Ex Parte Florent et al

Patent Trial and Appeal Board

May 17, 2018

13637373 (P.T.A.B. May. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/637,373 09/26/2012 Raoul Florent
24737 7590 05/21/2018
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.
201 OP00282WOUS 6406
EXAMINER
KINNARD, LISA M
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
05/21/2018 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):
patti. demichele@Philips.com
marianne.fox@philips.com
katelyn.mulroy@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAOUL FLORENT, WILLEM FREDERIK DEN HARTOG,
and VINCENT MAURICE ANDRE AUVRA Y
Appeal2017-002513
Application 13/637,373 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to devices and
methods for identifying the anatomical location of an inserted medical
device. The Examiner rejected the claims as being directed to subject matter
ineligible for patenting, as failing to comply with the written description
requirement, as being indefinite, and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b )(1 ).
1 Appellants state that the "real party in interest is the assignee of the present
application, Koninklijke Philips Electronics N. V." Appeal Br. 3.
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Application 13/637,373
We affirm the Examiner's subject matter ineligibility and
indefiniteness rejections.
We affirm the Examiner's written description rejection as to one of
the claims rejected on that ground, but reverse as to the other claim subject
to the rejection.
We reverse the Examiner's obviousness rejections.
STATEMENT OF THE CASE
The Specification discloses that the radiation dosage used for
visualizing the heart during angioplasty procedures can be optimized
automatically. Spec. 1-2. The Specification discloses, however, that
automatic optimization of the imaging radiation requires an initial manual
input as to whether the right or left coronary tree is being treated. Id. at 2.
The Specification discloses that if the right or left coronary tree treatment is
inputted incorrectly, the radiation dosage cannot be optimized automatically.
Id.
Appellants' invention is directed to determining whether an
interventional device, such as an inserted catheter, is in a particular part of a
patient's anatomy, such as the right or left coronary tree. Id. Appellants'
invention involves using a characteristic feature of the device's appearance,
such as the device's shape, to determine the part of the anatomy in which the
device is deployed. Id. at 2-3.
For example, an angioplasty catheter deployed in the aorta has two
distinct characteristic shapes, depending on whether the catheter is guided
into the left or right coronary ostium. Id. at 6-7. The Specification explains
further:
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The shape of the aorta 20 and coronary ostia locations
20a, 20b are such that a tool such as the injection catheter tip 21
that enters one of the ostia 20a, 20b does not bend at all in the
same way, depending in which ostium 20a, 20b it is entered. It
is therefore possible, by examining the device shape DS of this
intervention device 21, as seen in a projective image (in this
case either from an angiogram or a fluoroscopy sequence), to
determine which side of the coronary tree currently is imaged or
treated.
Id. at 7; see also Figs. 2, 3 (showing different shapes of catheter 21
when guided into left coronary ostium 20a and right coronary ostium
20b).
The Specification explains that, to determine which coronary tree
contains the device, the acquired image data regarding the shape of the
deployed device is compared to image data from a database. Id. at 7 ("It is
therefore possible to determine whether the intervention device 21 is located
in a portion 20a, 20b of the vessel structure 20 by correlating the extracted
device shape being the characterizing feature DS extracted by the feature
extraction unit 11 with the provided classifier data CD."); see also id. at 6
("The classifier data CD can e.g. be provided by a database storing classifier
data CD being characteristic for the appearance of intervention device 21
when located in certain anatomy parts 20a, 20b.").
Claims 1 and 7 are illustrative and read as follows:
1. A device configured for automatically identifying
an anatomical part of an anatomy structure comprising two or
more anatomical parts, in which anatomy structure an
intervention device resides, comprising:
an imaging system via which said device is configured
for using radiation to interrogate said anatomy structure, said
device being further configured for, based on a result of the
interrogating, deriving image content data;
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an imaging-feature extraction unit; and
an imaging-based anatomy classification unit;
said imaging-feature extraction unit being configured for
extracting at least one characterizing feature of the appearance
of the intervention device using the derived image content data;
said classification unit being configured for:
a) correlating the at least one characterizing feature
with provided classifier data that is linked correspondingly to
particular anatomical categories into which said parts would be
placeable in classifying said parts; and
b) with the links already having been created,
determining, based on said links, in which part, from among
said two or more anatomical parts, the interventional device is
located.
7. A method for automatically identifying a part of an
anatomy structure comprising two or more parts, in which
anatomy structure an intervention device resides, comprising
the steps of:
(a) extracting a characterizing feature of the appearance
of the intervention device using provided image content data;
(b) correlating the extracted characterizing feature with
provided classifier data;
( c) determining in which part of the two or more parts of
the anatomy structure the intervention device is located; and
( d) providing the classifier data using provided three
dimensional data of a model of the intervention device being
located in a part of the two or more parts of the anatomy
structure and using provided system geometry data of an
imaging system.
Appeal Br. 43, 45--46.
The following rejections are before us for review:
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(1) Claims 1-5, 7-12, and 14--28, as being directed to a
patent-ineligible judicial exception (i.e., a law of nature, a natural
phenomenon, or an abstract idea) (Ans. 2--4);
(2) Claims 3 and 27, under 35 U.S.C. § 112, first paragraph, as failing
to comply with the written description requirement (Ans. 4--5);
(3) Claims 1-5, 19, 20-24, and 27, under 35 U.S.C. § 112, second
paragraph, as being indefinite (Ans. 5---6);
(4) Claims 1, 4, 5, 7, 10, 11, 14--17, 20, 23, and 25-28, under 35
U.S.C. § 103(a) as being unpatentable over Simon2 and Markowitz3 (Ans. 7-
10);
(5) Claims 2, 3, 8, 9, 12, and 24, under 35 U.S.C. § 103(a) as being
unpatentable over Simon, Markowitz, and Brummer4 (Ans. 10-14);
(6) Claim 18, under 35 U.S.C. § 103(a) as being unpatentable over
Simon, Markowitz, and Solem5 (Ans. 14);
(7) Claim 21, under 35 U.S.C. § 103(a) as being unpatentable over
Simon, Markowitz, Brummer, and Solem (Ans. 14--15); and
(8) Claim 18, under 35 U.S.C. § 103(a) as being unpatentable over
Simon, Markowitz, and Wittenbrink6 (Ans. 15).
STANDARD OF REVIEW
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
2 US 8,608,481 B2 (issued Dec. 17, 2013).
3 US 2009/0264752 Al (published Oct. 22, 2009).
4 US 6,898,302 B 1 (issued May 24, 2005).
5 US 2006/0039600 Al (published Feb. 23, 2006).
6 US 2004/0179010 Al (published Sept. 16, 2004).
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record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
PATENT ELIGIBILITY
The Examiner's Prima Facie Case
In rejecting claims 1-5, 7-12, and 14--28, as being directed to
patent-ineligible subject matter, the Examiner finds that the claimed
invention "relies upon collecting and comparing known information,
obtaining and comparing intangible data, comparing new and stored
information and using rules to identify options, using categories to organize
store and transmit information, data recognition and storage, organizing
information through mathematical correlations .... " Ans. 2. The Examiner
finds that those activities are "abstract ideas, or a concept similar to those
found by the courts to be abstract, as it involves mathematically relating data
or an idea of itself (prong 1 of the two-part test)." Id.
As to "prong 2 of the two-part test," the Examiner finds that the
recited steps and elements are directed to "insignificant post-solution activity
and/or data gathering ( e,g.-acquiring an image); and/or applying the abstract
idea in a computer environment according to well-known, routine, and
conventional techniques (e.g. - determining image features and using a
classification technique to compare the image features to those in a
database)." Id. at 3 .
The Examiner reasons, therefore, that "these additional claim
element(s) do not provide meaningful limitation(s) to transform the abstract
idea into a patent eligible application of the abstract idea such that the
claim( s) amounts to significantly more than the abstract idea itself." Id.
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Analysis
Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner's conclusion that the rejected claims recite
subject matter ineligible for patenting.
35 U.S.C. § 101 states that "[w]hoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title."
The Supreme Court has "long held that this provision contains an
important implicit exception: Laws of nature, natural phenomena, and
abstract ideas are not patentable." Alice v. CLS, 134 S. Ct. 2347, 2354
(2014).
Our reviewing court has summarized the Supreme Court's two-part
test for distinguishing between (a) claims to patent-ineligible exceptions, and
(b) claims to patent-eligible applications of those exceptions, as follows:
Step one asks whether the claim is "directed to one of
[the] patent-ineligible concepts." [Alice, 134 S. Ct. at 2354]. If
the answer is no, the inquiry is over: the claim falls within the
ambit of§ 101. If the answer is yes, the inquiry moves to step
two, which asks whether, considered both individually and as
an ordered combination, "the additional elements 'transform the
nature of the claim' into a patent-eligible application." Id.
(quoting Mayo [Collaborative Services v. Prometheus Labs,
Inc., 132 S. Ct. 1289, 1297 (2012)]).
Step two is described "as a search for an 'inventive
concept."' Id. (quoting Mayo, 132 S. Ct. at 1294). At step two,
more is required than "well-understood, routine, conventional
activity already engaged in by the scientific community," which
fails to transform the claim into "significantly more than a
patent upon the" ineligible concept itself. Mayo, 132 S. Ct. at
1298, 1294.
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Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed.
Cir. 2016) (paragraphing added).
As to step one of the Alice test, our reviewing court has explained
that, when determining whether a claim is directed to an abstract idea, "both
this court and the Supreme Court have found it sufficient to compare claims
at issue to those claims already found to be directed to an abstract idea in
previous cases." Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327, 1334 (Fed.
Cir. 2016).
In the present case, Appellants' claimed invention is similar in certain
respects to the invention held by the court to be a patent-ineligible abstract
idea in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir.
2016). Like the process in the claim at issue in Electric Power, see id. at
1351-52, the inventive components of the device of Appellants' claim 1-
the imaging-feature extraction unit and imaging-based classification unit-
receive and analyze data (image data specifically), and inform a user of the
determined result of that data analysis (the anatomical part in which the
interventional device is located). Appeal Br. 43. As noted in the summary
of Appellants' Specification presented above, the correlating step performed
by claim 1 's device simply involves comparing certain extracted (i.e.,
selected) image data to image data from a database to determine the
anatomical location of the inserted device. Spec. 6-7.
In holding that the claims at issue in Electric Power Group were
directed to a patent-ineligible concept, the court explained that "merely
presenting the results of abstract processes of collecting and analyzing
information, without more (such as identifying a particular tool for
presentation), is abstract as an ancillary part of such collection and analysis."
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830 F.3d at 1354. Indeed, the court's statement of its ultimate conclusion as
to step one of the Alice analysis is applicable here:
[T]he claims are clearly focused on the combination of those
abstract-idea processes. The advance they purport to make is a
process of gathering and analyzing information of a specified
content, then displaying the results, and not any particular
assertedly inventive technology for performing those functions.
They are therefore directed to an abstract idea.
Id.; see also In re BRCAJ- and BRCA2-Based Hereditary Cancer Test
Patent Litigation, 774 F.3d 755, 761---63 (Fed. Cir. 2014) (holding step of
comparing two DNA sequences to be abstract idea).
We acknowledge that, in addition to the functionally claimed
components that perform the abstract data manipulation, the device of
Appellants' claim 1 includes an imaging system that obtains the image data
that is subsequently manipulated and compared to the database. Appeal Br.
43.
As our reviewing court has explained, however, "not every claim that
recites concrete, tangible components escapes the reach of the abstract-idea
inquiry." In re TL! Communications LLC Patent Litigation, 823 F.3d 607,
611 (Fed. Cir. 2016). In particular, in TL! Communications, the court noted
that claims that reciting general-purpose computer components, a "scanner,"
an "interface " "network " and a "database" were nevertheless "directed to"
' '
an abstract idea. Id. (citing Alice, 134 S.Ct. at 2360; Content Extraction &
Transmission LLC v. Wells Fargo Bank, Nat 'l Assn, 776 F.3d 1343, 1347
(Fed. Cir. 2014); Mortg. Grader, Inc. v. First Choice Loan Serv. Inc., 811
F.3d 1314, 1324--25 (Fed. Cir. 2016)).
Thus, because claim 1 is directed to a device in which functionally
claimed inventive elements merely collect and analyze information, we
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agree with the Examiner that, under step one of the Alice test, claim 1 is
directed to an abstract idea.
Step two of the Alice inquiry requires us to determine whether, aside
from the judicial exception, claim 1 includes something more than "'well-
understood, routine, conventional activity already engaged in by the
scientific community,' which ... transform[ s] the claim into 'significantly
more than a patent upon the' ineligible concept itself." Rapid Litigation
Mgmt. v. CellzDirect, 827 F.3d at 1047 (quoting Mayo, 132 S.Ct. at 1298,
1294. As to step two of the Alice test, we again agree with the Examiner.
Aside from the functionally recited components which perform the
abstract data manipulation-the imaging-feature extraction unit and
imaging-based classification unit-an imaging system is the only other
component in the device of Appellants' claim 1. Appeal Br. 43. As
evidenced by Appellants' Specification (Spec. 1 ), as well as Simon (see,
e.g., Simon Fig. 2C) and Markowitz (see, e.g., Markowitz i-f 6), imaging
systems using techniques such as fluoroscopy were routinely used when
determining the location of a medical device inserted into a patient.
Thus, we agree with the Examiner that under step two of Alice, claim
1 does not contain anything beyond the abstract idea that transforms the
claimed subject matter into significantly more than a claim to the abstract
idea itself. Accordingly, we also agree with the Examiner that, under the
two-step test of Alice, claim 1 is directed to subject matter ineligible for
patenting.
We acknowledge Appellants' contention that the claimed combination
of elements "provide[ s] a technical improvement over the prior art of
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record." Appeal Br. 38. Appellants, however, do not identify any specific
evidence of record, comparative or otherwise, that supports that assertion.
We acknowledge also Appellants' contention that, on this record, the
device of claim 1 is novel and unobvious. Appeal Br. 3 7.
As our reviewing court has explained, however, although Appellants
may have "made a '[g]roundbreaking, innovative, or even brilliant
discovery,' ... that is not enough" to establish patent eligibility. In re
BRCAJ- and BRCA2-Based Hereditary Cancer Test Patent Litigation, 774
F.3d at 759 (citing Association for Molecular Pathology v. Myriad, 133
S.Ct. 2107, 2117 (2013)). Thus, that the combination of components recited
in claim 1 might be novel and unobvious does not demonstrate that claim 1
recites subject matter eligible for patenting.
In sum, for the reasons discussed, we find that the preponderance of
the evidence supports the Examiner's conclusion that claim 1 recites subject
matter ineligible for patenting. We, therefore, affirm the Examiner's
rejection of claim 1 on that ground.
In arguing that the remaining claims subject to this ground of rejection
are directed to patent-eligible subject matter, Appellants rely on their
arguments in relation to the Examiner's obviousness rejections. See Appeal
Br. 3 9-41. As discussed above, however, that Appellants' claims might be
directed to novel and unobvious combinations of steps or components does
not demonstrate that those claims recite subject matter eligible for patenting.
See In re BRCAJ- and BRCA2-Based Hereditary Cancer Test Patent
Litigation, 774 F.3d at 759. Accordingly, we also affirm the Examiner's
rejection of claims 2-5, 7-12, and 14--28 as being directed to patent-
ineligible subject matter.
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WRITTEN DESCRIPTION
The Examiner's Prima Facie Case
In rejecting claims 3 and 27 as failing to comply with the written
description requirement, the Examiner found that "[ r ]egarding claim 3, the
disclosure does not define the term projection characteristic, therefore it has
been interpreted as an image characteristic. Regarding claim 27, the
disclosure does not define the term alternative, rendering the claim unclear."
Ans. 5.
Analysis
"In the context of the written description requirement, an adequate
prima facie case must ... sufficiently explain to the applicant what, in the
examiner's view, is missing from the written description." Hyatt v. Dudas,
492 F.3d 1365, 1370 (Fed. Cir. 2007).
The test for determining whether a specification is sufficient to
support a particular claim "is whether the disclosure of the application relied
upon 'reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter."' Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983)).
Thus, "[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations." In re Wertheim, 541F.2d257, 262 (CCPA
197 6) (citation omitted).
As to claim 3, Appellants do not persuade us that a preponderance of
the evidence fails to support the Examiner's determination that the term
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"projection characteristics" (Appeal Br. 44 (claim 3)), lacks descriptive
support in the Specification. Appellants contend that an ordinary artisan
would have understood the meaning of "projection characteristics" based on
disclosures in the Specification. Appeal Br. 26-27 (citing Spec. 6:12-19; id.
at 8:16-19, 28-31; id. at 10:9-12, 22-24; id. at 11:3-5).
We acknowledge that, of the identified portions of the Specification,
the term "projection characteristics" appears at pages 10 and 11. Those
pages of the Specification, however, do not include a specific definition for
"projection characteristics." See Spec. 10-11. Nor do Appellants explain
specifically why the cited portions of the Specification demonstrate that an
ordinary artisan would understand the meaning of the term. Nor do
Appellants identify any definition of the term elsewhere in the record.
Thus, because the Specification does not explain the meaning of the
term "projection characteristics" with sufficient clarity such that ordinarily
skilled artisans would have recognized Appellants as having invented a
process including those elements, Appellants do not persuade us that the
Examiner erred in finding that the term "projection characteristics" in claim
3 lacks descriptive support in the Specification. We, therefore, affirm the
Examiner's rejection of claim 3 under 35 U.S.C. § 112, first paragraph.
As to claim 27, however, we find that the preponderance of the
evidence does not support the Examiner's determination that the term
"alternative" in claim 27 lacks descriptive support.
Claim 27 recites "[t]he device of claim l, said determining entailing
selecting from among alternatives, said alternatives respectively representing
ones [sic] of said parts." Appeal Br. 49.
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Claim 1 recites, as to the step further defined in claim 2 7,
"determining, based on said links [of data corresponding to anatomical
categories], in which part, from among said two or more anatomical parts,
the interventional device is located." Id. at 43.
Thus, viewing claim 2 7 in light of the claim from which it depends,
claim 1, the term "alternatives" means the plurality of anatomical parts from
which one part may be selected. As the meaning of the term is, therefore,
not unclear, and is supported in the Specification (see, e.g., Spec. 8-9
(explaining that selection may be made from a plurality of anatomical
portions of the heart)), we reverse the Examiner's rejection of claim 27
under 35 U.S.C. § 112, first paragraph.
INDEFINITENESS
The Examiner's Prima Facie Case
In rejecting claims 1-5, 19, 20-24, and 27 for indefiniteness, the
Examiner determines that the terms "feature extraction unit," "classification
unit," "classifier-data generation unit," and "estimation unit" are directed to
"generic placeholder[ s] coupled with functional language." Ans. 6.
The Examiner determines that those terms are indefinite under 35
U.S.C. § 112, second and sixth paragraphs, because they "are not associated
with specific structures in the disclosure." Id.
Analysis
Terms recited using means plus function language are indefinite when
the Specification does not provide specific structures or algorithms for
performing the functions associated with the claimed means. Ex parte
Rodriguez, 92 USPQ 2d 1395, 1400-1403 (BP AI) (precedential). Claim
terms that do not use means plus function language, such as those identified
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by the Examiner in this case, are also subject to the means plus function
requirements when they use nonce words as generic placeholders to identify
elements otherwise described solely by functional language. Id. at 1403-
1406; see also MPEP § 2181.I.A. (describing "unit for" as nonce term
potentially invoking means plus function requirements).
In the present case, Appellants do not contend that the Examiner erred
in determining that the terms at issue, all recited in terms of a "unit" (Ans.
5---6), invoke the means plus function requirements. Rather, Appellants
contend that the Examiner failed to acknowledge the claims' full recitations
regarding the terms at issue. Appeal Br. 27; Reply Br. 15. Moreover,
Appellants contend, the terms at issue find adequate structural or algorithmic
support in the Specification. Appeal Br. 27-35; Reply Br. 15-18.
We find that the preponderance of the evidence supports the
Examiner's position.
We acknowledge that the full terms determined by the Examiner to be
indefinite are "imaging-feature extraction unit" (Appeal Br. 43--44 (claims 1
and 2)), "imaging-based anatomy classification unit" (id.), "medical-image-
based classifier-data generation unit" (id. at 44 (claim 2)), and "estimation
unit" (id. at 44 (claim 3)). Having carefully reviewed each of the portions of
the Specification cited by Appellants, however, we are not persuaded that
the Specification provides sufficiently specific structures or algorithms for
performing the functions associated with the claimed units.
The portions of the Specification cited in relation to the imaging-
feature extraction unit (Appeal Br. 28; Reply Br. 16) do not describe a
specific device or algorithm that performs the image feature extracting
function. Rather, the cited portions of the Specification state only that the
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extraction is performed "using usual segmentation or image analysis tools."
See, e.g., Spec. 6, 9, 10. Appellants do not identify any specific disclosure
in the Specification, or elsewhere in the record, explaining what specific
algorithms or devices correspond to the "usual segmentation or image
analysis tools." Accordingly, we agree with the Examiner that claims 1 and
2 are indefinite in their recitation of an "imaging-feature extraction unit."
Similarly, the portions of the Specification cited by Appellants in
relation to the imaging-based anatomy classification unit (Appeal Br. 28;
Reply Br. 16-17) do not describe a specific device or algorithm that perform
the imaging-based anatomy classification function. For example, at page 2,
the portion of the Specification cited by Appellants discloses the following:
The anatomy part classification unit correlates the at least one
characterizing feature DS with provided classifier data CD
which are characteristic for a projection feature of the
intervention device viewed under certain geometry of an
imaging system. After correlating, the anatomy part
classification unit determines in which part of the anatomy
structure comprising several parts the intervention device is
located.
Spec. 2.
As is evident, the cited portion of the Specification simply restates the
function performed by the unit, without disclosing either an algorithm
explaining specifically how that function is performed, or disclosing a
specific device that performs that function.
Similarly, the portions of the Specification cited by Appellants (see
Appeal Br. 29--30; Reply Br. 17-18) in relation to the medical-image-based
classifier-data generation unit merely restate the function performed by the
unit, without disclosing either an algorithm explaining specifically how that
function is performed, or disclosing a specific device that performs that
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function. For example, the cited portion of the Specification discloses the
following at pages 2-3:
According to another aspect of the invention the device
further comprises a characterisation unit. The characterisation
unit uses provided three dimensional data 3DD of a model of
the intervention device which is located in a part of the several
parts of the anatomy structure and uses provided system
geometry data SGD of an imaging system to provide the
classifier data CD.
Spec. 2-3.
Similarly, the portions of the Specification cited by Appellants (see
Appeal Br. 34; Reply Br. 18-19) in relation to the estimation unit merely
restate the function performed by the unit, without disclosing either an
algorithm explaining specifically how that function is performed, or
disclosing a specific device that performs that function. For example, the
cited portion of the Specification discloses the following at page 3:
According to yet another aspect of the invention the
device further comprises an estimation unit. The estimation
unit uses provided system geometry data SGD and provided
three dimensional data 3DD of a model of the intervention
device being located in a part of the several part of the anatomy
structure to estimate a projection characteristics PS of the
intervention device being located in a part of the several part of
the anatomy structure.
Spec. 3.
In sum, for the reasons discussed, Appellants do not persuade us that
the Examiner erred in determining that the claimed "imaging-feature
extraction unit" (Appeal Br. 43--44 (claims 1 and 2)), "imaging-based
anatomy classification unit" (id.), "medical-image-based classifier-data
generation unit" (id. at 44 (claim 2)), and "estimation unit" (id. at 44 (claim
3)), render the claims containing those terms, and their dependent claims,
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indefinite. We, therefore, affirm the Examiner's rejection of claims 1-5, 19,
20-24, and 27 under 35 U.S.C. § 112, second and sixth paragraphs.
OBVIOUSNESS
The Examiner's Prima Facie Case
In rejecting claims 1, 4, 5, 7, 10, 11, 14--17, 20, 23, and 25-28 over
Simon and Markowitz, the Examiner cites Simon as describing devices and
processes that differ from the rejected claims in that "Simon does not
explicitly disclose details regarding an imaging system." Ans. 8
The Examiner cites Markowitz as disclosing an imaging system
having the features required by the rejected claims, and reasons that "[i]t
would have been obvious to one of ordinary skill in the art, having the
teachings of Simon and Markowitz before him at the time the invention was
made to add an imaging system, as disclosed by Markowitz, for the purpose
of tracking a device [Markowitz, paragraph [00081]." Id.
Analysis
In KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized "an expansive and flexible approach" to the
obviousness question, id. at 415, the Court also reaffirmed the importance of
determining "whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue." Id. at 418 (emphasis
added).
Ultimately, therefore, "[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
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In this instance, Appellants persuade us that the preponderance of the
evidence does not support the Examiner's conclusion of obviousness. In
particular, Appellants persuade us (see, e.g., Appeal Br. 8-12) that the
combined teachings of Simon and Markowitz do not suggest using "at least
one characterizing feature of the appearance of the intervention device" (id.
at 43 (claim 1, emphasis added)) as a basis for the correlating (comparison)
function that determines the location of the inserted device.
Claim 1 recites a device that includes an imaging-feature extraction
unit that extracts at least one characterizing feature of the appearance of the
intervention device from image data obtained by an imaging system. Id. As
noted above, one characterizing feature of the appearance of the intervention
device is the shape the device assumes when deployed in a particular portion
of the patient's anatomy, such as the right or left coronary ostium. See Spec.
2-3, 6-7.
The device of claim 1 also contains an imaging-based anatomy
classification unit that correlates, i.e. compares, the image data regarding the
characterizing feature of the appearance of the intervention device to
classifier data, e.g., from a database, thereby allowing determination of the
location of the device. Appeal Br. 43; see also Spec. 6 (classifier data may
be from a database).
Appellants' remaining independent claims similarly require the use of
the appearance of the inserted device as an indication of the anatomical
location of the device. See Appeal Br. 45--46 (claim 7 reciting "extracting a
characterizing feature of the appearance of the intervention device using
provided image content data [and] correlating the extracted characterizing
feature with provided classifier data"); id. at 4 7--48 (claim 14 reciting
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computer readable medium having executable instructions for "extracting a
characterizing feature of the appearance of the intervention device using the
derived image content data [and] correlating the extracted characterizing
feature with provided classifier data").
In contrast to Appellants' claimed use of a feature of the appearance
of the inserted device as an indication of the anatomical location of an
inserted device, Simon discloses using measured physical properties or
physiological conditions to determine the device's location. Simon, abstract
("A method to determine the location of an instrument within a patient can
be based upon the measuring of a characteristic within the patient and
matching the currently measured characteristic with a previously measured
characteristic.").
In the portion of the reference cited by the Examiner as teaching or
suggesting Appellants' claimed location-determining feature (see Ans. 17),
Simon explains that, by measuring multiple physical properties or
physiological conditions at a particular anatomical location, a "fingerprint"
of the particular location can be created:
An example of a blend of multiple features in the
fingerprint may include a measured position (but may also
include a pulsative pressure, velocity, etc.) during a
physiological cycle, such as a cardiac cycle. The measured
position can be blended with the cardiac cycle to generate a
blended curve indicating the change in position over the time of
the cardiac cycle. Also, the curve could be based on an average
of several cardiac cycles and several subjects, as discussed
herein. The blended curve could then be matched to a patient
or procedure curve.
Id. 5:65---6:7.
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Simon explains that, when a surgical device is subsequently deployed,
the sensed physical properties or physiological conditions at a particular
anatomical location, can be compared to the fingerprint to determine the
device's location. Id. at 7:42--45 ("During a second procedure, such as the
positioning of a second stent or a[ n] angioplasty, the patient specific
fingerprint can be used ... to identify the location of a catheter during the
second procedure.").
Thus, Simon's device is similar to the device of Appellants' claim 1 in
that Simon compares measured features to a previously determined set of
features in a fingerprint to determine the location of an inserted medical
device. We are not persuaded, however, that the Examiner has explained
adequately how or why Simon's disclosure of determining a device's
location using physical properties at anatomical locations or physiological
conditions, such as "multiple features in the fingerprint [which] may include
a measured position (but may also include a pulsative pressure, velocity,
etc.) during a physiological cycle, such as a cardiac cycle" (id. at 5:65-6: 1 ),
teaches or suggests using a characterizing feature of the device's appearance,
such as shape, to determine the device's location, even when viewing Simon
in light of Markowitz.
We acknowledge, as the Examiner contends, that Simon teaches that
multiple measured features may be used to create the location-determining
fingerprint, including "instrument motion [which] can include acceleration,
velocity, position, or other information" (id. at 7:56-57), "fluid motion ...
such as the direction, turbulence, velocity or other fluid motion information"
(id. at 8: 18-20), "electrical activity" (id. at 8:25), "pressure information
[which] can include fluid pressure, tissue pressure, pulsative pressure, or
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other pressure measurements" (id. at 8:35-37), and "tissue stiffness or
density" (id. at 8:46). The Examiner, however, does not explain specifically
why any of the features disclosed in Simon as providing the location-
determining fingerprint would have taught or suggested Appellants' claimed
use of a characterizing feature of the appearance of the inserted device, such
as its shape, as an indication of the anatomical location of an inserted device.
Accordingly, because we are not persuaded that the Examiner has
explained with adequate specificity why the combination of Simon and
Markowitz teaches or suggests using a feature of the appearance of an
inserted medical device as an indication of the anatomical location of the
device, as required by each of Appellants' independent claims 1, 7, and 14,
we reverse the Examiner's rejection of those claims, and their dependents,
over Simon and Markowitz.
As to the remaining obviousness rejections, the Examiner relies on
Brummer, Solem, and Wittenbrink as evidence that features in certain
dependent claims would have been obvious variations on the subject matter
recited in independent claims 1, 7, and 14. See Ans. 10-15. Accordingly,
because the Examiner does not explain why Brummer, Solem, and
Wittenbrink remedy the deficiencies discussed above of Simon and
Markowitz as to independent claims 1, 7, and 14, we reverse the Examiner's
obviousness rejections based on the combinations of Simon and Markowitz
with Brummer, Solem, and Wittenbrink.
SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 1-5, 7-12, and 14--28, as being directed to a patent-ineligible judicial
exception;
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For the reasons discussed, we affirm the Examiner's rejection of
claim 3, under 35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement;
For the reasons discussed, however, we reverse the Examiner's
rejection of claim 27, under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement;
For the reasons discussed, we affirm the Examiner's rejection of
claims 1-5, 19, 20-24, and 27, under 35 U.S.C. § 112, second paragraph, as
being indefinite;
For the reasons discussed, however, we reverse each of the
Examiner's rejections for obviousness under 35 U.S.C. § 103(a).
TIME PERIOD
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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