Ex Parte Megens et al

Patent Trial and Appeal Board

Aug 9, 2016

13393857 (P.T.A.B. Aug. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/393,857 03/02/2012 Mischa Me gens
24737 7590 08/11/2016
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.
2009P01218WOUS 6173
EXAMINER
TURCHEN, ROCHELLE DEANNA
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
08/11/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MISCHA MEGENS and JAN SUIJVER
Appeal2014-007832 1
Application 13/393,857
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134 involving claims to a
medical ultrasound device with temperature detection at the distal end. The
Examiner rejected the claims on the grounds of provisional obviousness-type
double-patenting, failing to comply with the written description requirement,
anticipation, and obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm the double patenting and written description rejections, reverse
the anticipation rejection and enter new grounds of rejection for
obviousness.
1 This Appeal is related to Appeal No. 2014-006831 (Application No.
13/393,244) that affirmed the rejection of record entered June 23, 2016.
2 Appellants identify the Real Party in Interest as Koninklijke Philips N.V.
(see App. Br. 3).
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Application 13/393,857
Statement of the Case
Background
Appellants' invention "relates to a medical ultrasound device, such as
a probe or catheter-based device. In particular the invention relates to such
devices capable of detecting the temperature at the distal end of the device"
(Spec. 1 :2--4 ).
The Claims
Claims 1-13 are on appeal. Independent claim 1 is representative and
reads as follows (emphasis added):
1. A medical ultrasound device comprising:
an elongated body (3) having a proximal end (90), a
distal end (10), a distal end region (1) and a length axis (9)
along the elongation;
one or more ultrasound transducers ( 4) for generating
acoustic radiation, the one or more ultrasound transducers
being positioned in the distal end region, inside the elongated
body;
a transmission element ( 5) positioned in the radiation
path of the acoustic radiation, wherein the transmission
element is substantially transparent to acoustic radiation; and
a controller unit (91) operatively connected to the
ultrasound transducer to detect the acoustic path length
through the transmission element and to determine a
temperature at the distal end from the detected acoustic path
length.
The Issues
A. The Examiner provisionally rejected claims 1-11 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1-15 of Barley et al., US 13/393,244, filed Feb. 29, 2012
("Barley") (Ans. 2-3).
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B. The Examiner rejected claims 12 and 13 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 3--4).
C. The Examiner rejected claims 1, 2, 4, 11, and 12 under 35 U.S.C.
§ 102(b) as being anticipated by Lang3 (Ans. 4--5).
D. The Examiner rejected claims 3 and 7-9 under 35 U.S.C. § 103(a) as
obvious over Lang and Sliwa4 (Ans. 5-6).
E. The Examiner rejected claims 5, 10, and 13 under 35 U.S.C. § 103(a)
as obvious over Lang and Mast5 (Ans. 6-7).
F. The Examiner rejected claim 6 under 35 U.S.C. § 103(a) as obvious
over Lang and Bames6 (Ans. 7).
A. Provisional obviousness-type double patenting over claims 1-15 of
Barley
The Examiner determines that "[a]lthough the conflicting claims are
not identical, they are not patentably distinct from each other because claims
1-11 of the present application disclose all of the structural limitations of
claim 1-15 of the co-pending application" (Ans. 3).
Appellants contend that
the inventive force detection concept of Barley is derived from
"the acoustic path length between the ultrasound transducer and
the transmission element" and the inventive temperature
detection concept of Megens is derived from ... "the acoustic
path length through the transmission element", which is neither
3 Lang et al., US 2003/0078498 Al, published Apr. 24, 2003.
4 Sliwa et al., US 2010/0168572 Al, published July 1, 2010.
5 Mast et al., US 2004/0127791 Al, published July 1, 2004.
6 Barnes et al., US 2004/0236223 Al, published Nov. 25, 2004.
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Application 13/393,857
identical to nor equivalent to "the acoustic path length between
the ultrasound transducer and the transmission element".
(Reply Br. 12.)
We find that the Examiner has the better position. We agree with the
Examiner that "[i]t was well known in the ultrasound medical field of
endeavor, at the time of the invention to detect contact force and temperature
of ultrasound to provide optimized use of an ultrasound system during a
procedure" (Ans. 9--10). Accordingly, because the claims recite the same
structures differing only in the obvious detection of temperature rather than
contact force, we agree with the Examiner that the claims are not patentably
distinct and affirm the provisional obviousness-type double patenting
rejection.
B. 35 USC§ 112, First Paragraph, New Matter
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that the phrase "wherein the transmission
element and the one or more ultrasound transducers are mounted so that an
acoustic path length through the transmission element varies with the
temperature at the distal end" represents new matter?
Findings of Fact
1. The Specification teaches that:
Due to the ablative process, the temperature of the ablation
electrode and the tissue increases and as a result, the acoustical
path length through the transparent ablation electrode increases
too. By monitoring the positioning of the two peaks, the acoustic
path length can be monitored. From analysis of the monitored
data, it is possible to obtain sub-pixel resolution. The main
physical effect which gives rise to the changes in the acoustical
path length is the change of the speed of sound in dependence
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upon the temperature changes. It can be mentioned that the
material expansion of either the electrode or the transmission
element over the relevant temperature ranges is nearly negligible.
As the temperature rises, the speed of sound decreases, resulting
in an increase[d] acoustical path length, which is seen as an
increase in the distance 43, 44 between the two peaks.
(Spec. 7:22-8:7.)
2. The Specification teaches that
In a situation of use, the temperature at the distal end may
be determined based on a look-up table or a functional
relationship between a parameter related to the acoustic path
length and the temperature at the distal end, e.g. as deduced from
a measurement as presented in FIG. 7. Look-up table, functional
relationships etc. may be stored by and computed in the
controller unit or a computing unit in or connected to the
controller unit.
(Id. at 9: 1-5.)
Principles of Law
[I]t is the specification itself that must demonstrate possession
[of the invention]. And while the description requirement does
not demand any particular form of disclosure ... or that the
specification recite the claimed invention in haec verba, a
description that merely renders the invention obvious does not
satisfy the requirement.
Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir.
2010).
Analysis
The Examiner determines that"[ c ]laims 12 and 13 disclose 'wherein
the transmission element and the one or more ultrasound transducers are
mounted so that an acoustic path length through the transmission element
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varies with the temperature at the distal end.' There is no support for this
limitation i[ n] the written description" (Ans. 4).
Appellants contend that "the subject matter recited by dependent
claims 12 and 13 is supported by the written description of FIGS. 1, and 4--7
of Megens. See, Megens at page 6, line 3 to page 9, line 5" (App. Br. 11;
see also Reply Br. 13). More particularly, Appellants argue that the
Specification teaches
In FIG. 4, it can be seen that the two peaks (maxima indicated by
reference numerals 40, 41) are observed. . . . In the area between
the two peaks, the ultrasound radiation is propagating inside the
transmission element. Due to the ablative process, the
temperature of the ablation electrode and the tissue increases and
as a result, the acoustical path length through the transparent
ablation electrode increases too. . . . The main physical effect
which gives rise to the changes in the acoustical path length is
the change of the speed of sound in dependence upon the
temperature changes. . . . As the temperature rises, the speed of
sound decreases, resulting in an increases acoustical path length,
\'l1hich is seen as an increase in the distance 43, 44 bet\'l/een the
two peaks."
(App. Br. 12-13; see also Reply Br. 14--15).
We find that the Examiner has the better position. As Appellants
point out, the Specification teaches that "f djue to the ablative process, the
temperature of the ablation electrode and the tissue increases and as a result,
the acoustical path length through the transparent ablation electrode
increases too" and that "[ t ]he main physical effect which gives rise to the
changes in the acoustical path length is the change of the speed of sound in
dependence upon the temperature changes" (FF 1 (emphasis added)). The
Specification also teaches that "the material expansion of either the electrode
or the transmission element over the relevant temperature ranges is nearly
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negligible" (FF 1) and that "the temperature at the distal end may be
determined based on a look-up table" (FF 2 (emphasis added)).
Therefore, we agree with the Examiner that
the disclosures that "the main physical effect which gives rise to
the changes in the acoustical path length is the change of the
speed of sound in dependence upon temperature changes," and
"as the temperature rises, the speed of sound decreases, resulting
in an increased acoustical path length, which is seen as an
increase in the distance 43, 44 between the two peaks" are
directed inherent properties of the acoustic path length based on
temperature changes, not that the specific configuration of figs.
1 and 4--7 in which the transmission element and the one or more
ultrasound transducers are mounted so that the acoustic path
length to vary with the temperature at the distal end.
(Ans. 11-12; see also FF 1-2.)
We recognize, but are not persuaded by, Appellants' contention that
"[t ]he implication of the scope of the aforementioned limitation of
dependent claims 12 and 13 is a transmission element and ultrasound
transducer( s) may be mounted so that an acoustic path length through the
transmission element does not vary with a temperature at the distal end"
(Reply Br. 13) because the claims do not recite "does not vary."
C. 35 USC§ 102(b) over Lang
Appellants contend that Lang "fails to describe ... 'a controller unit
operatively connected to the ultrasound transducer to detect the acoustic path
length through the transmission element and to determine a temperature at
the distal end from the detected acoustic path length' as recited in
independent claims 1and11" (App. Br. 14).
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We agree with Appellants. Claim 1 does not recite "capable of'
determining a temperature, instead, claim 1 recites "operatively connected
... to determine a temperature at the distal end from the detected acoustic
path length." Accordingly, we conclude that claim 1 requires a controller
unit that determines a temperature at the distal end from the detected
acoustic path length. The Examiner does not identify a teaching in Lang
where a controller determines a temperature.
We, therefore, reverse the anticipation rejection over Lang.
D.-F. 35 US.C. § 103(a)
Because the Examiner's reasoning relies upon Lang as an anticipation
reference of independent claims 1 and 11, we will reverse the obviousness
rejections. However, because Mast teaches the elements missing from Lang,
we will enter New Grounds of Rejection.
New Grounds of Rejection
We reject claims 1, 2, 4, 5, and 10-13 under 35 U.S.C. § 103(a) as
being obvious over Lang and Mast.
We reject claims 3 and 7-9 under 35 U.S.C. § 103(a) as obvious over
Lang, Mast, and Sliwa.
We reject claim 6 under 35 U.S.C. § 103(a) as obvious over Lang,
Mast, and Barnes.
Findings of Fact
3. Lang teaches "a hand-held ultra-sonic system that includes a
transducer for transmitting and receiving ultra-sonic waves for ... tissue
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measurement, an electronic operating unit to control and process ultrasonic
wave generation and detection, and a display" (Lang i-f 95).
4. Lang's Figure 1 is reproduced below:
I
I ............ '.i\t
..... -)
...
Figure 1 "shows an object plane relative to an ultrasonic probe 2 with an
acoustic coupling gel 3 between the probe 2 and the object plane and having
a connection 1 to signal processing unit" (Lang i-f 18).
5. Lang teaches that the
computational unit is capable of determining the shortest
reflective distance when two or more ultra-sonic sources are
employed at different transmission angles. The computational
unit may also be used for controlling the ultra-sonic generator or
source, for defining or varying the firing rate and pulse repetition
rate (as well as other parameters related to the ultra-sonic
generator or source), for measuring the reflected signal, for
image reconstruction in B-scan mode and for filtering and
thresholding of the ultra-sonic signal.
(Lang i-f 40).
6. Lang teaches an "adjustment sets the threshold of signal
amplitudes that are permitted to enter a data storage, processing or display
system" (Lang i-f 72).
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7. Mast teaches that
[ s ]ince the travel time of an ultrasonic echo depends on both the
path length (which is changed by any thermal expansion) and
sound speed (which depends on temperature), temperature
changes in tissue being treated cause measurable alterations to
echo travel times. By estimation and further processing of these
travel times, temperature rises can be approximately mapped.
This arrangement is highly desirable, since heating effects of
ultrasound treatment may be measured using inexpensive,
portable, and unobtrusive ultrasound apparatus. For
configurations in which therapy and monitoring are performed
using the same ultrasound probe, this approach is particularly
desirable, since a temperature map may be automatically co-
registered with the therapeutic ultrasound beams.
(Mast ii 12).
8. Figure IA of Mast is reproduced below:
Time
Fig. 1A
"FIG. lA generally illustrates a first ultrasound signal 11 returning to an
ultrasound transducer (not shown) before treatment of a region of tissue,
while ultrasound signal 13 represents an ultrasound signal returning to the
ultrasound transducer after treatment of the tissue" (Mast ii 29).
9. Mast teaches that the "relative delay between ultrasound echos
returning to an ultrasound transducer, measured before and after treatment,
is estimated as a function of depth, ... The slope of the depth-dependent
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delay represents echo strain ... The amount of echo strain is proportional to
the temperature rise of the heated region" (Mast i-f 29).
10. Sliwa teaches that "catheter body 12 will define at least one
lumen 22 ... lumen 22 may be employed, for example, to deliver an
irrigating fluid to tip region 20 ... Irrigation may advantageously maintain
the acoustic transducer(s) carried by tip region 20 at an acceptable
temperature in order to avoid thermal damage thereto" (Sliwa i-f 35).
11. Sliwa teaches that "the tip region of catheter 10 generally
includes at least one ablation element, such as a radiofrequency ('RF')
electrode, and at least one acoustic transducer" (Sliwa i-f 39) and further
teaches "the desirability of making RF electrode 702 both electrically
conductive and acoustically transparent, for example by employing a thin
film metal overlaid on an acoustically transparent polymer" (Sliwa i-f 56).
12. Barnes teaches that the "acoustic window 20 is glass, plastic,
polymer, rubber, or other acoustically transparent material" (Barnes i-f 21 ).
13. The Specification teaches that "the transmission element should
be substantially transparent to acoustic radiation. A number of materials,
including various polymer materials, fulfill this. In general any material can
be used, as long as the transparency is sufficient to enable clinical use as
well as to enable detection of the acoustic path length through the element"
(Spec. 3:15-18).
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."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
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patentability." Id. at 417. As noted by the Court in KSR, "[a] person of
ordinary skill is also a person of ordinary creativity, not an automaton." Id.
at 421.
Analysis
Claims 1, 2, 4, 5, and 10-13 over Lang and Mast
Lang teaches an ultrasound device with an elongated body, proximal
and distal ends (FF 4) that includes ultrasound transducers (FF 3), a
transmission element that is the acoustic coupling gel 3 (FF 4), and a
controller unit that measures the reflected signal (FF 5).
Lang does not teach determining acoustic path length or temperature
from that acoustic path length.
Mast teaches measuring temperature changes based on ultrasound,
specifically teaching that "travel time of an ultrasonic echo depends on both
the path length" and that "temperature changes in tissue being treated cause
measurable alterations to echo travel times" (FF 7).
We conclude that the person of ordinary skill reasonably would have
found it obvious to modify the ultrasound device of Lang to measure
temperature based on travel time of ultrasonic signals as taught by Mast
because Mast teaches that "[t]his arrangement is highly desirable, since
heating effects of ultrasound treatment may be measured using inexpensive,
portable, and unobtrusive ultrasound apparatus" (FF 7). Such a combination
is merely a "predictable use of prior art elements according to their
established functions." KSR, 550 U.S. at 417.
With regard to claim 2, Mast teaches separation of reflection peaks in
Figure IA (FF 8), and teaches that this "relative delay between ultrasound
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echos returning to an ultrasound transducer ... is proportional to the
temperature rise of the heated region" (FF 9).
With regard to claim 4, Mast teaches generating acoustic radiation and
detecting the acoustic path (FF 7).
With regard to claim 5, Mast teaches a functional relationship where
the "slope of the depth-dependent delay represents echo strain ... The
amount of echo strain is proportional to the temperature rise of the heated
region" (FF 9), demonstrating an association between path length and
temperature.
With regard to claim 10, Lang teaches the ultrasonic device (FF 3-5)
while Mast teaches generating and detecting acoustic radiation and using the
reflected radiation to analyze the path length and determine a temperature,
and the combination of these teachings as discussed above renders the
method obvious (FF 7-9).
With regard to claim 11, Lang teaches data storage means (FF 6).
With regard to claims 12 and 13, we interpret these claims as
encompassing ultrasound devices with path lengths that vary based on
temperature and Mast teaches ultrasound devices with path lengths that vary
based on temperature (FF 7).
We will address Appellants' arguments regarding the combination of
Lang and Mast.
Appellants contend that "Mast teaches a determination of a
temperature rise of tissue undergoing ultrasound treatment derived from a
pre-ultrasound signal obtained before the treatment and a post-ultrasound
signal obtained sometime after commencement of the treatment. See, Mast
at paragraphs at [0029]-[0057]" (App. Br. 21-22).
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To the extent that Appellants are arguing that Mast does not teach
determination of a temperature other than "undergoing ultrasound treatment
derived from a pre-ultrasound signal obtained before the treatment and a
post-ultrasound signal obtained sometime after commencement of the
treatment," we are not persuaded. The claims do not exclude determining of
a temperature rise of tissue undergoing ultrasound treatment that is derived
from a pre-ultrasound signal obtained before the treatment and a post-
ultrasound signal obtained sometime after commencement of the treatment.
"[L ]imitations are not to be read into the claims from the specification." In
re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self,
671F.2d1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the
outset because ... they are not based on limitations appearing in the
claims.").
Appellants contend that "Mast fails to teach or suggest a modification
of Lang directed to the acoustic path through a transmission element of
probe 2 of Lang as opposed to an entire acoustic path from the ultras-sonic
source within probe 2 (e.g., an ultrasound transducer) to an object 3" (App.
Br. 22).
We are not persuaded. Appellants' contention fails to account for
Lang's contribution to the combination of Lang and Mast (FF 3-5).
"Non-obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references []. [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole." In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
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In regard to claims 5 and 13, we observe that Appellants merely recite
the claim limitations. "A statement which merely points out what a claim
recites will not be considered an argument for separate patentability of the
claim." 3 7 C.F .R. § 41.3 7 ( c )(l)(iv ).
Claims 3 and 7-9 over Lang, Mast, and Sliwa
Lang and Mast render claim 1 obvious for the reasons given above,
but do not teach fluid delivery or polymer-based bodies.
With regard to claim 3, Sliwa teaches that "lumen 22 may be
employed, for example, to deliver an irrigating fluid to tip region 20" (FF
10).
With regard to claims 7-9, Sliwa teaches an acoustically transparent
polymer body for an electrode for ablation treatment with an integrated
electrode (FF 11 ).
We conclude that the person of ordinary skill reasonably would have
found it obvious to modify the ultrasound device rendered obvious by Lang
and Mast with the ablation electrodes and lumen of Sliwa in order to permit
treatment while performing ultrasound, measure temperature and maintain
proper ablation electrode temperature (FF 10-11). KSR, 550 U.S. at 417.
Claim 6 over Lang, Mast, and Barnes
Lang and Mast render claim 1 obvious for the reasons given above,
but do not teach the polymer-based body with a particular change of velocity
as required by claim 6.
The Specification teaches that "[i]n general any material can be used,
as long as the transparency is sufficient to enable clinical use" (FF 13), while
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Barnes teaches that the "acoustic window 20 is glass, plastic, polymer,
rubber, or other acoustically transparent material" (FF 12).
The Specification provides no specific structure required by a
polymer-based body to have "a change of velocity of the acoustic radiation
larger than 0.1 % per degree Celsius", nor does the Specification identify any
specific material that is required to achieve this result.
We, therefore, agree with the Examiner that the acoustic materials of
Barnes, including the polymers, reasonably render claim 6 obvious because
these polymers would have been expected to have sufficient transparency for
clinical use and would necessarily satisfy the velocity based limitation. See
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) ("Where, as here, the claimed
and prior art products are identical or substantially identical ... the PTO can
require an applicant to prove that the prior art products do not necessarily or
inherently possess the characteristics of his claimed product.").
SUMMARY
We affirm the provisional rejection of claims 1-11 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1-15 of Barley.
We affirm the rejection of claims 12 and 13 under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement.
We reverse the rejections under 35 U.S.C. § 102(b) and 35 U.S.C.
§ 103(a).
We reject claims 1, 2, 4, 5, and 10-13 under 35 U.S.C. § 103(a) as
being obvious over Lang and Mast.
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We reject claims 3 and 7-9 under 35 U.S.C. § 103(a) as obvious over
Lang, Mast, and Sliwa.
We reject claim 6 under 35 U.S.C. § 103(a) as obvious over Lang,
Mast, and Barnes.
Regarding the affirmed rejections, 37 C.F.R. § 41.52(a)(l) provides
"Appellant may file a single request for rehearing within two months from
the date of the original decision of the Board."
In addition to affirming the Examiner's rejection(s) of one or more
claims, this decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
Examiner, in which event the proceeding will be remanded to
the Examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record ....
Should Appellants elect to prosecute further before the Examiner
pursuant to 3 7 C.F .R. § 41. 50(b )( 1 ), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
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prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If Appellants elects prosecution before the Examiner and this does not
result in allowance of the application, abandonment or a second appeal, this
case should be returned to the Patent Trial and Appeal Board for final action
on the affirmed rejections, including any timely request for rehearing
thereof.
AFFIRMED;§ 41.50(b)
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