Dennis Tribble et al.

Patent Trials and Appeals Board

Sep 26, 2019

11844135 - (D) (P.T.A.B. Sep. 26, 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.
11/844,135 08/23/2007 Dennis Tribble P6409USD1
BX2013T00122
6265
118075 7590 09/26/2019
K&L Gates LLP-Chicago
Baxter
P.O. Box 1135
Chicago, IL 60690-1135
EXAMINER
MORGAN, ROBERT W
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
09/26/2019 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DENNIS TRIBBLE, JOEL A. OSBORNE,
ABDUL WAHID KHAN, MATTHEW VALENTINE, and
BHAVESH PADMANI
____________

Appeal 2018-005875
Application 11/844,135
Technology Center 3600
____________

Before MICHAEL J. STRAUSS, HUNG H. BUI, and
NABEEL U. KHAN, Administrative Patent Judges.

KHAN, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Final Rejection
of claims 1–29, 31–41, and 43. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellant identifies Baxter Englewood Corporation as the real party in
interest. Appeal Br. 1.

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BACKGROUND
THE INVENTION
According to Appellant, the invention relates to:
A centralized system and method for preparing and
managing medications prepared in anticipation of use for at a
remote location. An order processing server receives a patient-
specific dose order from a remote site connected to a remote
location through a network. A dose preparation station prepares
doses in anticipation of use, information about which is stored in
a database. The dose preparation stations can be instructed to
prepare certain non-patient-specific doses based on the
availability of the stations or the patient-specific dose orders
received from the remote site. An application server matches any
received dose order with one of the prepared inventory doses
based on the stored inventory data, and associates the patient-
specific dose order with the inventory dose order. The inventory
data is managed to reflect the association of the patient-specific
dose order with the matched inventory dose, and the association
can be stored in the database.
Abstract.
Exemplary independent claim 1 is reproduced below.
1. A centralized system for preparing and managing sterile
compounded medication products prepared in anticipation of use
at a remote location, the system comprising:
a dose preparation station for sterile compounded
preparation of a plurality of inventory doses in anticipation of use
based on corresponding non-patient-specific inventory dose
orders, wherein the inventory doses are non-patient specific
doses independent of any particular patient-specific dose order,
and wherein the inventory doses are sterile compounded
medication products suitable for administration by intravenous
introduction to a patient that do not require any further sterile
compounded preparation;
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an inventory database configured to store inventory data
concerning the plurality of inventory doses prepared at the dose
preparation station;
an application server executing software on a processor
thereof and configured to access an order database to:
analyze a plurality of previously received patient-
specific dose orders contained in the order database,
wherein the plurality of patient-specific dose orders are
collectively analyzed without regard to any particular
patient-specific dose order to make a determination of how
frequently patient-specific-dose orders for a particular
type of medication are received, and
generate at least one inventory dose order for a
given particular type of medication for preparation at the
dose preparation station to produce a corresponding
inventory dose for the given particular type of medication
according to the determination of how frequently patient-
specific-dose orders for the given particular type of
medication are received; and
an order processing server connected by a network to a
remote site configured to receive a patient-specific dose order
from the remote site, wherein, after receipt of the patient specific
dose order, the application server is configured to:
query the inventory data stored in the inventory
database regarding the plurality of inventory doses
prepared by the dose preparation station for a matching
inventory dose corresponding to the patient-specific dose
order, wherein:
in the absence of a match, the application
server provides instructions to the dose preparation
station for preparation of a patient-specific dose that
fulfills the received patient-specific dose order and
prints a label reflecting an association of the
received patient-specific dose order with the
patient-specific dose order prepared by the dose
preparation station; or
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in the event of a match, the order processing
server is operative to associate the received patient-
specific dose order with at least one of the plurality
of inventory doses previously prepared by the dose
preparation station to thereby satisfy the received
patient-specific dose order and print a label
reflecting an association of the received patient-
specific dose order with the at least one of the
inventory doses matched to the received patient-
specific dose order;
wherein a match at least comprises the inventory dose and
the received patient-specific dose order corresponding to an
identical medication.

REFERENCES AND REJECTIONS
1. Claims 1–29, 31–41, and 43 stand rejected under 35 U.S.C.
§ 101. Final Act. 2–9.
2. Claims 1–14, 16–29, 31–34, 36–38, and 43 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Halvorson (US 4,847,764, issued
Jul. 11, 1989) and Roden (US 6,249,774 B1, issued Jun. 19, 2001). Final
Act. 9–28
3. Claims 15, 35, and 39–41 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Halvorson, Roden, and Waugh (WO
2008/006203 A1, published Jan. 17, 2008). Final Act. 28–31.
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DISCUSSION
REJECTION UNDER 35 U.S.C. § 1012
Legal Principles
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 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. v. CLS Bank Int’l, 573 U.S. 208,
216 (2014).
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.”).

2 We note that a separate panel of the Board, in relation to related patent
application (US Appl. No. 13/399,092), found claims with subject matter
similar to that of the pending claims in this case, to be patent ineligible. Ex
parte Tribble, Appeal No. 2015-008278 (PTAB June 13, 2017) (Rehearing
Req. denied). That decision was affirmed by the Federal Circuit on appeal.
In re Baxter Corp. Englewood, 739 Fed. Appx. 643 (Fed. Cir. 2018). We
note that the aforementioned decision issued before the PTO published
revised guidance on the application of § 101. 2019 Revised Patent Subject
Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019).
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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
mental processes (Gottschalk v. Benson, 409 U.S. 63, 69 (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 (1853))); 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 176; 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.”).
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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 patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks 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. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (Jan. 7, 2019) (“Revised Guidance”). Under the Revised 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); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)).
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.
See Revised Guidance.
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Guidance Step 1
Under step 1 of the Guidance, the Examiner finds the claims are
directed to a statutory category. For example, the Examiner finds “[c]laim
1-20 & 43 are drawn to a system for preparing and managing sterile
compounded medication products prepared in anticipation of use at a remote
location, which is within the four statutory categories (i.e. machine). Final
Act. 2. The Examiner also finds “[c]laims 21–29 & 31–41 are drawn to a
method for support of centralized preparation and management of sterile
compounded medication products in anticipation of use at a remote location,
which is within the four statutory categories (i.e. process).” Final Act. 2.
We agree with the Examiner that the pending claims are directed to one of
the statutory categories, i.e. either a machine, or process.
Revised Guidance Step 2A - Whether the Claims are
Directed to a Judicial Exception
The Examiner analyzed the pending independent claims and
summarized them as reciting to the following general steps:
storing inventory data, analyzing previously received patient-
specific dose orders, determining frequency that the patient-
specific dose orders are received, generating inventory dose
orders based on the determination of frequency that the patient-
specific dose orders are received, querying an inventory
databased to find a match between the inventory & patient-
specific dose orders, printing a label indicating if the outputted
patient-specific orders matched orders from the inventory dose
database.
Final Act. 3 (emphasis removed). Based on this summary, the Examiner
analogized the claims to “the court-defined abstract idea in Electric Power
Group.” Final Act. 3. The Examiner found that the claims involve
collecting information by tracking previously received patient-specific dose
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orders, analysis of that information to determine the frequency that the
patient-specific dose orders are received and displaying the results of that
analysis by printing a label indicating if the patient-specific does orders
matched those in an inventory database. Final Act. 3.
Prong One
Under prong one, we note that claim 1 recites at least the following
steps: (1) “an inventory database configured to store inventory data
concerning the plurality of inventory doses prepared at the dose preparation
station;” (2) “analyze a plurality of previously received patient-specific dose
orders contained in the order database, wherein the plurality of patient-
specific dose orders are collectively analyzed without regard to any
particular patient-specific dose order to make a determination of how
frequently patient-specific-dose orders for a particular type of medication are
received” (3) “query the inventory data stored in the inventory database
regarding the plurality of inventory doses prepared by the dose preparation
station for a matching inventory dose corresponding to the patient-specific
dose order” (4) “in the absence of a match, the application server provides
instructions to the dose preparation station for preparation of a patient-
specific dose that fulfills the received patient-specific dose order” (5) “in the
event of a match, the order processing server is operative to associate the
received patient-specific dose order with at least one of the plurality of
inventory doses previously prepared by the dose preparation station to
thereby satisfy the received patient-specific dose order.”
These limitations, under the broadest reasonable interpretation, recite
collecting inventory data and analyzing patient-specific dose orders so that
those orders can be filled quickly using already prepared inventory of dose
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orders, which is nothing more than a series of “mental processes” that could
be performed in the human mind or by a human using a pen and paper—a
subject matter that is identified in the Revised Guidance, and therefore, an
abstract idea. See CyberSource, 654 F.3d at 1372–73 (“[A] method that can
be performed by human thought alone is merely an abstract idea and is not
patent-eligible under § 101.”); see also In re Comiskey, 554 F.3d 967, 979
(Fed. Cir. 2009) (“[M]ental processes—or processes of human thinking—
standing alone are not patentable even if they have practical application.”);
Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (“Phenomena of nature, . . .
mental processes, and abstract intellectual concepts are not patentable, as
they are the basic tools of scientific and technological work.” (Emphasis
added)). Additionally, mental processes remain unpatentable even when
automated to reduce the burden on the user of what once could have been
done with pen and paper. CyberSource, 654 F.3d at 1375 (“That purely
mental processes can be unpatentable, even when performed by a computer,
was precisely the holding of the Supreme Court in Gottschalk v. Benson.”);
see also In re Salwan, 681 F. App’x 938, 941 (Fed. Cir. 2017) (claims for
organizing patient health information, transferring patient health information
to a patient network, and billing insurance companies held patent-ineligible).
For example, the inventory database stores inventory data, which is a
step that may be performed a person administrator with aid of a pen and
paper for recording purposes. Analyzing previous orders to make a
determination of how frequently orders are received for a particular
medication is also a step that can be performed mentally. Querying a
database to see if a dose order matches an already existing inventory dose is
again a step that can be performed mentally by looking up a table or ledger
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containing information about stored inventory doses. Finally, determining
whether there is or is not a match between the incoming dose order and the
stored inventory doses is also a step that can be performed mentally.
As further recognized by the Examiner, several of the claim
limitations also involve collection and analysis of information that is
analogous to the claims identified by the Federal Circuit as directed to an
abstract idea in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350 (Fed.
Cir. 2016). Final Act. 3. .
Alternatively, these limitations of Appellant’s claim 1 also recite
“preparing and managing sterile compounded medication products,”
collecting inventory data and analyzing dose orders so that those orders can
be filled quickly using already prepared inventory of dose orders. The
Specification explains that one of the goals of the invention was “to prepare
medications in an environment that uses economies of scale to prevent the
demand for medications from outstripping the supply and/or preparation
capabilities of the pharmacy.” Spec. 6:4–6. Anticipating demand for
products so that demand does not outstrip supply is crucial to inventory
management and is a typical problem encountered generally in sales of a
product. As such, the recitation of “a dose preparation station for sterile
compounded preparation of a plurality of inventory doses in anticipation of
use” signifies that the claims also recite limitations related to inventory
management, which is a commercial practice involving the acquisition and
monitoring of stocked goods to maintain stock levels in a business.
Commercial practices fall under the category of certain methods of
organizing human activity which is one of the categories of abstract ideas
under the Guidance. As such, in addition to finding that the claims recite
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mental processes, we also determine the claims recite a fundamental
economic practice—one of the certain methods of organizing human activity
identified in the Revised Guidance, and thus an abstract idea. See Revised
Guidance (Revised Step 2A, Prong One), 84 Fed. Reg. at 52 (describing an
abstract idea category of “[c]ertain methods of organizing human activity—
fundamental economic principles or practices . . . commercial or legal
interactions (including . . . advertising, marketing or sales activities or
behaviors; business relations)”).
Prong 2
Under prong 2 of step 2A of the Revised Guidance, we determine
whether the claim as whole integrates the recited abstract idea into a
practical application of the abstract idea. A claim that integrates a judicial
exception into a practical application will apply, rely on, or use the judicial
exception in a manner that imposes a meaningful limit on the judicial
exception, such that the claim is more than a drafting effort designed to
monopolize the judicial exception. To evaluate whether the claims integrate
the abstract idea into a practical application, we identify whether there are
any additional elements recited beyond the abstract idea, and evaluate those
additional elements individually and in combination.
Some exemplary considerations laid out by the Supreme Court and the
Federal Circuit indicative that an additional element integrates an abstract
idea into a practical application include (i) an improvement in the
functioning of a computer or to another technological field, (ii) an
application of the judicial exception with, or by use of, a particular machine,
(iii) a transformation or reduction of a particular article to a different state or
thing, or (iv) a use of the judicial exception in some other meaningful way
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beyond generally linking the use of the judicial exception to a particular
technological environment. See MPEP § 2106.05(a)–(c), (e)–(h).
Appellant argues
each of claims 1 and 21 enables preparation and management of
medication products in anticipation of use by incorporating a
dose preparation station, an inventory database, an application
server, and an order processing server. The specific
configuration and interoperation of the components claimed are
limited to rules with specific characteristics, which allow for
improvement to the specifically identified problem with respect
to traditional pharmacy practice in large institutional pharmacies.
Namely, the configuration and interoperation of the components
claimed improve both pharmacy information technology systems
and automated pharmacies.
Appeal Br. 8; see also Reply Br. 7 (analogizing the claims to those in
BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341
(Fed. Cir. 2016) and arguing that claim 1 recites components that are
“arranged in a particular way” that improves pharmacy information
technology.) Appellant argues that the instant claims are comparable to
those in BASCOM, and provides a chart comparing independent claims 1
and 21 to the claims in BASCOM. Appeal Br. 13–17. Appellant emphasizes
that “the present claims specifically recite the relative location and
characteristics of various technological components, specific interactions
therebetween, and the results of the specific interactions that improve dose
preparation and management of sterile compounded medication products.”
Appeal Br. 19.
Appellant argues that the limitations of claim 1 indicate that the
claims include specific rules that lead to a technological improvement. For
example, Appellant argues
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independent claim 1 requires that the application server accesses
the order database, analyzes previously received patient-specific
dose orders in the order database to make a determination of how
frequently patient-specific-dose orders for a particular type of
medication are received, and generates at least one inventory
dose order for a given particular type of medication for
preparation at the dose preparation station. Likewise, the order
processing server receives a patient-specific dose order from the
remote site and queries the inventory database for a matching
inventory dose corresponding to the patient-specific dose order.
When there is no match, the application server provides
instructions to the dose preparation station for preparation of a
patient-specific dose that fulfills the received patient-specific
dose order and prints a label reflecting an association with the
patient-specific dose order prepared by the dose preparation
station. By comparison, when there is a match, the order
processing server is operative to associate the received patient-
specific dose order with at least one of the plurality of inventory
doses previously prepared to thereby satisfy the received patient-
specific dose order and print a label reflecting an association with
the at least one of the inventory doses matched to the received
patient-specific dose order. Independent claim 21 includes
similar specific rules.
Appeal Br. 8–9.
Appellant also argues the claims improve computer technology and
are directed to a technological improvement. Specifically, Appellant argues
Each of present independent claims 1 and 21 are directed
improving a centralized system including a dose preparation
station, an inventory database, and an application server. By
maintaining an order database containing records corresponding
to the previously received orders, when a large volume of orders
is received, the pharmacy is poised to respond to the orders by
matching at least some orders to inventory doses and having to
prepare medications on-demand for only those orders that were
not anticipated based on the analysis of previously received
patient-specific orders. Claims 1 and 21 are directed to a
technological improvement, improving computer technology
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with respect to the centralized system, and are therefore not
abstract.
Appeal Br. 10. Appellant argues that claims include “specific technical
modifications [that] are intended to resolve a problem: the tension between
maintaining an inventory of medication for use in fulfilling orders and the
need to keep pace with potentially large volumes of orders . . . .” Appeal Br.
11.
We are unpersuaded by Appellant’s arguments. Appellant’s emphasis
on limitations reciting a server accessing the inventory database, analyzing
previously received dose orders, determining how frequently patient-
specific-dose orders for a particular type of medication are received,
generating dose orders, querying a database to see if a received dose order
matches an already stored inventory dose, providing instructions for
preparation of a patient-specific dose, or associating the received patient-
specific dose order with a previously prepared inventory dose are all, as
explained above, mental processes. Thus, these claim limitations are not
additional elements beyond the recited mental processes. Furthermore, the
problem of dealing with “the tension between maintaining an inventory of
medication for use in fulfilling orders and the need to keep pace with
potentially large volumes of orders” (Appeal Br. 11) is, as explained above,
a problem related to inventory management and commercial practices. This
too, is simply a restatement of the abstract idea recited by the claims.
Claim 1, does, however, recite elements such as a “dose preparation
station,” and “inventory database” an “application server” and an “order
processing server.” Appellant argues these elements are specifically
configured and interoperate in specific way which allows for improvement
to both pharmacy information technology systems and automated
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pharmacies. Appeal Br. 8. Similarly, Appellant argues the claims “recite
the relative location and characteristics of various technological
components” similar to the claims in BASCOM. Appeal Br. 19.
Although the claims recite the aforementioned elements and their
functions, they do not specify any particular configuration that evidences an
improvement to pharmacy technology. Unlike the claims in BASCOM,
which involved “the installation of a filtering tool at a specific location,
remote from the end-users, with customizable filtering features specific to
each end user,” and provided “the benefits of a filter on a local computer and
the benefits of a filter on the ISP server” (BASCOM, 827 F.3d at 1350), there
is no evidence that the physical arrangement of the components here leads to
any technological benefits. Indeed, contrary to Appellant’s argument, we do
not find the claims recite the relative location of its components. The only
location recited in claim 1 involves the use of the medication products
occurring at a “remote location” and that the order processing server is
configured to receive a dose order from a “remote site.” The remote site,
however, does not appear to be an explicit component of the claim. Nor
does Appellant explain the technological benefit of this site being remote to
the order processing server or to any of the other explicitly recited
components.
It is true that the recited components interact with each other (e.g. the
application server queries the inventory database), but such interaction does
not improve the technology of either the components or the system as a
whole. Rather such interaction appears to occur in a conventional manner
where, for example, the database is used to store information and other
programs query the database to acquire relevant information.
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In addition to the elements discussed above, the claims also recite that
the application server “prints a label reflecting an association of the received
patient-specific dose order with” either the order prepared by the dose
preparation station (when the dose order does not match an inventory order)
or with an inventory dose (when the dose order matches an inventory order).
We find the printing of the claimed labels to be insignificant post-solution
activity that occurs after analyzing previous dose orders to predict future
orders, and after it is determined whether a received does order matches an
already stored inventory order. As such, the printing limitations do not show
that the claims recite a practical application of the recited abstract ideas.
Appellant’s arguments above, largely addressed the first factor under
the practical application analysis, namely whether the claims include any
additional elements of the claims reflects an improvement in the functioning
of a computer or to another technological field. For the reasons stated
above, we do not find that they do. We also do not find the claims reflect an
application of the judicial exception with, or by use of, a particular machine,
or a transformation or reduction of a particular article to a different state or
thing. Finally, we also do not find the claims use the recited mental
processes and commercial practices in some meaningful way beyond
generally linking the use of the judicial exception to a particular
technological environment. Here, the recitation of “dose preparation
station,” and “inventory database” an “application server” and an “order
processing server” simply link the claimed inventory management practice
of anticipating demand for a product, and the mental processes involved in
determining such anticipation, to the field of pharmacy.
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Guidance Step 2B - Whether the Claims
Provide an Inventive Concept
Under step 2B of the Guidance we analyze the claims to determine
whether they provide an inventive concept (i.e., whether the additional
elements amount to significantly more than the exception itself).
Considerations that are evaluated with respect to step 2B include
determining whether the claims as a whole add a specific limitation or
combination of limitations that are not well-understood, routine,
conventional activity in the field (see MPEP § 2106.05(d)).
The claim limitations include the “dose preparation station,” and
“inventory database” an “application server” and an “order processing
server.” These components, however, either perform functions that are the
recited mental processes (e.g. the application server analyzes previous dose
orders and determines the frequency of orders for a particular type of
medication) and therefore are not beyond the abstract ideas, or operate in
their well-understood, routine, and conventional manner. For example, the
Specification describes the application server as communicating with
healthcare providers over a network such as the Internet. Spec. 27:14–19,
28:1–2. The Specification also describes the communication function of the
application server to be accomplished by a “webserver, such as MS IIS or
Apache” which one of ordinary skill in the art would recognize as standard
webservers. The claimed database is also described as functioning in its
ordinary and customary way. Spec. 28:14–21. In fact, many of the
functions of the claimed components can be “performed by one computer.”
Spec. 29:3–7.
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Thus, we do not find that the claims add limitations beyond the
judicial exception that are not “well-understood, routine, conventional” in
the field.
Accordingly, we sustain the Examiner’s rejection of independent
claim 1 and of independent claim 21, which Appellant argues together with
claim 1, under 35 U.S.C. § 101. Appellant does not present any separate
arguments against the Examiner’s rejection under § 101 for any other
pending claims, except for claims 8 and 9, which we address below. Thus,
we sustain the Examiner’s rejection of the pending dependent claims 2–20,
22–29, 31–41, and 43.
Claims 8 and 9
Claim 8 depends from claim 1, and further recites “a plurality of
preparation stations,” and claim 9 adds “wherein the plurality of preparation
stations includes at least one automated preparation station and at least one
manual preparation station.” Although Appellant argues claims 8 and 9
separately, Appellant makes essentially the same arguments for claims 8 and
9 as it did for the independent claims 1 and 21. For example, Appellant
argues “[t]he specific configuration and interoperation of the components
claimed are limited to rules with specific characteristics, which allow for
improvement to the specifically identified problem with respect to traditional
pharmacy practice in large institutional pharmacies.” Appeal Br. 20.
Appellant also argues the “present claims 8 and 9 are directed to improving
accuracy, improving computer technology, and involve specific technical
modifications.” Appeal Br. 21. Similarly, Appellant argues claims 8 and 9
“are directed to specific technical modifications including implementation of
an application server analyzing previously received patient-specific dose
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orders and generating inventory dose orders among a plurality of preparation
stations” and that the technical modification “are intended to resolve a
problem: the tension between maintaining an inventory of medication for
use in fulfilling orders and the need to keep pace with potentially large
volumes of orders across a number of preparation stations.” Appeal Br. 22.
Appellant also compares claims 8 and 9 to the claims in BASCOM. Appeal
Br. 23–24.
We have addressed these arguments above with respect to claim 1.
We do not find the recitation of “a plurality of preparation stations” and that
the “preparation stations includes at least one automated preparation station
and at least one manual preparation station” to recite a practical application
of the abstract ideas recited in independent claim 1 or to add significantly
more to the abstract idea that is not “well-understood, routine,
conventional.”
Accordingly, we sustain the Examiner’s rejection of dependent claims
8 and 9 under 35 U.S.C. § 101.
REJECTION UNDER 35 U.S.C. § 103(A)
Appellant argues that Halvorson
expressly recognizes that intravenous medications are not
stocked in the cabinet 32. Rather, such medications are prepared
and delivered according to the traditional approach described
above in relation to an on-demand context. As such, while the
Examiner relies on teachings in Halvorson regarding
methodology associated with delivery of medications from a
cabinet, Halvorson expressly recognizes that such teachings
related to a cabinet are inapplicable to IV doses like those recited
in claim 1, as they are treated differently “for a variety of
reasons.” In this regard, Halvorson suggests, to a person having
ordinary skill in the art at the time of the invention, that the types
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of medication orders of claim 1 would be handled traditionally
in relation to an on-demand context.
Appeal Br. 25. According to Appellant, the portions of Halvorson that the
Examiner relies upon, are “inapplicable to the subject matter of claim 1
related to sterile compounded medication products suitable for
administration by intravenous introduction to a patient, because Halvorson
expressly states that such medications are not stocked in a cabinet.” Appeal
Br. 26. Appellant contends “[T]here is no scenario in Halvorson in which
intravenous medication orders are matched to stock in a cabinet, as those
types of medications are expressly taught as not being stocked in the
cabinets in Halvorson.” Appeal Br. 26.
Appellant’s arguments are unpersuasive. In particular, Halvorson
teaches “[t]he system will also schedule other medications that, for a variety
of reasons, are not stocked in the cabinet 32; such as intravenous
medications that will be needed by patients at a dispensing station.”
Halvorson 4:64–67. We do not find this teaching to go so far as to render
Halvorson inapplicable to intravenous mediation and or that such medication
must be delivered according to the traditional on-demand approach. Instead,
we agree with the Examiner that Halvorson’s teaching is intended to be
inclusionary, indicating that Halvorson’s system can apply its methodology
to intravenous medication even if they are not stocked in Halvorson’s
cabinet. Moroever, we do not find this statement to indicate that
Halverson’s teachings could not apply to intravenous medication even if
they are not stocked in Halvorson’s cabinet.
Appellant argues that t Halvorson’s preparation station is “unrelated
to a preparation station for preparing doses of any kind, much less sterile
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compounded medication products suitable for administration by intravenous
introduction to a patient.” Appeal Br. 26.
We disagree with Appellant. Claim 68 of Halvorson, which the
Examiner relies upon for teaching the claimed “dose preparation station,”
discloses that if a medication order is not found in the unreserved doses of
the cabinet then a notification is sent to personnel on a pharmacy terminal
means so that medications to fulfill the order can be delivered. Halvorson
36:3–15. Halvorson also discloses that when medication orders are
scheduled, the lead time offered by the schedule “allow[s] the medications to
be prepared and delivered for use at the appropriate time.” Halvorson 4:64–
5:2; see also Ans. 14. Thus, we agree with the Examiner that Halvorson
teaches or suggests a dose preparation station.
Appellant argues that Halvorson does not disclose “generating
inventory dose orders (i.e. non-patient-specific orders).” Appeal Br. 27.
Rather, according to Appellant, Halvorson describes “retrieval of a multi-
dose and bulk packages specifically for a patient where any excess is stored
in that patient’s drawer” and that “[t]he check of the dispenser or reorder
from the pharmacy is related specifically to that patient, and [thus] does not
involve any generation of an inventory dose order claimed in claim 1.”
Appeal Br. 27–28. Appellant emphasizes that the Examiner acknowledges
that Halvorson does not teach “collectively analyzing previously received
patient-specific dose orders” and therefore “[g]iven Halvorson fails to teach
making such a determination, which is recognized by the Examiner,
Halvorson also fails to teach producing an inventory dose according to such
a determination.” Appeal Br. 28.
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We are unpersuaded by Appellant’s arguments. The Examiner finds
Halvorson teaches generating medication orders at the pharmacy, “which is
where inventory doses are prepared, to fulfill & replace the specific
medications that have been depleted at the dispensing station.” Final Act.
10. The Examiner also relies on Roden as teaching the “analyze” step of
claim 1 where previously received orders are collectively analyzed so that an
inventory order may be generated. Final Act. 13 (citing Roden 8:28–49).
The Examiner finds, and we agree, that combination of Halvorson and
Roden therefore teaches generating an inventory dose order based on a
determination of how frequently patient-specific-dose orders are received.
Appellant’s argument attacks Halvorson individually and fails to
acknowledge the teachings of Roden and how they are applied to Halvorson
by the Examiner.
Appellant also argues that Roden does not remedy the deficiencies of
Halvorson. Appeal Br. 29–31. Specifically, Appellant argues that “there is
no disclosure regarding analysis of medication dose orders at all [in Roden],
much less previously received patient-specific dose orders that are
collectively analyzed without regard to any particular patient-specific dose
order to make a determination of how frequently patient-specific orders for a
particular type of medication are received.” Appeal Br. 30. Appellant
argues that Roden’s disclosures “do not relate to medication orders at all”
but are rather more generic applying to inventory in general. Appeal Br. 30.
We are unpersuaded by Appellant’s argument. Roden teaches
tracking sales of a customer for a start-up period of several weeks to
establish a history of consumer demand which will then be used to create a
perpetual forecast to accurately predict the quantity and schedule of
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replenishment items to be shipped to the customer. Roden 3:46–56, 8:29–
49. Roden’s teachings apply generally to many different types of inventory
items, including medication. See Roden 4:7–37 (discussing the sale of
pharmaceuticals). Thus, one of ordinary skill in the art would have
understood that the teachings of Roden, which discusses determining and
anticipating demand for inventory items, could be applied to Halvorson,
which discusses the inventory of medication specifically.
Accordingly, we sustain the Examiner’s rejection of independent
claim 1 and of independent claim 21, which Appellant argues together with
claim 1. See Appeal Br. 32. Appellant does not separately argue the
pending dependent claims, thus the Examiner’s rejection of these dependent
claims is also sustained.

DECISION
The Examiner’s rejection of claims 1–29, 31–41, and 43 under 35
U.S.C. § 101 is affirmed.
The Examiner’s rejections of claims 1–29, 31–41, and 43 under 35
U.S.C. § 103 is affirmed.
In summary:
Claims
Rejected
Basis Affirmed Reversed
1–29, 31–41, and
43
35 U.S.C. § 101 1–29, 31–41,
and 43

1–29, 31–41, and
43
35 U.S.C. § 103 1–29, 31–41,
and 43

Overall Outcome 1–29, 31–41,
and 43

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No time period for taking any subsequent action in connection with
this appeal may be extended. See 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED