a result, we reverse the Examiner's rejections of claims 1-21 as
obvious over White in view of Hoang, as evidenced by the Rice Declaration
and the Examiner's rejection of claims 1-21 as anticipated by Hoang as
evidenced by the Rice Declaration.
Rejections II and III (Grounds 2 and 4) Anderson or Anderson/White
Because Rejections II and III rely on similar references, positions, and
arguments, we address these two rejections together. (RAN 6-9; App. Br.
11-14; Resp't Br. 13.)
ISSUE
The dispositive issue with respect to this rejections is:
Does Anderson alone or in combination with White disclose or render
obvious the "at least one aperture to the inner cavity to allow venting from
the inner cavity" recited in the claims?
DISCUSSION
The Examiner found that Anderson discloses an antiseptic cap having
a chamber containing an absorbent material such as a sponge, where a
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portion of the interior surface of the cap may be formed with a set of threads
for mating with a catheter access site. (RAN 6-7.) The Examiner found
that: "Anderson does not disclose the presence of any means sealing the
threaded connection thus it would have been intrinsic to the configuration
that some venting would occur through that threaded connection thereby
meeting all limitations of claims 1-21." (RAN 7 .)
Anderson discloses an antiseptic cap that is attached to a catheter
lumen, which delivers antiseptic compositions or liquid to a lumen of the
catheter. (Col. 1, 11. 15-20.) Specifically, Anderson discloses a cap
assembly 80 having a cap 82 defining a chamber 84 containing an absorbent
material such as a sponge 86. (Col. 5, 11. 25-31.) The cap 82 has an interior
surface 87 "with a set of threads 88 for mating with a set of threads on the
access site 39." (Col. 5, 11. 31-33.)
Figure 5 of Anderson is reproduced below:
Figure 5 is a perspective view assembly drawing of an antiseptic cap
equipped plunger. (Col. 3, 11. 26-27.) In addition to the above description
of the cap 82, Figure 5 depicts a housing 60 including a chamber 64 having
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an open end 66, where the cap assembly 80 fits within chamber 64. (Col. 5,
11. 16-25; see Fig. 6.)
Anderson discloses that the threads 88 of the cap assembly "engage"
with the threads of the access site. (Col. 5, 11. 45--47, discussing operation of
the cap in connection with Figures 3 and 4.) Anderson discloses that when
the antiseptic cap assembly is docked to the catheter, the catheter is sealed to
block the ingress of pathogens and contaminants and the access site is
exposed to the antiseptic material in sponge 86. (Col. 5, 11. 54--57.)
Patent Owner contends that Anderson does not disclose venting
through the threads and that a person of ordinary skill in the art would have
understood from Anderson that a fluid tight seal was formed by the threads.
(App. Br. 12-14.) Patent Owner reiterates the same arguments with respect
to White as addressed above with respect to the gap created being
completely internal to the protective cap. (App. Br. 14.)
Requester relies on Figure 3 of the provisional application that
matured into Anderson to show a space for venting as well as the same
arguments with respect to White as discussed above. (Resp 't Br. 13.)
We agree with Patent Owner that Anderson does not anticipate the
recited venting apertures by merely disclosing that the cap and the medical
implement to be treated are joined via threads. Anderson discloses that
catheter connections to catheter caps are used to seal the end of a catheter to
protect the sterility of the catheter and prevent fluid loss and/ or particle
contamination and are most often made utilizing the medical industry's
standardized Luer taper fittings. (Anderson, col. 1, 1. 59- col. 2, 1. 3.). We
have not been directed to sufficient evidence of record to support the
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position that that the above described threaded connection includes threads
that allow for venting.
With respect to Figure 3 of the provisional application, we observe, as
does Patent Owner, that this Figure is hand drawn. We note also that the
Examiner did not rely on Figure 3 to support the rejection. (RAN 7.) While
Requester indicates that Figure 3 can be relied upon for what it shows, there
is no indication that the Figure is drawn to any kind of scale or was intended
to show the presence of a gap. Indeed, the express disclosure of Anderson
of a seal formed by the threaded connection is evidence that there were no
gaps or vents intended by the drawing. Thus, we do not agree with
Requester's argument that Figure 3 of the provisional application may be
relied upon to show that Anderson discloses venting apertures as recited in
the claims.
Requester relies on similar arguments with respect to White as
discussed above, with which we did not agree. We incorporate that analysis
here as well.
Accordingly, we reverse the Examiner's decision to reject claims 1-21
as anticipated by Anderson or obvious over Anderson in view of White.
Rejection V (Ground 7) Tennican/ISO Luer
ISSUE
The dispositive issue with respect to this rejection is:
Does Tennican in combination with ISO Luer render obvious the "at
least one aperture to the inner cavity to allow venting from the inner cavity"
recited in the claims?
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DISCUSSION
The Examiner found that Tennican discloses a device and method for
disinfecting surfaces of an intravascular port device. (RAN 12.) The
Examiner found that Tennican discloses a cap provided with a sponge
containing antiseptic solution. (RAN 12.) The Examiner found that
Tennican also discloses a threaded connection with a luer type fitting of a
medical implement. (RAN 13.) The Examiner found that "ISO Luer
discloses the tolerances of standard luer type fittings identifying relative
dimensions that provide clearance between threads of interconnected luer
devices." (RAN 12.) The Examiner found that although Tennican does not
"explicitly acknowledge" the apertures for venting recited in the claims,
T ennican also does not disclose a means to seal the connection between the
luer connection and the cap means for preventing venting. (RAN 12-13.)
As a result, the Examiner concluded that in view of the disclosure in ISO
Luer, an airtight connection would not be formed resulting in some venting,
which would satisfy the limitations of claims 1-21. (RAN 13.)
Tennican discloses an intravascular port access device including a
first component having a catheter and a second component that reversibly
attaches to the first component containing a disinfecting agent and an
applicator material. (i-f 6.) In one embodiment, Tennican discloses that the
second component can comprise a housing having an internal receiving port
which is threaded to thread onto a "LEUR[sic]-LOK®" type fitting. (i1i160-
61.)
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ISO Luer discloses "requirements for conical lock fittings with a 6 %
(Luer) tape for use with hypodermic syringes and needles with certain other
apparatus for medical use, e.g. transfusion equipment." (Page 1, section
entitled "Scope.") ISO Luer discloses requirements for the fittings regarding
Liquid and Air Leakage, such that for liquid "there shall be no leakage
sufficient to form a falling drop" and for air, "there shall be no signs of
continued formation of air bubbles. Bubbles formed during the first 5
[seconds] shall be disregarded." (ISO Luer, p. 6, Sections 4.2.1and4.2.2.)
Patent Owner contends that one of ordinary skill in the art would not
have relied on ISO Luer to modify threads on a cleaning cap. (App. Br. 15.)
Patent Owner argues that ISO Luer has been taken out of context, because it
relates to 6% luer lock fittings, and Tennican's cap is designed to mate with
a "LEUR[sic]-LOK®" fitting, which is a name and not a reference to the
ISO Luer standard. (App. Br. 15.) Patent Owner contends that Tennican's
cap does not have the features that would suggest modification with ISO
Luer. (App. Br. 15.) Patent Owner argues that the Examiner concedes that
Tennican does not teach venting and that ISO Luer was a standard
established to ensure consistent fluid-tight connections, and in fact teaches
away from venting. (App. Br. 16-17.)
Requester reiterates that ISO Luer discloses a clearance between
threading, which would allow for venting, and that there is nothing inventive
in choosing standardized luer threading, which would provide the recited
venting. (Resp't Br. 14.) According to Requester, ISO Luer discloses
threading with at least 0.035 millimeters of radial clearance and at least 0.3
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millimeters of vertical clearance. (Request 75-78; see ISO Luer, Figs. 1 and
4; Table 1.)
DISCUSSION
We are not persuaded by the Examiner's and the Requester's reliance
on ISO Luer for spacing between threads that would allow for venting.
Requester appears to read ISO Luer as providing standards for threading
between a medical implement that is a luer connector and female threading
adjacent to it, and also a luer lock connector connected to another luer lock
connector. (See Request 77-78.) However, we find no support for
concluding that, despite the presence of some clearance in standard luer
fittings that these standard connections would allow for venting in the
manner recited in the claims. We also agree with Patent Owner, that ISO
Luer appears to describe only fittings that are in the fluid path. (App. Br.
15-16.) That is, ISO Luer discloses that with the threadings disclosed
therein, there is an expectation that the threading would be air and
fluid-tight. (ISO Luer Section 4.2.1, 4.2.2.) There is no indication in ISO
Luer that the requirements disclosed therein would apply to some other
connection, such as between an antiseptic cap and a medical implement. As
a result, we agree with Patent Owner that there is no indication that venting
would occur even if the concepts disclosed in ISO Luer were applied to
Tennican. (App. Br. 16-17.)
Accordingly, we reverse the Examiner's decision to reject claims 1-21
as obvious over Tennican and ISO Luer.
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Patent 7 ,985,302 C 1
Rejection VI (Ground 8) Hoang and Buchman
ISSUE
The dispositive issue with respect to this rejection is:
Does Hoang in combination with Buchman render obvious the
"venting apertures" recited in the claims?
DISCUSSION
Regarding claims 1-25, the Examiner relied on the teachings of Hoang
as discussed above. (RAN 14, see RAN 4.)
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 14.) The Examiner found that Buchman discloses a cap
with threading, and apertures formed in the threading containing a sponge
material. (RAN 14.) The Examiner concluded that "it 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
connection by scrubbing the threads and sides thereof in addition to the top
of the site." (RAN 15.)
Buchman discloses a catheter cleaning device. (Col. 3, 11. 12-21.)
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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
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.)
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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. 18, 22, 23, 24.) Patent Owner argues that contrary
to the statements made by the Examiner, Buchman does not disclose
apertures in the cap threading. (App. Br. 18-20, 22-23.) Patent Owner
contends also that Buchman does not disclose venting of disinfection
solution from the inner cavity of the cap. (App. Br. 20-21.) 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. 22, 24--25.) Patent Owner argues that even accepting the Examiner's
position that venting occurs through the sponges present in the cap of
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Buchman, the language of the claims would still not be satisfied because
venting would occur only after the attachment occurs. (App. Br. 23-24, see
App. Br. 21.)
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. 5, 7-8.) Requester argues that Buchman
does not require a seal in the embodiments relied upon by the Examiner.
(Resp't Br. 5-6.) Requester agrees with the Examiner that Buchman
discloses a break in the threads where sponges reside. (Resp't Br. 6.)
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. 7.)
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.
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
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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,
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.
29-32.) 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.
Therefore, we reverse the Examiner's rejection of the claims as
obvious over Hoang in view of Buchman.
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Rejection VII (Ground 9) 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 the teachings of Hoang as discussed above.
(RAN 16, see RAN 4.)
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 16.) 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)." (RAN 16.) The
Examiner concluded:
It would have been obvious to one of ordinary skill in the art to
including [sic] 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 17.)
Chin-Loy discloses a cap that is capable of being attached to a
hydraulic port, and which "serves to maintain an internal condition (such as
sterility or cleanliness) of the medical device until time of use." (Col. 2, 11.
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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. 25-26.)
Accordingly, Patent Owner contends that the channel of Chin-Loy would be
provided for a fundamentally different function to satisfy the claim. (App.
Br. 26.) That is, Patent Owner argues that the venting disclosed in Chin-Loy
is entirely distinct from the venting provided by the aperture. (App. Br. 28-
29 .) 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. 29.) Patent Owner
also contends that Bousquet, 4 cited by Requester to show that it is desirable
4 Bousquet, US 2005/0147524 Al, published July 7, 2005.
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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. 29.)
Requester argues that modifying Hoang with the channel of Chin-Loy
is a combination of known methods yielding predictable results. (Resp 't Br.
9-10.) 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 build-up without allowing undesirable
ingress of microorganisms. (Resp 't Br. 9, 10.) Requester contends that
vents as disclosed in Chin-Loy can be formed in the cap of Hoang. (Resp 't
Br. 9-10.) 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.
10-11.)
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).
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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 '302 Patent, col. 1, 11. 53-57), 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 fact finder." 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
for similar relief of pressure build-up in cleaning caps such as disclosed in
Hoang. (RAN 17; Resp't Br. 10-11.) 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.
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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 '302 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.
11, Ex. B. pp. 12-13.) However, as pointed out by Patent Owner, there are
other ways to manage pressure build-up other than providing venting. (App.
Br. 6; 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. 27;
Reb. Br. 3--4.) In addition, the Rice Declaration discusses an increase in
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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 '302 Patent acknowledges that drying of the cleaning fluid is
important to kill microorganisms (col. 1, 11. 53-57), 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. 26, 28; Reb. Br. 3--4; 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 have led one of ordinary skill in the
art to have utilized 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
Accordingly, 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
5 For similar reasons, we find Bousquet unpersuasive because as 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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technique to alter a similar device; or that there was a reason to modify
Hoang disclosed in the prior art, are not persuasive. (Resp 't Br. 8-11.) As a
result, any ability of the channel of Chin-Loy to maintain an aseptic
environment in preventing the incursion of microorganisms (RAN 40) 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.
Therefore, we reverse the Examiner's decision to reject the claims as
obvious over Hoang in view of Chin-Loy.
DECISION
The Examiner's decision to reject claims 1-25 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 ).
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.
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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
33