Ex Parte Partanen et al

Patent Trial and Appeal Board

Oct 16, 2017

13879412 (P.T.A.B. Oct. 16, 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.
13/879,412 04/15/2013 Ari Ilkka Mikael Partanen PMIP.USPAT.1000 9086
93255 7590 10/16/2017
Intrinsic Law Corp.
760 Main Street
Third Floor
Waltham, MA 02451
EXAMINER
SMITH, RUTH S
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
10/16/2017 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ARI IIKKA MIKAEL PARTANEN,
MATTHEW ROBERT DREHER,
PAVEL SERGEYEVICH YARMOLENKO,
ANTTI JOHANNES VIITALA,
JULIA KRISTINA ENHOLM, and MAX OSKAR KOHLER
____________

Appeal 2016-006030
Application 13/879,4121
Technology Center 3700
____________

Before DONALD E. ADAMS, TIMOTHY G. MAJORS, and
DAVID COTTA, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1–3, 5–13, and
15 (Final Act.2 1). Examiner entered rejections under 35 U.S.C. § 112,
second paragraph, 35 U.S.C. § 112 fourth paragraph, and the written
description and enablement provisions of 35 U.S.C. § 112. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellants identify the real party in interest as “Koninklijke Philips, N.V.”
(App. Br. 4.)
2 Examiner’s August 19, 2015 Final Office Action.
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STATEMENT OF THE CASE
Appellants’ disclosure “relates to magnetic resonance guided high
intensity focused ultrasound therapy, in particular to the controlled heating
of a target zone in a subject” (Spec. 1). Claims 1, 5, 12, and 13 are
representative and reproduced below:
1. A therapeutic apparatus comprising:
a high intensity focused ultrasound system for heating a
target zone of a subject;
a magnetic resonance imaging system for acquiring
magnetic resonance data;
a processor for controlling the therapeutic apparatus;
a memory containing machine executable instructions for
execution by the processor, wherein execution of the
instructions cause the processor to generate heating commands
which cause the high intensity focused ultrasound system to
sonicate the subject in accordance with heating trajectories;
wherein execution of the instructions further cause the
processor to repeatedly:
acquire the magnetic resonance data during execution of
the heating commands;
calculate a spatially dependent parameter from the
magnetic resonance data; and
modify the heating commands in accordance with the
spatially dependent parameter such that within the target zone
the spatially dependent parameter remains below a first
predetermined threshold and above a second predetermined
threshold; and
wherein execution of the instructions further cause the
processor to generate waiting commands which cause the high
intensity focused ultrasound system to halt sonication for a
predetermined period of time after executing the heating
commands; wherein execution of the instructions further cause
the processor to generate maintaining commands which cause
the high intensity focused ultrasound system to sonicate the
subject in accordance with maintaining trajectories, wherein
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execution of the instructions further cause the processor to
repeatedly:
acquire the magnetic resonance data during execution of
the maintaining commands;
calculate the spatially dependent parameter from the
magnetic resonance data acquired during execution of the
maintaining commands; and
modify the maintaining commands in accordance with
the spatially dependent parameter such that within the target
zone the spatially dependent parameter remains below the first
predetermined threshold and above the second predetermined
threshold;
wherein execution of the instructions cause the processor
to allow the spatially dependent parameter to exceed the first
predetermined threshold in the target zone if the sonication
duration is less than a predetermined minimum sonication
duration.
(App. Br. 26–27 (emphasis added).)
5. The therapeutic apparatus of claim 1, wherein the spatially
dependent parameter is any one of the following: proton signal
intensity, maximum proton signal intensity, minimum proton
signal intensity, mean proton signal intensity, median proton
signal intensity, Tl signal intensity, maximum Tl signal
intensity, minimum Tl signal intensity, mean Tl signal intensity,
median Tl signal intensity, T2 signal intensity, maximum T2
signal intensity, minimum T2 signal intensity, mean T2 signal
intensity, median T2 signal intensity, T2* signal intensity,
minimum T2* signal intensity, maximum T2* signal intensity,
mean T2* signal intensity, mean T2* signal intensity,
temperature, minimum temperature, mean temperature, median
temperature, minimum ultrasonic dose, maximum ultrasonic
dose, median ultrasonic dose, maximum temperature deviation,
minimum signal intensity, maximum signal intensity, mean
signal intensity, median signal intensity, minimum thermal
dose, mean thermal dose, median thermal dose, and maximum
thermal dose, and combinations thereof.
(App. Br. 28 (emphasis added).)
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12. A non-transitory computer program product comprising
machine executable instructions for execution by a processor
controlling a therapeutic apparatus, wherein the therapeutic
apparatus comprises a high intensity focused ultrasound system
for heating a target zone of a subject, wherein the therapeutic
apparatus further comprises a magnetic resonance imaging
system for acquiring magnetic resonance data, wherein
execution of the instructions causes the processor to generate
heating commands which cause the high intensity focused
ultrasound system to sonicate the subject in accordance with
heating trajectories, wherein execution of the instructions
further cause the processor to repeatedly:
acquire the magnetic resonance data during execution of
the heating commands;
calculate a spatially dependent parameter from the
magnetic resonance data; and
modify the heating commands in accordance with the
spatially dependent parameter such that within the target zone
the spatially dependent parameter remains below a first
predetermined threshold and above a second predetermined
threshold, and
allow the spatially dependent parameter to exceed the
first predetermined threshold in the target zone if the sonication
duration is less than a predetermined minimum sonication
duration.
(App. Br. 30–31.)
13. A method of operating a therapeutic apparatus, wherein the
therapeutic
apparatus comprises a high intensity focused ultrasound system
for heating a target zone of a subject, wherein the therapeutic
apparatus further comprises a magnetic resonance imaging
system for acquiring magnetic resonance data, wherein the
method comprises the steps of generating heating commands
which cause the high intensity focused ultrasound system to
sonicate the subject in accordance with heating trajectories,
wherein the method comprises the steps of repeatedly:
acquiring the magnetic resonance data during execution
of the heating commands;
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calculating a spatially dependent parameter from the
magnetic resonance data; and
modifying the heating commands in accordance with the
spatially dependent parameter such that within the target zone
the spatially dependent parameter remains below a first
predetermined threshold and above a second predetermined
threshold and
generating waiting commands which cause the high
intensity focused ultrasound system to halt sonication for a
predetermined period of time after executing the heating
commands; further to generate maintaining commands which
cause the high intensity focused ultrasound system to sonicate
the subject in accordance with maintaining trajectories, and to
repeatedly:
acquiring the magnetic resonance data during execution
of the maintaining commands;
calculating the spatially dependent parameter from the
magnetic resonance data acquired during execution of the
maintaining commands; and modifying the maintaining
commands in accordance with the spatially dependent
parameter such that within the target zone the spatially
dependent parameter remains below the first predetermined
threshold and above the second predetermined threshold,
allowing the spatially dependent parameter to exceed the
first predetermined threshold in the target zone if the sonication
duration is less than a predetermined minimum sonication
duration.
(App. Br. 31–32.)

The claims stand rejected as follows:
Claims 1–3, 5–13, and 15 stand rejected under 35 U.S.C. § 112,
second paragraph.
Claim 6 stands rejected under 35 U.S.C. § 112, fourth paragraph.
Claims 1–3, 5–13, and 15 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
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Claims 1–3, 5–13, and 15 stand rejected under the enablement
provision of 35 U.S.C. § 112, first paragraph.

Definiteness:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellants’ claims are indefinite?
ANALYSIS
Claim 1:
Appellants’ claim 1 is reproduced above.
I
Appellants’ claim 1 requires, inter alia, the modification of “heating
commands in accordance with [a] spatially dependent parameter such that
within the target zone the spatially dependent parameter remains below a
first predetermined threshold and above a second predetermined threshold
. . .” (see App. Br. 26). Examiner finds that the foregoing limitation
“appear[s] to be inconsistent with,” the limitation in “[t]he last three lines [of
Appellants’] claim 1,” which requires the “execution of [machine
executable] instructions cause the processor to allow the spatially dependent
parameter to exceed the first predetermined threshold in the target zone if
the sonication duration is less than a predetermined minimum sonication
duration” (Ans. 3; see App. Br. 27 (emphasis added)). In this regard,
Examiner finds that Appellants’ claim fails to require “that the heating
commands are modified such that within the target area the spatially
dependent parameter remains below a first predetermined threshold and
above a second predetermined threshold except when a [sonication] duration
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is less than a predetermined minimum [sonication] duration as argued” by
Appellants (Ans. 7; see App. Br. 18). We are not persuaded.
Notwithstanding Examiner’s assertion to the contrary, Appellants’
claim 1 requires that the “execution of [machine executable] instructions
cause the processor to allow the spatially dependent parameter to exceed the
first predetermined threshold in the target zone if [(i.e. except when)] the
sonication duration is less than a predetermined minimum sonication
duration” (see App. Br. 27 (emphasis added)).
As Appellants explain, “[t]he conditional execution [required by
Appellants’ claim] does not create an inconsistency” (App. Br. 18; Reply Br.
12).
II
Appellants’ claim 1 uses the term “spatially dependent parameter”
(see App. Br. 26). Appellants’ claim 5 limits the scope of the genus defined
by the term “spatially dependent parameter” to include, inter alia,
“temperature” (see id. at 28). In addition, Appellants’ Specification defines
the term “spatially dependent parameter” as “a physical property of the
subject since it may be a local temperature or some other local parameter
which is affected by the heating of the various sonication points within the
target zone” and specifically identifies various spatially dependent
parameters (Spec. 7:10–13; see also id. at 10:5–12:14). Appellants also
disclose that “[t]he spatially dependent parameter may be a single numerical
value or it may also be a mapping, . . . such as a temperature map” (Spec.
9:17–23).
Examiner finds that “if the spatially dependent parameter[, set forth in
Appellants’ claim 1,] is not temperature, it is unclear as to what would be
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defined as a first and second predetermined threshold” (Ans. 3). In this
regard, Examiner finds that Appellants’
only disclosed examples for the first and second predetermined
threshold are ones applicable for a spatially dependent
parameter being temperature. Therefore, while the claims do
not preclude the parameter being temperature, it is unclear as to
what the limits would be for the predetermined threshold to be
used if the parameter is other than temperature. [] Appellant[s]
[] provided no guidance for determination of other thresholds
that can be defined when different parameters are used.
(Id. at 7.) We are not persuaded.
Initially, we note that Appellants’ Specification is not limited to its
exemplified embodiments, i.e. temperature (cf. Ans. 7). See generally In re
Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982) (working examples are not
required to satisfy section 112, first paragraph). Therefore, we are not
persuaded by Examiner’s assertion that Appellants’ “only disclosed
examples for the first and second predetermined threshold are ones
applicable for a spatially dependent parameter being temperature” (Ans. 7).
Further, as Appellants explain,
the subject matter of claim 1 determines whether the value of a
spatially dependent parameter is between the values of first and
second thresholds. [Examiner] seemingly asserts that
temperature is the only parameter whose value may be
compared to two other values. [Examiner, however,] does not
explain its basis for this assertion, and none would be
discernible to a skilled artisan.
(App. Br. 18–19; Reply Br. 14.) On this record, we agree with Appellants.
Examiner failed to precisely explain why Appellants’ claim is indefinite (see
e.g., App. Br. 19). More specifically, Examiner failed to explain why a
person of ordinary skill in this art, reading Appellants’ claimed invention in
light of Appellants’ Specification, would have difficulty determining first or
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second predetermined thresholds for any spatially dependent parameter
within the scope of Appellants’ claimed invention or comparing a spatially
dependent parameter to first or second predetermined thresholds (cf. Ans. 7).
See, Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1217
(Fed. Cir. 1991) (The legal standard for indefiniteness under 35 U.S.C § 112,
second paragraph, is whether a claim reasonable apprises those of skill in the
art of its scope). See also In re Mattison, 509 F.2d 563, 565 (CCPA 1975)
(Claims are not indefinite simply because they do not describe the invention
using numerical values).

Claim 7:
Appellants’ claim 7 depends from and further limits “the instructions”
of Appellants’ claim 1 to “further cause the processor to: receive medical
image data; receive a treatment plan, wherein the treatment plan is
descriptive of the location of the target zone; and generate the heating
trajectories in accordance with the medical image data and the treatment
plan” (App. Br. 29).
Examiner finds that “one skilled in the art would recognize that the
magnetic resonance data acquired by the magnetic resonance imaging
system of claim 1 is imaging data” and that “the data acquired in claim 1
and received in claim 7 [is] the same data” (Ans. 7–8). Therefore, Examiner
finds that “it is unclear as to how the medical image data differs from the
magnetic resonance data set forth in claim 1” (Ans. 3). In this regard,
Examiner finds that “[i]f the data is not the same, such a limitation appears
to conflict with the disclosed invention” (id.; see id. at 8 (“If the data is not
the same (meaning both are not magnetic resonance image data), it is unclear
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as to where the medical image data is received from and how it differs from
the magnetic resonance data acquired by the imaging system”)). We are not
persuaded. Instead, we agree with Appellants assertion that
those of ordinary skill in th[is] art [would recognize that],
magnetic resonance data is not data of an image; instead, it is
data of magnetic resonance, as is implied by the nomenclature
“magnetic resonance data.” Image data is data of an image, as is
similarly implied by the nomenclature “image data.”
(App. Br. 19; Reply Br. 15.)

Claim 8:
Appellants’ claim 8 depends from and further limits the phase
“execution of the instructions,” as it appears in Appellants’ claim 7 to
“further cause[] the processor to: receive magnetic resonance data from the
magnetic resonance imaging system; and reconstruct the medical image data
from the magnetic resonance data” (App. Br. 29).
Examiner finds that “[i]n claim 8, it is unclear as to how one
reconstructs medical image data from magnetic resonance data” (Ans. 3). In
this regard, Examiner asserts that “one skilled in the art would recognize that
the magnetic resonance data is used to reconstruct a medical image and not
medical image data” (id. at 8). We are not persuaded.
As Appellants explain, “those of ordinary skill in th[is] art, [would
recognize that] magnetic resonance data is transformed into imagery data
through a mathematical algorithm (App. Br. 20; see Reply Br. 16–17).

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Claim 10:
Appellants’ claim 10 makes use of the acronym “LINAC” (App. Br.
30). Examiner finds that “the acronym ‘LINAC’ should be defined” in
Appellants’ claim 10 (Ans. 3; see also id. at 8). We are not persuaded.
Examiner recognizes that a person of ordinary skill in this art would
recognize that, on this record, the term “LINAC” refers to a linear
accelerator (Ans. 8; see also Spec. 14:14–15 (“the radiation therapy system
is linac or a linear accelerator”)). See Standard Oil Co. v. Am. Cyanamid
Co., 114 F.2d 448, 452 (Fed. Cir. 1985) (“[T]he specification aids in
ascertaining the scope and meaning of the claims inasmuch as the words of
the claims must be based upon the description. The specification is, thus,
the primary basis for construing the claims”). On this record, Examiner
failed to establish an evidentiary basis to support a finding that a person of
ordinary skill in this art would not understand that the acronym LINAC
refers to a linear accelerator.

Claim 12:
Appellants’ claim 12 is reproduced above.
I
Appellants’ claim 12 requires, inter alia, the modification of “heating
commands in accordance with [a] spatially dependent parameter such that
within the target zone the spatially dependent parameter remains below a
first predetermined threshold and above a second predetermined threshold
. . .” (see App. Br. 31). Examiner finds that the foregoing limitation
“appear[s] to be inconsistent with,” the limitation in “[t]he last three lines [of
Appellants’] claim 12,” which “allow[s] the spatially dependent parameter to
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exceed the first predetermined threshold in the target zone if the sonication
duration is less than a predetermined minimum sonication duration” (Ans. 3;
see also id. at 7; see App. Br. 31).
We are not persuaded for the reasons set forth above, with respect to
rejection I of claim 1.
II
Examiner finds that Appellants’ “[c]laim 12 is incomplete for
omitting essential steps, such omission amounting to a gap between the
steps” (Ans. 3). In this regard, Examiner finds:
The omitted steps are: causing the processor to generate waiting
commands which cause the high intensity focused ultrasound
system to halt sonication for a predetermined period of time
after executing the heating commands; causing the processor to
generate maintaining commands which cause the high intensity
focused ultrasound system to sonicate the subject in accordance
with maintaining trajectories, causing the processor to
repeatedly acquire the magnetic resonance data during
execution of the maintaining commands; calculating the
spatially dependent parameter from the magnetic resonance
data acquired during execution of the maintaining commands;
and modifying the maintaining commands in accordance with
the spatially dependent parameter such that within the target
zone the spatially dependent parameter remains below the first
predetermined threshold and above the second predetermined
threshold.
(Id. at 3–4; see id. at 8 (“such limitations are considered to be essential steps
in the disclosed invention” and Appellants “failed to provide any evidence to
the contrary”).) We are not persuaded.
As Appellants explain, Examiner “provides no evidence to support
[Examiner’s] assertion that [] claim 12 omits essential steps” (Reply Br. 18;
see App. Br. 21). We agree. It is Examiner who “bears the initial burden,
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on review of the prior art or on any other ground, of presenting a prima facie
case of unpatentability.” In re Oetiker, 977 F.2d 1442, 1445 (Fed. Cir.
1992). On this record, Examiner failed to carry the initial burden of
presenting a prima facie case of unpatentability (see Reply Br. 18).
III
Examiner finds that “if the spatially dependent parameter[, set forth in
Appellants’ claim 12,] is not temperature, it is unclear as to what would be
defined as a first and second predetermined threshold” (Ans. 4; see id. at 7).
We are not persuaded for the reasons set forth above, with respect to
rejection II of claim 1.

Claim 13:
Appellants’ claim 13 is reproduced above.
I
Appellants claim 13 requires, inter alia, the modification of “heating
commands in accordance with [a] spatially dependent parameter such that
within the target zone the spatially dependent parameter remains below a
first predetermined threshold and above a second predetermined threshold
. . .” (see App. Br. 31). Examiner finds that the foregoing limitation
“appear[s] to be inconsistent with,” the limitation in “[t]he last three lines [of
Appellants’] claim 13,” which “allow[s] the spatially dependent parameter to
exceed the first predetermined threshold in the target zone if the sonication
duration is less than a predetermined minimum sonication duration” (Ans. 3;
see also id. at 7; see App. Br. 31).
We are not persuaded for the reasons set forth above, with respect to
rejection I of claim 1.
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II
Examiner finds that “if the spatially dependent parameter[, set forth in
Appellants’ claim 13,] is not temperature, it is unclear as to what would be
defined as a first and second predetermined threshold” (Ans. 4; see id. at 7).
We are not persuaded for the reasons set forth above, with respect to
rejection II of claim 1.

Claim 15:
Appellants’ claim 15 depends from and further limits the therapeutic
apparatus of Appellants’ claim 1 to:
Further compris[e] a thermometry module to measure
temperature in a measurement field and in particular to compute
a thermal dose, wherein execution of the instructions cause the
processor to generate heating commands which cause the high
intensity focused ultrasound system to sonicate the subject in
accordance with heating trajectories on the basis of the
measured temperature and/or thermal dose.
(App. Br. 32.)
According to Examiner, “the MRI system and the processor that
calculates temperature from the magnetic resonance data provides means to
measure temperature and compute thermal dose” (Ans. 8). Therefore,
Examiner finds that “it is unclear as to how the thermometry module differs
from the magnetic resonance imaging system” (Ans. 4). In this regard,
Examiner finds that Appellants’ “claim appears to define means other than
the MRI system and processor for providing such temperature measurements
and thermal dose” (id. at 9).
We are not persuaded. Appellants Specification discloses “a therapy
system comprising: . . . a thermometry module to measure temperature [in] a
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measurement field and in particular to compute a thermal dose . . .” (Spec. 1:
6–10). Although, Appellants disclose that “[t]he thermometry module may
be the magnetic resonance imaging system” (Spec. 15: 32–33 (emphasis
added)), Examiner failed to establish that, as presented, the thermometry
module of Appellants’ claim 15 is the magnetic resonance imaging system
of Appellants’ claim 1. To the contrary Appellants’ claim 15 requires that
the therapeutic apparatus of Appellants’ claim 1, which requires a magnetic
resonance imaging system, further comprises a thermometry module (see
App. Br. 32; cf. id. at 26). Therefore, we agree with Appellants’ assertion
that “claim 15 unequivocally recites that a thermometry module measures
the temperature and computes the thermal dose” and “a skilled artisan would
recognize that the ‘thermometry module differs from the magnetic resonance
imaging system’ in that the: (1) thermometry module measures temperature
and computes a thermal dose and (2) the magnetic resonance imaging
system acquires magnetic resonance data” (see Reply Br. 19; App. Br. 22,
see also Reply Br. 19 (“Appellants’ respectfully submit that measuring
temperature and calculating temperature are not identical things, as would be
recognized by a skilled artisan in light of the definitions of calculating and
measuring”).
CONCLUSION OF LAW
The preponderance of evidence fails to support Examiner’s conclusion
that Appellants’ claims are indefinite. The rejection of claims 1–3, 5–13,
and 15 under 35 U.S.C. § 112, second paragraph is reversed.

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Improper Dependency:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellants’ claim 6 fails to further limit the subject matter of
Appellants’ claim 1?
ANALYSIS
Appellants’ claim 6 depends from and limits the “trajectories” of
Appellants’ claim 1 to “define any one of the following: concentric circles,
concentric spheres, closed loops, closed surfaces, a single sonication
location, and linear patterns” (App. Br. 28).
Examiner finds that Appellants’ claim 6 “fails to set forth a further
structural limitation of the apparatus” set forth in Appellants’ claim 1 (Ans.
5; see id. at 9 (“Examiner maintains that the claim fails to set forth a further
structural limitation of the apparatus and merely define[s] an intended
use/result of using the apparatus”)). We are not persuaded.
As Appellants explain, their claim 6 uses functional language to
define and further limit the scope of the term “trajectories,” as set forth in
their claim 1 (App. Br. 23–25; see generally Reply Br. 20). See In re
Swinehart, 439 F.2d 210, 213 (CCPA 1971) (“We are convinced that there is
no support, either in the actual holdings of prior cases or in the statute, for
the proposition, put forward here, that ‘functional’ language, in and of itself,
renders a claim improper.”)
CONCLUSION OF LAW
The preponderance of evidence fails to support Examiner’s conclusion
that Appellants’ claim 6 fails to further limit the subject matter of
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Appellants’ claim 1. The rejection of claim 6 under 35 U.S.C. § 112, fourth
paragraph is reversed.

Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellants’ Specification fails to provide written
descriptive support for the claimed invention?
ANALYSIS
Examiner recognizes that Appellants’ “claims fail to specifically set
forth a step of determining the minimum [sonication] duration or a
maximum [sonication] duration” (Ans. 5). Examiner reasons, however, that
“in order to program the processor to carry out functions as set forth in
[Appellants’] claims . . ., one must determine or know [] the [values for the]
predetermined minimum [sonication] duration and the predetermined
maximum [sonication]” and “[n]owhere in [Appellants’] disclosure is such
an example provided nor is there any explanation as to how one would know
how to determine such a value” (id.). In this regard, Examiner reasons that
“[w]ithout such information, one skilled in the art would not be able to carry
out [Appellants’] claimed invention” (id.). Therefore, Examiner finds that
“[i]t is unclear as to how one would determine the minimum [sonication]
duration that would allow the spatially dependent parameter to exceed the
first predetermined threshold in the target zone” and “how a predetermined
maximum [sonication] duration is determined” (id. at 2). In this regard,
Examiner finds that Appellants fail “to provide any guidance used by one
skilled in the art to make such determinations” (id.).
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It is Examiner who “bears the initial burden of presenting a prima
facie case of unpatentability.” In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir.
2002). Examiner’s burden is discharged by “presenting evidence or reasons
why persons skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims.” In re Wertheim, 541
F.2d 257, 263 (CCPA 1976).
On this record, Examiner found that: (1) a minimum and maximum
sonication duration value must be determined or known in order to practice
Appellants’ claimed invention and (2) Appellants’ Specification does not
exemplify or describe known values or how such values are determined
(Ans. 5). Examiner further makes clear that Appellants “failed to provide
evidence” to support a finding that a person of ordinary skill in this art knew
or would have been able to determine minimum and maximum sonication
duration values (Ans. 5–6). Cf. Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed.
Cir. 1998) (Because the sufficiency of the written description is evaluated by
one of ordinary skill in the art, details that would be known by the skilled
artisan need not be included in a patent specification).
For the foregoing reasons, we find that Examiner established a prima
facie case that Appellants’ Specification lacks written descriptive support for
the claimed invention (see Reply Br. 7 (referencing Examiner’s “prima facie
case of an insufficient written description set forth in the Final Rejection”)).
Therefore, we are not persuaded by Appellants’ contention that Examiner
failed to provide “‘evidence or reasoning’ to rebut the presumption that
Appellants’ description, as filed, is adequate” (see App. Br. 12; see also id.
at 12–13 (Examiner’s statements that “‘it is unclear . . . are conclusions, not
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findings of fact from which an inference may be drawn that the disclosure is
inadequate”); Reply Br. 4 and 6).
Because a minimum and maximum sonication duration value must be
determined or known in order to practice Appellants’ claimed invention, we
are not persuaded by Appellants’ contention that, “Appellants’ claims do not
recite ‘determin[ing] the minimum sonification [sic] duration that would
allow the spatially dependent parameter to exceed the first predetermined
threshold in the target zone,’” and thus Examiner’s “basis for rejecting the
claims is misdirected toward subject matter that is not claimed by
Appellants” (App. Br. 9–10).
We appreciate Appellants’ contention that, once a minimum or
maximum sonication duration value is known or determined, “a person of
ordinary skill in the art of computer programming would have no difficulty
programming this subject matter into computer code” (App. Br. 11).
Appellants’ contention, however, fails to establish that those of ordinary
skill in this art would have, a priori, known such values or known how to
determine such values.
In addition, we are not persuaded by Appellants’ contention that:
Appellants’ guidance is that a skilled artisan would use his/her
ability to think and, by the act of thinking, select a maximum
value of the duration that he/she deems appropriate.
Appellants’ claims require nothing more, and a skilled artisan is
capable of thinking and selecting a value that he/she deems
appropriate
(App. Br. 13; see also id. at 13–14 (“Appellants’ patent application ‘need not
teach, and preferably omits,’ the guidance for a skilled artisan to think and,
by the act of thinking, select minimum and maximum values of the duration
that he/she deems appropriate”); see Reply Br. 8). Appellants’ contention, at
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best, supports a finding that a person of ordinary skill in this art would have
found it obvious to determine appropriate minimum and maximum
sonication duration values. Our reviewing court has, however,
repeatedly stated that actual “possession” or reduction to
practice outside of the specification is not enough. Rather, [] it
is the specification itself that must demonstrate possession.
And while the description requirement does not demand any
particular form of disclosure, Carnegie Mellon Univ. v.
Hoffmann–La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir.
2008), or that the specification recite the claimed invention in
haec verba, a description that merely renders the invention
obvious does not satisfy the requirement, Lockwood v. Am.
Airlines, 107 F.3d 1565, 1571–72 (Fed. Cir. 1997).
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed.
Cir. 2010.
For the foregoing reasons, we are not persuaded by Appellants’
contention that Examiner “does not identify any fact or reasoning to support
an inference that Appellants’ evidence is insufficient to rebut the Office’s
prima facie case of an insufficient written description set forth in the Final
Rejection” (Reply Br. 7).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Appellants’ Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 1 under the written
description provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims
2, 3, 5–13, and 15 are not separately argued and fall with claim 1.

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Enablement:
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention?
ANALYSIS
Examiner finds that, although Appellants provide an enabling
disclosure of a spatially dependent parameter that is temperature, “[i]t is
unclear as to how a spatially dependent parameter other than temperature
could be used to provide the procedure disclosed and claimed,” as
encompassed by the full scope of Appellants’ claimed invention (Ans. 2; see
id. at 6 (Appellants “failed to disclose other types of parameters and
thresholds associated with such other parameters”)). In this regard,
Examiner finds that Appellants fail to disclose a first and second
predetermined threshold that is not a temperature threshold (id. at 2–3).
Therefore, Examiner finds that Appellants’ “[S]pecification does not enable
any person skilled in the art to which it pertains, or with which it is most
nearly connected, to make and use the invention commensurate in scope
with [Appellants’] claims” (id. at 6).
The scope of Appellants’ claimed invention does not limit the
spatially dependent parameter to temperature; therefore, we are not
persuaded by Appellants’ contention their “claims 1–3, 6–13, and 15 do not
require that the recited spatially dependent parameter be anything other than
temperature. And the Final Rejection expressly acknowledges that
Appellants’ specification is ‘enabling for the spatially dependent parameter
being temperature’ (see Final Rejection page 3, lines 2 and 3 of last
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22
paragraph)” (App. Br. 14; see Reply Br. 9 (Examiner “tacitly acknowledges
such (see Examiner’s Answer 6, last sentence)”)).
Nevertheless, we are persuaded by Appellants’ contention that
Examiner failed to “provide evidence that undue experimentation would be
required to make or use the invention if a ‘spatially dependent parameter
other than temperature [was] used to [practice] the procedure disclosed and
claimed’” (App. Br. 15; see id. at 16–17; see also Reply Br. 10–11).
Whether the disclosure is enabling, is a legal conclusion based on
several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735–
737 (Fed. Cir. 1988). Factors to be considered in determining whether a
claimed invention is enabled throughout its scope without undue
experimentation include the quantity of experimentation necessary, the
amount of direction or guidance presented, the presence or absence of
working examples, the nature of the invention, the state of the prior art, the
relative skill of those in the art, the predictability or unpredictability of the
art, and the breadth of the claims. Id.
Rather than provide a fact-based reasoned analysis, Examiner
provides only unsupported conclusions as to why Examiner believes
Appellants’ Specification does not enable the claimed invention. Ans. 6. In
the absence of a fact-based statement of a rejection based upon the relevant
legal standards, Examiner failed to meet the initial burden of establishing a
prima facie case of non-enablement. The burden of proof does not shift to
Appellants until Examiner establishes a prima facie case of non-enablement.
In re Marzocchi, 439 F.2d 220, 223–224 (CCPA 1971).
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CONCLUSION OF LAW
The evidence of record fails to support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention.
The rejection of claims 1–3, 5–13, and 15 under the enablement provision of
35 U.S.C. § 112, first paragraph is reversed.

TIME PERIOD FOR RESPONSE
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