RENISHAW (IRELAND) LIMITED

Patent Trials and Appeals Board

Mar 3, 2020

14581549 - (D) (P.T.A.B. Mar. 3, 2020)

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.
14/581,549 12/23/2014 Steven Streatfield GILL 141546.01 3168
25944 7590 03/03/2020
OLIFF PLC
P.O. BOX 320850
ALEXANDRIA, VA 22320-4850
EXAMINER
SCHMIDT, EMILY LOUISE
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
03/03/2020 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):
OfficeAction25944@oliff.com
jarmstrong@oliff.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte STEVEN STREATFIELD GILL and PAUL DAVID FIELDER
____________

Appeal 2018-006122
Application 14/581,549
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and
TARA L. HUTCHINGS, Administrative Patent Judges.

HUTCHINGS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1–3 and 5–17. An oral hearing was held on February 6,
2020. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Our decision references Appellant’s Appeal Brief (“Appeal
Br.,” filed Jan. 29, 2018), Reply Brief (“Reply Br.,” filed May 25, 2018),
and Declaration of Steven Streatfield Gill, filed October 29, 2017), and the
Examiner’s Answer (“Ans.,” mailed April 2, 2018) and Final Office Action
(“Final Act.,” mailed Aug. 28, 2017). Appellant identifies Renishaw PLC as
the real party in interest. Appeal Br. 1.
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CLAIMED INVENTION
Appellant’s claimed invention relates to a “percutaneous implant,
especially neurological apparatus comprising a percutaneous access device
suitable for use with an implanted intracranial catheter.” Spec. ¶ 2.
Claims 1 and 16 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. Apparatus for delivering a therapeutic agent to the central
nervous system, comprising:
at least two intracranial catheters; and
a percutaneous access device, the percutaneous access
device comprising a body having at least one extracorporeal
surface and at least one subcutaneous surface, the body defining
at least two ports for connection to said intracranial catheters,
each port being accessible from the extracorporeal surface of
the device, but being provided with a seal between the lumen of
the port and the extracorporeal surface, each port separately
passing through the body such that each intracranial catheter is
separately accessible from the extracorporeal surface of the
device.
REJECTIONS
Claims 1–3, 6, 8, 11, 12, 16, and 17 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Baudino (US 5,954,687, iss. Sept. 21, 1999),
Brown (US 4,695,273, iss. Sept. 22, 1987), and Haarala
(US 2003/0004520 A1, pub. Jan. 2, 2003).
Claim 5 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Baudino, Brown, Haarala, and Nussbaum (US 5,352,207, iss. Oct. 4, 1994).
Claim 7 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Baudino, Brown, Haarala, and Sommerich (US 2004/0243064 A1, pub. Dec.
2, 2004).
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Application 14/581,549

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Claims 1–3, 5, 6, and 8–17 are rejected under 35 U.S.C. § 103(a) as
obvious over Inman (US 4,578,063, iss. Mar. 25, 1986), Brown, and
Haarala.
Claim 7 is rejected under 35 U.S.C. § 103(a) as obvious over Inman,
Brown, Haarala, and Sommerich.

ANALYSIS
Obviousness Over Baudino, Brown, and Haarala
We are persuaded by Appellant’s argument that the Examiner erred in
rejecting claims 1 and 16 under 35 U.S.C. § 103(a) because Baudino does
not disclose a percutaneous access device comprising a body having at least
one extracorporeal surface and at least one subcutaneous surface, as recited
by claim 1, and similarly recited in claim 16. The Examiner relies on
Baudino for teaching a percutaneous access device. Final Act. 2 (citing
Baudino, Fig. 2).
Baudino relates to a low profile access port for establishing fluid
communication with the brain, such as for the administration of drugs.
Baudino 1:5–9. Baudino teaches with reference to Figure 2, a burr hole
ring 16 that is secured within a burr hole drilled into the skull. Id. at 1:52–
55, 3: 49–51, 4:9–12. After insertion of burr hole ring 16 into the burr hole,
threads or ridges 30 of the burr hole ring engage the skull at the inner sides
of the drilled burr hole. Id. at 3:51–53. A septum 32 is placed in the top
portion of burr hole ring 16 to isolate fluid reservoir 24 from the ambient
environment. Id. at 3:61–63. A pharmaceutical can be delivered to a patient
by inserting hypodermic needle 34 through septum 32 to inject the fluid
agent. Id. at 3:63–67. Stylet 14 is inserted through septum 32 into central
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connection tube 22 and, ultimately, catheter 12 for insertion into the
patient’s brain. Id. at 4:5–12.
To support the finding that Baudino teaches the claimed percutaneous
device, the Examiner finds that Baudino at Figure 2 shows burr hole ring 16
having extracorporeal surface 18. See Final Act. 10; see also Ans. 2.
Baudino’s Figure 2 depicts a patient’s skull with a burr hole drilled into the
skull. Burr ring 16 is placed into the burr hole, threads 30 of ring 16 engage
the skull, and upper flange 18 of ring 16 seats against the skull. However,
Figure 2 does not depict a patient’s skin or otherwise indicate that the burr
ring has an extracorporeal surface, as required by claims 1 and 16.
Moreover, as pointed out by Appellant, upper flange 18, which is
seated against the skull, is shown in all figures to be approximately half the
thickness of the skull, suggesting that the flange has been designed to be
subcutaneous. Appeal Br. 7 (citing Declaration 2–3); see also Reply Br. 2–3
(arguing that “the Baudino device simply is not thick enough to protrude
through the skin, as explained in the Declaration”), Decl. 3 (declaring that
Baudino’s burr hole is approximately the same thickness as the skull; the
upper flange of its burr hole ring is shown in all figures as approximately
half the burr hole thickness; and the upper flange resting on the skull with
half the height of the skull would not have sufficient height to emerge
through the scalp, indicating that the flange has been designed to be low
profile and subcutaneous).
The Examiner further reasons that Baudino’s description of a septum
isolating the reservoir from the ambient/external environment, indicates that
the device would have an extracorporeal surface. Final Act. 10 (citing
Baudino 3:61–63, 4:50–52). However, we agree with Appellant that the
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Examiner does not adequately support the finding that the ambient
environment described in Baudino is intended to refer to the environment
outside of the patient’s body (i.e., an extracorporeal environment) instead of
outside the reservoir. See Appeal Br. 8; see also Reply Br. 4–5;
Declaration 3–4. For example, the cited portions of Baudino do not describe
a need to isolate the contents of the reservoir from the environment outside
of the patient’s skin, as opposed to isolating the contents from the
environment immediately above the septum and external the reservoir, but
below the skin.
The Examiner also reasons that the device has at least one
extracorporeal surface because Baudino describes replacing a filter of the
device, and that it would not follow to install the device under the skin
where it would require repeatedly cutting the skin of the patient. Final
Act. 10 (citing Baudino 6:10–15); see also Ans. 3. However, Baudino
describes at column 6, lines 10–15 that the mounting member is detachable,
allowing the filter assembly to be replaced when clogged or inoperable.
Contrary to the Examiner’s suggestion, there is no indication in the cited
portion of Baudino that this service occurs frequently or that the mounting
member is easy to replace. See Reply Br. 5; see also Baudino 6:10–15.
Moreover, Appellant provides a declaration that subcutaneous devices are
serviced and/or replaced periodically by cutting through skin. Appeal Br. 8
(citing Decl. 4); see also Decl. 4 (declaring that Baudino’s filter replacement
likely would occur infrequently, such as every few years, and that servicing
and/or replacing implants every few years by cutting through the skin is a
common neurosurgical practice). The Examiner does not address
Appellant’s argument.
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We are not persuaded that the Examiner adequately supported the
finding that Baudino is a percutaneous access device, as recited in claim 1,
and similarly recited in claim 16. For at least this reason, we reverse the
rejection of independent claims 1 and 16, and their dependent claims, under
35 U.S.C. § 103(a) as unpatentable over Baudino, Brown, and Haarala.
Obviousness Over Baudino, Brown, Haarala, and Nussbaum
The Examiner’s rejection of dependent claim 5 under 35 U.S.C.
§ 103(a) as unpatentable over Baudino, Brown, Haarala, and Nussbaum does
not cure the deficiency in the Examiner’s rejection of independent claim 1
under 35 U.S.C. § 103(a) as unpatentable over Inman, Brown, and Haarala.
Therefore, we do not sustain the Examiner’s rejection of claim 5
under 35 U.S.C. § 103(a) as unpatentable over Baudino, Brown, Haarala,
and Nussbaum, for the same reasons set forth above with respect to the
rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Baudino,
Brown, and Haarala.
Obviousness Over Baudino, Brown, Haarala, and Sommerich
The Examiner’s rejection of dependent claim 7 under 35 U.S.C.
§ 103(a) as unpatentable over Baudino, Brown, Haarala, and Sommerich
does not cure the deficiency in the Examiner’s rejection of independent
claim 1 under 35 U.S.C. § 103(a) as unpatentable over Baudino, Brown, and
Haarala.
Therefore, we do not sustain the Examiner’s rejection of claim 7
under 35 U.S.C. § 103(a) as unpatentable over Baudino, Brown, Haarala,
and Sommerich, for the same reasons set forth above with respect to the
rejection of independent claim 1 under 35 U.S.C. § 103(a) as unpatentable
over Baudino, Brown, and Haarala.
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Obviousness Over Inman, Brown, and Haarala
We are persuaded by Appellant’s argument that the Examiner erred in
rejecting independent claims 1 and 16 under 35 U.S.C. § 103(a), because
Inman does not disclose at least two intracranial catheters, as recited in
claim 1, or more than two intracranial catheters, as recited in claim 16.
Appeal Br. 12–13, 17. The Examiner relies on Inman for disclosing an
intracranial catheter, and Haarala for teaching a plurality of catheters
attached to multiple ports. See Final Act. 6 (citing Inman, Fig. 4; Haarala
¶ 56, Figs. 3, 13).
Appellant argues that Inman discloses a venous catheter, not an
intracranial catheter, as required by claims 1 and 16. Appeal Br. 12–13, 17.
In response, the Examiner finds that “the limitation regarding the intracranial
catheter is functional[,] and a catheter would need to be functional of such
use.” Ans. 6. The Examiner finds that the diameter of Inman’s “barb
indicates the diameter of the tube” (id. (citing Inman 10:55)), and that Inman
teaches that such ports are beneficial for monitoring brain implants (id.
(citing Inman 1:25). The Examiner finds that claims 1 and 16 do not recite
any particular rate for dispensing fluid or dimensions for the catheter. Id.
at 7. Therefore, the Examiner concludes that claims 1 and 16 require “only
that a catheter be capable of intracranial placement” and finds that Inman at
column 10, line 55 teaches a size that is capable of intracranial use. Id.
(addressing claim 1), 9 (rejecting claim 16 on the same basis set forth with
respect to claim 1).
As an initial matter we disagree with the Examiner’s interpretation
that the claimed intracranial catheter requires only a catheter capable of
intracranial placement. Even if claims 1 and 16 do not recite dimensions of
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the intracranial catheter or a rate for dispensing fluid, one of ordinary skill in
the art would recognize that the claimed intracranial catheter is capable not
only of intracranial placement but also of intracranial use.
Here, Appellant disputes the Examiner’s finding that Inman’s venous
catheter is capable of being used as an intracranial catheter. Appeal Br. 12–
13; see also Reply Br. 8–9, Decl. 7. Specifically, Appellant argues that a
venous catheter delivers liters of fluid, such as hundreds of milliliters of
drugs, to the bloodstream. Appeal Br. 12–13; see also Decl. 7. In contrast, a
brain infusion dispenses small amounts of fluid over a period of time, such
as 300 microliters over two hours. Appeal Br. 13; see also Decl. 7.
Appellant contends that because a venous catheter delivers a much larger
volume of drugs, its diameter is larger than an intracranial catheter. Appeal
Br. 12–13. Thus, if one were to use this type of catheter in a neuro
application, the catheter would be unable to dispense a precise but small
amount of liquid due to the dead volume during dispensing. See id.; see also
Declaration 12–13 (comparing the use of a venous catheter in a neuro
application to using a garden hose to apply a drop of oil to a door hinge).
Appellant further supports this argument by pointing out that
Appellant’s Specification at paragraph 18 cites Gill2 as an exemplary
intracranial catheter. Gill describes that an external catheter of a
neurosurgical catheter has an external diameter of no more than 1.0
millimeter, a preferred diameter of no more than 0.7 millimeter, a more
preferred diameter of no more than 0.65 millimeter, and a most preferred
diameter of no more than 0.5 millimeter. Gill 3–4.

2 Gill (WO 2003/077785 A1, pub. Sept. 25, 2003).
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The Examiner finds that column 10, line 55 of Inman indicates that
Inman’s venous catheter is sized for use as an intracranial catheter, asserting
that the diameter of the barb indicates the diameter of the tube. Ans. 6–7.
Yet, Inman at column 10, lines 53–57 provides that barbs 45 on
connector 42 range from 0.1 inch to 0.6 inch, and provide a snap-in fit at the
port. Inman further describes that the outer diameter of connector 42 is 0.2
inch to 0.5 inch. Inman 10:46–47. As pointed out by Appellant (Reply
Br. 8), Inman’s dimensions are equivalent to a metric range of 5.1 mm to
12.7 mm, which are much larger than the exemplary dimensions for an
intracranial catheter as provided by reference to Gil in Appellant’s
Specification.
For at least this reason, we are persuaded that the Examiner erred in
rejecting independent claims 1 and 16, and dependent claims 2, 3, 5, 6, 8–15,
and 17 under 35 U.S.C § 103(a) as unpatentable over Inman, Brown, and
Haarala.
Obviousness Over Inman, Brown, Haarala, and Sommerich
The Examiner’s rejection of dependent claim 7 over Inman, Brown,
Haarala, and Sommerich does not cure the deficiency in the Examiner’s
rejection of independent claim 1 under 35 U.S.C. § 103(a) as unpatentable
over Inman, Brown, and Haarala.
Therefore, we do not sustain the Examiner’s rejection of claim 7
under 35 U.S.C. § 103(a) as unpatentable over Inman, Brown, Haarala, and
Sommerich, for the same reasons set forth above with respect to the rejection
of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Inman, Brown, and
Haarala.

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CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 6, 8,
11, 12,
16, 17
103(a) Baudino, Brown,
Haarala
1–3, 6, 8, 11,
12, 16, 17
5 103(a) Baudino, Brown,
Haarala, Nussbaum
5
7 103(a) Baudino, Brown,
Haarala,
Sommerich
7
1–3, 5, 6,
8–17
103(a) Inman, Brown,
Haarala
1–3, 5, 6, 8–
17
7 103(a) Inman, Brown,
Haarala,
Sommerich
7
Overall
Outcome
1–3, 5–17

REVERSED