Ex Parte Hungerford et al

Patent Trial and Appeal Board

Mar 29, 2018

12322898 (P.T.A.B. Mar. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/322,898 0210912009
107568 7590 04/02/2018
Greer, Burns & Crain, Ltd.
300 S. Wacker Drive, Suite 2500
Chicago, IL 60606
FIRST NAMED INVENTOR
Roger L. HUNGERFORD
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.
5360.115516 8862
EXAMINER
PATEL,NEHA
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
04/02/2018 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):
docket@gbclaw.net
ptomail@ gbclaw. net
verify@gbclaw.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROGER L. HUNGERFORD and CURT MATTHEW ALLEN
Appeal2016-005227 1
Application 12/322,8982
Technology Center 3600
Before MICHAEL C. ASTORINO, JAMES A. WORTH, and
TARA L. HUTCHINGS, Administrative Patent Judges.
HUTCHINGS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 1--4, 6, 7, 11, 12, 14, 16, 17, and21. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Our decision references Appellants' Appeal Brief ("App. Br.," filed
Nov 10, 2015) and Reply Brief ("Reply Br.," filed Apr. 20, 2016), and the
Examiner's Answer ("Ans.," mailed Feb. 25, 2016) and Final Office Action
("Final Act.," mailed July 24, 2015).
2 Appellants identify Baxter Healthcare S.A. and Baxter International Inc. as
the real parties in interest. App. Br. 5.
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Application 12/322,898
CLAIMED INVENTION
Claims 1, 6, 11, 16, and 21 are the independent claims. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A computer-based method to prevent titration errors
in infusion therapies, comprising:
receiving, using a graphical user interface for an interface
unit for an infusion pump, first data for a first infusion regimen
for a medication, the first regimen including a first unit of
measure of dosage of a first parameter in which the first regimen
is executed;
initiating, using a processor for the pump, the first infusion
regimen;
receiving, using the graphical user interface and the
interface unit, and after receipt of the first data and initiation of
the first regimen, second data for a second infusion regimen for
the medication, the second regimen including a second unit of
measure of dosage in which the second regimen is executed;
determining, using the processor in the pump, whether the
first and second units of measure of the medication are the same
for ensuring the units of measure of dosage are the same; and
initiating, using the processor in the pump, the second
infusion regimen responsive to the determination that the first
and second units of measure are the same.
REJECTIONS
Claims 1--4, 6, 7, 11, 12, 14, 16, 17, and 21 are rejected under
35 U.S.C. § 101 as directed to non-statutory subject matter.
Claims 1--4, 11, 12, 14, and 21 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Condurso (US 2006/0047538 Al, pub. Mar. 2, 2006)
and Martucci (US 2004/0172302 Al, pub. Sept. 2, 2004).
Claims 6, 7, 16, and 17 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Condurso and Vanderveen (US 2005/0145009 Al, pub.
July 7, 2005).
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ANALYSIS
Non-Statutory Subject Matter
Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a
"new and useful process, machine, manufacture, or composition of matter."
35 U.S.C. § 101. The Supreme Court, however, has long interpreted§ 101
to include an implicit exception: "[l]aws of nature, natural phenomena, and
abstract ideas" are not patentable. See, e.g., Alice Corp. Pty. Ltd. v. CLS
Bankint'l, 134 S. Ct. 2347, 2354 (2014).
The Supreme Court, in Alice, reiterated the two-step framework
previously set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012), "for distinguishing patents that claim
laws of nature, natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts." Alice, 134 S. Ct. at 2355.
The first step in that analysis is to "determine whether the claims at issue are
directed to one of those patent-ineligible concepts." Id. If the claims are not
directed to a patent-ineligible concept, e.g., an abstract idea, the inquiry
ends. Otherwise, the inquiry proceeds to the second step 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. (quoting Mayo,
566 U.S. at 79, 78).
The step-one analysis calls upon us to consider "the claims ... in their
entirety to ascertain whether their character as a whole is directed to
excluded subject matter." Internet Patents Corp. v. Active Network, Inc.,
790 F.3d 1343, 1346 (Fed. Cir. 2015). The question is whether the claims as
a whole "focus on a specific means or method that improves the relevant
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technology" or are "directed to a result or effect that itself is the abstract idea
and merely invoke generic processes and machinery." McRO, Inc. v. Bandai
Namco Games Am. Inc., 837 F.3d 1299, 1314 (Fed. Cir. 2016).
In this case, the preamble of claim 1, for example, provides for a
"computer-based method to prevent titration errors in infusion therapies."
The method performs the following five steps: (1) receiving first data for a
first infusion regimen for a medication; (2) initiating the first infusion
regimen; (3) receiving, after receipt of the first data and initiation of the first
regimen, second data for a second infusion regimen for the medication; ( 4)
determining whether the first and second units of measure of the medication
are the same; and ( 5) initiating the second infusion regimen responsive to the
determination that the first and second units of measure are the same. The
Specification provides that an "error that can occur in the process of
delivering medication to a patient is to initiate an infusion in a first unit of
measure and then modify the infusion by changing to a different unit of
measure without properly adjusting the remaining infusion parameters."
Spec. i-f 21. The claimed invention, thus, seeks to "address[] and prevent[]
errors related to changes in units of measure." Id. Independent claims 1, 6,
11, 16, and 21, while of differing scope, each focus on addressing such
errors. In this context, the character of Appellants' claimed invention as a
whole focuses on improving a process for initiating a second infusion
regimen by collecting and comparing data, namely units of measure of
dosage.
It is well-established that § 101 covers neither "mental processes" -
associated with or as part of a category of "abstract ideas" - nor processes
that merely invoke a computer and its basic functionality for implementing
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such mental processes, without even specifying arguably new physical
components or specifying processes defined other than by the mentally
performable steps. See, e.g., SmartGene, Inc. v. Advanced Biological Labs.,
SA, 555 Fed. App'x 950, 954 (Fed. Cir. 2014), cert. denied, 135 S. Ct. 58
(2014 ). If a claim recites a mental process or abstract idea, it must recite
"enough else-applying the idea in the realm of tangible physical objects
(for product claims) or physical actions (for process claims}-that is beyond
'well-understood, routine, conventional activity." Id. at 955 (citation and
internal quotations omitted). In SmartGene, the Federal Circuit held that the
claim at issue recited a patent-ineligible mental process involving the mental
steps of comparing new and stored information, and using rules to identify
medical options. Id. The Court determined that the claim "calls on a
computer to do nothing that is even arguably an advance in physical
implementations of routine mental information-comparison and rule
application processes." Id.
Here, in rejecting the claims under 35 U.S.C. § 101, the Examiner
determines that Appellants' claims are directed to an abstract idea because
the claims recite a "series of step[ s] that can be perform[ ed] manually" and
thus, are directed to an abstract idea. Ans. 4 ("For example, [a] care giver or
nurse can manually determine the unit of measure of the medication and
initiate or block delivery of [the] infusion regimen."). The Examiner finds
that the claims do not recite additional elements or a combination of
elements that amount to significantly more than the abstract idea. Id. at 4--5.
In particular, the Examiner finds that the claims recite no more than "generic
computer structure that serves to perform generic computer functions that
serve to merely link the abstract idea to a particular technological
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environment (i.e. infusion pump processor, interface, etc.)." Id. at 5 (citing
Spec. i-f 4). The Examiner further finds that the functions recited in the steps
(e.g., receiving, determining, initiating) are "well-understood, routine, and
conventional activities" previously known to the pertinent industry. Id.
Appellants argue that the claims are not abstract because they are
directed to an infusion pump used in infusion therapies (claims 11 and 16),
and a computer-based method for controlling an infusion pump using a
computer processor and graphical user interface (claims 1, 6, and 21 ). App.
Br. 19; see also id. at 20 ("the infusion pump, which is clearly a mechanical
device"). In the Reply Brief, the Appellants ostensibly argue that the claims
satisfy the machine-or-transformation test because they are tied to a machine
(e.g., graphical user interface, pump, and processor) and/or transform an
operation state of the pump. See Reply Br. 7-16 (discussing each of the
independent claims, as well as dependent claims 2--4, 7, 12, 14, and 17). As
an initial matter, the Supreme Court clarified in Bilski v. Kappas, 130 S. Ct.
3218, 3227 (2010) that the machine-or-transformation test, although a useful
tool, "is not the sole test for deciding whether an invention is a patent-
eligible 'process' [under § 101]."
Here, the focus of Appellants' invention is not on technological
improvements to an infusion pump, its processor, or a graphical user
interface. For example, the claimed pump does not improve the mechanical
delivery of fluids. Instead, it is directed to an improvement to the process
for determining whether to initiate a second infusion regimen based on
whether the units of measure of dosage in the first regimen are the same as
those in the second regimen. See, e.g., Spec. i-f 21 (invention addresses and
prevents errors related to changes in units of measure). Thus, the claimed
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method involves the steps of collecting information, analyzing the
information, and uses rules to determine how to proceed based on the results
of the collecting and analysis, i.e., a mental process comprising steps that are
individually abstract. See, e.g., Elec. Power Grp., LLC v. Alstom S.A., 830
F.3d 1350, 1353-54 (Fed. Cir. 2016). As such, we agree with the
Examiner's determination that the claims are directed to an abstract idea.
Because the claims are directed to an abstract idea, the question before
us at step two of the analysis is whether the claims include any additional
features constituting an inventive concept. Here, our analysis uncovers no
inventive concept in the individual claim limitations or their ordered
combinations. The claims recite additional generic computer components
(e.g., an infusion pump, a processor, and a graphical user interface), but
merely requiring generic computer implementation fails to transform an
abstract idea into a patent-eligible invention. Alice, 134 S. Ct. at 2357.
Here, we are not persuaded that the Examiner erred in determining that these
components do no more than provide a particular environment for
implementing the abstract idea.
Appellants argue that the claims are analogous to those in Diamond v.
Diehr, 450 U.S. 175 (1981), which involved the use of mathematical
equations in operation of a rubber molding press to cure raw rubber into a
product that retains its shape. See Reply Br. 14 (citing US PTO Example
25 3); see also July Examples 14--19 (describing Example 25). We disagree.
In Diamond, the claimed invention improved the operation of a rubber
3 July 2015 Update Appendix 1: Examples, available at
https://www.uspto.gov/sites/default/files/ documents/ieg-july-2015-app 1.pdf
(hereinafter "July Examples").
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molding press by taking measurements, and feeding those measurements
into a digital computer that repeatedly recalculates the cure time based on
the Arrhenius equation, resulting in a transformation of raw rubber to a
molded, rubber product. Diamond, 450 U.S. at 177-179, 184. Appellants
contend that claim 1 transforms the infusion pump into a different state, i.e.,
states for first and second regimens. Reply Br. 15. However, "merely
transform[ing] data from one form to another is not patent eligible," as the
Supreme Court made clear in Gottschalk v. Benson, 409 U.S. 63, 71-72
(1972). In contrast to the situation in Diamond, applying Appellants'
claimed steps (e.g., receiving data, and determining whether the units of
measure of dosage are the same) does not result in any analogous
transformation of matter from one state (i.e., raw ruber) to another (i.e., a
molded product). We determine Appellants' claim 1 is more analogous,
instead, to the process claim deemed patent-ineligible in Gottschalk.
In Gottshalk, the Supreme Court held that a process claim that
converted binary-coded decimal numbers into pure binary were patent-
ineligible. See Gottschalk, 409 at 73. In reaching its conclusion, the Court
found that the steps of the claimed process "can be performed mentally" and
also "can be carried out in existing computers long in use," here, a generic
"graphic user interface" and "processor" in a generic "infusion pump,"
respectively. See id. at 67. Similarly, here, Appellants' steps of receiving
and determining can be performed mentally, and also can be carried out
using existing computers (e.g., an exising graphic user interface, processor,
and infusion pump). See CyberSource Corp. v. Retail Decisions, Inc., 654
F.3d 1366, 1375 (Fed. Cir. 2011) ("[t]hat purely mental processes can be
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unpatentable, even when performed by a computer, was precisely the
holding of the Supreme Court in Gottschalk v. Benson").
We are not persuaded by Appellants' argument that the claims are
similar to those described in USPTO Example 26. See Reply Br. 10-11; see
also July Examples 19--21 (describing Example 26). There, the invention
solved a problem peculiar to internal combustion engines related to
declining engine performance due to increasing exhaust gas recirculation
("EGR"). Id. at 19. To address this problem, the invention in Example 26
modifies the amount of EGR using a control system to control the opening
and closing of an exhaust gas recirculation valve based upon a rate of change
of the engine throttle. Id. at 20. We see no comparable adjustment to the
operation of Appellants' infusion pump here.
Like the situation in SmartGene, we find nothing in the application of
the abstract idea that is "arguably an advance in physical implementation of
routine mental information-comparison and rule-application processes."
SmartGene, 555 Fed. App'x at 955. The claims recite the steps of initiating
the regimens, but there is no indication in the claims, Specification, or
briefing that this step is more than well-understood, routine, additional
activity, which is not sufficient for patent eligibility. Although the claims
recite various physical components, the focus of the claim is not on the
improvement of any technology or technical field, or to the components
themselves, but instead on implementing the abstract idea in a particular
technological environment (i.e., infusion pump, processor, graphical user
interface), which is insufficient. See Alice, 134 S. Ct. at 2358. We are not
persuaded that the Examiner erred in finding that the elements or
combination of elements amount to no more than mere instructions to
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implement the idea using generic computer components, such as an infusion
pump and graphical interface, in their ordinary capacities (e.g., receiving
data, processing data).
Therefore, we are not persuaded that the Examiner erred in rejecting
the claims under 35 U.S.C. § 101. Therefore, we sustain the Examiner's
rejection.
Obviousness
Independent Claims 1, 11, and 21, and Dependent Claims 2-4, 12, and 14
We are persuaded by Appellants' argument that the Examiner erred in
rejecting independent claims 1, 11, and 21under35 U.S.C. § 103(a) at least
because Martucci does not disclose or suggest "determining, using the
processor in the pump, whether the first and second units of measure of the
medication are the same for ensuring the units of measure of dosage are the
same," as recited in claim 1, and similarly recited in claims 11 and 21. App.
Br. 22-26. The Examiner relies on Martucci as disclosing the argued
limitation. Final Act. 9 (citing Martucci i-f 402, Figs. 39A, 52). However,
we find nothing in the cited portions of Martucci that discloses or suggests
the argued limitation.
Martucci relates to a system and method for verifying operational
parameters of medical devices. Martucci i-f 4. Martucci describes at
paragraphs 276-278 that different units of measurements (UOMs) are used
by different portions of the patient care system, such that, for example, a
physician's UOM is general a different unit than the administering
clinician's UOM. With reference to Figures 39A and 52, Martucci describes
ensuring pharmacy prescription parameters match programmed pump
channels before starting an infusion pump. Id. i-f 402. Stated differently, the
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cited portions of Martucci describe comparing two different UOM's to
ensure a correspondence before starting an infusion pump. However, we
agree with Appellants that the cited portions of Martucci do not disclose or
suggest comparing the same UOM (i.e., first and second units of measure of
dosage) for two infusion regimes. See App. Br. 24--25.
In view of the foregoing, we do not sustain the Examiner's rejection
of independent claims 1, 11, and 21, and their dependents under
35 U.S.C. § 103(a).
Independent Claims 6 and 16, and Dependent Claims 7 and 17
We are persuaded by Appellants' argument that the Examiner erred in
rejecting independent claims 6 and 16 under 35 U.S.C. § 103(a) at least
because Condurso does not disclose or suggest "generating ... a query
regarding inclusion, in the second data, of a volume of the second
medication, in contrast to a query of a specified dosage rate of the second
medication," as recited in claim 6, and similarly recited in claim 16. The
Examiner relies on Condurso for the argued limitation. See Final Act. 18-19
(citing Condurso i-fi-f 125, 126, Fig. 1). However, we find nothing in the cited
portions of Condurso that teaches or suggests the argued limitation.
Condurso describes at paragraph 125 checking a database to
determine if a second drug may be safely delivered to a patient. The
inventors in Condurso recognized that drugs in a multiple source infusion
region may not be compatible, requiring that mixing of certain drugs be
prevented, or that infusion of the second drug be delayed for a period of
time. Condurso i-f 123. To address this problem, the system displays a
prompt to a caregiver, inquiring whether the drug is to be delivered using a
Y-site connector and, if so, requesting the caregiver to "enter[] the dose rate
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and other pertinent parameters into the system." Id. i-f 125. The system
determines whether these parameters are appropriate for the patient. Id. In
particular, the system inputs patient characteristics, such as weight, age, and
gender, into a pharmacokinetic (PK) model to help a caregiver generate a
proposed dose or schedule. Id. i-fi-1128-29.
Therefore, the cited portion of Condurso describes that a caregiver
provides parameters regarding dose rate to the system, but does not disclose
or suggest that a processor for the pump generates a query regarding
"inclusion in the second data, of a volume of the second medication, in
contrast to a query of a specified dosage rate of the second medication."
In view of the foregoing, we do not sustain the Examiner's rejection
of independent claims 6 and 16, and their dependent claims under
35 U.S.C. § 103(a).
DECISION
TheExaminer'srejectionofclaims 1--4, 6, 7, 11, 12, 14, 16, 17, and
21under35 U.S.C. § 101 is affirmed.
The Examiner's rejections of claims 1--4, 6, 7, 11, 12, 14, 16, 17, and
21under35 U.S.C. § 103(a) are reversed.
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).
AFFIRMED
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