Amisha S. Patel et al.

Patent Trials and Appeals Board

Aug 1, 2019

14257232 - (D) (P.T.A.B. Aug. 1, 2019)

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.
14/257,232 04/21/2014 Amisha S. Patel P0030224.USU1/
LG10126.L33
4807
27581 7590 08/01/2019
Medtronic, Inc. (CVG)
8200 Coral Sea Street NE.
MS: MVC22
MINNEAPOLIS, MN 55112
EXAMINER
REICHERT, RACHELLE LEIGH
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
08/01/2019 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):
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte AMISHA S. PATEL, KENNETH M. RIFF, and
LUC R. MONGEON
____________

Appeal 2018-006098
Application 14/257,2321
Technology Center 3600
____________

Before CATHERINE SHIANG, CARL L. SILVERMAN, and
STEVEN M. AMUNDSON, Administrative Patent Judges.

SHIANG, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1, 3–5, 7–11, 13–15, and 17–28, which are all the claims
pending and rejected in the application. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.

1 Appellants identify Medtronic, Inc. as the real party in interest. App. Br. 3.

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Application 14/257,232

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STATEMENT OF THE CASE
Introduction
The present invention relates to “a system and associated method for
using individual patient data and clinical database data to report outcomes.”
Spec. 1. Claim 1 is exemplary:
1. A system, comprising:
a database coupled to a communication network and
configured to store medical data for a plurality of patients
received via the network from a plurality of data sources
comprising data retrieved from implantable medical devices
implanted in the plurality of patients;
a processor coupled to the database for accessing the
stored medical data and configured to:
receive, from a remote computer, a request for a report of
a predictive outcome of a therapy intervention for a patient
group of at least one patient, the therapy intervention
comprising a change in an operating parameter of an automated
medical device, and, in response to the request:
generate a dataset from the stored medical data having at
least one data characteristic matching a corresponding data
characteristic of the patient group;
determine from the dataset at least one subset that had the
therapy intervention take place subsequent to a time point that
the at least one subset had the at least one matching data
characteristic;
determine an outcome of the at least one subset;
produce the predictive outcome for the patient group
based on the outcome of the at least one subset; and
transmit the report of the predictive outcome to the
remote computer; and
automatically, in response to new data received by the
database, produce an updated predictive outcome of the therapy
intervention for the patient group and transmit an updated
report of the updated predictive outcome to the remote
computer.
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References and Rejections2
Claims 1, 3–5, 7–11, 13–15, and 17–28 are rejected under 35 U.S.C.
§ 101 because they are directed to patent-ineligible subject matter. Final
Act. 2–6.
Claims 1, 3–5, 11, 13–15, and 21–22 are rejected under 35 U.S.C.
§ 103 as being obvious over Cazares (US 2008/0162182, published Jul. 3,
2008) and Scarlat (US 2005/0261941, published Nov. 24, 2005). Final Act.
7–17.
Claims 7–9 and 17–19 are rejected under 35 U.S.C. § 103 as being
obvious over Cazares, Scarlat, and Anderson (US 2013/0024207 A1,
published Jan. 24, 2013). Final Act. 17–23.
Claims 10, 20, 25, and 28 are rejected under 35 U.S.C. § 103 as being
obvious over Cazares, Scarlat, Anderson, and Morris (US 2012/0245953 A1,
published Sept. 27, 2012). Final Act. 23–25.
Claims 23, 24, 26, and 27 are rejected under 35 U.S.C. § 103 as being
obvious over Cazares, Scarlat, Anderson, and Sarkar (US 2012/0253207 A1,
published Oct. 4, 2012). Final Act. 25–27.

ANALYSIS
35 U.S.C. § 101

2 Throughout this opinion, we refer to the (1) Final Office Action dated
Oct. 6, 2017 (“Final Act.”); (2) Appeal Brief dated Feb. 27, 2017 (“App.
Br.”); (3) Examiner’s Answer dated Apr. 20, 2018 (“Ans.”); and (4) Reply
Brief dated May 24, 2018 (“Reply Br.”).
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We have reviewed the Examiner’s rejection in light of Appellants’
contentions and the evidence of record. We concur with Appellants’
contentions that the Examiner erred in this case.
Section 101 of the Patent Act provides “[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.” 35 U.S.C. § 101. However, the Supreme Court has long interpreted
35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural
phenomena, and abstract ideas” are not patentable. E.g., Alice Corp. Pty.
Ltd. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014) (internal quotation marks
and citation omitted).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
and Alice. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
we first determine what concept the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
Concepts determined to be abstract ideas, and, thus, patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
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mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that “[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). Having
said that, the Supreme Court also indicated that a claim “seeking patent
protection for that formula in the abstract . . . is not accorded the protection
of our patent laws, . . . and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment.” Id. (citing Benson and Flook); see, e.g., id. at 187 (“It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.”).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a
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patent-eligible application.” Alice, 573 U.S. at 221 (citation omitted). “A
claim that recites an abstract idea must include ‘additional features’ to
ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (quoting Mayo, 566 U.S. at 77).
“[M]erely requir[ing] generic computer implementation[] fail[s] to transform
that abstract idea into a patent-eligible invention.” Id.
The PTO recently published revised guidance on the application of
§ 101. USPTO’s 2019 REVISED PATENT SUBJECT MATTER ELIGIBILITY
GUIDANCE, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”). Under the
guidance set forth in the Guidance, we first look to whether the claim
recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into
a practical application (see MANUAL OF PATENT EXAMINING
PROCEDURE (“MPEP”) § 2106.05(a)–(c), (e)–(h)) (9th ed., rev.
08.2017, 2018) (Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception. (Step 2B.)
See Guidance, 84 Fed. Reg. at 54–56.
Turning to Step 2B of the Guidance, “[t]he second step of the Alice
test is satisfied when the claim limitations ‘involve more than performance
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of []well-understood, routine, [and] conventional activities previously
known to the industry.’” Berkheimer v. HP Inc., 881 F.3d 1360, 1367 (Fed.
Cir. 2018) (quoting Content Extraction & Transmission LLC v. Wells
Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1347–48 (Fed. Cir. 2014), and
Alice, 573 U.S. at 225). “Whether something is well-understood, routine,
and conventional to a skilled artisan at the time of the patent is a factual
determination.” Berkheimer, 881 F.3d at 1369.
In this case, the Examiner finds “[t]he claimed invention performs
data processing functions that are most certainly well-understood, routine,
conventional in the field of healthcare.” Ans. 8.
However, the Examiner has not provided the evidence required by
Berkheimer to support that factual finding. See Berkheimer, 881 F.3d at
1369. And the Examiner’s assertion that “unlike rejections under 35 U.S.C.
§ 102 & 103 which are questions of fact, a rejection under 35 USC 101 is a
question of law for which evidence is not required” (Ans. 8) contradicts the
Berkheimer standard. In particular, we agree with Appellants (Reply Br. 6–
7) that the Examiner has not provided any of the four categories of
information required by the Memorandum of Changes in Examination
Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter
Eligibility Decision (Berkheimer v. HP, Inc.) (“Berkheimer
Memorandum”)3:
1. A citation to an express statement in the specification or to a
statement made by an applicant during prosecution that

3 Because Appellants filed the Appeal Brief before the date of the
Berkheimer Memorandum, Appellants had good cause to raise arguments
based on the Berkheimer Memorandum in the Reply Brief. See 37 C.F.R.
§ 41.41(b)(2).
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demonstrates the well-understood, routine, conventional
nature of the additional element(s). . . .
2. A citation to one or more of the court decisions discussed in
MPEP § 2106.05(d)(II) as noting the well-understood,
routine, conventional nature of the additional element(s).
3. A citation to a publication that demonstrates the well-
understood, routine, conventional nature of the additional
element(s). . . .
4. A statement that the examiner is taking official notice of the
well-understood, routine, conventional nature of the
additional element(s). . . .
Berkheimer Memorandum at 3–4.
Therefore, the Examiner erred with respect to Step 2B of the
Guidance, and we are constrained by the record to reverse the Examiner’s
rejection of claims 1, 3–5, 7–11, 13–15, and 17–28 on procedural grounds.

35 U.S.C.§ 103

We have reviewed the Examiner’s rejections in light of Appellants’
contentions and evidence of record. We concur with Appellants’
contentions that the Examiner erred in finding the cited portions of Cazares
teach “receive, from a remote computer, a request for a report of a
predictive outcome of a therapy intervention for a patient group of at least
one patient, the therapy intervention comprising a change in an operating
parameter of an automated medical device” as recited in independent claim
1 (emphases added). See App. Br. 23–25; Reply Br. 9–11.
The Examiner cites Cazares’ paragraphs 143 and 145–148 and
Scarlat’s paragraphs 46, 47, 52, and 53 for teaching the italicized limitation.
See Final Act. 8–10; Ans. 15–16. We have reviewed the cited prior art
portions, and they do not describe “receive, from a remote computer, a
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request for a report of a predictive outcome of a therapy intervention for a
patient group of at least one patient, the therapy intervention comprising a
change in an operating parameter of an automated medical device” as
required by claim 1 (emphases added). Absent further explanation from the
Examiner, we do not see how the cited prior art paragraphs teach the
italicized limitation. Thus, we reverse the Examiner’s rejection of claim 1.
Each of independent claims 11, 21, and 22 recites a similar limitation,
and Examiner applies the same findings and conclusions discussed above
with respect to that limitation. See claims 11, 21–22; Final Act. 12–15, 17.
Therefore, for similar reasons, we reverse the Examiner’s rejection of
independent claims 11, 21, and 22.
We also reverse the Examiner’s rejections of corresponding dependent
claims 3–5, 7–10, 13–15, 17–20, and 23–28. Although the Examiner cites
additional references for rejecting some dependent claims, the Examiner has
not shown the additional references overcome the deficiency discussed
above regarding the rejection of claim 1. See Final Act. 17–27.

DECISION
We reverse the Examiner’s decision rejecting claims 1, 3–5, 7–11,
13–15, and 17–28 under 35 U.S.C. § 101.
We reverse the Examiner’s decision rejecting claims 1, 3–5, 7–11,
13–15, and 17–28 under 35 U.S.C. § 103.
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). See 37
C.F.R. § 41.50(f).
REVERSED