Ex Parte Jho et al

Patent Trial and Appeal Board

Jun 22, 2017

13101968 (P.T.A.B. Jun. 22, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/101,968 05/05/2011 Jiaye Z. Jho 101672.0132P 6080
34284 7590
Rutan & Tucker, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
06/26/2017 EXAMINER
TURCHEN, ROCHELLE DEANNA
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
06/26/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents @ rutan. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JIAYE Z. JHO and JEREMY B. COX1
Appeal 2016-003438
Application 13/101,968
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a system
for identifying an attribute of an access port, which have been rejected as
obvious. Wehavejurisdictionunder35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses “a system for identifying an attribute of an
implanted medical device, such as an access port. Information about the
1 Appellants identify the Real Party in Interest as C. R. Bard, Inc. (Appeal
Br. 4.)
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Application 13/101,968
device, such as type, size, location, power injectability, etc. can be
ascertained, thus increasing device success, user convenience, and patient
safety.” (Spec. 12.)
“Access portals, or ports, provide a convenient method to repeatedly
deliver medicants to remote areas of the body without utilizing surgical
procedures. The port is implantable within the body.” (Beasley21 6.) The
access port includes a fluid cavity sealed by a cannula-penetrable septum
and attached via an outlet stem to an implanted catheter. (Id.)
Once the access port and the catheter have been implanted
beneath the skin of a patient, quantities of fluid, such as
medication, blood, etc., may be dispensed through one such fluid
cavity by, for example, a cannula (e.g., a needle), passed through
the skin of the patient and penetrating the septum into one of the
respective fluid cavities.
(Id.)
The Specification discloses that ultrasound-detectable markers can be
provided on the implanted catheter. (Spec. 126.) “[T]he markers 24 can be
arranged in a specified pattern, such as a ‘barcode’ format, that can provide
information regarding one or more attributes of the access port to which the
catheter 20 is operably connected.” (Id.) “In addition, other attributes of the
access port and/or catheter or other medical device can also be indicated by
the markers 24, including port size, type, fluid cavity capacity, date of
implantation, etc.” (Id.)
Claims 1—5 and 30-44 are on appeal. Claim 1 is illustrative and reads
as follows:
2 Beasley et al., US 2006/0264898 Al, pub. Nov. 23, 2006.
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Application 13/101,968
1. An identification system, comprising:
a catheter and access port in fluid communication, the
catheter including at least one marker positioned on the catheter
detectable via ultrasound when the catheter and access port are
subcutaneously implanted in a patient, the marker designed to
provide information regarding at least one attribute of the access
port; and
a self-contained handheld external detection device,
including:
an ultrasound transducer for producing ultrasound signals
for impingement on the marker of the catheter and for detecting
ultrasound signal reflection by the marker; and
a display for depicting the information regarding the
attribute of the access port.
Claim 30, the only other independent claim, is directed to an
identification system similar to that of claim 1, except that it does not require
an external detection device.
The claims stand rejected as follows:
Claims 1—5 and 40-42 under 35 U.S.C. § 103(a) as obvious based on
Beasley, Brodsky,3 and Slager4 (Ans. 3);
Claims 30 and 36—39 under 35 U.S.C. § 103(a) as obvious based on
Beasley and Slager (Ans. 5);
Claims 31—33 under 35 U.S.C. § 103(a) as obvious based on Beasley,
Slager, and Brodsky (Ans. 5);
3 Brodsky et al., US 2002/0067359 Al, pub. June 6, 2002.
4 Slager, US 5,771,895; iss. June 30, 1998.
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Claims 34 and 35 under 35 U.S.C. § 103(a) as obvious based on
Beasley, Slager, Brodsky, and Pelissier5 (Ans. 6); and
Claims 43 and 44 under 35 U.S.C. § 103(a) as obvious based on
Beasley, Brodsky, Slager, and Pelissier (Ans. 7).
I
The Examiner has rejected claims 1—5 and 40-42 as obvious based on
Beasley, Brodsky, and Slager. The Examiner finds that Beasley discloses a
system comprising a catheter and an access port, including a marker
detectable via ultrasound that provides information about an attribute of the
access port. (Ans. 3.) The Examiner finds that Brodsky teaches a self-
contained handheld ultrasound detection device that includes a display. (Id.)
The Examiner concludes that it would have been obvious to modify
Beasley’s system to include Brodsky’s ultrasound detection device in order
to detect the ultrasound-detectable marker in Beasley’s system. (Id.)
The Examiner finds that Slager discloses a catheter with markers on
the catheter body, where the markers are arranged in a pattern. (Id. at 4.)
The Examiner concludes that it would have been obvious to modify the
system made obvious by Beasley and Brodsky to include Slager’s catheter
because it would “provide tracking data of the in vivo device.” (Id.) That is,
the Examiner finds that “it is well known in the art to use markers to
determine the location of an implanted medical device within a patient” and
concludes that modifying the Beasley/Brodsky system with Slager’s
5 Pelissier et al., US 2010/0298704 Al; pub. Nov. 25, 2010.
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Application 13/101,968
catheter-body markers “would be an obvious modification to provide
position/location information regarding the access port.” {Id. at 10.)
We agree with the Examiner that the system of claim 1 would have
been obvious based on the cited references. Beasley discloses “an access
port 50 including a base 56, a cap 54, a septum 80, and an outlet stem 70.”
(Beasley 179.) “Generally, catheter 73 may be coupled to the outlet stem 70
for fluid communication with the reservoir 66 and for conducting fluid to a
desired remote location from the reservoir 66 and within patient 67.” {Id.
184.)
Beasley discloses that “at least one attribute of a housing of an access
port may provide at least one identification attribute for identifying the
access port as being structured for power injection.” {Id. 1135.) The
attribute can be radiographic, visually perceivable, or an ultrasound-
detectable feature. {Id. 1138.)
Brodsky discloses a portable ultrasound probe system that includes
“front-end probe 3 [that] integrates a transducer array 10 and control
circuitry into a single hand-held housing.” (Brodsky 132.) Brodsky
discloses that “[a] display can be mounted directly on the handheld probe,
for example, to provide a more usable and user-friendly instrument.” {Id.
138.)
Slager discloses that “combining X-ray ANGiography and
intravascular Ultra-Sound (ANGUS) is a substantial improvement and
provides a unique reconstruction of 3-D coronary geometry.” (Slager 2:20—
22.) Slager discloses a catheter system adapted for ANGUS imaging, where
the catheter sheath includes a series of radiopaque markers. {Id. at 2:32—35,
41 42.) Slager states that “[t]he distal region 18 of sheath 12 includes a
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distal tip 60 and radiopaque markers 68 wrapped around or integral with
sheath 12 to enable fluoroscopic imaging.” {Id. at 11:7—9.) “Because these
markers are also visible by ultrasound, these markers enable the operator to
correlate the transducer position relative to each marker for each image with
a precise anatomical/vessel location.” {Id. at 11:11—14.) In one
embodiment, Slager states that the markers can take the form of a gray scale
pattern, and “[t]he pattern can be applied over just the distal length 18 on the
sheath, or over the entire length.” {Id. at 11:38—40.)
We agree with the Examiner that the system of claim 1 would have
been obvious based on these teachings. Specifically, it would have been
obvious to combine Brodsky’s portable ultrasound device with Beasley’s
system because Beasley says its markers can be visible under ultrasound,
and Brodsky states that its device provides “small size, thermal
management, low-power consumption, and the capability and flexibility to
allow efficient high resolution imaging.” (Brodsky 134.)
In addition, it would have been obvious to include Slager’s marked
catheter with the system made obvious by Beasley and Brodsky because
Slager states that the markings allow the precise anatomical/vessel location
to be determined by ultrasound. (Slager 11:11—14.) Slager also discloses
that the markings on its catheter can be applied over the entire length of
catheter, in which case they would provide information about the location of
the access port; i.e., the access port would be located where the markings
end because the catheter is attached to the access port.
Appellants’ Specification states that the invention is “directed to a
system for identifying an attribute of an implanted medical device, such as
an access port. Information about the device, such as type, size, location,
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power injectability, etc. can be ascertained.” (Spec. 12, emphasis added.)
Thus, “at least one attribute of the access port,” as recited in claim 1,
includes its location. The combination made obvious by the cited references
meets all of the limitations of claim 1.
Appellants argue that “[t]he Examiner has not established any reason
to modify these asserted prior art references to include a marker(s) on a
catheter that provides information regarding an access port.” (Appeal Br.
11.) That is, Appellants argue, “the Examiner has not cited any aspect of
Beasley, Brodsky, or Slager that teaches that the markers on one component
(i.e., the catheter) provide information about a different component (i.e., the
access port).” {Id. at 13.) Appellants argue that “[njothing in Slager teaches
or suggests that it would be beneficial to have information or ‘tracking data’
regarding a separate in vivo device on the catheter” {id. at 15) and “there is
no reason ‘to provide tracking data of’ an access port that does not move and
therefore need not be tracked” (id. at 16).
These arguments are not persuasive. The Examiner notes that “it is
well known in the art to use markers to determine the location of an
implanted medical device within a patient.” (Ans. 10.) And, “when data
regarding the marker on the catheter is acquired, information regarding the
at least one attribute of the access port would also be provided.” {Id.)
Specifically, markers on a catheter, as disclosed by Slager, would “provide
position/location information regarding the access port.” {Id.) As Beasley
discloses, determining the location of an implanted access port is important
because medications are dispensed by putting a cannula through the patient’s
skin and inserting it into the fluid cavity of the access port. (Beasley 1 6.)
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Claims 2—5 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Appellants separately argue claims 40-42. (Appeal Br. 16—17.)
Claims 40 and 41 depend from claim 2, which reads:
2. The identification system as defined in claim 1,
further comprising a first marker positioned on a body of the
access port.
Claim 40 reads:
40. The identification system as defined in claim 2,
wherein the first marker is configured to indicate an implanted
location of the access port.
Appellants argue that “Slager’s marker gives information only about
the access port’s location and orientation.” {Id. at 16.) Slager’s markers,
however, are on the catheter, rather than the access port itself like the “first
marker” of claim 40. Beasley discloses markers on the access port itself
(Beasley 1138) and those markers would inherently indicate the location of
an implanted access port. We therefore affirm the rejection of claim 40.
Claim 41 reads:
41. The identification system as defined in claim 2,
wherein the first marker is configured to configured to assist in
determining an orientation of the implanted access port.
Appellants argue that “Slager’s marker gives information only about
the access port’s location and orientation.” (Appeal Br. 16.) Again,
however, Slager’s markers are on the catheter, rather than the access port
itself like the “first marker” of claim 41.
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The Examiner finds that “Beasley et al disclose the limitations of
claims 40-42 regarding an implanted location, orientation or attribute of the
implanted access port ([0138]).” (Ans. 11.) The Examiner has not pointed
to any specific disclosure in Beasley that expressly or inherently describes
markers that indicate the orientation of an access port. Rather, Beasley
describes its markers as “indicating] that the access port is structured for
accommodating a particular flow rate, pressure, or both.” (Beasley 1138.)
And an “inherent result must inevitably result from the disclosed steps;
‘[i]nherency . . . may not be established by probabilities or possibilities.’” In
re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012) (alteration in
original). We therefore reverse the rejection of claim 41.
Claim 42 depends from claim 4 and reads (with the limitations of
claim 4 included):
42. (The identification system as defined in claim 1,
wherein the at least one marker positioned on the catheter
includes a plurality of markers arranged in a predetermined
pattern for detection by the detection device,) wherein the
detection device is able to interpret the predetermined pattern to
determine the information regarding the attribute of the access
port.
Appellants argue that “this limitation requires the detection device to
be configured to process the imaging data from the marker and analyze the
imaging data to determine what the data indicates with regard to information
about the access port. Therefore, the limitation requires processing
intelligence that is not taught in the asserted art.” (Appeal Br. 17.)
We agree with Appellants that the Examiner has not shown that this
limitation is taught by, or would have been obvious based on, the cited
references. The Examiner concludes that this limitation “suggests or makes
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optional but does not further limit the structure and therefore does not
provide any further patentable weight, as the detection device of Beasley et
al is capable of interpreting.” (Ans. 11.)
We disagree. Claim 42 requires a detection device having the
capability of determining information regarding the access port based on a
pattern of detected markers. “[Tjhere is nothing unusual or improper in
construing device claims to require particular functionality.” Nazomi
Commc’ns, Inc. v. Nokia Corp., 739 F.3d 1339, 1344 (Fed. Cir.
2014). “[T]he claims are properly construed as claiming an apparatus
comprising a combination of hardware and software capable of practicing
the claim limitations.” Id. The Examiner has not shown that any of the cited
references discloses or would have made obvious a detection device having
the capability required by claim 42. We therefore reverse the rejection of
that claim.
Claims 43 and 44 depend from claim 42. The Examiner rejected
claims 43 and 44 as obvious based on Beasley, Brodsky, Slager, and
Pelissier. (Ans. 7.) However, the Examiner cited Pelissier only for its
disclosure of “a display comprising a written message comprising alphabetic
characters.” (Id.) Thus, the Examiner has not shown that Pelissier makes up
for the deficiencies of Beasley, Brodsky, and Slager regarding the
limitations of claim 42. The rejection of claims 43 and 44 is reversed.
II
The Examiner has rejected claims 30 and 36—39 as obvious based on
Beasley and Slager. As previously noted, independent claim 30 is directed
to an identification system like that of claim 1, except that it does not require
an external detection device.
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The Examiner relies on Beasley and Slager for the same disclosures
that are discussed above with regard with claim 1. (Ans. 5.) The Examiner
also finds that Slager’s markers meet the limitations of dependent claims 36—
39. (Id.) The Examiner concludes that it would have been obvious “to
modify the catheter and markers of Beasley et al with a marker on the
catheter of Slager as it would provide tracking data of the in vivo device.”
(Id.)
We agree with the Examiner that the system of claim 30 would have
been obvious based on Beasley and Slager, for essentially the same reasons
as previously discussed for claim 1. That is, it would have been obvious to
include Slager’s marked catheter with Beasley’s access port system because
Slager states that the markings allow the precise anatomical/vessel location
to be determined by ultrasound. (Slager 11:11—14.) Applying markings to
the entire length of catheter, as suggested by Slager, would provide
information about the location of the access port, because the access port
would be located where the catheter markings end because the catheter is
attached to the access port. Appellants’ Specification states that location is
one attribute of an access port (Spec. 12), so the markings on the catheter
would indicate an attribute of the access port.
Appellants “submit[] (for the same reasons as set forth with respect to
claim 1) that claim 30 is patentable over the combination of Beasley and
Slager because the combination does not teach a marker on a catheter that
provides information about the attributes on an access port.” (Appeal Br.
17.) Similarly, with respect to claim 37, Appellants argue that “[njeither
Beasley nor Slager teaches or suggests that the markers on the catheter
would convey information relating to an attribute of the access port.” (Id.)
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These arguments have been addressed above. We therefore affirm the
rejection of claims 30 and 37. Claim 36 has not been argued separately and
therefore falls with claim 30. 37 C.F.R. § 41.37(c)(l)(iv).
With regard to claim 38, Appellants argue that “the prior art does not
teach or suggest the markers arranged in a bar code,” as required by that
claim. (Appeal Br. 18.) Appellants argue that Slager’s Figure 1, which the
Examiner cited as disclosing a bar code (Ans. 5), “shows the markers spaced
equidistant from each other, and certainly not in a bar code pattern.”
(Appeal Br. 18.) Appellants argue that claim 39 is patentable because it
depends from claim 38. {Id. at 19.)
We conclude that the Examiner has not shown that Slager discloses
markers arranged in a bar code, giving that term its broadest reasonable
interpretation in light of the Specification. Appellants’ Specification states
that “the markers 24 can be arranged in a specified pattern, such as a
‘barcode’ format, that can provide information regarding one or more
attributes of the access port to which the catheter 20 is operably connected.”
(Spec. 126.) The Specification thus describes markers in a barcode format
as being arranged to provide information. The Specification’s Figures 1 and
2 are consistent with the conventional use of the term “barcode.”
Figure 1 of Slager, by contrast, shows a catheter with radiopaque
markers 68 encircling it, where the markers appear to be uniformly spaced
along the catheter. (Slager 11:7—11; Fig. 1.) The Examiner reasons that
“[t]he claim limitations do not define a specific embodiment of the
arrangement ‘in a bar code.’ Further, an arrangement of a bar code is a
group of printed and variously patterned bars and spaces.” (Ans. 13.)
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As the Examiner has noted, a bar code is typically understood to be a
pattern of bars that vary in width and spacing so as to convey information
(i.e., form a code). That interpretation is consistent with Appellants’
Specification, and the Examiner has not persuasively explained what
information would be conveyed by Slager’s uniform distribution of markers
along a catheter. We therefore agree with Appellants that the Examiner has
not shown that the limitations of claims 38 and 39 would have been obvious
based on the cited references.
Ill
The Examiner has rejected claims 31—33 as obvious based on Beasley,
Slager, and Brodsky (Ans. 5). Claim 31 reads as follows:
31. The identification system of claim 30, further comprising
an external detection device, including:
an ultrasound transducer for producing ultrasound signals
for impingement on the marker positioned on the catheter and for
detecting ultrasound signal reflection by the marker; and
a display for depicting information relating to the attribute
of the access port.
Thus, claim 31 defines a system having the same components as the
system of claim 1, and the Examiner concludes that the system of claim 31
would have been obvious based on the disclosures of Beasley, Slager, and
Brodsky for the same reason as the system of claim 1. (See Ans. 5—6.) We
agree with the Examiner’s reasoning and conclusion.
Appellants argue, as with claim 1, that the prior art does not teach a
marker on a catheter that provides information about an access port.
(Appeal Br. 19.) This argument is addressed above with respect to claim 1.
To reiterate, Slager discloses that its markers can extend the full length of
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the catheter, which inherently provides information relating to the location
of the access port because the catheter is attached to the access port, and
Appellants’ Specification defines the attributes of an access port as including
its location. Thus, the catheter in the system made obvious by the cited
references includes a catheter having markings that provide information
about an attribute of the attached access port.
Claims 32 and 33 have not been argued separately and therefore fall
with claim 31. 37 C.F.R. § 41.37(c)(l)(iv).
IV
The Examiner has rejected claims 34 and 35 under 35 U.S.C. § 103(a)
as obvious based on Beasley, Slager, Brodsky, and Pelissier (Ans. 6).
Claims 34 and 35 depend from claim 33, which requires that “the
information relating to the implanted access port is an ability to withstand
power injection.” Claims 34 and 35 add the limitation that the displayed
information is a written message or comprises alphabetic characters,
respectively.
The Examiner finds that Brodsky’s device includes a display (Ans. 6),
and Pelissier “disclose[s] a display comprising a written message comprising
alphabetic characters ([0334])” {id. at 7). The Examiner concludes that it
would have been obvious to modify the system made obvious by Beasley,
Slager, and Brodsky to include a written message with alphabetic characters
“as it would provide an alternate display of acquired information.” {Id.)
Appellants argue that “the prior art reference cited (Pelissier) does not
teach that the information relating to the access port attributes is displayed as
a written message (claim 34) or comprises alphabetic characters (claim 35).”
(Appeal Br. 20.) Rather, Appellants argue, the passage relied on by the
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Examiner “states that a warning or alert may be provided when the tracking
signal is too weak. . . . But even if the warning is displayed in alphabetic or
written form, a warning as to a weak signal is not ‘information relating to the
implanted access port’ as required by both claim 34 and 35.” (Id.)
We agree with Appellants that the Examiner has not shown that
claims 34 and 35 would have been prima facie obvious based on the cited
references. Brodsky discloses a portable ultrasound probe system, where
“[a] display can be mounted directly on the handheld probe, for example, to
provide a more usable and user-friendly instrument.” (Brodsky 138.)
Brodsky does not provide any further details regarding the display. Pelissier
discloses an ultrasound system (Pelissier 1279) that includes “[controller
311 .. . configured to generate images from ultrasound data and display
such images on display 313” (id. 1287). Pelissier states that
[i]n some embodiments, controller 311 is configured to generate
an alert when tracking signal quality falls below a threshold. A
tracking signal quality threshold may comprise, for example, a
mean received power level, an error rate, or the like. An alert
generated by controller 311 may comprise, for example, ... a
textual warning message displayed on display 313; [etc.].
(Id. 11334—335.)
Claims 34 and 35, by virtue of their dependency from claims 30—33,
require that the written message relates to an ability to withstand power
injection and that it was derived by the external detection device processing
the ultrasound reflection signal. As discussed above with respect to claim
42, the Examiner has not shown that any of the cited references discloses or
would have made obvious a detection device having the capability to process
or interpret the ultrasound signals. The Examiner has also not adequately
shown that it would have been obvious to use the markings on Slager’s
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catheter to encode information relating to an ability of the attached access
port to withstand power injection. Thus, the Examiner has not shown that
the system defined by claims 34 and 35 would have been obvious to a
person of ordinary skill in the art based on Beasley, Slager, Brodsky, and
Pelissier. The rejection of claims 34 and 35 is reversed.
SUMMARY
We affirm the rejection of claims 1—5 and 40 under 35 U.S.C.
§ 103(a) based on Beasley, Brodsky, and Slager.
We reverse the rejection of claims 41 and 42 under 35 U.S.C. § 103(a)
based on Beasley, Brodsky, and Slager.
We affirm the rejection of claims 30, 36, and 37 under 35 U.S.C.
§ 103(a) based on Beasley and Slager.
We reverse the rejection of claims 38 and 39 under 35 U.S.C. § 103(a)
based on Beasley and Slager.
We affirm the rejection of claims 31—33 under 35 U.S.C. § 103(a)
based on Beasley, Slager, and Brodsky
We reverse the rejection of claims 34 and 35 under 35 U.S.C. § 103(a)
based on Beasley, Slager, Brodsky, and Pelissier
We reverse the rejection of claims 43 and 44 under 35 U.S.C. § 103(a)
based on Beasley, Brodsky, Slager, and Pelissier.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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