Ex Parte Manzke et al

Patent Trial and Appeal Board

Jul 5, 2018

14123547 (P.T.A.B. Jul. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/123,547 12/03/2013 Robert Manzke
24737 7590 07/09/2018
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2011P00647WOUS 7260
EXAMINER
GUPTA,VANI
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
07 /09/2018 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):
patti. demichele@Philips.com
marianne.fox@philips.com
katelyn.mulroy@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT MANZKE, RAYMOND CHAN,
HAYTHAM ELHAWARY, and ALEKSANDRA POPOVIC
Appeal2017-005330
Application 14/123,547
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
guidance system, workstation, and method for guided injection during
endoscopic surgery. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"Minimally invasive endoscopic CABG (MI-CABG) [coronary artery
bypass grafting] is a promising and growing alternative for many patients
otherwise having to undergo open chest surgery" (Spec. 1 ). "Manual intra-
1 Appellants identify the Real Party in Interest as KONINKLIJKE PHILIPS
N.V. (see App. Br. 4).
Appeal2017-005330
Application 14/123,547
myocardial injection of agents during MI-CABG is challenging due to a lack
of information about the extent and location of scar, ischemia or other region
of pathology as well as other missing data, such as, cardiac wall thickness"
(id.). "The lack of information is due in part to the fact that the only
intraoperative imaging modality available during MI-CABG is endoscopy"
(id.).
The Specification teaches "an injection device, systems and methods
for guiding the device to a correct location in a patient, and systems and
methods for retrieval and visualization of anatomical information in
endoscope images" (Spec. 3).
The Claims
Claims 1-35 are on appeal. Claim 1 is representative and reads as
follows:
1. A guidance system, comprising:
a real-time imaging device configured to intra-
operatively collect image data of a target region to provide a
real-time image;
a target determination module configured to generate an
overlay map registered to the real-time image to project
morphological feature information on corresponding features in
the real-time image of the target region; and
at least one medical instrument for performing a
procedure on the target region such that the at least one medical
instrument is guided to a region suitable for performing an
operative task based upon the overlay map, the at least one
medical instrument being configured to perform the operative
task based on the morphological feature information.
2
Appeal2017-005330
Application 14/123,547
The Rejections2·3
A. The Examiner rejected claims 1, 5-9, 12, 13, 17, 18, 23-26, and 28-
33 under 35 U.S.C. § 103(a) as obvious over Shmulewitz4 and Wang5 (Final
Act. 3-9).
B. The Examiner rejected claims 2 and 14 under 35 U.S.C. § 103(a) as
obvious over Shmulewitz, Wang, and Zeng6 (Final Act. 9).
C. The Examiner rejected claims 3, 4, 15, 16, and 27 under 35 U.S.C.
§ 103(a) as obvious over Shmulewitz, Wang, and O'Donnell7 (Final Act. 9-
10).
D. The Examiner rejected claims 10, 11, 20-22, 34, and 35 under
35 U.S.C. § 103(a) as obvious over Shmulewitz, Wang, and Bartlett8 (Final
Act. 10-12).
2 We note that the Examiner interpreted the claims under 35 U.S.C. § 112,
sixth paragraph, but did not reject the claims under this section. Because
neither party relies upon this section, we will not further address § 112, sixth
paragraph.
3 The Examiner inadvertently omitted claim 19 from any statement of
rejection, but addressed the claim limitation in the body of the rejection in
stating "displaying acceptable injection sites using the overlay map to
control guidance to an operable site" and "providing automatic or robotic
means to perform the aforementioned tasks," rendering the error harmless
(see Final Act. 7). Thus, while claim 19 was not listed in the rejection, we
consider the claimed to have been rejected.
4 Shmulewitz et al., US 5,660,185, issued Aug. 26, 1997.
5 Wang et al., US 2003/0007598 Al, published Jan. 9, 2003.
6 Zeng et al., US 2005/0059894 Al, published Mar. 17, 2005.
7 O'Donnell et al., US 2004/0132006 Al, published July 8, 2004.
8 Bartlett, US 2011/0202012 Al, published Aug. 18, 2011.
3
Appeal2017-005330
Application 14/123,547
A. 35 U.S.C. § 103(a) over Shmulewitz and Wang
The Examiner finds that Shmulewitz teaches a computerized guidance
system with a real-time imaging device and analysis of "a target region of
[a] patient" with a "medical instrument being configured to perform the
operative task based on the image data information" (Final Act. 5-6). The
Examiner acknowledges Shmulewitz "does not teach specifically a target
determination module configured to generate an overlay map registered to
the real-time image to project morphological feature information on
corresponding features in the real-time image of the target region" (Final
Act. 6). The Examiner relies upon Wang to suggest "an overlay map
registered to the real-time image to project morphological feature
information" and to determine "the region suitable for performing an
operative task based upon the overlay map" (id.). The Examiner finds it
obvious to modify Shmulewitz' guidance system with Wang's overlap may
"so that one may have improved means to direct the medical instrument to a
correct region of interest based on the overlaid morphological image data"
(Final Act. 7).
Findings of Fact
1. The Specification teaches, with regard to "real-time imaging"
devices, that the "imaging system 110 may include, but is not limited to
Computed Tomography, Magnetic Resonance Imaging, X-ray, X-ray
angiography, etc." (Spec. 6).
2. The Specification teaches, with regard to a "target
determination module," that a "workstation includes a processor and
memory coupled to the processor," "[a] target determination module is
4
Appeal2017-005330
Application 14/123,547
stored in the memory and configured to generate an overlay map registered
to the real-time image on a display" (Spec. 1-2).
3. The Specification provides no specific structure, algorithm,
software, or other details regarding the "target determination module,"
instead teaching "functions of the various elements shown in the FIGS. can
be provided through the use of dedicated hardware as well as hardware
capable of executing software in association with appropriate software"
(Spec. 4).
4. Shmulewitz teaches an "apparatus and methods by which a
biopsy needle may be initially positioned in real-time for insertion so as to
have a predetermined trajectory to a targeted tissue region" (Shmulewitz
3:39--42).
5. Shmulewitz teaches:
[N]eedle support system 15 provides computer 20 with
corresponding coordinates that enable the clinician to align
cross-hair 45 with region 101 of the suspected lesion ....
Biopsy system 10 further provides for continually
updating the ultrasound image of the entire tissue mass 100, or
of a selected portion thereof, by operating ultrasonic scanner 13
to continually generate images of the tissue interior. Thus, for
example, when the clinician has aligned the biopsy needle with
region 101, he or she may lock needle support system 15
against further movement in the Y-Z plane, and issue
appropriate commands to the ultrasonic scanner to scan only
that portion of tissue 100 in the vicinity of the biopsy needle
trajectory, for example, within dotted lines ....
(Shmulewitz 9 :26-49).
6. Shmulewitz teaches this system "provides real-time monitoring
of the actual needle trajectory" (Shmulewitz 10:40--41 ).
5
Appeal2017-005330
Application 14/123,547
7. Shnmlewitz teaches:
Computer 20 may be a general purpose personal computer,
having for example, an 80386 or greater microprocessor, or
similar processor, and a hard disk drive, or similar memory
device sufficient for storing software programs, to manipulate
imaging data generated by ultrasonic scanner 13 and
positioning data generated by needle support system 15.
(Shmulewitz 5:49-54).
8. Wang teaches a "computer-assisted microcalcification-
highlighting algorithm is performed whose output is optionally displayed by
the user in an overlay fashion on the thick-slice images and/or individual
ultrasound slices" (Wang i-f 175).
9. Wang teaches a "single thick slice view 2528 with a
superimposed CAD marker 2542 . . . . In one preferred embodiment, a star
or cross-hair symbol is used to denote a suspicious mass, while triangles are
drawn around suspected microcalcifications" (Wang i-f 170).
10. Wang teaches: "Results from the two-dimensional CAD
algorithms are superimposed on the thick-slice image display in a manner
that highlights the location of possible tumors and their degree of
suspiciousness" (Wang i-f 39).
11. Wang teaches:
[O]ne skilled in the art would readily be able to apply the thick-
slice display apparatus of the preferred embodiments in the
context of computerized tomography (CT) and/or magnetic
resonance imaging (MRI) environments. In each case,
individual image slices generated from CT scans or MRI scans
of the breast are compounded so as to form thick-slice images
of slab-like portions of the breast along planes parallel to a
standardized x-ray mammogram view plane, and the thick-slice
images are displayed to the radiologist in close proximity to an
6
Appeal2017-005330
Application 14/123,547
x-ray mammogram of the breast to assist in interpreting that x-
ray mammogram.
(Wang iT 193).
12. Wang teaches:
A surgeon can instantiate an automatic biopsy extraction
procedure by graphically selecting the precise three-
dimensional location (x, y, z) of a target lesion on the real-time
adjunct ultrasound display as the breast is held steady by the
compression device. A biopsy needle is automatically
manipulated by a motorized mechanism that translates the
biopsy needle in two dimensions to the desired (x, y) location,
and then guides the physician in inserting the needle or
automatically inserts the needle in the "z" direction to enter the
tumor ....
(Wang iT 193).
13. Wang teaches: "By way of further example, real-time
implementations of the preferred embodiments may be readily extended to
operate with an ultrasound-guided, computer-controlled biopsy apparatus"
(Wang iT 193).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! 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 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3-9; FF 1-13). Arguments not
7
Appeal2017-005330
Application 14/123,547
presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
We have identified claim 1 as representative; therefore, all claims fall with
claim 1. We address Appellants' arguments below.
Appellants contend "Wang fails to specifically teach or suggest at
least a system that is configured to generate an overlay map that is overlaid
on real-time images of the target region" (App. Br. 11 ). In particular,
Appellants contend Wang's "images are clearly processed images which
combine numerous different ultrasound data and they are not real-time
images. Wang is completely silent with respect to superimposing an overlay
image on a real-time image" (App. Br. 12; cf Reply Br. 9 ("displayed on an
adjunctive ultrasound display for a radiologist to analyze after a procedure is
performed")). Appellants further contend:
Wang also does not teach a system which includes a medical
instrument that is "guided to a region suitable for performing an
operative task based upon the overlay map" or that is
"configured to perform the operative task based on the
morphological feature information" as recited in the guidance
system of independent claim 1.
(App. Br. 12; cf Reply Br. 10). Appellants similarly contend the "guidance
of the instrument to the region suitable for performing an operative task in
this embodiment taught by Wang is clearly provided automatically by the
motorized mechanism and is not provided by the provision of an overlay on
a real-time image of the target region" (App. Br. 14).
We find these arguments unpersuasive because both Shmulewitz and
Wang teach real-time imaging used for positioning biopsy needles (FF 4, 5,
12). Wang specifically teaches that a "computer-assisted microcalcification-
highlighting algorithm is performed whose output is optionally displayed by
the user in an overlay fashion" (FF 8). Wang further teaches that "real-time
8
Appeal2017-005330
Application 14/123,547
implementations of the preferred embodiments may be readily extended to
operate with an ultrasound-guided, computer-controlled biopsy apparatus"
(FF 13).
Thus, the evidence supports the Examiner's determination that Wang
would have suggested to one of ordinary skill in the art real-time overlay of
the computer identified targets (microcalcifications) in order to perform real-
time surgery with the biopsy apparatus (see Ans. 14--15) as recited in claim
1. Indeed, when Wang suggests superimposed images to highlight the
location and suspiciousness of tumors (FF 10), and further teaches using
real-time display to biopsy such tumors (FF 12), we agree with the Examiner
that the ordinary artisan would have reasonably found it obvious to use the
location identified by the superimposed ( overlayed) images to direct the
biopsy needle to the highlighted location (FF 10, 12; cf Ans. 7 ("improved
means to direct the medical instrument to a correct region of interest based
on the overlaid morphological image data")).
Appellants contend "the main embodiment of Wang solely discloses a
system that is configured to use previously-acquired adjunct ultrasound
imaging to enhance diagnosis of the previously acquired x-ray
mammogram" (App. Br. 13). Appellants acknowledge "Wang discloses an
alternative embodiment wherein real-time implementations may be extended
to operate with an ultrasound-guided, computer-controlled biopsy
apparatus," but contend "Wang solely teaches that a surgeon may utilize the
adjunct ultrasound display by 'graphically selecting the precise three-
dimensional location of a target lesion on the real-time adjunct ultrasound
display as the breast is held steady by the compression device"' (App. Br.
13).
9
Appeal2017-005330
Application 14/123,547
We find this argument unpersuasive because Appellants' arguments
substantially focus on Wang not anticipating the claims. However, the
Examiner's rejection is for obviousness, and the obviousness "analysis need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ." KSR, 550 U.S.
at 418. Here, the reasoning that an ordinary artisan would use the location
already identified by overlay in Wang of a microcalcification (FF 8) or
suspicious mass (FF 9) to guide the biopsy needle as suggested by Wang (FF
12) represents a predictable variation and "[i]f a person of ordinary skill can
implement a predictable variation, § 103 likely bars its patentability." KSR,
550 U.S. at 417. That is, the ordinary artisan would have found it obvious to
guide the biopsy needle to a target in real-time as directed by overlays
registered to real-time morphological feature data where "a star or cross-hair
symbol is used to denote a suspicious mass, while triangles are drawn
around suspected microcalcifications" (FF 9) in order to accurately place the
biopsy needle using real-time imagining.
Claims 13, 17, 18, 23, 25
Appellants separately list these claims, but rely upon the same
arguments that we found unpersuasive above (see App. Br. 15-16). We
therefore find these claims obvious for the reasons given above and by the
Examiner.
Claims 26 and 28-33
Appellants separately list these claims, but rely upon the same
arguments that we found unpersuasive above (see App. Br. 16-17). We
10
Appeal2017-005330
Application 14/123,547
therefore find these claims obvious for the reasons given above and by the
Examiner.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that the
prior art renders the claims obvious.
B.-D. 35 U.S.C. § 103(a)
Appellants separately argue these obviousness rejections, but rely
upon the same arguments regarding Shmulewitz and Wang to overcome the
further combinations with Zeng, O'Donnell, and Bartlett. The Examiner
provides sound fact-based reasoning for combining each of Zeng,
O'Donnell, and Bartlett with Shmulewitz and Wang (see Final Act. 9-12).
Having affirmed the obviousness rejection of claim 1 over Shmulewitz and
Wang for the reasons given above, we also find that the further combinations
render the rejected claims obvious for the reasons given by the Examiner.
We find the arguments unpersuasive for the reasons give above.
SUMMARY
In summary, we affirm the obviousness rejections.
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
11