Ex Parte Piferi

Patent Trial and Appeal Board

Aug 13, 2018

13781049 (P.T.A.B. Aug. 13, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/781,049 02/28/2013
20792 7590
MYERS BIGEL, P.A.
PO BOX 37428
RALEIGH, NC 27627
08/14/2018
FIRST NAMED INVENTOR
Peter Piferi
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.
9450-94 3507
EXAMINER
HOFFMAN, JOANNE M
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
08/14/2018 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
Ex parte PETER PIFER!
Appeal2017-007674
Application 13/781,049
Technology Center 3700
Before FRANCISCO C. PRATS, MICHAEL J. FITZPATRICK, and
JOHN G. NEW, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Peter Piferi ("Appellant") 1 appeals under 35 U.S.C. § 134(a) from a
decision finally rejecting claims 1-18. We have jurisdiction under 35 U.S.C.
§ 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification
According to Appellant, the claimed invention is directed to
"methods, devices and systems for localized placement and/or delivery of
1 Appellant identifies MRI Interventions, Inc. as the real party in
interest. Appeal Br. 1.
Appeal2017-007674
Application 13/781,049
diagnostic or therapeutic devices or substances." Spec. 1: 16-18. The
invention is used "to guide and/or place diagnostic or interventional devices
and/or therapies to any desired internal region of the body or object using
MRI." Id. at 11: 14--17.
Figure 13 is reproduced below.
FIG. 13
Figure 13, reproduced above, "is a partial exploded perspective view
of a trajectory frame [1100] utilized in an MRI-guided interventional system,
according to some embodiments of the present invention, wherein a guide
includes a threaded proximal end portion for removably retaining a cap
thereon that is configured to cover a targeting cannula and other devices
inserted within the guide." Spec 7: 18-22. The trajectory frame includes
base 110, yoke 120, platform 130, and a plurality of actuators 140a-140d.
Id. at 15:20-21. The base includes patient access aperture 112, which, in
use, is centered over a burr hole in a patient's skull. Id. at 15:21-24.
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The trajectory frame includes elongated guide support 1102 that "is
configured to removably receive various probes and/or tools" (Spec. 21 :23-
24), including, for example targeting cannula 200 (id. at Fig. 13), drill guide
1110 (id. at Fig. 15a), skull fixation device driver 1120 (id. at Fig. 16a), and
catheter guide 1130 (id. at Fig. 18a).
The Claims on Appeal
Of the pending and finally rejected claims, claims 1 and 12, are
independent. Appeal Br. 14--17. Claim 1 is representative and reads as
follows with italics added to a term of particularly significance to this
Decision:
1. A trajectory frame for use with an MRI-guided
interventional system, comprising:
a base having a patient access aperture formed therein,
wherein the base is configured to be secured to the body of a
patient;
a yoke movably mounted to the base and rotatable about
a roll axis;
a platform movably mounted to the yoke and rotatable
about a pitch axis;
an elongated guide support secured to the platform,
wherein the guide support comprises opposite proximal and
distal end portions, wherein the guide support distal end portion
is positioned proximate the patient access aperture, wherein the
guide support comprises a bore therethrough that extends from
the proximal end portion to the distal end portion; and
a first device guide and a second different device guide
releasably and separately positionable within the bore of the
guide support such that a respective distal end of each is
positioned proximate the patient access aperture, wherein the
first device guide, when separately positioned within the bore
of the guide support, is removably secured directly to the guide
support, and wherein the second device guide, when separately
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Application 13/781,049
positioned within the bore of the guide support, is removably
secured directly to the guide support.
Id. at 14 ( emphasis added).
The Appealed Rejections
The following rejections are before us for review:
(1) Claims 1-3 and 7-11 under 35 U.S.C. § I03(a) as obvious over
Piferi2 and Jewell3 (Final Act. 2);
(2) Claim 4 under 35 U.S.C. § I03(a) as obvious over Piferi,
Jewell, and Webster4 (Final Act. 5);
(3) Claims 5 and 6 under 35 U.S.C. § I03(a) as obvious over Piferi,
Jewell, Webster, and Mohammed5 (Final Act. 6);
(4) Claims 12 and 16-18 under 35 U.S.C. § I03(a) as obvious over
Piferi, Jewell, and Mohammed (Final Act. 7); and
(5) Claims 13-15 under 35 U.S.C. § I03(a) as obvious over Piferi,
Jewell, Mohammed, and Webster (Final Act. 9).
DISCUSSION
Rejection 1
The Examiner rejected claims 1-3 and 7-11 under 35 U.S.C. § I03(a)
as obvious over Piferi and Jewell. Final Act. 2.
Appellant is named co-inventor of Piferi. Piferi, like the instant
Specification, discloses "methods, devices and systems for highly localized
placement and/or delivery of diagnostic or therapeutic devices or
2 US 2009/0112084 Al (published April 30, 2009) ("Piferi").
3 US 5,116,345 (issued May 26, 1992) ("Jewell").
4 US 2011/0083672 Al (published April 14, 2011) ("Webster").
5 US 2006/0282044 Al (published Dec. 14, 2006) ("Mohammed").
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Application 13/781,049
substances." Piferi at ,I6; see also Spec. 1: 16-18 (same statement). And, as
in the instant Specification, these methods, devices, and systems are used "to
guide and/or place diagnostic or interventional devices and/or therapies to
any desired internal region of the body or object using MRI." Piferi at i-fl29;
see also Spec. 11: 14--17 ( same statement).
Figure 3a of Piferi is reproduced below.
150b •'"-,
'\,.- '\., \\ 150d
1 ~{k \'( \ \l )
....... Y\ ...... t-i.-· ; t\ /.
"" ~~>---\ \;./ \t 204
...... ··, . ..., \~ ~\ \\ \~""':~ I'
1 )un ·,. \\ \\ \\ fr""" 4..i _ .--·-,,:--,, __
. ·~ '11 \\ \\ \\\ ;J 2?8 140-~\?) \\ ~f ·---<\. t· __ . /"-·,I /~/¢
140,: \\ k::-tlr·,,,.· _ .,.,_ _;..· m I i /
.... /;
20..i·· 117 \..m'----..'----~-----><:
FIG 3A ~:-~- ~A
""
Figure 3a of Piferi, reproduced above, is a perspective view of trajectory
frame 100 used in an MRI-guided interventional system. Piferi at i-f60. The
trajectory frame of Piferi includes base 110, yoke 120, platform 130, and
targeting cannula 200. The base includes patient access aperture 112, which,
in use, is centered over a burr hole in a patient's skull.
The Examiner relies on Piferi as teaching the entire subject matter of
independent claim 1, except for the first and second device guides, each of
which is "separately positionable within the bore of the guide support" such
that each is "removably secured directly to the guide support." Final Act. 3.
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The Examiner relies on Jewell's drill guide 44 as a first device guide and
Jewell's cannula 56 as a second device guide. Id.; see also Jewell at 3:59--
63 and Fig. 2.
For reference, Figures 1 and 2 of Jewell are reproduced below.
FIG. I FIG.2
Figure 1 of Jewell, reproduced above, "is a diagrammatic perspective
showing a patient having a stereotactic locating fixture secured to the skull"
and having "support arm 1 O" attached thereto. Spec. 3: 13-17, 3:35-37.
Figure 2 of Jewell, reproduced above, "is a set of tools used with support
arm for drilling a skull opening, inserting and securing an intracranial device
40 at target 36 in the skull. The set includes a drill collar 42, drill guide 44,
drill bit 46, skull bolt 48, screwdriver sleeve 50, screwdriver 52, cannula
holder 54, cannula 56, stylet 58, and clip 60 for supporting device 40." Id. at
3:56-63.
In the Final Action, the Examiner acknowledges that the Specification
defines "directly" and concedes that neither Piferi nor Jewell teaches
"removably secured directly to the guide support." See Final Act. 3 ("Piferi
and Jewell do not explicitly teach 'direct' or 'directly' securing the device
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guide to the elongated guide support using the definition of 'there are no
intervening elements present' for 'direct' and 'directly."'). In the Final
Action, the Examiner concludes as follows:
[I]t would be obvious to a person of ordinary skill in the art at
the time of invention that drill collar 44 and holder 54 function
for changing/adjusting the diameter, and that in lieu of using a
collar or holder, one could change the diameter and thickness of
drill guide 44 or cannula 56, such that it directly attaches to 30.
The motivation for doing so is that it is basic mechanical
knowledge that one can change/fabricate the diameter/thickness
of the guides to fit the application, such as fitting smaller or
larger drill bits and/or electrodes. Jewell even states that "while
dimensions are not critical," (Column 4 Line 53) which means
that there is room to adjust the size of the components.
Final Act. 3--4.
The purported "motivation" offered by the Examiner is the
"knowledge that one can" do something. Id. (emphasis added). Motivation
( or other reasoning), however, should explain why a person of ordinary skill
in the art would have done something, not merely why he could have.
Further, Jewell expressly contemplates differently sized device guides
without contemplating doing so, as the Examiner asserts, "in lieu of using a
collar or holder." Final Act. 3. Rather, as Appellant points out, when Jewell
uses different device guides ( e.g., drill guide 44 and cannula 56), it teaches
securing them via an intervening component ( e.g., drill collar 42 and holder
54). Appeal Br. 8. In fact, and as Appellant further argues, the language in
Jewell on which the rejection hinges (i.e. "dimensions are not critical"),
should be read in the context of the entire paragraph, which states the
following:
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While dimensions are not critical, the following examples
indicate useful relations of diameters (in inches) of the
components, in the case of a 9/64" (0.149") drill bit 46.
I.D. guide bore 30--0.502"
O.D. of drill collar 42--4.99
I.D. of opening 62 in drill collar--0.235
O.D. of drill guide 44--0.234
I.D. of drill guide 44--0.149
O.D. of screwdriver sleeve 50--0.500
I.D. of screwdriver sleeve 50--0.377
O.D. of screwdriver shank 70--0.375
O.D. of bolt shank 72--0.160
I.D. of opening 76 in bolt 48--0.084
O.D. of cannula holder 54--0.499
I.D. of cannula holder 54--0.084
O.D. of cannula 56--0.083
I.D. of cannula 56--0.061
width of slot in cannula 56--0.045
O.D. of stylet--0.060
O.D. of device 60--0.059
Jewell, 4:53-5:5 (emphasis added); see also Appeal Br. 8 (quoting the
same). As reproduced above, in every instance of a differently sized device
guide, Jewell discloses a differently sized collar to hold it. Jewell does not
disclose or suggest omitting the collar and implementing a direct attachment.
Jewell 4:53-5:5.
In the Examiner's Answer, the Examiner responds to Appellant's
arguments with two new theories for how the asserted references meet claim
1 's "directly" limitation. Ans. 11.
First, the Examiner asserts an erroneous claim construction for the
"directly" limitation, stating as follows:
[T]he specification does not explicitly state that "removably
secured directly to" means that an element is secured with no
intervening elements. Furthermore, removable secured would
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imply that there is either a locking piece or element that allows
for the coupling although direct to be able to be moved and
removed. Meaning this can be interpreted as needing an
intervening element be it a coupler, spring, bolt or other
element.
Ans. 11. This construction is erroneous because it is directly at odds with an
explicit definition of "directly" set forth in the Specification. See Spec.
9:23-25 ("[W]hen an element is referred to as being, for example, 'directly
on', 'directly attached' to, 'directly connected' to, 'directly coupled' with or
'directly contacting' another element, there are no intervening elements
present.") ( emphasis added).
Second, the Examiner asserts an erroneous construction for the
"device guide" limitations, stating the following:
Further there is no definition of element and no mention of
element in the claims as the device guide could be and can be
two elements that are removably secured directly to the guide
support and therefore there would be no intervening element.
Ans. 11. This construction, or at least its application to the asserted
structures of Jewell, is erroneous because it reads out the limitation
"directly." This is not to say that a "device guide" may not be composed of
multiple components. It is merely to say Jewell's collar 42 and holder 54 are
not part of a "device guide" within the meaning of that term. For example,
Jewell's collar 42 does not guide drill bit 46. Drill guide 44 alone does that.
What Jewell's collar 42 does is secure the drill guide 44 to support arm 10.
Appellant persuades us of error in the Examiner's rejection of claim 1,
and thus also the rejection of dependent claims 2, 3, and 7-11. Accordingly,
the rejection of claims 1-3 and 7-11 is reversed.
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Rejections 2 and 3
The Examiner rejected, under 35 U.S.C. § 103(a), claim 4 as obvious
over Piferi, Jewell, and Webster and claims 5 and 6 as obvious over Piferi,
Jewell, Webster, and Mohammed. Final Act. 5-6.
The rejections of these claims, which depend from claim 1, do not rely
on the additional references (i.e., Webster and Mohammed) to cure the
deficiency of the Examiner's rejection of claim 1 over Piferi and Jewell. See
id. at 5-7. Accordingly, the rejection of claims 4--6 likewise is reversed.
Rejection 4
The Examiner rejected claims 12 and 16-18 under 35 U.S.C. § 103(a)
as obvious over Piferi, Jewell, and Mohammed. Final Act. 7.
Independent claim 12 recites "an elongated guide support" and "a
targeting cannula and a drill guide releasably and serially inserted within the
bore" wherein "the targeting cannula and drill guide are removably and
separately secured directly to the guide support proximal end portion for
quick release therefrom." Appeal Br. 16 ( emphasis added). The Examiner
relies on Piferi and Jewell for meeting the quoted limitations save the "quick
release" feature. Final Act. 8. 6 For the same reasons as with claim 1, the
asserted prior art does not meet the "directly" limitation of claim 12.
Accordingly, the Examiner's rejection of claim 12, and thus also the
rejection of dependent claims 16-18, is reversed.
6 The Examiner relies on Mohammed for teaching the "quick release" aspect
of claim 12. Final Act. 8.
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Rejection 5
The Examiner rejected claims 13-15 under 35 U.S.C. § 103(a) as
obvious over Piferi, Jewell, Mohammed, and Webster. Final Act. 9.
The rejections of these claims, which depend from claim 12, do not
rely on the additional reference (i.e., Webster) to cure the deficiency of the
Examiner's rejection of claim 12 over Piferi, Jewell, and Mohammed. See
Final Act. 9. Accordingly, the rejection of claims 13-15 likewise is
reversed.
SUMMARY
For the reasons discussed, we reverse the Examiner's rejection of all
claims on appeal.
REVERSED
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