Ex Parte Munrow et al

Patent Trial and Appeal Board

Feb 28, 2018

13589975 (P.T.A.B. Feb. 28, 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.
13/589,975 08/20/2012 Michael Munrow 31992-709.302 1016
21971 7590 03/02/2018
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
IMPINK, BRADLEY GERALD
ART UNIT PAPER NUMBER
3768
NOTIFICATION DATE DELIVERY MODE
03/02/2018 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):
patentdocket @ wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL MUNROW, JORDAN BAJOR, and
MALCOLM G. MUNRO
Appeal 2017-002061
Application 13/589,975
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants submit this appeal under 35 U.S.C. § 134(a) involving
claims to a system for deploying a needle in tissue.1 The Examiner rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify Gynesonics, Inc. as the real party in interest. App. Br.
3.
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STATEMENT OF THE CASE
Appellants’ “invention relates to methods and systems for controlling
the deployment of needles using visual feedback from an ultrasonic or other
image.” Spec. 12.
Appellants’ drawings are helpful in understanding the invention.
Figure 4, which shows an exemplary needle treatment probe for treating
uterine fibroids, is reproduced below.
"A
\.
46
FIG. 4
Id. 122, Fig. 4. Figure 4 depicts the distal portion of probe (14) including,
inter alia, a shaft (20) with an ultrasound imaging array (un-numbered in
Fig. 4) near the shaft’s distal end (23), which array provides a field of view
(46) for display. Id. 129, Fig. 1 (showing probe (14) with imaging array
(26) connected to system controller (12), including an ultrasound display
(18)). Probe (14) also includes a needle guide (44) through which a
treatment needle (24) (e.g., for tissue ablation) is deployed. Id. Tflf 30-31.
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Figure 8B from the Specification is also reproduced below.
FIG. 8B
Id. Fig. 8B. Figure 8B shows an ultrasound display image for viewing by
the physician when using the needle deployment probe to treat a uterine
fibroid (F). Id. 126. The Specification explains that the probe is placed in
the uterus, and the physician scans the myometrium (M) to locate fibroids
(F) and other anatomical features like the treatment-sensitive serosa (S). Id.
132. To aid proper alignment of the needle with the targeted fibroid (F),
projected needle information (e.g., a needle guide overlay (lines 70) showing
the projected needle deployment path) is provided on the ultrasound display
so the probe and needle path can be adjusted accordingly before needle
deployment. Id. 14, 33—34, and Fig. 8C (realigning so projected needle
path (lines 70) more accurately targets the fibroid).
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Application 13/589,975
Claims 24, 26—32, 38, and 40 are on appeal. Claim 24 is illustrative:
24. A system for deploying a needle in tissue, said
system comprising:
a probe having a shaft;
a needle deployable outwardly from the shaft along a fixed
path relative to the shaft;
an imaging transducer on the shaft, wherein the fixed path
of the needle lies within an image field produced by the imaging
transducer; and
a system controller including a screen for displaying the
image produced by the transducer, wherein the system controller
displays an overlay with projected needle treatment information
on the screen, wherein the projected needle treatment
information includes a projected needle path, wherein a user can
manipulate the probe to simultaneously align both the image
field and the projected needle path with a target anatomy visible
on the screen prior to deployment of the needle, wherein the
location of the projected needle path in the image field remains
fixed relative to the image field as the probe is manipulated.
App. Br. 14 (Claims App.) (emphases added).
The claims stand rejected as follows:
I. Claims 24, 26, 27, 31, 32, and 38 under 35 U.S.C. § 103(a) over
Grossman2 and Burbank,3 in view of Steins4 and/or Wang5
(“Rejection I”).
2 Grossman, US 2006/0189972 Al, published Aug. 24, 2006.
3 Burbank et al., US 6,254,601 Bl, issued July 3, 2001.
4 Steins et al., US 6,733,458 Bl, issued May 11, 2004.
5 Wang et al., US 6,695,786 B2, issued Feb. 24, 2004.
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II. Claims 28—32 and 40 under 35 U.S.C. § 103(a) over Grossman
and Burbank, in view of Steins and/or Wang, and in further
view of Rittman6 and Podhajsky7 (“Rejection II”).
III. Claims 30 and 31 under 35 U.S.C. § 103(a) over Grossman and
Burbank, in view of Steins and/or Wang, and in further view of
Rittman, Podhajsky, and Dobak8 (“Rejection III”).
For each rejection, the Examiner relies on the combination of
Grossman and Burbank (along with the other references) as an “alternative”
to Grossman (along with the other references) without Burbank’s teachings.
Ans. 3, 8, and 13. In this appeal, we consider the “alternatives” together.
The Examiner withdrew the rejection of the claims under 35 U.S.C.
§ 112, second paragraph. Final Act. (mailed Aug. 10, 2015) 2—3; Ans. 14.
REJECTION I
Issue
Has the Examiner established by a preponderance of the evidence that
claims 24, 26, 27, 31, 32, and 38 would have been obvious over Grossman,
Burbank, and Steins and/or Wang?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 3—9 of the Final Rejection dated Aug. 10, 2015. See also
Ans. 3—8, 14—19. The following findings are provided for emphasis.
6 Rittman, III et al., US 6,575,969 Bl, issued June 10, 2003.
7 Podhajsky, WO 2006/042117 A2, published Apr. 20, 2006.
8 Dobak, III, US 2001/0035189 Al, published Nov. 1, 2001.
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FF 1. Grossman teaches devices, systems, and methods for imaging
and treating uterine fibroid tumors in real-time. Grossman, Abstract. More
specifically, Grossman teaches:
A sheath, catheter, or probe may be transcervically introduced
into the uterus. A location of the fibroid tumor may be
determined by using a visualization element within or on the
sheath. Preferably, the physician will be able to image the
tumors transendometrially from within the uterine cavity. This
visualization element may comprise an ultrasonic element . . .
that is capable of producing a visual image. Once having
identified the location, a portion of the sheath is steered to
position at least one treatment needle at the determined location.
The needle is anchored within the uterine tissue and the fibroid
is treated with the needle.
Id. 116.
FF 2. Figure 3C of Grossman is reproduced below.
Id. at Fig. 3C. Figure 3C shows an embodiment of a device with telescoping
ablation needles and an on-board ultrasound imaging array. Id. 126. As
depicted, the device includes, inter alia, a steerable catheter (10), an
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ultrasound catheter (12) providing ultrasound visualization (dashed lines 30)
of a fibroid tumor (24), and a lumen (34) through which telescoping needles
(32 and 40) are deployed. Id. 139. Grossman teaches “[rjadiofrequency
ablative energy is delivered in a bipolar fashion between the two telescoping
needles 40, 32” to ablate the fibroid tumor. Id.
FF 3. Grossman teaches an ultrasound recognition and
radiofrequency treatment computer system that includes ultrasound
mapping, ultrasound recognition of treatment area, and radiofrequency
ablation treatment under ultrasound imaging. Id. 1 50, Fig. 13 A—B (showing
system (88) with a computer interface and display of the image field, and
coupled to a probe device (90)).
FF 4. Burbank teaches devices for treating uterine disorders,
including uterine fibroids. Burbank, Abstract. Burbank’s Figure 8 is below.
Id. at Fig. 8. Figure 8 shows a distal end portion of an embodiment of
Burbank’s device. A shown, the device includes, among other features,
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Application 13/589,975
cannula (36), locating device (70) (e.g., ultrasonic imaging device) with an
imaging window (54) generating an image plane (68). The device further
includes a guide port (63) through which tissue penetrating member (52) is
extendable. Id. at 9:20-56; see also id. at 8:14—28 and Figs. 6—7.
FF 5. Steins relates to ultrasound and needle-guidance systems.
Steins, Abstract. As background, Steins teaches:
Medical device guidance systems are used in medical
applications for the purpose of guiding various types of invasive
medical devices, such as aspiration and biopsy needles,
endoscopes, etc., towards specific targets within a patient’s body.
These guidance systems simplify such procedures and make
them safer and quicker to perform.
Id. at 1:7—12. As further background, Steins describes an example of
guiding a biopsy needle based on an ultrasound image, wherein:
From the relative position information [of the needle and
ultrasound imaging plane], the projected or actual needle path is
computed and is superimposed in real time on the displayed
diagnostic image of the patient. This enables the physician to
visualize the projected needle path and plan the biopsy procedure
even before the needle is inserted into the body.
Id. at 1:24—30.
FF 6. Steins teaches “displaying a projected and actual trajectory of
an invasive medical device relative to and within a portion of a subject for
use in a diagnostic medical ultrasound system.” Id. at 2:1—4, Figs. 2A—B
(showing actual (206) and predicted trajectory (208) of needle (132) relative
to target (210) in an image (118)). Steins teaches “the clinician can refer to
graphical cues [lines, dots, dashes etc.] generated by the guidance system to
the ultrasound image 118 to modify the invasive device’s 132 trajectory 208
or reposition the ultrasound probe 104.” Id. at 12:30—33. Steins teaches
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“the clinician is able to more clearly see the relationship between the
predicted trajectory 208 as represented on the image 118 and the
representation 210 of the target 204.” Id. at 12:38-41.
FF 7. Wang relates to an instrument guide “for mounting an invasive
instrument such as a biopsy needle to an imaging probe, controlling its
position, monitoring its position, and/or predictively displaying its position
on a user display of the medical imaging system.” Wang, Abstract.
FF 8. Wang’s Figure 9B is reproduced below.
Id. at Fig. 9B. Figure 9B shows an ultrasound display (904) and a needle
projection image (908) in ultrasound image area (906). Id.', see also id. Fig.
9A and 8:1—25; see also id. at 4:58—61 (“[Ejven if the biopsy needle is
outside the field of view of the imaged plane being displayed, its projection
will appear on the display. This can be of great assistance in guiding the
biopsy needle to the desired target location.”).
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Analysis
Claim 24
We select claim 24, the only independent claim, as representative. 37
C.F.R. §41.37(c)(l)(iv).
The Examiner finds that Grossman teaches the limitations of the
system recited in claim 24, except that “Grossman does not appear to
explicitly disclose displaying projected needle treatment information
including a projected needle path as claimed.” Ans. 4. According to the
Examiner, however, both Steins and Wang disclose “displaying needle
treatment information in the form of a projected needle path.” Id.', see also
id. at 15 (“Steins and Wang are relied upon to teach the fundamental concept
of overlaying projected needle path information on an image.”). The
Examiner reasons it would have been obvious to include a “projected needle
path” in Grossman’s system to “help[] the clinician plan the deployment of
the needle,” to “ensure that the desired target can be reached,” and to
enhance “safety and outcome of the patient.” Id. at 4, 5.
As to the “fixed” relationship between the projected needle path and
image field required in claim 24, and its final two “wherein” clauses, the
Examiner finds that Grossman and Burbank teach a fixed relationship
between the location of the ultrasound imaging module and the end of the
lumen through which the needle passes. Id. at 5—7 (“Burbank discloses a
probe very similar to that of Grossman [and] includes a guide port which
guides a tissue penetrating member along a fixed path in the imaging
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plane.”).9 With this “fixed” structure and relationship, the Examiner reasons
that simultaneous “movement of the probe also results in movement of the
lumen through which the needle will pass,” thus, providing the same relative
change to both the image field and projected needle path, meeting the
limitations of claim 24. Id. at 5—6.10
We agree with and adopt the Examiner’s fact finding, reasoning, and
conclusion of obviousness. Grossman and Burbank disclose known probe
structures, having a distal end with an imaging transducer and outwardly
deployable needle that, once deployed is visible in the image field. FF 1^4.
Grossman discloses that the needle and imaging transducer may be fixed or,
optionally, movable relative to each other. FF 1—3;* 11 see also Ans. 15—16
(“independent movement... is not a requirement of the device, but simply a
possible option.”). Even if Grossman did not teach a fixed relationship
between the probe/transducer and the needle lumen/needle (we are
9 Even if Grossman did not teach such a fixed relationship, the Examiner
concludes it would have been obvious modify Grossman’s device in view of
Burbank to allow a constant view of the needle and avoid the need to align
multiple structures in the viewing plane. Ans. 7.
10 The Examiner alternatively reasons it would have been obvious “that the
projected needle path should be updated such that it maintains a fixed
relationship with the imaging field as the probe is moved.” Ans. 6.
According to the Examiner, given a fixed relationship between the probe and
needle-deploying lumen, updating as proposed provides a more accurate
prediction of where the needle would be deployed in the tissue when the
probe is moved. Id.
11 See also, e.g., Grossman || 17, 21 (“The sheath, visualization element,
and/or treatment needle may be integrally formed or comprise[] separate,
modular components. . . . Further, at least a portion of the sheath,
visualization element, and/or treatment needle may be steerable, rotatable,
deflectable, flexible, pre-shaped, or pre-formed . . . .”).
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persuaded it does), Burbank provides this teaching, and Appellants provide
no persuasive argument or evidence to the contrary. The Examiner also
finds that overlaying a projected needle path on an ultrasound image is a
“fundamental concept,” as evidenced by Steins and Wang, so it would have
been obvious to include this feature in a device/system as taught in
Grossman and Burbank. Ans. 15; Reply Br. 2 (“Applicant does not
necessarily disagree that Steins and Wang include the ‘fundamental concept
of overlying projected needle path information on an image.’”). And we
agree with the Examiner’s finding. The reason to include a projected needle
path in the image is so the clinician knows with reasonable precision, a
priori, where the needle is going to go in the patient once deployed. It would
have been obvious to incorporate such a feature in the Grossman/Burbank
system for, at minimum, planning and safety — and Steins and Wang,
regardless of their specific implementations of this fundamental concept,
support the Examiner on this point. FF 5—8. Modifying the cited art as
proposed by the Examiner, thus, results in a system with all the limitations
of claim 24.
We address below Appellants’ arguments.
Appellants argue the Examiner’s combination of the prior art would
not result in the system of claim 24. App. Br. 6—7. More specifically,
Appellants contend the combination would not result in a system meeting
claim 24’s final two wherein clauses: “wherein a user can manipulate the
probe to simultaneously align both the image field and the projected needle
path . . .” and “wherein the location of the projected needle path in the image
field remains fixed relative to the image field as the probe is manipulated.”
Id. at 7. According to Appellants, this is because Steins and Wang “are
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directed to systems where the needle is not constrained to a fixed path
relative to the imaging probe.” Id.
Appellants’ argument is unpersuasive because it fails to grapple
adequately with the combination/modification of the prior art actually
proposed by the Examiner. As noted above, the Examiner is relying on
Grossman and Burbank as teaching a fixed relationship between the probe
and needle lumen, and for Steins and Wang for the “fundamental concept” in
this art of adding projected needle path information for safety, planning, etc.
FF 5—8; Ans. 4—7, 15. The Examiner provided a persuasive rationale for
why and how this feature would be included in a system as disclosed in
Grossman and Burbank to meet the limitations of claim 24. See, e.g., Ans.
4—7, 15—19.12 Appellants provide no persuasive argument or evidence
otherwise, and instead focus on disclosures in Steins and Wang where at
least some independent movement between the needle and ultrasound probe
is desired. But arguing the teachings of the references individually, as
Appellants do here, does not rebut the Examiner’s rejection relying on what
the references teach or suggest in combination. In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986).
For similar reasons, Appellants’ argument that the Examiner has
improperly relied on inherency are unpersuasive. App. Br. 7—8. The art, as
12 The Examiner explains that the skilled person need only modify the user
interface (e.g., via software) of Grossman’s system and that “[gjiven a
known shape/size of the needle and knowing the location of the end of the
needle lumen would allow one of ordinary skill in the art to easily create an
overlay on an image of the projected needle path without requiring any
additional tracking of the needle or altering the structure of the needle and
probe of Grossman.” Ans. 17—19.
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combined and modified by the Examiner to add the needle path information,
does indeed appear to provide the functionality recited in claim 24’s final
two wherein clauses. But even if it did not, the Examiner provided a
reasoned explanation why it would have been obvious to include that
functionality. See, e.g., Ans. 5—6. Appellants’ attorney argument does not
overcome the Examiner’s findings and explanation on this record.
Appellants also argue the Examiner fails to establish that the skilled
person would have combined the cited art based on “clear differences”
between the references. App. Br. 9. Appellants contend Steins and Wang
use “mobile needles that are not fixed relative to the imaging probe,” and
thus rely on “an entirely different principle of operation from the Grossman
device.” Id.n Indeed, Appellants contend Wang desires “unfettered
freedom of movement of the instrument within the imaged plane,” which
“teach[es] away” from use of needle guides like Grossman that restrict
movement of the needle within the imaged plane. Id. (quoting portions of
Wang at 2:36-47). Appellants contend “the proposed modification cannot
change the principle of operation of the reference being modified.” Id. at 9.
According to Appellants, modifying Grossman as proposed “would
necessitate at least some changes to the structure of the needle and imaging
probe, such as to incorporate [tracking] sensors,” or else the combination
“would result in a non-functional device.” Id. at 10.
13 Appellants contend “Burbank, like Grossman, describes constrained
deployment of a needle form the imaging probe,” and therefore Appellants
arguments related to teaching away and changing the device’s principle of
operation similarly apply to Burbank. App. Br. 10
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We remain unpersuaded. The Examiner is not proposing wholesale
incorporation of the devices exemplified in Steins or Wang into the system
of Grossman. In re Keller, 642 F.2d 413, 425 (CCPA 1981) (holding “[t]he
test for obviousness is not whether the features of a secondary reference may
be bodily incorporated into the structure of the primary reference”). Quite
the opposite, the Examiner is relying on the Steins and Wang as evidence
that it was well known in the art to include projected needle path information
as a desirable feature in devices using an ultrasound image and a treatment
needle for ablating uterine fibroids. Ans. 4—5, 14—15; FF5—8. While true
that Steins and Wang seemingly desire devices where the ultrasound probe
and treatment needle are independently movable, Appellants point us to no
persuasive evidence that criticizes, discredits, or discourages including a
needle path feature in other systems, even if those systems operate on the
principle of “fixing” the ultrasound probe and needle lumen/needle relative
to each other. In re Fulton, 391 F.3d at 1201 (“The prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from . . . alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed.”). The Examiner is neither
proposing to “unfix” the probe and needle lumen in Grossman or Burbank,
nor to “fix” together the needle and probe of Steins or Wang. To the extent
any change in the principle of operation of Grossman’s system is being
proposed, it is only by an improvement — the addition of an art-recognized
feature (projected needle path information) in a predictable way would make
that system better, more accurate, and safer.
As for Appellants’ contention that Grossman’s system would require
at least some structural changes, including additional needle-tracking
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sensors, this contention is unsupported with evidence. So too, Appellants
provide no evidentiary support for the contention that, without such changes,
the result is a “non-functional device.” App. Br. 10. The Examiner, on the
other hand, has provided a persuasive explanation of how the proposed
modification would be done without the structural changes Appellants urge
would have been necessary. Ans. 17—19. And, even assuming Grossman’s
device would need additional sensors, we are not persuaded those changes
would have exceeded the abilities of the skilled artisan seeking to add a
projected needle path feature.
Conclusion of Law
The preponderance of the evidence on this record supports the
Examiner’s conclusion that claim 24 would have been obvious over
Grossman and Burbank, in further view of Steins and/or Wang. Claims 26,
27, 31, 32, and 38 have not been argued separately and fall with claim 24.
REJECTIONS II & III
We adopt the Examiner’s fact finding, reasoning, and conclusion of
obviousness in support of Rejections II and III. Ans. 8—14.
Appellants rely on their arguments related to Rejection I and claim 24,
arguing only that the additional references (Rittman, Podhajsky, and Dobak)
do not make up for the alleged deficiencies of Grossman, Burbank, Steins,
and Wang. App. Br. 11—12. We are not persuaded this combination is
deficient for reasons explained above (Section I). Accordingly, we affirm
Rejections II and III.
SUMMARY
We affirm the rejections for obviousness on appeal.
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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
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