Ex Parte Huston et al

Patent Trial and Appeal Board

Feb 24, 2017

13453070 (P.T.A.B. Feb. 24, 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.
13/453,070 04/23/2012 John Huston III 630666.00361.MMV-2011-062 7331
26710 7590 02/28/2017
QUARLES & BRADY LLP
Attn: IP Docket
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
LUONG, PETER
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
02/28/2017 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN HUSTON III, CLIFFORD R. JACK JR.,
KEVIN J. GLASER, ARMANDO MANDUCA,
JOEL P. FELMLEE, RICHARD L. EHMAN,
and MATTHEW C. MURPHY
Appeal 2015-005965
Application 13/453,070
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a system
and a method for determining the presence of a neurodegenerative disease
using magnetic resonance elastography. The Examiner rejected the claims
on the grounds of anticipation and obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Mayo Foundation for
Medical Education and Research (see Br. 2).
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Application 13/453,070
Statement of the Case
Background
Appellants’ “invention relates to systems and methods for performing
magnetic resonance elastography (MRE) to provide clinical information
relating to potential neurodegenerative diseases and, in particular,
Alzheimer’s disease” (Spec. 13).
The Claims
Claims 1—20 are on appeal. Independent claim 1 is representative and
reads as follows (emphasis added):
1. A method for generating a report on a subject using
data acquired using a magnetic resonance imaging (MRI)
system:
positioning a subject within the MRI system;
coupling a driver to the subject to impart vibrational
energy to the subject;
using the MRI system and in coordination with
operation of the driver, acquiring medical imaging data from
the subject's brain;
deriving stiffness information of the subject's brain
from the medical imaging data; and
generating a report indicating the stiffness
information of the subject’s brain relative to at least one of
baseline stiffness information and amyloid tracer
information to indicate a status of the subject with respect to
a neurodegenerative disease.
The Issues
A. The Examiner rejected claims 1—9 and 11—19 under 35 U.S.C.
§ 102(b) as being anticipated by Li2 (Ans. 2—3).
2 Li, US 2008/0255444 Al, published Oct. 16, 2008.
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B. The Examiner rejected claims 1, 10, and 20 under 35 U.S.C. § 103(a)
as obvious over Li and Klunk3 (Ans. 3—4).
A. 35 U.S.C. § 102(b) over Li
The Examiner finds that
Li discloses a method and apparatus for generating a
report on a subject using data acquired using a magnetic
resonance imaging (MRI) system comprising a magnetic
system, a plurality of gradient coils, a radiofrequency (RF)
system, a driver system ([0066]), and a computer system.
The Examiner’s position is that a MRI system comprises a
magnetic system, a plurality of gradient coils, a RF system,
and a computer system. Li discloses the computer system
acquiring medical imaging data from the subject’s brain
including stiffness information for each ROI (Figs. 13 A—
13C; [0075—0084]). Li discloses baseline stiffness
information (normal patient, Fig. 13A— 13C and 14). Li
discloses elastogram images (MRE). The Examiner notes
that the use of the system discloses the method steps
substantially as claimed.
(Ans. 2-3.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Li anticipates the claims?
Findings of Fact
1. Li teaches
an acoustic, piezoelectric, electric, electro-mechanical or
pneumatically driven surface drum driver, . . . and a method
for its use . . . via the production of magnetic resonance
elastographic images (MRE), without artifact production, in
a magnetic resonance imaging (MRI) machine. In a second
embodiment, the invention is directed toward ... a device
and process for determination, ... of organ stiffness, e.g.
3 Klunk et al., Imaging Brain Amyloid in Alzheimer’s Disease with
Pittsburgh Compound-B, 55 Annals of Neurology 3:306-319 (2004).
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brain stiffness, which can be quantified so as to be useful in
elucidating and quantifying brain cognitive state, e.g.
normal, mild cognitive impairment (MCI) or Alzheimer’s
dementia (AD).
(Li Abstract; see also id. at 12, Ans. 2—3.)
2. Figures 13 A— 13C of Li is reproduced below:
Figures 13A— 13C “show the results of MRE using twin pneumatic drivers
on normal (13C), MCI (13B), and AD (13A) patients” (Li | 57; see also
Ans. 2-3).
3. Figure 14 of Li is reproduced below:
f s an By sin Stiff ns (kFa) i
I.St&fects. MM8E WNt-6 Grsy Mat«f
26 6.700 2.566
Mosmal 28 7.024 2.S42
Nosmai 30 6.078 2.340
M^trna) 24 ? 23 5 2.269
MO; 2k> 5 6 5; 2.081
yci 21 '2.633
1 AD 1$ 6.783 1,4 f 1
1 AD to 0 223 2.065
1 AD n 4.414 1.428
1 AD 14 4,100 1,202
i AD to 2.041 1,108
FIGURE 14
Figure 14 shows “relative brain stiffness for subjects suffering from various
mental impairment versus normal subjects” (Li | 58; see also Ans. 2—3).
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4. Li teaches
Compared with normal subjects (FIG. 13C), the brain
stiffness of both white matter and grey matter is lower in
MCI patients (FIG. 13B). Also the brain stiffness is lower in
AD patients (FIG. 13A) than in MCI patients (FIGS. 13 and
14). The technique is potentially valuable for early
detection and diagnosis of MCI and Alzheimer’s disease.
(Li 1 84; see also Ans. 2—3.)
5. Appellants’ Specification discloses that
[t]he elastograms, . . . can be compared to baseline
elastograms at process block ... to then generate a report at
process block. . ., such as serves to illustrate or show in a
clinically discemable mechanism, indicators of a
neurodegenerative disease, such as AD. Specifically, the
report or images provided yields a noninvasive measure of
the change in brain stiffness due to brain amyloid load.
(Spec. 141.)
6. Appellants’ Figure 4 is reproduced below:
FIG, 4
Figure 4 shows “a report including a set of images for comparison including
anatomical images, wave images, and elastograms” (Spec. 117).
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Principles of Law
A prior art reference can only anticipate a claim if it discloses all the
claimed limitations “arranged or combined in the same way as in the claim.”
Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361
(Fed. Cir. 2012).
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) (“[Djuring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.”).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2—6; FF 1— 7) and agree that the
claims are anticipated by Li. We address below Appellants’ arguments.
Claims 1, 7—9, 12, and 17:
Appellants contend that “Li fails to disclose ‘generating a report
indicating the stiffness information of the subject’s brain relative to at least
one of baseline stiffness information and amyloid tracer information to
indicate a status of the subject with respect to a neurodegenerative disease,’
as claimed” (App. Br. 5).
This argument is unpersuasive. As the Examiner explains,
Appellant has failed to disclose a special meaning or
definition for the term “report”. Therefore, the term report
is given its broadest reasonable interpretation. The
Examiner’s position is that Figs. 13A—13C and 14 are
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interpreted to be reporting baseline stiffness information
(normal; Figs. 13C and 14).
(Ans. 4; FF 1 4.) Moreover, we observe that Appellants’ Specification
indicates that a report encompasses a display of images (FF 5—6). Here, Li
teaches images (FF 2) and a table (FF 3), either of which reasonably
constitutes a report consistent with the teachings of the Specification.
“[C]laims in an application are to be given their broadest reasonable
interpretation consistent with the specification and that claim language
should be read in light of the specification as it would be interpreted by one
of ordinary skill in the art.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir.
1983).
Appellants argue that “the Examiner failed to provide any support that
Li discloses or teaches ‘indicating] a status of the subject with respect to a
neurodegenerative disease,’ other than to state that Li discloses ‘a
neurodegenerative disease (Alzheimer's).”’ (App. Br. 6.)
This argument is also unpersuasive. As the Examiner explains, “[t]he
Li [reference] discloses brain stiffness can be quantified so as to be useful in
elucidating and quantifying brain cognitive state, e.g. normal, mild cognitive
impairment (MCI) or Alzheimer’s dementia (AD) (abstract; [0002]; [0084])”
(Ans. 4; FF 2-4). In other words, Appellants do not define “status,” or limit
“status” to other than relating to a subject and a neurodegenerative disease.
We thus find reasonable the Examiner’s determination that Li’s data and
images showing brain stiffness between normal, mild cognitive impairment,
and Alzheimer’s dementia meets this claimed limitation. See In re Sneed,
710 F.2d at 1548.
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Claim 11:
Claim 11 recites “a computer system programmed to: . . . determine a
plurality of regions of interest (ROIs) within the subject’s brain; derive
stiffness information of the subject’s brain from the medical imaging data by
determining a stiffness map for each ROI without contributions from brain
tissue adjacent to the ROI” (see Appellants’ claim 11).
Appellants contend that
Li fails to disclose, among other things, “a computer system
programmed to[] ... derive stiffness information of the
subject's brain from the medical imaging data by
determining a stiffness map for each ROI without
contributions from brain tissue adjacent to the ROI,” as
claimed. Specifically, Appellants continue to assert that Li
fails to disclose “determining a stiffness map for each ROI
without contributions from brain tissue adjacent to the
Roir
(App. Br. 6—7.)
We are not persuaded. As the Examiner explains, “Li discloses
deriving stiffness information for different ROI (white and grey matter).
The Examiner interprets the stiffness information for white matter does not
include contributions from brain tissue adjacent to that ROI (excludes grey
matter)” (Ans. 4). In other words, Appellants again do not define “stiffness
map.” We thus find the Examiner’s interpretation reasonable, in which this
claimed element is met by Li’s image of the entire brain with respect to
stiffness, which includes white and grey matter, showing at least other
regions of the brain having normal stiffness (see FF 2). See In re Sneed, 710
F.2d at 1548.
We recognize, but are not persuaded by, Appellants’ contention that
“Li also fails to disclose the element of Claim 11 that calls for a computer
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system programmed to ‘determine a plurality of regions of interest (ROIs)
within the subject’s brain[]’” (App. Br. 8). As discussed above, Appellants’
claims do not exclude obtaining an image of the entire brain or differentiate
one region of interest from another. We thus agree with the Examiner that
“[a]s shown in Figs. 13A—13C, Li discloses an image of the brain. The
Examiner notes that the image comprises multiple pixels showing a slice
image of the brain. Li further discloses regions including white matter and
grey matter” (Ans. 5; FF 2). See In re Sneed, 710 F.2d at 1548.
Claim 2\
Claim 2 recites “wherein acquiring medical imaging data includes
reconstructing an elastogram of the subject’s brain and generating the report
includes comparing the elastogram of the subject’s brain to an elastogram of
a baseline subject’s brain” (see Appellants’ claim 2).
Appellants argue that “[a]t no point does Li disclose ‘generating a
report,’ let alone generating a report including ‘comparing the elastogram of
the subject’s brain to an elastogram of a baseline subject’s brain,’ as
claimed” (App. Br. 10).
We are not persuaded. Regarding Appellants’ “generating a report”
argument, we are not persuaded for the reasons discussed above. Regarding
Appellants’ argument concerning comparing the elastograms, we are not
persuaded as Li shows images for “normal” versus “MCI” and “AD” (FF 2).
Accordingly, we agree with the Examiner that “Fig. 13C is interpreted as
baseline of a normal subject” (Ans. 5; FF 2).
Claim 3:
Claim 3 recites “wherein the elastogram of the subject’s brain and the
elastogram of the baseline subject’s brain are color coded to reflect relative
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stiffness information to indicate the status of the subject with respect to the
neurodegenerative disease” (see Appellants’ claim 3).
Appellants argue that “Li fails to disclose ‘wherein the elastogram of
the subject’s brain and the elastogram of the baseline subject’s brain are
color coded to reflect relative stiffness information to indicate the status of
the subject with respect to the neurodegenerative disease,’ as claimed” (App.
Br. 10).
We are not persuaded. As the Examiner explains, “[t]he Examiner
interprets brightness as color coding” (Ans. 5). Moreover, gray, white and
black are colors (see FF 2).
Appellants further argue that “even if the elastograms of Li are indeed
in color, there is no disclosure in Li that the color can ‘indicate the status of
the subject with respect to the neurodegenerative disease,’ as claimed” (App.
Br. 10). Appellants, however, do not require “status” to be data other than
color coding.
Claims 4 6, 13, and 16:
Claim 4 recites “wherein generating the report includes indicating a
decrease in the stiffness information of the subject’s brain when compared to
the baseline stiffness information corresponds to a relative increase in a
likelihood of the subject having the neurodegenerative disease” (see
Appellants’ claim 4).
Claim 5 recites “wherein generating the report includes indicating a
consistency in the stiffness information of the subject’s brain when
compared to the baseline stiffness information corresponds to a relative non­
change in a likelihood of the subject having the neurodegenerative disease”
(see Appellants’ claim 5).
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Claim 6 recites “wherein the baseline stiffness information includes
medical imaging data acquired from the subject during a prior medical
imaging process” (see Appellants’ claim 6).
Claim 13 recites “wherein the computer system is further programmed
to reconstruct an elastogram of the subject’s brain to derive the stiffness
information and compare the elastogram of the subject’s brain to an
elastogram of a baseline subject’s brain to indicate the status of the subject
with respect to the neurodegenerative disease” (see Appellants’ claim 13).
Claim 16 recites “wherein the computer system is further programmed
to determine a global brain stiffness decrease and correlate the global
decrease in brain stiffness to an adverse pathological condition” (see
Appellants’ claim 16).
In regard to claim 4, Appellants argue that “Li fails to disclose
‘wherein generating the report includes indicating a decrease in the stiffness
information of the subject’s brain when compared to the baseline stiffness
information corresponds to a relative increase in a likelihood of the subject
having the neurodegenerative disease,’ as claimed” (App. Br. 10).
In regard to claim 5, Appellants argue that “[njothing in the figures, or
the specification, discloses ‘indicating a consistency in the stiffness
information’ which ‘corresponds to a relative non-change in a likelihood of
the subject having the neurodegenerative disease,’ as claimed” (id. at 11).
In regard to claim 6, Appellants argue that “[n]o disclosure is made
which involves a subject being monitored over time such that, ‘the baseline
stiffness information includes medical imaging data acquired from the
subject during a prior medical imaging process[]’” (id. at 12).
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In regard to claim 13, Appellants argue that “Appellants have been
unable to find any disclosure of Li which disclose a computer which can
‘compare the elastogram of the subject’s brain’ to a baseline brain image and
‘indicate the status of the subject with respect to neurodegenerative
disease[]’” {id.).
In regard to claim 16, Appellants argue that “Li, at no point, discloses
a computer system programmed to correlate a global decrease in brain
stiffness ‘to an adverse pathological condition^’” (id. at 13).
These arguments are unpersuasive. The limitations of claims 4—6, 13,
and 16 are met by viewing the numerical data concerning stiffness for
“MCI” and “AD” versus “Normal” in Li’s Table (see FF 3). In regard to
claim 13, there is a comparison when the images or data are presented side
by side or top and bottom (see FF 2—3). We thus agree with the Examiner
that “the table [of Li] shows stiffness information as compared to the
baseline (Fig. 14). The Examiner notes that the table is a representation of
example information showing a decrease in the stiffness information as a
diagnosis for a neurodegenerative disease” (Ans. 5).
Claims 14 and 15:
In regard to claims 14 and 15, Appellants argue that they “should be
allowable for at least the reasons corresponding to” claims 4 and 5,
respectively (see App. Br. 13). We are not persuaded for the reasons
discussed above.
Claim 18:
Claim 18 recites “wherein the computer is further programmed to
derive fiber tract information from the medical imaging data and correlate
therewith the image of the subject’s brain indicating the status of the subject
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with respect to the neurodegenerative disease, based on the stiffness
information” (see Appellants’ claim 18).
We recognize, but are not persuaded by, Appellants’ contention that
“Li fails to disclose, teach or suggest deriving fiber tract, or white matter
tract, information from medical imaging data. In fact, Li fails to disclose,
teach or suggest fiber tract or white matter tract information at all” (App. Br.
13).
As the Examiner explains, “[t]he Examiner notes that appellant has
claimed fiber tract information which can include any type of information
related to fiber tract, including white matter” (Ans. 5). We note that the
images in Li’s Figures 13A—13C show the entire brain image which includes
both white matter and grey matter (FF 2).
Claim 19:
Claim 19 recites “wherein determining the stiffness map for each
ROI without contributions from brain tissue adjacent to the ROI includes
performing a single erosion from each ROI” (see Appellants’ claim 19).
Appellants argue that
[a]s discussed above in the remarks associated with Claim
11, Li fails to disclose both “determining a stiffness map for
each ROI without contributions from brain tissue adjacent to
the ROI,” and determining a plurality of RO Is in general.
Additionally, Li further fails to disclose performing a single
erosion from each ROI.
(App. Br. 14.)
We are not persuaded for the reasons discussed above. We further
agree with the Examiner that “each ROI is interpreted as individual pixels of
the image. Therefore, determining mean stiffness for white matter would
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include data from individual pixels which are white matter which would
exclude adjacent brain tissue (grey matter)” (Ans. 5; FF 2).
B. 35 U.S.C. § 103(a) over Li andKlunk
The Examiner acknowledges that “Li discloses the subject matter
substantially as claimed except for the use of an amyloid tracer” (Ans. 3).
The Examiner finds that “Klunk et al. teaches that it is known to use
an amyloid tracer, e.g. PIB, to provide diagnostic information regarding
Alzheimer’s disease” {id.).
The Examiner concludes that “it would have been obvious to have
provided Li with the data from the amyloid tracer to provide further
diagnostic information regarding the subject’s Alzheimer’s progression”
{id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Li and Klunk render the claims
obvious?
Findings of Fact
7. Klunk teaches a “study of a novel amyloid-imaging positron
emission tomography (PET) tracer, termed Pittsburgh Compound-B (PIB),
in 16 patients with diagnosed mild AD and 9 controls,” in which “[t]he
results suggest that PET imaging with the novel tracer, PIB, can provide
quantitative information on amyloid deposits in living subjects” (Klunk
Abstract; see also Ans. 3).
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.”
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KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If aperson of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We agree with the Examiner that Li and Klunk render the claims
obvious. We address Appellants’ arguments below.
Claims 1 and 10:
Appellants contend that “the Examiner took the position that
‘combining multiple data/diagnosis/modalities for a diagnosis to confirm or
track the progression of a disease is well within the skill level of one in
ordinary skill in the art. ’ Id. This conclusory reasoning shows the
Examiner’s continuing reliance on unsupported, conclusory reasoning”
(App. Br. 15).
Appellants also argue that “it would not have been obvious to
combine the global stiffness measurements of Li with the amyloid tracer
disclosed in Klunk,” and that “[b]oth Li and Klunk rely solely on individual
and distinct methods for analyzing human brains for neurodegenerative
diseases, and fail to provide any guidance on how to combine their disparate
teachings. Thus, the Examiner relied on impermissible hindsight to support
the present rejections” (id. at 15—16).
We are not persuaded.
Li evidences that “organ stiffness, e.g. brain stiffness, which can be
quantified so as to be useful in elucidating and quantifying brain cognitive
state, e.g. normal, mild cognitive impairment (MCI) or Alzheimer’s
dementia (AD)” (FF 1). Klunk applies an “amyloid-imaging positron
emission tomography (PET) tracer, termed Pittsburgh Compound-B (PIB),
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in 16 patients with diagnosed mild AD and 9 controls” in a study in which
“[t]he results suggest that PET imaging with the novel tracer, PIB, can
provide quantitative information on amyloid deposits in living subjects” (FF
7). We therefore agree with the Examiner that it would have been obvious
to provide Pittsburgh Compound-B (PIB) as an amyloid tracer as taught by
Klunk to the method of quantifying Alzheimer’s dementia by Fi (see Ans.
3). The combined teachings of Klunk’s Pittsburgh Compound-B (PIB) and
Fi’s regarding determining organ stiffness for Alzheimer’s dementia, would
yield predictable results of a more accurate diagnosis of patients having
Alzheimer’s dementia (see id. at 6).
Appellants argue that “Klunk fails to teach or suggest ‘generating a
report indicating the stiffness information of the subject’s brain relative to at
least one of baseline stiffness information and amyloid tracer[]’” (App. Br.
16).
This argument is unpersuasive as it fails to account for Fi’s
contribution to the combination of Fi and Klunk, teaching a “report” as
discussed above. “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).
Claim 20\
Appellants similarly argue that
Fi and Klunk fail to teach or suggest the method steps of
“acquiring amyloid tracer information about the subject; and
generating a report indicating a status of the subject with
respect to a neurodegenerative disease based on the stiffness
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information of the subject’s brain and the amyloid tracer
information about the subject[]”
(App. Br. 17).
We are not persuaded for the reasons discussed above. Because
Klunk teaches PET imaging with the PIB tracer, and that such imaging can
provide quantitative information on amyloid deposits (FF 7), this suggests
and would have made obvious the generating a report based on that imaging
and information.
SUMMARY
In summary, we affirm the rejection of claims 1 and 11 under 35
U.S.C. § 102(b) as being anticipated by Fi. Claims 2—9 fall with claim 1 and
claims 12—19 fall with claim 11.
We affirm the rejection of claims 1, 10, and 20 under 35 U.S.C.
§ 103(a) as obvious over Fi and Klunk.
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
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