Ex Parte Powers et al

Patent Trial and Appeal Board

Feb 21, 2018

14171364 (P.T.A.B. Feb. 21, 2018)

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.
14/171,364 02/03/2014 Kelly B. Powers 102202.0008P6 7111
7590
RUT AN & TUCKER, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
EXAMINER
HAYMAN, IMANI N
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
02/23/2018 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 KELLY B. POWERS, JIM C. BEASLEY,
KEVIN W. SHEETZ, MATTHEW M. LOWE,
EDDIE K. BURNSIDE and JAY GERONDALE
Appeal 2016-008422
Application 14/171,364
Technology Center 3700
Before: STEVEN D.A. McCARTHY, BRETT C. MARTIN and
ERIC C. JESCHKE, Administrative Patent Judges.
McCARTHY, Administrative Patent Judge.
DECISION ON APPEAL
1 STATEMENT OF THE CASE
2 The Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner’
3 decision finally rejecting claims 1—5 and 7—11 under pre-AIA 35 U.S.C.
4 § 103(a) as being unpatentable over Fago (US 2004/0024361 Al, publ. Feb.
5 5, 2004) and Tallarida (US 2003/0181878 Al, publ. Sept. 25, 2003); and of
6 claims 6 and 12 under § 103(a) as being unpatentable over Fago, Tallarida
1 The Appellants identify C.R. Bard, Inc. as the real party in interest.
We note that a “Notice of Change in Real Party-in-Interest Pursuant to 37
C.F.R. § 41.8,” dated January 15, 2018, was filed in Inter partes
Reexamination Control No. 95/002,089, saying that C.R. Bard, Inc., has
become a wholly owned subsidiary of Becton, Dickinson and Company.
Appeal 2016-008422
Application 14/171,364
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and Borchard (US 2004/0078000 Al, publ. Apr. 22, 2004). We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Claims 1 and 7 are independent:
1. A method of power injecting a fluid through an access
port, comprising:
providing a power-injectable access port suitable for
injecting contrast media therethrough at a rate of at
least 1 milliliter per second, the access port
including:
a housing;
a septum;
a reservoir; and
an outlet stem in fluid communication with the
reservoir, the access port structured for
accommodating a pressure developed within
the reservoir of at least 35 psi;
attaching a catheter to the outlet stem;
implanting the power-injectable access port and catheter
into a patient;
inserting a distal end of a needle through the septum and
into the reservoir; and
injecting contrast media through the needle at a rate of at
least one milliliter per second.
7. A method of power injecting a fluid through a power-
injectable access port, comprising:
inserting a distal end of a needle through a septum and into
a reservoir of a power-injectable access port
suitable for injecting contrast media therethrough at
a rate of at least 1 milliliter per second, the access
port structured for accommodating a pressure
developed within the reservoir of at least 35 psi, the
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Appeal 2016-008422
Application 14/171,364
power-injectable access port including an outlet
stem in fluid communication with the reservoir, the
outlet stem attached to a catheter implanted into a
patient along with the power-injectable access port;
and
injecting contrast media through the needle at a rate of at
least one milliliter per second.
Fago describes an injector 20 for “deliver[ing] radiographic contrast
media at a controlled flow rate and volume into a patient’s vascular system
for the purpose of obtaining enhanced diagnostic [x-ray] images.” (Fago,
paras. 16 & 47; see also id., para. 56). Fago’s injector 20 includes a
powerhead 22. The powerhead 22 includes a drive system 24 for extending
a plunger drive ram 46 and a syringe plunger 74 through a cavity 70 of a
syringe 28 mounted on the powerhead 22 to expel fluid from the syringe into
a catheter leading to tissue of interest in the imaging process. (See Fago,
paras. 48, 58 & 69; & Figs. 2 & 3). Fago indicates that the injector 20 is
capable of generating a pressure as high as 250 psi in the syringe 28; and
that the plunger drive ram 46 and syringe plunger 74 are capable of
expelling fluid from the syringe at a flow rate of 2.5 ml/sec. (See Fago, para.
89). Paragraph 56 of Fago teaches expelling fluid from the syringe 28 at a
rate of 1 ml/sec to 6 ml/sec, at a maximum pressure limit of about 250 psi.
Fago taught that, as of its filing date:
Many [then-]current power injectors [had] a maximum pressure
limit in order to provide safety to the components of the power
injector. This prevented] the injector from being damaged by
being subjected to forces greater than [the injector’s components
were] rated to withstand. These injectors also allow[ed] the
operator to reduce the set maximum pressure limit to provide
safety to a patient or other subject to be injected. For example,
access ports [were] inserted into patients who need[ed]
medication intravenously, but whose veins [could not] tolerate
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Appeal 2016-008422
Application 14/171,364
multiple needle sticks. Access ports that [were] implanted into
patients [could not] tolerate many of the high pressures capable
of being generated by these large injectors. High flow rates and
pressures [could] cause the implanted catheter portion of the
access port to break and require surgery to remove. For example,
100 psi [was] generally a threshold of pressure that a typical
access port [was] able to withstand. However, a typical large
[computed tomography (“CT”)] injector [could] attain pressures
during delivery of media of 300 psi at all flow rates. Thus, unless
the pressure of such an injector [was] manually reduced, the
access ports in a patient [could] become over-pressured and
possibly fail. Limiting the pressure for the injection of fluid into
an access port for a contrast study require[d] a technologist to
reprogram the injector to reduce the pressure limit. If the
technologist [forgot] to reset the limit to the higher setting once
the application [had] been performed, the desired flow rate
[might] not be achieved during injections for subsequent
patients.
(Fago, para. 5). Fago addressed this problem by programming the injector
20 to automatically set the pressure within the syringe 28 based on the flow
rate of liquid from the syringe (see Fago, paras. 26 & 47); and automatically
slowing or halting the flow of fluid from the syringe if the pressure exceeds
a predetermined limit (see id., paras. 88 & 89).
As the Appellants correctly point out, Fago did not teach “providing a
power-injectable access port suitable for injecting contrast media
therethrough at a rate of at least 1 milliliter per second,” or providing an
“access port structured for accommodating a pressure developed within the
reservoir of at least 35 psi,” as recited in claim 1. Neither did Fago teach
providing an “access port structured for accommodating a pressure
developed within the reservoir of at least 35 psi,” as recited in claim 7. (See
Appeal Brief, dated Jan. 25, 2016 (“App. Br.”), at 8—10). Instead, Fago
taught that the pressures generated in an implanted access port by a power
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Appeal 2016-008422
Application 14/171,364
injector communicating with the reservoir of the port typically exceeded the
maximum pressures for which such access ports were rated.2
The Examiner has not shown that paragraph 56 of Fago teaches
injecting a contrast medium into an implanted access port, as found in the
last sentence on page 6 of the Examiner’s Answer, mailed July 29, 2016
(“Ans”). For example, the teachings of paragraph 56 are consistent with
injecting the contrast medium through a percutaneous central venous
catheter.
Paragraph 5 of Fago taught a problem that might be addressed by
“providing a power-injectable access port suitable for injecting contrast
media therethrough at a rate of at least 1 milliliter per second,” or by
2 In the event that the underlying application undergoes further
prosecution in the wake of this Final Decision, we direct the Examiner’s
attention to Gebauer et al., Contrast Media Power Injection Using Central
Venous Port Catheters—Results of an In-Vitro Study, 117 RoFo—
Advances in the Field of X-Rays & Imaging Techniques 1417 (Georg
Thieme Verlag KG, Stuttgart, Germany, Oct. 2005). An English-language
abstract of the article appearing, as of the date of this opinion, at
https://www.ncbi.nlm.nih.gov/pubmed/16170712, describes the article as a
study answering in the affirmative the question: “Are implanted central
venous port catheters suitable for contrast media pressure (power) injection
in computed tomography?” Tables 2 and 3, reproduced on page 9 and 10 of
an English-language translation submitted in Inter partes Reexamination
95/002,089 as an attachment to an Information Disclosure Statement, dated
February 7, 2013, list several examples of implantable port catheter systems
having manufacturer rated pressures above 35 psi that were tested at flow
rates of 2 ml/sec and higher. The article appears to pre-date each parent
application listed in paragraph 1 of the underlying application, except for US
Provisional Application 60/675,309. Although paragraph 45 of US
Provisional Application 60/675,309 mentions power injection, it is not
apparent that the port pressure and flow rate ranges recited in claims 1 and 7
appear in the provisional application.
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Appeal 2016-008422
Application 14/171,364
providing an “access port structured for accommodating a pressure
developed within the reservoir of at least 35 psi,” as recited in claim 1.
Nevertheless, as the Appellants point out, Fago teaches solving the problem
by regulating the pressure of the fluid in the syringe 28, as well as the flow
rate of the fluid from the syringe, rather than by using a power-injectable
access port. (See Fago, paras. 26, 47 & 87—89; see also App. Br. 8).
Tallarida does not remedy this deficiency. As depicted in Figures 2A
and 2B, Tallarida describes an implantable access device 10 including a
housing member 12, a septum 16, a reservoir 22 and an outlet stem 20. (See
Tallarida, para. 42). Tallarida addresses problems associated with known
access devices having metallic or polymeric housings by providing the
polymeric housing member 12 with a metallic cup member 14 and a molded
top member 24 for improved durability. (See Tallarida, paras. 29, 31, 35 &
44). Tallarida does not describe the access device depicted in Figures 2A
and 2B as power-injectable; provide a pressure rating or flow rate for the
device; or address any problem relating to the use of the device for power
injecting a contrast medium.
The Examiner concludes that:
[it would have been obvious] to include the structure of the
access port and the steps of implanting an access port as taught
by Tallarida et al. since it was well known in the art that
subcutaneous access ports are utilized to deliver fluids into the
bloodstream of a patient and typically include a housing, septum,
reservoir, and outlet stem.
(Final Office Action, mailed June 25, 2015 (“Final Act.”), at 3, citing
Tallarida, para. 12). The conclusion does not address the deficiencies in the
teachings of Fago and Tallarida as applied to claims 1 and 7. We do not
sustain the rejection of claims 1—5 and 7—11 under § 103(a) as being
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Appeal 2016-008422
Application 14/171,364
unpatentable over Fago and Tallarida. Based on our holding, we do not
address the Appellants’ separate arguments regarding the dependent claims.
Borchard describes an implantable drug pump having a reservoir
refillable through an access port 210. (See Borchard, para. 20 & 21).
Borchard also describes a kit for supplying drug to the implantable access
pump. (See Borchard, para. 24 & Fig. 10). The Examiner cites Borchard as
disclosing “an identification feature separate from the power-injectable
access port comprising visually perceptible information.” (Final Act. 4 & 5,
citing Borchard, para. 8). This teaching does not remedy the deficiencies in
the combined teachings of Fago and Tallarida as applied to independent
claims 1 and 7. We do not sustain the rejection of claims 6 and 12 under
§ 103(a) as being unpatentable over Fago, Tallarida and Borchard.
DECISION
We REVERSE the Examiner’s decision rejecting claims 1—12.
REVERSED
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