Ex Parte Hynynen

Patent Trials and Appeals Board

May 30, 2019

13170367 - (D) (P.T.A.B. May. 30, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/170,367 06/28/2011
293 7590 06/03/2019
DOWELL & DOWELL, P.C.
2560 HUNTINGTON A VE, SUITE 203
ALEXANDRIA, VA 22303
FIRST NAMED INVENTOR
Kullervo Henrik Hynynen
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.
19115 3670
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
06/03/2019 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):
DOWELL@DOWELLPC.COM
DVejerano@dowellpc.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KULLERVO HENRIK HYNYNEN
Appeal2018-007501
Application 13/170,367
Technology Center 3700
Before STEFAN STAICOVICI, EDWARD A. BROWN, and
BRENT M. DOUGAL, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE-
Kullervo Henrik Hynynen ("Appellant") appeals under 35 U.S.C.
§ 134(a) from the Examiner's decision in the Final Office Action (dated Oct.
5, 2017, hereinafter "Final Act.") rejecting claims 17-19, 21, 29-31, and 33-
37.1 We have jurisdiction over this appeal under 35 U.S.C. § 6(b).
SUMMARY OF DECISION
We AFFIRM.
1 Claims 1-16, 20, 22-28, 32, and 38 are canceled. Appeal Brief (filed Mar.
5, 2018 (hereinafter "Br."), Appendix A, Al-A4.
Appeal2018-007501
Application 13/170,367
INVENTION
Appellant's invention relates to a method "for thermal therapy using
focused ultrasound sources." Spec. para. 1.
Claim 1 7, the sole independent claim, is representative of the claimed
invention and reads as follows:
1 7. A method for providing ultrasonic therapy to a target
volume, comprising:
providing a first driving signal at a first characteristic
operating frequency, to drive a first acoustical source to deliver
a first acoustic field comprising a high-frequency burst of one
or more pulses, wherein the first acoustical source is selected
from the group consisting of a first geometrically focused
ultrasound transducer, a first set of geometrically focused array
elements, and a first set of phased array elements;
providing a second driving signal at a second
characteristic operating frequency to drive a second acoustical
source to deliver a second acoustic field comprising a low-
frequency waveform, wherein said second characteristic
operating frequency is lower than said first characteristic
operating frequency, and wherein the second acoustical source
is selected from the group consisting of a second geometrically
focused ultrasound transducer, a second set of geometrically
focused array elements, and a second set of phased array
elements; and
controlling said first driving signal such that said first
acoustical field generates acoustic pressures to produce
nonlinear distortion of the first acoustical field during
propagation, such that prior to encountering the target volume,
the first acoustical field includes higher frequency components
than said first characteristic operating frequency, thereby
increasing energy deposition at the target volume due to
frequency-dependent attenuation within the target volume;
focusing said first acoustic field within an extended focal
zone along a direction of propagation within the target volume,
such that additional nonlinear waveform distortion occurs
within the target volume; and
2
Appeal2018-007501
Application 13/170,367
controlling said first driving signal such that, within the
target volmne, the high-frequency burst overlaps in time with a
maximum in the low-frequency waveform to increase peak
positive pressures within the target volume and lower peak
negative pressures within the target volume.
REJECTION
The Examiner rejects claims 1 7-19, 21, 29-31, and 3 3-3 7 under
35 U.S.C. § I03(a) as being unpatentable over Fujimoto et al. (US
2007/0161944 Al, pub. July 12, 2007, hereinafter "Fujimoto"), Angelsen et
al. (US 2007/0035204 Al, pub. Feb. 15, 2007, hereinafter "Angelsen"),
Darlington et al. (US 2010/0241005 Al, pub. Sept. 23, 2010, hereinafter
"Darlington"), and Jeong et al. (US 2012/0143100 Al, pub. June 7, 2012,
hereinafter "Jeong").
ANALYSIS
Appellant does not present arguments for the patentability of claim 1 7
apart from claims 18, 19, 21, 29-31, and 33-37. See Br. 11. Therefore, in
accordance with 37 C.F.R. § 4I.37(c)(l)(iv), we select claim 17 as the
representative claim to decide the appeal of the rejection of these claims,
with claims 18, 19, 21, 29-31, and 33-37 standing or falling with claim 17.
The Examiner finds that Fujimoto discloses an ultrasound therapy
method including, inter alia, using a phased array to provide a high-
frequency burst W2 as a first driving signal at a first characteristic frequency,
providing a low-frequency signal W 1 as a second driving signal at a second
characteristic frequency lower than the first characteristic frequency, and
controlling the first and second driving signals such that the high-frequency
burst overlaps with a maximum of the low-frequency signal. Final Act. 2-3
3
Appeal2018-007501
Application 13/170,367
( citing Fujimoto, paras. 4 7, 52, 60, Fig. 3). The Examiner further finds that
"Fujimoto does not disclose a second set of phased array elements;
produc[ing] non-linear distortion prior to encountering the target volume and
creat[ing an] extended focal zone." Id. at 3.
Nonetheless, the Examiner finds that Angel sen discloses using first
and second phase arrays for providing low and high frequency ultrasound
signals. Id. ( citing Angelsen, para. 15). Thus, according to the Examiner, it
would have been obvious to a person of ordinary skill in the art "to modify
Fujimoto to have a second set of phased array elements as taught by
Angelsen." Id. The Examiner reasons that "combin[ing] low-frequency
with high frequency array[s] into one transducer ... provide[s] a better
design to improve the device working range ... by using better spacing."
Id. at 3--4 (citing Angelsen, paras. 4--10, 60).
The Examiner further finds that Darlington discloses producing a non-
linear distortion of an ultrasound waveform prior to it reaching a target
volume, and, thus, creating an extended focal zone. Id. at 4 ( citing
Darlington, paras. 43, 66, Fig. 7). Furthermore, the Examiner finds that
Jeong discloses producing a non-linear distortion of an ultrasound wave to
create an extended focal zone as well, and, in addition, discloses that the
extended focal zone is located along a propagation direction within the target
volume. Id. (citing Jeong, Abstract, paras. 5, 6, 61, 63, 65, Fig. 1). Thus,
the Examiner concludes that:
[i]t would have been obvious to one of ordinary skill in
the art at the time of the invention to [further] modify
Fujimoto[, as modified by Angelsen ], to produce non-linear
distortion prior to encountering the target volume and create
[an] extended focal zone as taught by Darlington and Jeong
because this improve[ s] treatment, allow[ s] for treatment of [a]
4
Appeal2018-007501
Application 13/170,367
bigger, deeper region and more energy [is] deposited at
treatment target.
Id. ( citing Darlington, para. 66, Jeong, para. 66).
Appellant argues that a person of ordinary skill in the art would not
combine the teachings of Fujimoto, Darlington, and Jeong because the
Examiner's modification "would render the method of Fujimoto ...
inoperable." Br. 5. According to Appellant, Fujimoto's method of
"accelerating drug delivery" supplies ultrasound energy to drugs contained
in microbubbles in nearby tissue rather than "delivering ultrasound energy to
the tissue itself." Id. at 6 ( emphasis omitted). Appellant explains that as
"Fujimoto's [drug delivery] method employs the collapse of microbubbles,"
whereas Darlington's thermal processing method leads "to the generation of
microbubbles," the Examiner's "combination would ... render Fujimoto's
treatment method inoperable." Id. at 7. According to Appellant, "the
production of nonlinear distortion in order to achieve increased energy
absorption within the target region," as taught by Darlington and Jeong,
"would destroy the ability [in Fujimoto] to collapse drug-containing
microbubbles." Id.
We are not persuaded that the Examiner's combination would render
the method of Fujimoto inoperable for its intended purpose. As noted supra,
the Examiner reasons that modifying Fujimoto, according to the teachings of
Darlington and Jeong, would have been obvious to a skilled artisan because
such a modification is an "improve[ d] treatment ... [that] allow[ s] for
treatment of bigger, deeper region[ s] ... [with] more energy deposited at
[the] treatment target." Final Act. 4. "[I]f a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
5
Appeal2018-007501
Application 13/170,367
obvious unless its actual application is beyond his or her skill." KSR Int 'l
Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Here, the Examiner's
modification represents an improvement to Fujimoto's method "to enlarge
the treatment zone" and "decrease[] the treatment time" in the same way as
taught by Darlington and Jeong to lead to a predictable result, namely,
delivering drugs to an expanded region and shortening treatment time.
Examiner Answer (dated May 14, 2018, hereinafter "Ans."), 8 (emphasis
omitted). Moreover, as the Examiner correctly determines, because
Darlington discloses a method that avoids the formation of bubbles,
Darlington does not "conflict[] with Fujimoto's teaching of sonoporation."
Id. at 9--10 (citing Darlington, paras. 62, 63).
Although we appreciate Appellant's position that the ultrasound
processes of Darlington and Jeong are not the same as the ultrasound process
of Fujimoto, nonetheless, "[ w ]hen a work is available in one field of
endeavor, design incentives and other market forces can prompt variations of
it, either in the same field or a different one. If a person of ordinary skill can
implement a predictable variation, § 103 likely bars its patentability." KSR,
550 U.S. at 417. The Examiner is correct that the "'extended focal zone' [of
Darlington and Jeong would] perform[] the same functions (increase
treatment area; deposit ultrasound energy to a larger target region) and have
the same result ( decrease treatment time)" when applied to the method of
Fujimoto. Ans. 9.
Furthermore, Appellant's argument that "the production of nonlinear
distortion in order to achieve absorption within the target region," as taught
by Darlington and Jeong, "would destroy the ability [in Fujimoto] to
collapse drug-containing microbubbles ... via sonoporation" (see Br. 7
( emphasis added)) is unsupported attorney argument and cannot take the
6
Appeal2018-007501
Application 13/170,367
place of evidence in the record. See In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997) ("An assertion of what seems to follow from common
experience is just attorney argument and not the kind of factual evidence that
is required to rebut a prima facie case of obviousness.").
We appreciate that an extended treatment area resulting in the process
of Fujimoto, as modified by Darlington and Jeong "may increase the overall
ultrasound energy absorption." Ans. 9. Nonetheless, the Examiner is
correct that this does not mean that the extended treatment area receives a
level of ultrasound energy that would necessarily "destroy the ability to
collapse drug containing microbubbles" in Fujimoto's method, as Appellant
contends. Id. We further agree with the Examiner that a skilled artisan
would recognize that just like spraying a constant stream of water over an
enlarged area, although the overall amount of ultrasound energy absorbed
increases, nonetheless, as the energy is distributed over an extended
( expanded) focal zone the energy density would not necessarily increase to
such a level as to destroy Fujimoto's method of drug delivery. Id.; see also
In re Jacoby, 309 F.2d 513, 516 (CCPA 1962) (An artisan must be presumed
to know something about the art apart from what the references disclose.).
Appellant has not come forth with any persuasive reasoning to show
otherwise.
We are also not persuaded by Appellant's argument that "[n]one of
the cited references, taken alone or in combination, teach the use of such
temporal overlap in the presence of nonlinear-enhanced energy deposition
for the reduction of cavitation." Br. 7 (emphasis added). The Examiner is
correct that Appellant's arguments are directed to features not positively
recited in claim 17, and thus do not apprise us of error in the rejection. Ans.
7
Appeal2018-007501
Application 13/170,367
IO; see also In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (limitations not
appearing in the claims cannot be relied upon for patentability).
Appellant further argues that "none of the cited references disclose or
teach the lowering of peak negative pressures via the temporal overlap of the
high-frequency burst with a maximum in the low-frequency waveform." Br.
8. In response, we note that Appellant's Specification describes "lowering
of peak negative (absolute) pressures" when combining (overlapping) high-
frequency burst 402 with low-frequency waveform 404 to form composite
signal 406. See Spec., paras. 36, 37, Fig. 4. As Fujimoto discloses temporal
overlapping of high-frequency burst W2 with low-frequency waveform W1
(see Fujimoto, Fig. 3), the Examiner is on solid footing to shift the burden to
Appellant (see Ans. 10) to show Fujimoto's temporal overlapping of
waveforms WI, W2 does not "lower peak negative pressures," as called for
by claim 17. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) ("[W]hen
the PTO shows sound basis for believing that the products of the applicant
and the prior art are the same, the applicant has the burden of showing that
they are not.").
Finally, Appellant argues that neither Darlington nor Jeong discloses
that "nonlinear distortion of the first acoustic field occurs both during
propagation to the target region, and during propagation within the target
region." Br. 10 (emphasis omitted). According to Appellant, "Darlington ..
. teaches the formation of a shock ... within the waveform prior to the
waveform reaching the focus" and, in a similar manner, "Jeong
... teaches the generation of nonlinear distortion prior to reaching the
focus." Id. (citing Darlington, Fig. 8B; Jeong, para. 61). Thus, Appellant
contests that both Darlington and Jeong "are completely silent with regard to
the claimed step of generating additional nonlinear waveform distortion
8
Appeal2018-007501
Application 13/170,367
within the target region via the focusing of the first acoustical field within an
elongated focal zone." Id. at 9 ( emphasis added).
We are not persuaded by Appellant's arguments because as the
Examiner correctly finds, "Darlington explicitly discloses transmitting
nonlinear/distortion ultrasound waves prior to the time it reaches the HIFU
focus" and "Jeong explicitly discloses nonlinear/distortion ultrasound
waveform in the target tissue region." Ans. 11 ( citing Darlington, para. 66;
Jeong, para. 61) (emphasis added). We further agree with the Examiner that
Appellant's Specification describes that "additional waveform distortion
within the target region is generated by the extended focal zone." Id. (citing
Spec. para. 29 ("the long focal spot will generate additional distortion")). As
such, because "Fujimoto combined with Darlington and Jeong disclose[s]
transmitting non-linear ultrasound (distortion) with [an] extended/long focal
spot," the Examiner is on solid ground to shift the burden to Appellant to
show that the result is not "additional waveform distortion within the target
region." Id.
In conclusion, for the foregoing reasons, we sustain the rejection
under 35 U.S.C. § 103(a) of independent claim 17 as unpatentable over
Fujimoto, Angelsen, Darlington, and Jeong. Claims 18, 19, 21, 29--31, and
3 3-3 7 fall with claim 1 7.
SUMMARY
The Examiner's decision to reject claims 17-19, 21, 29--31, and 33-
37 under 35 U.S.C. § 103(a) as unpatentable over Fujimoto, Angelsen,
Darlington, and Jeong is affirmed.
9
Appeal2018-007501
Application 13/170,367
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
10