Ex Parte Webb et al

Patent Trial and Appeal Board

Dec 20, 2017

11741031 (P.T.A.B. Dec. 20, 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.
11/741,031 04/27/2007 James D. Webb P0026160.00/LG10126 2241
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
12/22/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES D. WEBB and AMISHA S. PATEL
Appeal 2016-007029
Application 11/741,0311
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a system that
analyzes data collected by an implanted medical device. The Examiner
rejected the claims as being directed to subject matter ineligible for
patenting, and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses that, in recent years, microprocessor-
containing implantable medical devices use algorithms that “detect and
1 Appellants state that the “real parties in interest are Medtronic, Inc. of
Minneapolis, Minnesota, the assignee of record, and Medtronic pic of
Dublin, Ireland, the ultimate parent entity of Medtronic, Inc.” Appeal Br. 3.
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Application 11/741,031
classify sensed episodes, which are characteristic of certain patient
conditions, for example, cardiac arrhythmias, and which could benefit from
therapy delivery, thereby guiding therapy delivery from the device.” Spec.
12.
The algorithms “may also monitor device integrity, for example, by
tracking events characteristic of sensing issues and/or device impedance
changes.” Id. In this regard, as explained in the Specification, “certain
components of implantable medical devices, like any other man-made
device, are subject to fault or failure, for example, either due to operator
error at the time of implant or due to normal ‘wear and tear’ on the
components during the life of the device.” Id.
Appellants’ invention is directed to a system that includes, in addition
to the implantable device, an external analysis service that collects data
sensed by the implantable device and classifies sensed episodes. Id. 13—
16. When the external analysis service classifies an episode differently than
the implanted medical device, or senses data otherwise indicative of an
integrity issued in the implanted medical device, the system of Appellants’
invention is adapted to notify a user interface of the situation. Id. ]Hf 20-22.
Claims 1, 3—28, and 30-45 are on appeal. Claims 1 and 36 are
representative and read as follows (Appeal Br. 24, 35; emphasis and some
indentation added):
Claim 1: A system facilitating analysis of data collected by
an implanted medical device that is implanted in a patient, the
system comprising:
one or more computers external to the patient;
a data handling system for storing a collection of data,
the collection of data including data sets collected by the
implanted medical device, wherein at least a portion of the data
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sets comprises one or more episode-describing data sets that
describe one or more episodes detected and classified by an
analysis performed by the implanted medical device that is
implanted in the patient;
an analysis service adapted to perform an analysis
services analysis that analyzes and classifies data sets, the
analysis service analysis being performed by the one or more
computers external to the patient; and
a software application executing on the one or more
computers external to the patient and adapted to receive a
selection of a group of the data sets stored in the data handling
system, invoke the analysis service to perform the analysis
service analysis for the selected group of the data sets, the one
or more computers being configured to determine whether
results of the analysis service analysis performed by the one
or more computers external to the patient include a
classification generated by the analysis service analysis that
differs from a classification generated by the analysis
performed by the implanted medical device that is implanted
in the patient,
the software application being further adapted to provide,
via a user interface, a notification informing a user of whether
the results of the analysis service analysis performed by the one
or more computers external to the patient include a
classification generated by the analysis service analysis that
differs from a classification generated by the analysis
performed by the implanted medical device that is implanted in
the patient.
Claim 36: A system facilitating analysis of data collected by
an implanted medical device, the system comprising:
a computer;
a data handling system for storing a collection of data,
the collection of data including data sets collected by the
implanted medical device;
an analysis service including a pre-programmed
algorithm adapted to analyze the data sets collected via sensing
electrodes of the implanted medical device; and
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a software application executing on the computer and
adapted to invoke the algorithm of the analysis service to
analyze a selected group of the data sets collected via the
sensing electrodes, organize results of the analysis service
analysis for each of the selected group of data sets collected via
the sensing electrodes, and provide, via a user interface, a
notification to a user of the system if any of the results are
indicative of a device integrity issue of the implanted medical
device.
The following rejections are before us for review:
(1) Claims 1, 3—28, and 30-45, as being directed to subject matter
ineligible for patenting (Ans. 3—5); and
(2) Claims 36-41, under 35 U.S.C. § 103(a), for obviousness over
Thompson2 and Hsu3 (Ans. 5—12).
PATENT ELIGIBILITY
The Examiner’s Position
The Examiner determines that “the instant claims are drawn to an
abstract process of mathematical relationships of analyzing and classifying
the selected group of data sets, and determining whether results of the
analysis differs from a classification generated by [a] medical device . . . i.e.
an abstract idea.” Ans. 4. In particular, the Examiner determines that the
“method steps themselves are considered to be an abstract idea because they
do not purport to improve the functioning of the computer itself, there is no
. . . limitation [or] recitation of improved computer technology, nor do they
effect an improvement in any other technology or technical field.” Id. at 4—
5.
2 US 6,648,823 B2 (issued Nov. 18, 2003).
3 US 6,091,990 (issued July 18, 2000).
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The Examiner determines further that “[n]o additional steps are
recited in the instantly claimed invention that would amount to significantly
more than the judicial exception. Without additional limitations, a process
that employs mathematical algorithms to manipulate existing information to
generate additional information is not patent eligible.” Id. at 5.
The Examiner determines further that the claimed “computer and/or
program/product amount to mere instruction to implement an abstract idea.
The hardware recited by the system claims do not offer a meaningful
limitation beyond generally linking ‘the use of the method to a particular
technological environment^] that is, implementation via computers.’” Id.
(citing Alice Corp. Pty. Ltd. v. CLS Bank Intern., 134 S. Ct. 2347 (2014)).
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, 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 “[wjhoever 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.”
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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. at 2354.
Our reviewing court has summarized the Supreme Court’s two-part
test for distinguishing between claims to patent-ineligible exceptions, and
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.
Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed.
Cir. 2016) (paragraphing added).
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.” Enfish, LLC v.
Microsoft Corp., 822 F.3d 1327, 1334 (Fed. Cir. 2016).
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In the present case, we find that Appellants’ claimed invention is
similar to that 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).
Specifically, Appellants’ claim 1 recites a system that facilitates
analysis of data collected by an implanted medical device. Appeal Br. 24.
The system is composed of one or more computers external to the patient, a
data handling system that stores data sets collected by the implanted device,
and an analysis service that uses the external computers to analyze and
classify the data sets. Id.,
The system of claim 1 also includes a software application that
determines whether the implanted medical device’s classification of a
particular set of data differs from the analysis service’s classification of the
same data, and if there is a difference, the software application notifies a
user that the difference exist. Id. at 24—25.
Neither the Specification, as summarized above, nor the claim itself
suggests that the software changes how the underlying hardware functions.
Ultimately, therefore, as the Examiner determined, the system of claim 1 is
directed to comparing the episode/event classification generated by the
implanted medical to the episode/event classification generated by the
analysis service, and informing a user whether a difference exists. As noted
above, the Specification explains that the comparison and notification are
important to inform a user of a potential problem with the implanted device.
See Spec. 12.
A similar fault-detecting invention was held to be a patent-ineligible
abstract idea in Electric Power Group. Specifically, like Appellants’ claim
1, the claim at issue in Electric Power Group involved collecting and
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receiving data, analyzing the data to determine whether there was a potential
deficiency in the underlying system (the power grid), and displaying (i.e.,
informing a user of) the analysis results. Electric Power Group, 830 F.3d at
1351-52.
In holding that the claims at issue 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.” Id. 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.
Turning to step two of the Alice analysis, as noted above, Appellants
do not identify, nor do we discern, any disclosure in either the Specification
or claim 1 suggesting that the claimed software application, or the claimed
underlying hardware, even when viewed as an ordered combination, adds an
inventive concept to the claimed invention that adds anything significantly
more to claim 1 beyond the abstract comparison of the two data
classifications recited in the claim.
In particular, our review of the Specification, summarized above,
confirms the Examiner’s finding that the claimed system uses conventional
hardware and software analytical methods. See, e.g., Spec 113 (devices
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external to implanted medical device “known to those skilled in the art”); id.
119 (stating, as to analysis algorithms, that “[mjethods which can be
incorporated by such an algorithm are described in the aforementioned
incorporated references, are known to those skilled in the art, and may
employ one or more of a number of well known techniques”).
Accordingly, for the reasons discussed, we find that a preponderance
of the evidence supports the Examiner’s determination that the system of
claim 1 is ineligible for patenting under the two-step Alice framework.
Appellants’ arguments do not persuade us to the contrary.
In particular, given the Examiner’s determination that the claimed
abstract idea is the comparison of the two data classifications recited in the
claims (see Ans. 4), Appellants do not persuade us (see Appeal Br. 11—12)
that the Examiner did not adequately identity what was considered the
abstract idea in the claims.
Moreover, that the problem addressed by claim 1 ’s system might be
particular to medical devices (see Appeal Br. 13—14) does not persuade us
that claim 1 is not ultimately directed to an abstract idea. As noted above,
the claims at issue in Electric Power Group involved detecting events
particular to an electrical power grid, yet the court concluded that the claims
were directed to an abstract idea. Electric Power Group, 830 F.3d at 1351—
54.
In addition, that the problem addressed by claim 1 ’s system might be
particular to medical devices (see Appeal Br. 15—16; Reply Br. 5—8) does
not persuade us that, under step two of the Alice framework, claim 1
involves something significantly more than the abstract idea of comparative
data analysis. As explained in Electric Power Group, “merely selecting
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information, by content or source, for collection, analysis, and display does
nothing significant to differentiate a process from ordinary mental processes,
whose implicit exclusion from § 101 undergirds the information-based
category of abstract ideas.” 830 F.3d at 1355.
In sum, for the reasons discussed, Appellants do not persuade us that
the preponderance of the evidence fails to support the Examiner’s
conclusion that the system of Appellants’ claim 1 is directed to patent-
ineligible subject matter. We, therefore, affirm the Examiner’s rejection of
claim 1 on that ground. Because they were argued in the same grouping,
claims 3—25, 42, and 43 fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants rely on their arguments, discussed above, as to the
remaining claims subject to this ground of rejection. See Appeal Br. 17—19.
For the reasons discussed above, we do not find those arguments persuasive.
We, therefore, affirm the Examiner’s rejection for patent-ineligibility as to
the claims listed in the groupings on pages 17—19 of the Appeal Brief.
OBVIOUSNESS
The Examiner’s Position
In rejecting claims 36-41 over Thompson and Hsu, the Examiner
finds that Thompson describes a system that differs from the rejected claims
in that Thompson’s system “does not teach implanted sensing electrodes.”
Ans. 7 (citing Thompson at Abstract and cols. 9, 14, and 17).
To address that deficiency, the Examiner cites Hsu as describing a
device having “implanted electrodes that receive data signals from the heart,
from an implanted cardiac defibrillator.” Id. (citing Hsu at Abstract, 5:19—
6:32, and figures).
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Based on the references’ combined teachings, the Examiner reasons
that an ordinary artisan would have considered it obvious to combine Hsu
with Thompson,
because Thompson provides a method and system for notifying
clinicians with patients with implantable medical devices about
pertinent information, (abstract) and Hsu et al. teaches
implanted medical device that provides information of
arrhythmia episodes of the patient, (abstract; column 2), thus
both notify based on information relevant to implanted medical
devices and are combinable.
Id. at 8.
Analysis
We select claim 36 as representative of the claims subject to this
ground of rejection. See 37 C.F.R. § 41.37(c)(l)(iv). Appellants do not
persuade us that a preponderance of the evidence fails to support the
Examiner’s prima facie case of obviousness as to claim 36.
Appellants contend initially that the Examiner did not explain with
adequate specificity where the prior art taught each of the features in the
system of claim 36. See Appeal Br. 20-21; see Reply Br. 10 (“To support a
prima facie rejection under § 103, the Examiner has the burden to articulate
how each element of the claims is disclosed or suggested by the cited art.”).
As our reviewing court has explained, however,
the PTO carries its procedural burden of establishing a prima
facie case when its rejection satisfies 35 U.S.C. § 132, in
“notify[ing] the applicant ... [by] stating the reasons for [its]
rejection, or objection or requirement, together with such
information and references as may be useful in judging of the
propriety of continuing the prosecution of [the] application.”
35 U.S.C. § 132. That section “is violated when a rejection is
so uninformative that it prevents the applicant from
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recognizing and seeking to counter the grounds for rejection. ”
Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990).
In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (emphasis added).
In the present case, the Examiner provided a summary restatement of
the claimed subject matter, followed by a citation to columns 9, 14, and 17,
and the abstract of Thompson, which was followed by an assertion of how
Thompson differs from the rejected claims. Ans. 6—7; see also Final Action
7—8.4 The Examiner then cited Hsu as addressing that deficiency, included a
citation of the portions of Hsu relied upon, and explained that the rejection
was based on the combination of the two references. Ans. 7—8; see also
Final Action 8.
Applying the Jung standard to the present facts, Appellants do not
explain why the Examiner’s rejection is so uninformative that it prevents
them from recognizing and seeking to counter the rejection. Indeed,
although Appellants initially did not address the majority of the portions of
Thompson cited by the Examiner (see Appeal Br. 21—22), the Examiner’s
rejection was sufficiently informative so as to allow Appellants to explain
why one cited portion of Thompson, column 14, was inadequate to teach or
suggest claim 36’s data handling system (see Reply Br. 11—12).
Appellants, however, ignored the teachings in column 17 of
Thompson, which the Examiner cited twice. See Ans. 7, 12.
In column 17, Thompson discloses that, external to its implanted
device, its system includes a data analysis feature in which “the measured
lead impedance from IMD [implanted medical device] 10 is compared to
limits to verify lead viability, expected longevity, and function per
4 Final Action entered May 20, 2015.
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recommendations in the Product Performance Report.” Thompson 17:29—
32. Appellants do not explain why this disclosure fails to teach or suggest
an analysis service for data collected by sensing electrodes in the implanted
device, as recited in Appellants’ claim 36.
Thompson goes on to explain that “if the lead impedance is less than
250 ohms and/or has changed 30% from the value measured at implant,
when measured at step 218, a recommended course of action and report is
generated at step 220.” Id. at 17:32—35. Thompson explains further that a
proposed course of action resulting from an analysis of reduced or changed
lead impedance “may include prophylactic replacement of the lead,
decreased follow-up intervals, or parameter changes to the IMD (e.g.,
increased pacing amplitude/pulse width, sensitivity threshold adjustments,
mode changes, etc.).” Id. at 17:36—39. Appellants do not explain how this
disclosure of generating a report based on an analysis of reduced or changed
lead impedance, so as to inform a user of potential corrective action, fails to
teach or suggest claim 36’s feature of providing to a user of the system a
notification when any data analysis results are indicative of a device
integrity issue of the implanted medical device.
In sum, for the reasons discussed, we are not persuaded that
Appellants have explained adequately how or why the Examiner erred in
maintaining the obviousness rejection of claim 36 over Thompson and Hsu.
We, therefore, affirm the Examiner’s rejection of that claim over those
references. Because they were argued in the same grouping, claims 37 and
38 fall with claim 36. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants rely on their arguments, discussed above, as to claims 39—
41. See Appeal Br. 22—23. For the reasons discussed above, we do not find
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those arguments persuasive. We, therefore, affirm the Examiner’s rejection
of claims 39-41 for obviousness over Thompson and Hsu.
SUMMARY
For the reasons discussed, we affirm both of the Examiner’s
rejections.
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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