Ex Parte Orome et al

Patent Trial and Appeal Board

Oct 23, 2017

13335587 (P.T.A.B. Oct. 23, 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.
13/335,587 12/22/2011 Amir Orome 101672.0157P 6426
34284 7590
Rutan & Tucker, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
10/25/2017 EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
10/25/2017 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 AMIR OROME, ERIC W. LINDEKUGEL,
PAUL D. MORGAN, and MATTHEW W. BROWN
Appeal 2016-007210
Application 13/335,587
Technology Center 3700
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
needle guide assembly. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
Statement of the Case
Background
“[Ejmbodiments of the present invention are directed to a needle
guide assembly for inserting a needle into the body of a patient in order to
access a subcutaneous target, such as a vessel” (Spec. 12). “[T]he needle
1 Appellants identify the Real Party in Interest as C.R. Bard, Inc. (see App.
Br. 4).
Appeal 2016-007210
Application 13/335,587
guide assembly ... is configured to at least indirectly and removably attach
to an image producing device, such as an ultrasound probe” (Id.).
The Claims
Claims 1—8, 16, 18, 19, and 21—26 are on appeal. Independent claim 1
is representative and reads as follows:
1. A needle guide assembly, comprising:
an image producing device;
a needle guide body configured to at least indirectly and
removably attach to the image producing device, the needle
guide body laterally slidable with respect to the image
producing device;
a plurality of guide channels defined by the needle guide
body, each of the plurality of guide channels defining a unique
insertion angle with respect to a longitudinal axis of the image
producing device and configured to receive needles of differing
gauges; and
a plurality of front faces that face radially outwardly
away from the image producing device when attached to the
image producing device, the plurality of front faces defined by
the needle guide body, each of the plurality of front faces
having a concavely shaped surface that slopes toward an open
proximal end of one of the plurality of guide channels.
The Issues2
A. The Examiner rejected claims 1, 2, 4, 6, 7, and 16 under 35 U.S.C.
§ 103(a) as obvious over Gorzitze,3 Floyd,4 and Arenson5 (Final Act. 3—8).
2 The Examiner withdrew the 35 U.S.C. § 112(b) rejection, so claim 26 is
not subject to any pending rejection (see Ans. 2).
3 Gorzitze, US 2010/0160787 Al, published June 24, 2010.
2
Appeal 2016-007210
Application 13/335,587
B. The Examiner rejected claim 3 under 35 U.S.C. § 103(a) as obvious
over Gorzitze, Floyd, Arenson, Welles,6 and Britt7 (Final Act. 8—9).
C. The Examiner rejected claim 5 under 35 U.S.C. § 103(a) as obvious
over Gorzitze, Floyd, Arenson, and Cermak8 (Final Act. 9-10).
D. The Examiner rejected claims 8 and 24 under 35 U.S.C. § 103(a) as
obvious over Gorzitze and Bonde9 (Final Act. 10—12).
E. The Examiner rejected claims 18, 21, 22, and 2510 under 35 U.S.C. §
103(a) as obvious over Gorzitze, Sandhu,* 11 “NSK”12 and “Slide-N-Fock”13
(Final Act. 12—14).
F. The Examiner rejected claim 19 under 35 U.S.C. § 103(a) as obvious
over Gorzitze, Sandhu, “NSK”, “Slide-N-Fock”, and Cermak (Final Act.
15-16).
G. The Examiner rejected claim 23 under 35 U.S.C. § 103(a) as obvious
over Gorzitze, Sandhu, “NSK”, “Slide-N-Fock”, Jaggi,14 and Dietz15 (Final
Act. 16-17).
4 Floyd et al., US 2005/0131291 Al, published June 16, 2005.
5 Arenson et al., US 5,076,279, issued Dec. 31, 1991.
6 Welles, US 5,138,748, issued Aug. 18, 1992.
7 Britt, US 4,341,303, issued July 27, 1982.
8 Cermak et al., US 2009/0143684 Al, published June 4, 2009.
9 Bonde et al., US 2008/0300491 Al, published Dec. 4, 2008.
10 While the Examiner inadvertently omitted claim 25 from the statement of
rejection, claim 25 was included in the body of the rejection, so we consider
the rejection to include this claim.
11 Sandhu, US 6,485,426 B2, issued Nov. 26, 2002.
12 “NSK”, https://web.archive.Org/web/20091127094145/http://
www.nskamericas.com/cps/rde/xchg/na_en/hs.xsl/linear-guides.html (2009).
13 “Slide-N-Fock”, https:/web.archive.org/web/20081202134039/http:
//www. hooverfence.com/tools/slide-n-lockhtm (2008).
14 Jaggi et al., US 6,425,871 Bl, issued July 30, 2002.
3
Appeal 2016-007210
Application 13/335,587
A. 35 U.S.C. § 103(a) over Gorzitze, Floyd, andArenson
The Examiner finds Gorzitze teaches an ultrasound system with “a
linear needle guide 750 including a top surface 752 and a plurality of needle
channels 354 that are each aligned to define differing needle insertion
angles” (Final Act. 3—4). The Examiner finds Gorzitze teaches “different
insertion angles correspond to different subcutaneous depths” (Id.).
The Examiner finds that either Figure 4 A of Gorzitze is “considered
to depict wherein a portion of the front face extends ‘radially, outwardly
away’ from the image producing device in its broadest reasonable
interpretation” or that the “mere change in shape (e.g. angle) of the front
face is considered to be an obvious design choice” (Final Act. 6). The
Examiner finds that Floyd teaches “ultrasound needle guide arrangements
where a front face is angled away from the probe before merging into the
needle guide channel that angles back toward the probe” (Id.).
The Examiner also finds Arenson teaches “a guide body (20) having a
‘front face’ which extends radially away from the probe (See Fig. 3) and that
includes a ‘funnel-shaped depression’ (25) to aid in inserting the needle into
the slot” (Final Act. 6—7).
The Examiner finds it obvious to incorporate the configurations of
Floyd or Arenson into the device of Gorzitze because either “such a
modification merely involves a simple substitution of one known needle
guide arrangement for another” or “to easily and efficiently guide needle tip
into a desired channel” (Final Act. 6, 8).
15 Dietz et al., US 6,840,954 B2, issued Jan. 11, 2005.
4
Appeal 2016-007210
Application 13/335,587
The issue with respect to these rejections is: Does the evidence of
record support the Examiner’s conclusion that Gorzitze, Floyd, and Arenson
render claims 1 and 16 obvious?
Findings of Fact
1. Figure 7 of the Specification is reproduced below:
Figure 7 shows a “needle . . . can then be inserted through the guide channel
and into the patient’s skin while the probe 50 is held in place against the skin
to continue imaging the target” (Spec. 134).
2. Gorzitze teaches “needle guide systems for a sonography
device. The needle guide systems include both fixed and adjustable needle
guides for use with a probe of the sonography device” (Gorzitze 12).
5
Appeal 2016-007210
Application 13/335,587
3. Figure 13 of Gorzitze is reproduced, in part, below:
“In FIG. 13, a semi-circular needle guide 850 is shown, including a top
surface 852 on which a plurality of needle channels 354 are disposed in a fan
pattern, each needle channel defining a different needle insertion angle”
relative to the ultrasound probe body 18 (Gorzitze 143).
4. Figures 9D of Grozitze and the Examiner’s annotated
description of figure 9E are reproduced below:
Figures 9D and 9E depict “a variation of the needle guide 450” (Gorzitze 1
39). Figures 9D and 9E also show “a needle channel 454 defined by lips
6
Appeal 2016-007210
Application 13/335,587
455 and on a bottom surface a connector 456 for attaching the needle guide
450 to the probe 18” (Gorzitze 135).
5. Figure 8B of Floyd is reproduced below:
FIG. 8B
Figure 8B shows needle guide 20 “is a device for holding a needle . . . within
groove 22. . . . guide 20 is rotated toward probe 10 and snaps in position . . .
releaseably locking on edge 21 of device 20” (Floyd 123).
6. Figure 3 of Arenson is reproduced below:
Figure 3 shows “needle guide 10 has a through guide slot 11 which receives
and guides a biopsy needle 12 for exit along the guide slot axis 13 to enable
7
Appeal 2016-007210
Application 13/335,587
puncture of the patient’s skin 14 as at 15 and permit insertion into the patient
along an extension of the guide slot axis 13” (Arenson 2:21—26).
7. The Examiner’s marked up Figure 8 of Arenson is reproduced
below:
Figure 8 shows the “needle guide body may have a funnel-shaped
depression 25 ... to aid in inserting a needle into the guide slot” (Arenson
2:46-47).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellants contend “the alleged front face of Gorzitze with the
alleged concave surface does not face outwardly in a radial direction away
8
Appeal 2016-007210
Application 13/335,587
from the ultrasound probe; rather, the channel is on the surface that faces
radially outwardly” (App. Br. 10). Appellants also contend “the front faces
of the described embodiments in Floyd and Arenson also face in a direction
parallel to the probe surface similar to that of Gorzitze” (Id. at 11).
Appellants contend “that if the front faces were modified to face
radially outwardly away, the needle channel would be directed into the
surface of the probe instead of in front of the probe as intended. It would not
be an obvious design choice given that the Gorzitze needle channel would be
rendered inoperable” (App. Br. 11).
The Examiner responds the radial facing limitation “is extremely
broad given that Appellant has failed to specify a specific radial direction or
value (e.g. angle). Thus, any surface (e.g. face) of a needle guide which
extends away from the ultrasound probe would meet the argued claim
limitation” (Ans. 3). The Examiner finds “Floyd’s faces do not face in a
direction parallel to the probe surface in its broadest reasonable
interpretation” (Id. at 7). The Examiner finds “Arenson’s faces do not face
in a direction parallel to the probe surface in its broadest reasonable
interpretation” (Id. at 8).
We find that Appellants have the better position. In particular, we
agree that the broadest reasonable interpretation of “front faces that face
radially outwardly away from the image producing device” is read in light of
Figure 7 (FF 1) and the Specification’s teaching that “each front face 22 A-
22C is oriented so as to be disposed at substantially a right angle with the
longitudinal length of the respective guide channel 20A-20C” (Spec. 121).
Therefore, we interpret this limitation as requiring an orientation where front
9
Appeal 2016-007210
Application 13/335,587
face is “the face that primarily faces away from the probe in a radial
direction” (Reply Br. 4).
Under this interpretation, we agree with Appellants that the front faces
of Gorzitze, Floyd, and Arenson do not face substantially radially outwardly
from their respective image producing devices as required by claims 1 and
16.
With regard to the Examiner’s design choice argument, there is no
evidence or reasoning establishing that this particular change in orientation
of the needle assembly, which results in insertion of the needle in a different
orientation than that disclosed by Gorzitze, Floyd, or Arenson, would have
been a simple design choice. By contrast, Appellants have provided specific
reasons why they chose this orientation, because the “front faces 22A-22C
of the needle guide body 12 in FIG. 6 are marked with a depth number
indicating the depth at which a needle inserted through the corresponding
guide channel 20A-20C would intercept the plane of the image produced by
the ultrasound probe” (Spec. 131). See In re Chu, 66 F.3d 292, 299
(Fed.Cir.1995) (finding of “obvious design choice” precluded where the
claimed structure and the function it performs are different from the prior
art). Here, while all of the prior art is drawn to needle guide assemblies, the
Examiner has not established a reason for the modification to the orientation
of the needle face.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Gorzitze, Floyd, and Arenson render claims 1 and 16 obvious.
10
Appeal 2016-007210
Application 13/335,587
B.-C. 35 U.S.C. § 103(a)
These rejections rely upon the underlying obviousness rejection over
Gorzitze, Floyd, and Arenson. Having reversed the rejection of claim 1, we
also necessarily reverse these obviousness rejections because the Examiner
does not identify where Welles, Britt, or Cermak suggest “front faces that
face radially outwardly away from the image producing device” as required
by claim 1.
D. 35 U.S.C. § 103(a) over Gorzitze andBonde
The Examiner finds Gorzitze teaches “a linear needle guide 750
including a top surface 752 and a plurality of needle channels 354 that are
each aligned to define differing needle insertion angles” where “different
insertion angles correspond to different subcutaneous depths” and “a
particular needle channel may be selected for use by laterally sliding the
needle guide” (Final Act. 10-11). The Examiner “Bonde teaches parallel
channels” (Ans. 11). The Examiner finds it obvious to modify “the shape of
the surface 752 as described by Gorzitze (Fig. 12) to provide a stepped
platform for each needle guide as described by Bonde in order to alter the
orientation of each needle guide with respect to the imaging region” (Final
Act. 11).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner’s conclusion that Gorzitze and Bonde render
claims 8 and 24 obvious?
Findings of Fact
8. Gorzitze teaches “a plurality of needle channels 354 that are
each aligned to define differing needle insertion angles. A particular needle
11
Appeal 2016-007210
Application 13/335,587
channel can be selected for use by laterally sliding the needle guide 750”
(Gorzitze 143).
9. Figure 8 of Bonde is reproduced below:
FIGURE 8
FIG. 8 further illustrates plate 81 including pointers 811, 812,
813, which extend over a length along an exposed surface of
12
Appeal 2016-007210
Application 13/335,587
plate 81; pointers 811, 812, 813 may be formed as grooves or
protruding surfaces, or any other type of marking on the
exposed surface of plate 81. According to the illustrated
embodiment, each of pointers 811, 812, 813 extend at a fixed
angle ((> with respect to plane 2, and are space apart from one
another in a direction approximately parallel with plane 2; each
of pointers 811, 812, 813 points to a needle entry site El, E2,
E3, respectively, each of which corresponds to a depth of a
target TD1, TD2, TD3, respectively, and depending on which
depth is measured for the target, the corresponding pointer is
selected to guide insertion of a percutaneous needle.
(Bonde 141).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 10—12; FF 2-4, 8, 9) and agree
that claims 8 and 24 are rendered obvious by Gorzitze and Bonde. We
address Appellants’ arguments below.
Appellants contend “the embodiment relied upon in the Office Action,
i.e., FIG. 8 of Bonde, is designed as a ‘fixed needle guide’ that does not slide
laterally across a surface” (App. Br. 14).
We find this argument unpersuasive because Bonde suggests a
“particular needle channel can be selected for use by laterally sliding the
needle guide” (FF 8), expressly teaching the limitation “hat the needle guide
body can be slid laterally across a surface of the ultrasound probe” in claim
8.
13
Appeal 2016-007210
Application 13/335,587
Appellants contend “neither Gorzitze nor Bonde discloses a guide
channel being ‘parallel’ to another guide channel as required” (App. Br. 14).
Appellants also contend the
alleged pointers 811, 812, and 813 in Bonde are not separate
platforms with a guide channel in each platform, and they are
not spaced apart in a lateral direction or direction the guide
would slide across a surface of the probe. Further, the pointers
are part of a guide body that cannot slide at all. Nothing cited
teaches parallel guide channels on multiple different platforms
spaced laterally in a direction the guide body slides.
(Reply Br. 9).
We do not find these arguments persuasive because they fail to
combine the teachings of Gorzitze and Bonde. Gorzitze teaches a “plurality
of needle channels 354 that are each aligned to define differing needle
insertion angles” (FF 8), thereby suggesting a needle guide with multiple
channels. While Gorzitze does not teach the guide channels are parallel,
Bonde teaches parallel pointers for insertion, Bonde teaches “each of
pointers 811, 812, 813 points to a needle entry site El, E2, E3” (FF 9).
Therefore, the ordinary artisan interested in needle channels for each of the
parallel needle entry sites of Bonde would have reasonably utilized the
needle guide assembly of Gorzitze to permit lateral movement of the needle
guide on the ultrasound probe body (FF 8—9). “Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references.” In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986). In determining obviousness, furthermore,
a reference “must be read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole.” Id.
14
Appeal 2016-007210
Application 13/335,587
Appellants contend “modifying Gorzitze to have parallel channels
would render it unsuitable for its intended purpose” (App. Br. 14).
We find this argument unpersuasive because Appellants provide no
reason or evidence why the modification would render Gorzitze unsuitable.
See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s
argument in a brief cannot take the place of evidence.”). See also In re De
Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (Arguments and conclusions
unsupported by factual evidence carry no evidentiary weight.)
Appellants also contend, regarding claim 24, that the “Examiner has
not cited anything in the asserted art that expressly discloses ‘the guide
channel of each platform is slid laterally across the surface of the ultrasound
probe to alternately center the guide channel of each platform with respect to
the ultrasound probe,’ as claimed” (App. Br. 15).
We find this argument unpersuasive because this limitation of claim
24 is drawn to an intended use of the obvious needle guide assembly, and no
specific structural element is required by claim 24. “[Apparatus claims
cover what a device is, not what a device does.'” Hewlett-Packard Co. v.
Bausch &Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). Merely stating
an intended use for an apparatus is not sufficient to distinguish the apparatus
from the prior art. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
1997).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Gorzitze and Bonde render claims 8 and 24 obvious.
15
Appeal 2016-007210
Application 13/335,587
E—G. 35 U.S.C. § 103(a) over Gorzitze, Sandhu, “NSK”, “Slide-N-Lock”
and Cermak, Jaggi, and Dietz
Because these rejections all turn on the same issue, we will consider
them together.
Appellants contend
the cited art does not show or describe “when the protrusion is
received within one of the one or more openings, the protrusion
is not visible to a user of the system viewing the needle guide
body.” The Office Action relies on Sandhu; however, the
alleged protrusion (dowel/pin fastener) in Sandhu is always
visible when Sandhu is in use because the dowel/pin fastener
extends outside of the holes 112 of Sandhu.
(App. Br. 15).
The Examiner responds
the amended limitations are purely directed toward the intended
use of the ultrasound and do not further define any already
claimed structure. Alternatively, it must be noted that the
needle guide extends beyond the width of the probe. Thus, one
standing behind the device would be unable to view the
protrusion when the guide is slid and also could be “viewing the
needle guide ” in its broadest reasonable interpretation.
(Ans. 12). The Examiner also contends “the top surface described by
Gorzitze would appear to block any locking pin or protrusion designed to
enable linear movement along a rail as depicted by ‘NSK NPL’” (Ans. 12).
We find that Appellants have the better position. We agree with
Appellants that the limitation “the protrusion is not visible to a user” is
structural, not intended use, because the needle guide assembly must
structurally permit a protrusion that is not visible to satisfy claim 18.
16
Appeal 2016-007210
Application 13/335,587
We are not persuaded by the Examiner’s argument that based on the
position of the user, the “protrusion is not visible”, because by that
reasoning, the visibility of the protrusion depends upon the user’s position,
not that of the protrusion. That is, the Examiner’s reasoning would allow the
claim to be satisfied for a user behind the device but not satisfied by a user
in front of the device. We interpret the “not visible” requirement as
applying to any user in in any ordinary location relative to the needle guide
assembly, and therefore find the Examiner’s position unpersuasive.
We reverse the rejection of claim 18, and necessarily reverse the
further obviousness rejections including Cermak, Jaggi, and Dietz because
the Examiner does not identify where these references suggest “the
protrusion is not visible to a user.”
SUMMARY
In summary, we reverse the rejection of
• claims 1, 2, 4, 6, 7, and 16 under 35 U.S.C. § 103(a) as obvious over
Gorzitze, Floyd, and Arenson.
• claim 3 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd,
Arenson, Welles, and Britt.
• claim 5 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Floyd,
Arenson, and Cermak.
• claims 18, 21, 22, and 25 under 35 U.S.C. § 103(a) as obvious over
Gorzitze, Sandhu, “NSK” and “Slide-N-Lock”.
• claim 19 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu,
“NSK”, “Slide-N-Lock”, and Cermak.
17
Appeal 2016-007210
Application 13/335,587
• claim 23 under 35 U.S.C. § 103(a) as obvious over Gorzitze, Sandhu,
“NSK”, “Slide-N-Lock”, Jaggi, and Dietz.
We affirm the rejection of claims 8 and 24 under 35 U.S.C. § 103(a)
as obvious over Gorzitze and Bonde.
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
18