Ex Parte Bergstrom et al

Patent Trial and Appeal Board

Jul 21, 2017

13601163 (P.T.A.B. Jul. 21, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/601,163 08/31/2012 Chris Bergstrom P-7151D1 (59788) 7141
47058 7590 07/25/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Dickinson Wright PLLC)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
GO, JOHN P
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
07/25/2017 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):
lorraine_kow alchuk @ bd .com
ip_docket @bd.com
DWPatents @ dickinson wright. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRIS BERGSTROM, JAY BUTTERBRODT,
ALAN W. FIEDLER, BARRY GINSBERG, TIM H. GORDON,
and PAUL UPHAM
Appeal 2016-003 5291
Application 13/601,163
Technology Center 3600
Before ANTON W. FETTING, CYNTHIA L. MURPHY, and
MATTHEW S. MEYERS, Administrative Patent Judges.
MURPHY, Administrative Patent Judge.
DECISION ON APPEAL
The Appellants2 appeal under 35 U.S.C. § 134 from the Examiner’s
rejections of claims 1—11 and 13—30. We have jurisdiction over this appeal
under 35 U.S.C. § 6(b).
We REVERSE.
1 The record includes a transcript of the oral hearing held July 11, 2017.
2 The Appellants identify the real party in interest as “Becton, Dickinson and
Company.” (Appeal Br. 1.)
Appeal 2016-003529
Application 13/601,163
STATEMENT OF THE CASE
According to the Appellants, “the present invention relates to real­
time communication of data between devices (e.g., blood glucose meters,
insulin delivery devices) and a repository and analysis of repository data to
obtain information to improve disease management and provide cost savings
to disease management stakeholders.” (Spec. 11.)
Illustrative Claim
1. A computer-implemented method of determining test strip
and insulin usage comprising:
storing testing data for a plurality of patients in a
repository, the testing data comprising for respective patients at
least one of the number of recommended tests per day and the
number of test strips allotted to the patient via one of a supplier
and an insurer according to their respective prescriptions for
testing;
automatically, without user involvement, transmitting test
results from a blood glucose meter to the repository in response
to detection of an event selected from the group consisting of
telephone activation if the blood glucose meter is built into or
connected to a cellular telephone configured to communicate
with the repository wirelessly, and selected motion activation of
the blood glucose meter, the test results comprising measured
glucose level;
analyzing, using the computer, the testing data and the
test results stored in the repository for at least a selected one of
the patients to determine at least one of the number of test strips
actually used by the patient within a selected time period and
the number of allotted test strips that are unused within a
selected time period;
storing, at the repository, prescription data indicating
insulin allotted to patients according to their respective
prescriptions for insulin;
automatically, without user involvement, transmitting to
the repository delivery data relating to insulin delivered by an
2
Appeal 2016-003529
Application 13/601,163
insulin delivery device in response to detection of complete
insulin delivery;
analyzing, using the computer, the stored prescription
data and the delivery data stored at the repository that
corresponds to insulin delivered by the insulin delivery device
over a selected period of time to determine if a prescribed
patient supply of insulin requires replenishment; and
generating an output indicative of at least one of a
number of the allotted test strips determined to be actually used
or determined to remain unused, and an order for more insulin
when the prescribed patient supply of insulin is determined to
require replenishment.
References
Spanswick US 5,905,262 May 18, 1999
Huerga US 2001/0028308 A1 Oct. 11,2001
Hochman US 2001/0049608 A1 Dec. 6, 2001
Gottlieb US 2002/0007290 A1 Jan. 17, 2002
Cohen US 2002/0019707 A1 Feb. 14, 2002
Roe US 2002/0156654 A1 Oct. 24, 2002
Itoh US 2003/0032077 A1 Feb. 13, 2003
Katou US 2003/0172009 A1 Sept. 11,2003
Bauer US 2003/0216969 A1 Nov. 20, 2003
Meserol US 2003/0229517 A1 Dec. 11,2003
Barry US 2004/0015397 A1 Jan. 22, 2004
Brown US 2004/0106855 A1 June 3, 2004
Mindala US 2004/0117323 A1 June 17, 2004
Everett US 2004/0142722 A1 July 22, 2004
Renz US 2004/0186794 A1 Sept. 23, 2004
Steil US 2004/0193025 A1 Sept. 30, 2004
Fiacco US 2004/0230502 A1 Nov. 18, 2004
Braig US 2005/0038674 A1 Feb. 17, 2005
Talbot US 2005/0065464 A1 Mar. 24, 2005
Fox US 2005/0086071 A1 Apr. 21,2005
Kovatchev US 6,923,763 B1 Aug. 2, 2005
Vanderveen US 2005/0171815 A1 Aug. 4, 2005
Cooper US 2005/0197553 A1 Sept. 8, 2005
Paulsen US 2005/0197621 A1 Sept. 8, 2005
3
Appeal 2016-003529
Application 13/601,163
Rejections
I. The Examiner rejects claims 1—11 and 13—30 under 35 U.S.C.
§ 101 as reciting only non-statutory subject matter. (Final Action 2.)
II. The Examiner rejects claims 1—11 and 13—30 under 35 U.S.C.
§112, second paragraph, as indefinite. (Final Action 3.)
III. The Examiner rejects claims 1, 4, 5, and 9 under 35 U.S.C.
§ 103(a) as unpatentable over Meserol, Itoh, Hochman, Kovatchev, and
Huerga. (Final Action 5.)
IV. The Examiner rejects claim 2 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and Bauer.
(Final Action 16.)
V. The Examiner rejects claims 3 and 23 under 35 U.S.C. § 103(a)
as unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and
Katou. (Final Action 18.)
VE The Examiner rejects claim 6 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and Barry.
(Final Action 19.)
VIE The Examiner rejects claim 7 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and Brown.
(Final Action 21.)
VIII. The Examiner rejects claim 8 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and Cohen.
(Final Action 23.)
IX. The Examiner rejects claim 10 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, Steil, and
Spanswick. (Final Action 24.)
4
Appeal 2016-003529
Application 13/601,163
X. The Examiner rejects claims 11 and 19 under 35 U.S.C.
§ 103(a) as unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga,
and Poulsen. (Final Action 26.)
XI. The Examiner rejects claims 13—16, 18, 20, and 22 under
35 U.S.C. § 103(a) as unpatentable over Meserol, Itoh, Hochman,
Kovatchev, Huerga, Poulsen, and Talbot. (Final Action 29.)
XII. The Examiner rejects claim 17 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, Poulsen,
Talbot, Fox, and Vanderveen. (Final Action 34—35.)
XIII. The Examiner rejects claim 21 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, Poulsen,
and Everett. (Final Action 36.)
XIV. The Examiner rejects claim 24 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, Katou, and
Renz. (Final Action 37.)
XV. The Examiner rejects claim 25 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and Braig.
(Final Action 38.)
XVI. The Examiner rejects claims 26 and 27 under 35 U.S.C.
§ 103(a) as unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga,
Mindala, and Fiacco. (Final Action 40.)
XVII. The Examiner rejects claim 28 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, Gottlieb,
and Braig. (Final Action 41.)
5
Appeal 2016-003529
Application 13/601,163
XVIII. The Examiner rejects claim 29 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, and Cooper.
(Final Action 43.)
XIX. The Examiner rejects claim 30 under 35 U.S.C. § 103(a) as
unpatentable over Meserol, Itoh, Hochman, Kovatchev, Huerga, Cooper, and
Roe. (Final Action 45.)
ANALYSIS
Claims 1 and 9 are the independent claims on appeal, with the rest of
the claims on appeal (i.e., claims 2—8, 10, 11, and 13—30) depending
therefrom. (Appeal Br., Claims App.) Independent claims 1 and 9 recite a
“computer-implemented” method comprising steps requiring the storage,
transmission, and analysis of data. (Id.) Regarding the transmission of data,
independent claims 1 and 9 recite “automatically, without user involvement,
transmitting test results from a blood glucose meter to the repository in
response to detection of an event” and “automatically, without user
involvement, transmitting to the repository delivery data relating to insulin
delivered by an insulin delivery device in response to detection of complete
insulin delivery.” (Id.) Independent claims 1 and 9 also recite the
generation of “an order for more insulin when the prescribed patient supply
of insulin is determined to require replenishment.” (Id.)
Rejection 1—35 U.S.C. § 101 — Claims 1—11 and 13—30
As indicated above, the computer-implemented methods recited in
independent claims 1 and 9 involve the storage/transmission/analysis of data
and the generation of an order based upon the need for replenishment.
According to the Examiner, “[t]he claims are directed to the abstract idea of
a fundamental economic practice of billing based on quantity consumed or
6
Appeal 2016-003529
Application 13/601,163
to the abstract idea of organizing human activities by dictating shipping
supplies based on the quantity consumed” and “[t]he additional elements or
combination of elements in the claims” amount to “a recitation of generic
computer structure that serves to perform generic computer functions that
are well-understood, routine, and conventional activities previously known
to the pertinent industry.” (Final Action 2.) More succinctly, the Examiner
concludes that the claims on appeal do not pass muster under the two-step
Alice test.3
The Appellants argue that “even if the claims recite a fundamental
economic practice or organized human activity,” they “still amount to
significantly more than the abstract idea.” (Appeal Br. 11.) We are
persuaded by the Appellants’ argument because the claims on appeal recite
additional elements beyond conventional computer-related components. For
example, as indicated above, independent claims 1 and 9 recite an “insulin
delivery device.” (Appeal Br., Claims App.) The Examiner’s findings with
respect to the second step of the Alice test focus only on the computer-
related components and their performance of generic computer functions.
(See Final Action 2, 46-48; see also Answer 47—50.) We see nothing in the
record indicating that the Examiner considered the insulin delivery device
3 The Alice test entails two steps for distinguishing between an “abstract
idea[]” and a “patent-eligible application[]” of an abstract idea. Alice Corp.
Pty. Ltd. v. CLSBanklnt’l, 134 S. Ct. 2347, 2355 (2014). The first step of
the Alice test is to consider whether the claims at issue are “directed to” an
abstract idea. Id. If so, the inquiry proceeds to the second step of the Alice
test where the elements of the claims are considered “individually and ‘as an
ordered combination’” to determine whether there are additional elements
that “‘transform the nature of the claim’ into a patent-eligible application.”
Id.
7
Appeal 2016-003529
Application 13/601,163
individually, much less in an ordered combination with the recited
computer-related components, to determine whether additional elements
transform the nature of the claim into a patent-eligible application of an
abstract idea. As such, on the record before us, the Examiner’s findings
regarding the second step of the Alice test are incomplete.
Thus, we do not sustain the Examiner’s rejection of claims 1—11
and 13-30 under 35 U.S.C. § 101.
Rejection II— 35 U.S.C. § 112 — Claims 1—11 and 13—30
As indicated above, independent claims 1 and 9 recite steps requiring
data transmission to occur “without user involvement.” (Appeal Br., Claims
App.) According to the Examiner, the claims are indefinite as “it is unclear
how any activity [(e.g., the transmission of data)] takes place ‘without user
involvement.’” (Final Action 4.)
The Appellants argue that one of ordinary skill in the art of patient­
monitoring would appreciate what is meant by the transmission of data
“without user involvement.” (See Appeal Br. 13—14; see also Reply Br. 13.)
We are persuaded by the Appellants’ arguments because the Specification
conveys what is meant by “user involvement” in the transmission of diabetes
management data and the pitfalls thereof. For example, the Specification
conveys that diabetes-management data can be “entered” or “uploaded” on a
patient’s computer for transmission to a healthcare provider’s computer, but
patients quite often fail to “enter or upload a blood glucose test result or
insulin injection.” (Spec. 14.) The Examiner does not sufficiently explain
why the Specification fails to convey what is meant by “user involvement”
in the context of the claimed invention, and thus does not sufficiently
explain why one of ordinary skill in the art would be unable to ascertain the
8
Appeal 2016-003529
Application 13/601,163
scope of the negative limitation of “without user involvement.” As such, on
the record before us, the Examiner does not establish that independent
claims 1 and 9 are unclear or otherwise indefinite.
Dependent claim 15 recites “transmitting, via the blood glucose meter,
the delivery data to the repository substantially coincidentally with a blood
glucose testing event.” (Appeal Br., Claims App.) According to the
Examiner, “[o]ne ordinarily skilled in the art of healthcare would not, absent
further clarification, readily understand what timeframe would satisfy the
requirement of transmitting data ‘substantially coincidentally’ with a blood
glucose testing event.” (Answer 51.) However, the Appellants cite (see
Appeal Br. 15) to a statement in the Specification that “[t]he connected
syringe data can be sent when the meter data is sent.” (Spec. 190.) The
Examiner’s explanation of indefmiteness does not adequately address why
this statement is not sufficient clarification as to what is meant by
“substantially coincidental[]” transmission of data. (See Final Action 4, 49;
see also Answer 51).4 As such, on the record before us, the Examiner does
not establish that dependent 15 is unclear or otherwise indefinite.
Dependent claim 21 recites “selecting a protocol based on optimal
transmission qualities.” (Appeal Br., Claims App.) According to the
4 The cited sentence reads “[t]he connected syringe data can be sent when the
meter data is sent and basically coincides with blood glucose testing.” (Spec.
190.) The Examiner explains that defining the claim term at issue “as
‘basically [coinciding] ’ does not provide “any further guidance as to the
metes and bounds of this limitation.” (Answer 51.) This explanation
overlooks the first statement in the sentence, which plausibly clarifies that
“substantially coincidentally” requires the insulin-delivery data to be sent
when the blood-glucose testing data is sent (i.e., in response to a blood
glucose testing event).
9
Appeal 2016-003529
Application 13/601,163
Examiner, “one ordinarily skilled in the art of healthcare would not, absent
further clarification, readily understand what would constitute an ‘optimal’
transmission quality for a wireless protocol.” (Answer 51.) However, as
noted by the Appellants, dependent claim 21 “does not merely recite optimal
transmission qualities without context” but rather calls for “scanning [of]
available wireless frequencies” and ties the “optimal transmission qualities”
to that “of a scanned frequency.” (Reply Br. 14.) The Examiner’s
explanation regarding indefiniteness does not adequately address why these
additional recitals are not sufficient clarification as to what constitutes
“optimal” transmission quality. (See Final Action 4—5, 49; see also
Answer 5.) As such, on the record before us, the Examiner does not
establish that dependent claim 21 is unclear or otherwise indefinite.
Thus, we do not sustain the Examiner’s rejection of claims 1—11
and 13-30 under 35 U.S.C. § 112.
Rejection III—35 U.S.C. § 103 — Claims 1, 4, 5, and 9
As indicated above, independent claims 1 and 9 recite the automatic
transmission of insulin-delivery data. (Appeal Br., Claims App.)
Specifically, independent claims 1 and 9 recite “transmitting to the
repository delivery data relating to insulin delivered by an insulin delivery
device in response to detection of complete insulin delivery.” (Id.,
emphasis added.)
The Examiner finds that Meserol discloses a method concerned with
diabetes management, and “insulin is commonly used to treat diabetes.”
(Final Action 8.) The Examiner also finds that Hochman discloses a system
that “transmits data relating to delivered medications” so as to “subsequently
update the patient’s medication history.” (Id.) According to the Examiner,
10
Appeal 2016-003529
Application 13/601,163
it would have been obvious to incorporate such transmission of data into
Meserol’s diabetes-management system. (Id.)
The Appellants argue that Hochman does not teach the transmission
of insulin-delivery data required by independent claims 1 and 9. (See
Appeal Br. 17—18; see also Reply Br. 15—16.) We are persuaded by this
argument because the claims on appeal require this transmission be “in
response to detection of complete insulin delivery.” (Appeal Br., Claims
App.) According to the Examiner “Hochman is only provided to
demonstrate the storing of prescription data and the transmission of delivery
data.” (Final Act. 51.) As such, the Examiner does not sufficiently explain,
on the record before us, why the insulin delivery device in Meserol’s
modified diabetes-management system would detect “complete insulin
delivery” and/or trigger a data transmission “in response to” this detection.
(See Final Action 8—9; see also Answer 51.)
The Examiner also finds that Huerga discloses a system that
“measures a patient’s insulin levels” and maintains that insulin-level data is
related to insulin-delivery data in that “insulin levels may fluctuate based on
insulin already delivered.” (Final Action 10, 51.) Hence, according to the
Examiner, “it would have been obvious to one ordinary skilled in the art of
patient monitoring that [Meserol’s] system may be configured to dispense
insulin.” (Id. at 10.) However, insofar as measured insulin levels can be
equated to the claimed insulin-delivery data, the Examiner does not
sufficiently explain why Huerga teaches a transmission of insulin-level data
“in response to detection of complete insulin delivery” as required by
independent claims 1 and 9.
11
Appeal 2016-003529
Application 13/601,163
Thus, we do not sustain the Examiner’s rejection of independent
claims 1 and 9, and dependent claims 4 and 5, under 35 U.S.C. § 103.
Rejections IV—XIX— 35 U.S.C. § 103 — Claims 2, 3, 6—8, and 13—30
The Examiner’s further findings and determinations with respect to
limitations recited in the dependent claims and/or teachings of the additional
art references do not compensate for the above-discussed shortcomings in
the Examiner’s obviousness rejection of independent claims 1 and 9. (See
Final Action 18—46.)5 As such, the Examiner does not sufficiently establish,
on the record before us, that the combined teachings of the prior art
references would yield a diabetes-management system in which insulin-
delivery data is transmitted in response to detection of complete insulin
delivery.
Thus, we do not sustain the Examiner’s rejections of dependent
claims 2, 3, 6—8, and 13—30 under 35 U.S.C. § 103.
DECISION
We REVERSE the Examiner’s rejections of claims 1—11 and 13—30.
REVERSED
5 For example, the Examiner finds that Talbot discloses an insulin pump that
“stores the insulin delivery information” and “may communicate any
information to a remote computer.” (Final Action 30; see also Talbot || 39,
52—54, 64.) However, the Examiner does not sufficiently explain how or
why Talbot teaches that this insulin delivery device can transmits insulin-
delivery data “in response to detection of complete insulin delivery” as
required by independent claims 1 and 9.
12