Ex Parte MATA et al

Patent Trial and Appeal Board

Oct 26, 2016

12771767 (P.T.A.B. Oct. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121771,767 04/30/2010
92422 7590 10/28/2016
Schwegman Lundberg & Woessner I UVAPF
P.O. Box 2938
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Jaime F. MATA
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.
1036.272US 1 2421
EXAMINER
PARK, PATRICIA JOO YOUNG
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
10/28/2016 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAIME F. MAT A, KAI RUPPERT, and
JOHN P. MUGLER1
Appeal2014-004170
Application 12/771,767
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
systems and methods for assessing structural changes in a volume of
interest. The claims are rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is the University of
Virginia Patent Foundation (App. Br. 2).
Appeal2014-004170
Application 12/771,767
STATEMENT OF THE CASE
The Specification describes "a system, computer program product and
method to detect and assess in a single breath-hold the physiologic,
morphologic and structural changes in multiple organs" that use polarized
Xe-129 gas and chemical shift imaging (Spec. i-f 44). Claims 1, 4--9, 12-17,
and 20-24 are on appeal. Claim 1 is illustrative and reads as follows
(emphasis added):
1. A method for assessing structural changes in a volume of
interest, the method comprising:
(a) polarizing Xe-129 gas to form hyperpolarized Xe-129
gas;
(b) introducing the hyperpolarized Xe-129 gas into the
volume of interest;
( c) acquiring multiple spatially oriented spectra from the
volume of interest, using a magnetic resonance pulse sequence
capable of producing said multiple spatially oriented spectra
. t.. ,..J • ,..J • witum a preuetermmeu time;
( d) post-processing the multiple spatially oriented spectra
in a computing device to obtain magnetic resonance spectra and
chemical shift maps; and
( e) evaluating the magnetic resonance spectra, the
chemical shift maps, or the magnetic resonance spectra and the
chemical shift maps to assess the structural changes in the
volume of interest;
wherein the volume of interest is in a lung of a patient, and
wherein the predetermined time is less than a breath hold of the
patient.
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Application 12/771,767
The claims stand rejected as follows:
I. Claims 1, 4, 5, 9, 12, and 13 stand rejected under 35 U.S.C.
§ 103(a) as being obvious based on Swanson2 and Driehuys '516. 3
II. Claims 6 and 14 stand rejected under 35 U.S.C. § 103(a) as
being obvious based on Swanson, Driehuys '516, and Albert. 4
III. Claims 7 and 15 stand rejected under 35 U.S.C. § 103(a) as
being obvious based on Swanson, Driehuys '516, and Hatabu. 5
IV. Claims6 17, 18, 20, 21, and 24 stand rejected under 35 U.S.C.
§ 103(a) as being obvious based on Swanson, Driehuys '516, and
Driehuys '846. 7
V. Claim 22 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Swanson, Driehuys '516, Driehuys '846, and Albert.
VI. Claim 23 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Swanson, Driehuys '516, Driehuys '846, and Hatabu.
2 Swanson et al., Distribution and Dynamics of Laser-Polarized 129Xe
Magnetization In Vivo, 42 MAGNETIC RESONANCE IN MEDICINE 1137-1145
(1999).
3 Driehuys et al., US 2003/0152516 Al, published Aug. 14, 2003.
4 Albert et al., US 6,845,262 B2, issued Jan. 18, 2005.
5 Hatabu et al., Pulmonary Perfusion and Angiography: Evaluation with
Breath-Hold Enhanced Three Dimensional Fast Imaging Steady-State
Precession MR Imaging with Short TR and TE, 167 AJR 653---655 (1996).
6 We note that the Examiner identified claim 19 as being rejected (Ans. 8).
Appellants identified claim 19 as being canceled (Appellants' Claims
Appendix). Therefore, we do not include claim 19 in our deliberations.
7 Driehuys et al., US 2008/0089846 Al, published Apr. 17, 2008.
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Application 12/771,767
I.
We have considered Appellants' arguments, but are not persuaded that
the Examiner erred in rejected claims 1, 4, 5, 9, 12, and 13 under 35 U.S.C.
§ 103 (a) as being unpatentable over the combination of Swanson and
Driehuys '516. Because the claims are not separately argued, we focus our
discussion on claim 1, which is representative.
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3-10; FF 1-9), and agree that the
claims are rendered obvious by Swanson and Driehuys '516. We address
Appellants' arguments below.
Findings of Fact
FF 1. Swanson discloses "magnetic resonance imaging studies of
laser-polarized 129Xe, dissolved in the blood and tissue of the lungs and the
heart of Sprague-Dawley rats" (Swanson Abstract; see also Ans. 3--4, 8).
FF 2. Swanson discloses that "[a]ll experiments were performed on a
2.0 T Omega CSI ... and equipped with self-shielded gradients. A doubly-
tuned, slotted-cylinder NMR probe was constructed to resonate at the 129Xe
and 1H frequencies, enabling registration of xenon chemical-shift imaging
(CSI) data with proton images" (Swanson 1138, 1st col.; see also Ans. 3--4,
8).
FF 3. Swanson discloses that "[a]ll spectra and images in these
studies were cardiac gated and acquired with an effective repetition time
(TR) of 428 ms (two cardiac cycles at 280 beats per minute)" (Swanson
1138, 2nd col.; see also Ans. 3--4, 8).
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Application 12/771,767
FF 4. Swanson discloses that
[t]he data were then Fourier transformed along each dimension
and the magnitude was calculated. Summing the two-
dimensional (2D) planes across each resonance (blood, tissue,
and gas) created images shown in Figs. 4 and 5. Cardiac-gated
proton images, with an appropriate POV, were collected for
spatial registration of the 129Xe signal.
(Swanson 1139, 2nd col.; see also Ans. 3--4, 8.)
FF 5. Driehuys '516 discloses
MR spectroscopy and imaging methods for imaging pulmonary
and cardiac vasculature and the cardiac region and evaluating
blood flow or circulatory deficits use dissolved phase polarized
129Xe gas and large flip angle excitation pulses. Pulmonary and
cardiac vasculature MRI images are obtained by delivering gas
to a patient via inhalation such as with a breath-hold delivery-
procedure, exciting the dissolved phase gas with a large flip
angle pulse, and generating a corresponding image. Preferably,
the image is obtained using multi-echo imaging techniques.
Blood flow is quantified using low field MR spectroscopy and
an RF excitation pulse with a frequency which corresponds to the
resonance of the dissolved phase 129Xe.
(Driehuys '516 Abstract; see also Ans. 4, 8, 10.)
FF 6. Driehuys '516 discloses that "[t]he excitation repetition rate
should be fast enough to capture the 129Xe before it flows out of the chest
region. Such an imaging method can provide useful two (2) and three (3)
dimensional dissolved phase images of the pulmonary and cardiac
vasculature" (Driehuys '516 i-f 21; see also Ans. 4, 8, 10).
FF 7. Driehuys '516 discloses that "[t]he patient inhales a
(predetermined) quantity of polarized 129Xe gas into the pulmonary region
(i.e., lungs and trachea). Preferably, after inhalation, the patient holds his or
her breath for a predetermined time such as 5-20 seconds. This can be
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Appeal2014-004170
Application 12/771,767
described as a 'breath-hold' delivery" (nriehuys '516 i-f 39; see also Ans. 4,
8, 10).
FF 8. Driehuys '516 discloses that " [ i Jn one embodiment, for single
echoes, the repetition time between excitation pulses is set at 78 ms or
less" (Driehuys '516 i-f 58; see also Ans. 4, 8, 10).
FF 9. Driehuys '516 discloses that " [ i Jn a preferred embodiment, an
entire perfusion image (MR image directed to the dissolved phase polarized
gas) is generated in a single breath-hold period ('TB')" (Driehuys '516 i-f 60;
see also Ans. 8). Driehuys '516 further discloses that "[tJhe number of RF
pulses ('Nrr') which can be generated in a single breath-hold time is related
to repetition time (TR) and breath-hold time (TB), and can be expressed by:
Nrf =TB" (Driehuys '516 i-f 61; see also Ans. 8).
TR
FF 10. The Specification discloses "acquisition of multiple spatially
oriented spectrums, localized in the same plane (2D), in multiple different
planes (3D) or in 3D plus at multiple time intervals ( 4D)" (Spec. i-f 44; see
also Ans. 10).
FF 11. The Examiner finds that "imaging conducted within a breath
hold are well known in the art and suitable for use in the method of
pulmonary imaging using hyper-polarized gas" (Ans. 4). The Examiner
additionally finds that an ordinarily skilled artisan would have been
motivated to combine Swanson and Driehuys '516 because such
combination "provides [J less discomfort of holding breath for patients while
obtaining necessary data" (id.).
FF 12. The Examiner finds that "scan parameters such as MR pulse
sequence and associated repetition time are scan parameters that can be
adjusted in each imaging mode to optimize the imaging product. Therefore,
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Application 12/771,767
Swanson can adjust its imaging parameters when the imaging acquisition is
performed under predetermined time of Drieuhuys [' 516] with predictable
results" (id. at 10).
Analysis
We have considered, but do not find persuasive, Appellants'
contention the Examiner has not identified any teaching in Driehuys '516
that would have assisted an ordinarily skilled artisan in overcoming
Swanson's requirement for multiple breath-holds (App. Br. 5). Rather, we
agree with the Examiner that Driehuys '516 explicitly teaches imaging the
lung and heart using polarized 129Xe in a predetermined time that is less than
a breath-hold of the patient, i.e., 5-20 seconds (FF 5-9; Ans. 10). We
further agree with the Examiner that an ordinarily skilled artisan would have
been motivated, with an expectation of success to modify Swanson to
perform imaging in a single breath-hold as taught by Driehuys '516 in order
to improve patient comfort during image acquisition (FF 11-12; Ans. 4, 10).
We are likewise unpersuaded by Appellants' assertion that the cited
references teach away from the combination proposed by the Examiner
because they utilize different techniques and disclose different repetition
times (see App. Br. 5; Reply Br. 2-3). We instead agree with the Examiner
that the "MR pulse sequence and associated repetition time are scan
parameters that can be adjusted in each imaging mode to optimize the
imaging product ... with predictable results" (FF 12; Ans. 10). In re Aller,
220 F .2d 454, 456 (CCPA 1955) ("where the general conditions of a claim
are disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation"). "[T]he discovery of an
optimum value of a variable in a known process is usually obvious." Pfizer,
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Appeal2014-004170
Application 12/771,767
lrzc. v. Apotex, lrzc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for
determining the optimal parameters for prior art result effective variables
"flows from the 'normal desire of scientists or artisans to improve upon what
is already generally known."' Id. (quoting In re Peterson, 315 F.3d 1325,
1330 (Fed. Cir. 2003)). In this regard, we additionally note that
Driehuys '516 discloses the relationship between breath-hold time, repetition
time, and the number of pulses that can be generated in a single breath-hold
(FF 9).
Moreover, Appellants have not identified any disclosure in Swanson
or Driehuys '516 sufficient to support a determination that either reference
teaches away from the proposed combination. See In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not the kind of
factual evidence that is required to rebut a prima facie case of
obviousness."). For example, Appellants do not point us to any portion of
Swanson that discredits, criticizes, or disparages the predetermined time
being less than one breath-hold (FF 1--4). See DyStar Textilfarben GmbH &
Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir.
2006) ("We will not read into a reference a teaching away from a process
where no such language exists.").
In addition, disclosure by Driehuys '516 that "[i]n one embodiment,
for single echoes, the repetition time between excitation pulses is set at
78 ms or less" (FF 8; emphasis added) does not foreclose additional
embodiments having different repetition times (see, e.g., FF 9), or otherwise
teach away from combination with Swanson. See Merck & Co. Inc. v.
Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("the fact that a
specific [embodiment] is taught to be preferred is not controlling, since all
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Application 12/771,767
disclosures of the prior art, including unpreferred embodiments, must be
considered") (quoting In re Lamberti, 545 F.2d 747, 750(CCPA1976)).
We have also considered, but remain unpersuaded by, Appellants'
contention that the proposed combination fails to render obvious the
production of three- and four-dimensional information from a single breath-
hold acquisition, as is possible using the claimed invention (App. Br. 5). As
an initial matter, we note that Appellants' arguments fail to account for the
disclosure in Driehuys '516 of "two (2) and three (3) dimensional dissolved
phase images" (FF 6). Moreover, and critically, claim 1 does not require
three- or four-dimensional information (Ans. 1 O; see also FF 10).
"[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.2d 1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the
outset because ... they are not based on limitations appearing in the
claims.").
Appellants' assertions that the image acquisition process taught by
Driehuys '516 requires at least two separate breath holds and inhalations,
cannot acquire RBC and tissue images when dissolved chemical shift
frequencies are too close to each other, and is based on the Dixon method
differs from Appellants' techniques (App. Br. 5---6) are similarly unavailing.
Claim 1 does not require chemical shift frequencies that are close to each
other for acquiring RBC and tissue images, and Appellants do not provide
any evidentiary basis to support that conclusion that Swanson's method
cannot be modified based on the teachings of Driehuys '516. See In re Self,
671F.2d at 1348 and In re Geisler, 116 F.3d at 1470.
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Neither do we find persuasive Appellants' contentions that the
methods disclosed by Swanson require "long and risky breathing
maneuvers" not possible in human subjects, utilize only one- and two-
dimensional CSI techniques, and are not specifically optimized for
hyperpolazized gas imaging, while Appellants' invention is specific to
intrinsic properties as well as external nuclear magnetization (id. at 6-7). In
particular, we observe that Appellants do not provide evidence to support the
conclusion that Swanson's method cannot be modified based on the
teachings of Driehuys '516 because of the above-alleged characteristics of
that method. See In re Geisler, 116 F.3d at 1470. We further note that
Appellants arguments relate to limitations not present in claim 1. See In re
Van Geuns, 988 F.2d at 1184.
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that Swanson and Driehuys '516 render claim 1 obvious.
Claims 4, 5, 9, 12, and 13 fall with claim 1.
II.
The Examiner has rejected claims 6 and 14 under 35 U.S.C. § 103(a)
as being obvious based on Swanson, Driehuys '516, and Albert. Appellants
present no additional argument based on the teachings of Albert, and rely on
the same arguments addressed above with regard to Swanson and
Driehuys '516 (see App. Br. 8). For the reasons discussed above, therefore,
we affirm the rejection of claims 6 and 14, which depend from claims 1 and
9, respectively.
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III.
The Examiner has rejected claims 7 and 15 under 35 U.S.C. § 103(a)
as being obvious based on Swanson, Driehuys '516, and Hatabu. Appellants
present no additional argument based on the teachings of Hatabu, and rely
on the same arguments addressed above with regard to Swanson and
Driehuys '516 (see App. Br. 8). For the reasons discussed above, therefore,
we affirm the rejection of claims 7 and 15, which depend from claims 1 and
9, respectively.
IV.
The Examiner has rejected claims 17, 18, 20, 21, and 24 under
35 U.S.C. § 103(a) as being obvious based on Swanson, Driehuys '516, and
Driehuys '846. Similar to claim 1, independent claim 17 recites, in pertinent
part:
acquiring multiple spatially oriented spectra from the volume of
interest after hyperpolarized Xe-129 gas has been introduced into
the volume of interest, using a magnetic resonance pulse
sequence capable of producing said multiple spatially oriented
spectra within a predetermined time ...
such that the predetermined time is less than a breath hold of the
patient.
Appellants present no additional argument based on the teachings of
Driehuys '846, and rely on the same arguments addressed above with regard
to Swanson and Driehuys '516 with respect to this aspect of claim 17 (see
App. Br. 8). For the reasons discussed above, therefore, we affirm the
rejection of claim 17. Because they are not separately argued, we also
affirm the rejection of claims 18, 20, 21, and 24, which depend from
claim 17.
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v.
The Examiner has rejected claim 22 under 35 U.S.C. § 103(a) as
being obvious based on Swanson, Driehuys '516, Driehuys '846, and Albert.
Appellants present no additional argument based on the teachings of
Driehuys '846 and Albert, and rely on the same arguments addressed above
with regard to Swanson and Driehuys '516 (see App. Br. 8). For the reasons
discussed above, therefore, we affirm the rejection of claim 22, which
depends from claim 1 7.
VI.
The Examiner has rejected claim 23 under 35 U.S.C. § 103(a) as
being obvious based on Swanson, Driehuys '516, Driehuys '846, and
Hatabu. Appellants present no additional argument based on the teachings
of Driehuys '846 and Hatabu, and rely on the same arguments addressed
above with regard to Swanson and Driehuys '516 (see App. Br. 8). For the
reasons discussed above, therefore, we affirm the rejection of claim 23.
SUMMARY
We affirm the rejection of claims 1 and 9 under 35 U.S.C. § 103(a)
based on Swanson and Driehuys '516. Claims 4 and 5 fall with claim 1, and
claims 12 and 13 fall with claim 9.
We affirm the rejection of claims 6 and 14 under 35 U.S.C. § 103(a)
based on Swanson, Driehuys '516, and Albert.
We affirm the rejection of claims 7 and 15 under 35 U.S.C. § 103(a)
based on Swanson, Driehuys '516, and Hatabu.
We affirm the rejection of claims 17, 18, 20, 21, and 24 under 35
U.S.C. § 103(a) based on Swanson, Driehuys '516, and Driehuys '846.
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We affirm the rejection of claim 22 under 35 U.S.C. § 103(a) based on
Swanson, Driehuys '516, Driehuys '846, and Albert.
We affirm the rejection of claim 23 under 35 U.S.C. § 103(a) based on
Swanson, Driehuys '516, Driehuys '846, and Hatabu.
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)(l )(iv).
AFFIRMED
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