Ex Parte Ciarniello et al

Patent Trial and Appeal Board

Aug 19, 2016

12418607 (P.T.A.B. Aug. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/418,607 0410512009
23460 7590 08/23/2016
LEYDIG VOIT & MA YER, LTD
TWO PRUDENTIAL PLAZA, SUITE 4900
180 NORTH STETSON A VENUE
CHICAGO, IL 60601-6731
FIRST NAMED INVENTOR
Anthony Ciarniello
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.
257426 8873
EXAMINER
MISIASZEK, AMBER AL TSCHUL
ART UNIT PAPER NUMBER
3624
NOTIFICATION DATE DELIVERY MODE
08/23/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
Chgpatent@leydig.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY CIARNIELLO,
LONNY REISMAN,
and CHARLES BLANKSTEEN
Appeal2014--002265
Application 12/418,607
Technology Center 3600
Before ANTON W. PETTING, NINA L. MEDLOCK, and
BRUCE T. WIEDER, Administrative Patent Judges.
PETTING, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE1
Anthony Ciamiello, Lonny Reisman, and Charles Blanksteen
(Appellants) seek review under 35 U.S.C. § 134 of a final rejection of
claims 1-33, the only claims pending in the application on appeal. We have
jurisdiction over the appeal pursuant to 35 U.S.C. § 6(b).
1 Our decision will make reference to the Appellants' Appeal Brief ("App.
Br.," filed June 19, 2013) and Reply Brief ("Reply Br.," filed December 4,
2013), and the Examiner's Answer ("Ans.," mailed October 4, 2013), and
Final Action ("Final Act.," mailed May 17, 2012).
Appeal2014-002265
Application 12/418,607
The Appellants invented a way to perform medical analysis.
Specification para. 1.
An understanding of the invention can be derived from a reading of
exemplary claim 1, which is reproduced below (bracketed matter and some
paragraphing added).
1. A method of providing a personal health record to an
individual patient, the method comprising:
[ 1] aggregating electronic medical care information relating to
the patient
using an automated health care computer information
system programmed to integrate a plurality of disparate
medical data sources,
the health care computer information system having
access to at least one source of data,
including health plan claims data obtained from at
least one health care provider and submitted in
connection with a claim under a health plan;
[2] deriving clinical information from the health plan claims
data;
[3] organizing the aggregated medical care information into a
medical data file for the patient and storing the medical data file
in a computer readable medium of the health care computer
information system;
[ 4] providing a password-protected, personal Web page for the
patient,
the Web page including a display of certain elements of
the patient's healthcare history automatically populated
based on the contents of the medical data file, and further
including a section for use by the patient to enter
additional healthcare information;
[5] receiving the additional healthcare information entered by
the patient using the Web page;
2
Appeal2014-002265
Application 12/418,607
and
[ 6] updating the medical data file with the received information.
The Examiner relies upon the following prior art:
Summerell US 5,937,387
Segal
Knaus
US 2001/0041991 Al
US 2002/0004727 Al
Aug. 10, 1999
Nov. 15, 2001
Jan. 10,2002
Claims 1--4, 6-10, 11-14, 16-18, 25, 32, and 33 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Segal and Knaus.
Claims 5, 15, 19-24, and 26-31 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Segal, Knaus, and Summerell.
ISSUES
The issues of obviousness tum primarily on the weight afforded
non-functional data labels and to the extent weight is afforded, the breadth
in scope of the labels employed in the claims.
FACTS PERTINENT TO THE ISSUES
The following enumerated Findings of Fact (FF) are believed to be
supported by a preponderance of the evidence.
Facts Related to Claim Construction
01. The disclosure contains no lexicographic definition of
"clinical."
3
Appeal2014-002265
Application 12/418,607
02. The plain meaning of "clinical" is an adjective that modifies a
noun as involving or based on direct observation of a patient.2
Facts Related to the Prior Art
Segal
03. Segal is directed to the field of electronic commerce,
telemedicine, and global network medical record management
services, and more particularly, creating, storing, accessing, and
distributing focused patient medical records. Segal para. 3.
04. Segal describes a need for an integrated view of patient data
with the comprehensive medical history necessary for efficient
and accurate diagnosis and treatment because, in the face of
multiple health care providers, health care insurance companies,
and their corresponding individual computer medical record
systems, electronic medical records (EMRs) fail to provide
centralized and integrated records management. A single patient's
EMR is typically fragmented between different health care
providers and health insurance providers, with records distributed
across multiple repositories. As a result, a physician does not
have an integrated view of the patient data, and consequently lacks
the comprehensive medical history necessary for efficient and
accurate diagnosis and treatment. Segal para. 10.
2 The American Heritage Dictionary of the English Language, Fifth Edition
2015 by Houghton Mifflin Harcourt Publishing Company.
https://www.ahdictionary.com/word/search.html?q=clinical
4
Appeal2014-002265
Application 12/418,607
05. Segal describes Patient Power, a system for creating, storing,
accessing, updating, and distributing patient medical records,
especially diagnostic-quality medical imaging, under the control
of a patient and the coordinated care of the patient and physician.
Segal provides centralized and focused online medical record
storage, facilitates a patient-physician partnership by which to
create and maintain the focused online medical records, provides
means for obtaining and storing diagnostic-quality images,
establishes Internet-based communication through which to
transmit medical records, provides immediate means for
conveying critical medical information in emergency situations,
and provides means for storing, receiving, and transmitting
diagnostic-quality mammograms. Segal para. 21.
06. Segal describes entering data into the patient's medical record.
The data is in three primary forms: 1) textual records; 2) scanned
records, such as EKGs and special reports; and 3) medical images,
such as x-rays. An authorized user, who may be, for example, the
patient, a relative of the patient, or the patient's physician, enters
textual information through an online Internet connection that
interfaces with the GUis and the web server. The web server
stores in the clinical database the textual data received through the
GUis. For scanned records, the scanner (or a facsimile machine)
digitally encodes the original documents and stores the encoded
files in the clinical database. For medical images, which require
diagnostic quality (significantly higher than the quality required
for the scanned documents), the digitizer digitally encodes an
5
Appeal2014-002265
Application 12/418,607
original medical image in a high-resolution format file. Segal
para. 27.
07. Segal describes a website-accessible database on the Internet
that gathers and disseminates information related to patient
medical records. Users, e.g., patients and physicians, can access a
clinical database, account database, image archive, web-enabler,
and expanded memory image archive via the website. A user
enters the appropriate website address (e.g., URL) to obtain access
to these databases. Using a series of web pages, users can enter,
modify, and obtain information contained in the server databases.
Segal para. 84.
Knaus
08. Knaus is directed to creating and utilizing a broadband
computer-based networked system for individualized control and
management of medical records. Knaus para. 3.
09. Knaus describes the integration of medical records by obtaining
medical information of a patient, which may include medical
records, from a plurality of sources, and entering that information
electronically into a computer system of the invention. Sources
include primary sources (e.g., hospitals, physician's offices and
clinics that directly administer treatment to the patient), and
secondary sources (e.g., diagnostic services performed at
laboratories), and also payor sources such as insurers. Integration
according to the invention creates a completely uniform,
6
Appeal2014-002265
Application 12/418,607
cumulative medical record within a single computer system.
Knaus para. 52.
ANALYSIS
We are not persuaded by Appellants' argument that "[t]he cited
references fail to teach or suggest the limitation of 'aggregating electronic
medical care information ... [including] health plan claims data."' App.
Br. 13. As the Examiner finds, Knaus describes creating medical records
from compilations that can be used as primary records for insurers. Ans.
22. The limitation only recites aggregating information and does not recite
or narrow the manner or implementation, other than that it somehow use an
automated health care computer information system programmed to
integrate a plurality of disparate medical data sources. Again, no particular
implementation for such integration is recited, and therefore would include
Segal' s patient entry that integrates such disparate sourced records within its
scope. As the Examiner finds, Knaus also does this, but in an automated
form of data collection and entry. Knaus in particular describes its system as
accessing the health insurer's database.
Further, the phrase "health plan claims data" contains a noun, "data"
modified by the adjective phrase "health plan claims." Neither this phrase
nor the context narrows or suggests the manner of such modification, so any
data having to do with health plan claims are within the scope. In particular,
data from any source that are in some manner duplicative or indicative of
health plan claims would be within the scope of this limitation. Both
references consolidate data that would fall within such a scope. The phrase
7
Appeal2014-002265
Application 12/418,607
is not so narrow as to exclusively refer only to data that come from a health
insurer's database. Absent a step that explicitly would do so, we conclude
Appellants seek broader scope.
We are not persuaded by Appellants' argument that "[t]he cited
references fail to teach or suggest the limitation of 'deriving clinical
information from the health plan claims data."' App. Br. 14. The analysis
here is similar to that of the first argument, as this argument refines the
nature of the data obtained from health plan claims data. Both references
describe the data compiled as being about the patient and for the benefit of
patient and physician. Segal particularly refers to storing such data in a
clinical database.
But even if the data were not health plan claims data and clinical
information derived from the health plan claims data, this would not change
the conclusion. Our reviewing court has held that nonfunctional descriptive
material cannot lend patentability to an invention that would have otherwise
been anticipated by the prior art. In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir.
2004). Cf In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (noting that
when descriptive material is not functionally related to the substrate, the
descriptive material will not distinguish the invention from the prior art in
terms of patentability). King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267,
1279 (Fed. Cir. 2010) ("[T]he relevant question is whether 'there exists any
new and unobvious functional relationship between the printed matter and
the substrate."') (citations omitted).
Appellants argue that the claimed clinical information derived from the
health plan claims data patentably distinguishes over the prior art medical
8
Appeal2014-002265
Application 12/418,607
data. We disagree because Appellants have failed to establish that the
claimed clinical information derived from the health plan claims data label is
in any way functionally related to the claimed system and data file
(substrate). As a result, Appellants' claimed data label as being clinical
information derived from the health plan claims does not distinguish this
invention from the prior art.
To more readily see the issue, we construe the limitations at issue as
follows:
aggregating DATAl using an automated health care computer
information system programmed to integrate a plurality of disparate medical
data sources, the health care computer information system having access to
at least one source of data, including DATA2;
deriving DATA3 from the DATA2;
organizing the aggregated DATAl into a medical data file for the patient
and storing the medical data file in a computer readable medium of the
health care computer information system;
wherein DAT A 1 is labelled as electronic medical care information
wherein DATA2 is labelled as health plan claims data obtained from at
least one health care provider and submitted in connection with a claim
under a health plan
wherein DATA3 is labelled as clinical information.
To agree with Appellants' reasoning would mean that each novel set of
medical data labels, over which the known medical information system is
9
Appeal2014-002265
Application 12/418,607
used to collect data, is sufficient to warrant a separate patent even if the
remainder of the invention is unchanged. This would result not only in
Appellants' aggregation of personal health records in a health insurance
context distinguishing over the prior art, but equally the same personal
health records in a broader context would distinguish over the prior art, as
would every single unique set of personal health records. To give effect to
Appellants' argument, we would need to ignore our reviewing court's
concerns with repeated patenting. We decline to do so.
The rationale behind this prior art rejection is preventing the repeated
patenting of essentially a known product by the mere inclusion of novel
non-functional descriptive material. King Pharm., 616 F.3d at 1279 ("The
rationale behind this line of cases is preventing the indefinite patenting of
known products by the simple inclusion of novel, yet functionally unrelated
limitations.") Cf In re Ngai, 367 F.3d at 1339 ("If we were to adopt Ngai's
position, anyone could continue patenting a product indefinitely provided
that they add a new instruction sheet to the product.").
Here, the limitation of clinical information derived from the health plan
claims data in no way depends on the aggregation and aggregation in no way
depends on the perception of the data as being clinical information derived
from the health plan claims data. Thus, this limitation should be afforded no
patentable weight.
We agree with the Examiner that the prior art describes claim 1 because
it teaches each and every functional limitation of the claim. The difference
between the prior art and the claimed invention is simply a rearrangement of
10
Appeal2014-002265
Application 12/418,607
nonfunctional descriptive material (the particular labels). Therefore, we will
sustain the Examiner's rejection.
CONCLUSIONS OF LAW
The rejection of claims 1--4, 6-10, 11-14, 16-18, 25, 32, and 33 under
35 U.S.C. § 103(a) as unpatentable over Segal and Knaus is proper.
The rejection of claims 5, 15, 19-24, and 26-31 under 35 U.S.C.
§ 103(a) as unpatentable over Segal, Knaus, and Summerell is proper.
DECISION
The rejections of claims 1-33 are affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv) (2011).
AFFIRMED
11