Ex Parte Tribble et al

Patent Trial and Appeal Board

Jun 26, 2018

14022415 (P.T.A.B. Jun. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/022,415 09/10/2013
118075 7590
K&L Gates LLP-Chicago
Baxter
P.O. Box 1135
Chicago, IL 60690-1135
06/28/2018
FIRST NAMED INVENTOR
Dennis Tribble
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.
50012-00180 1050
EXAMINER
NG, JONATHAN K
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
06/28/2018 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):
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, ABDUL W ARID KHAN,
DENNIS SCHNEIDER, GREGORY T. OLSEN,
JAYSON LEE BENDER, BHA VESH S. P ADMAN!, and
MATTHEW A. VALENTINE
Appeal2017-001269
Application 14/022,415 1
Technology Center 3600
Before ERIC B. CHEN, IRVINE. BRANCH, and AMBER L. HAGY,
Administrative Patent Judges.
BRANCH, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from a rejection of claims
45-52 and 56-58, which are all of the claims pending in the application. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
Technology
The application relates to "the receipt, processing, filling on-demand
and in anticipation of use, management, and distribution of medication dose
1 According to Appellants, Baxter Corporation Englewood is the real party
in interest. App. Br. 1.
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Application 14/022,415
orders, as well as remote dose inspection for facilitating the practice of
telepharmacy." Spec. 1.
Illustrative Claim
Claim 45 is illustrative and reproduced below:
45. A medication preparation system for preparing and
managing dose orders for compounded doses that have been
entered into a first system, comprising:
an order processing server executing software on a
processor thereof and connected by a network to the first system
and configured to receive the dose orders for compounded doses
from the first system, the order processing server including a
database configured to store the dose orders and information that
relates to the dose orders in a dose record, the order processing
server being configured to generate a dose order queue listing all
dose orders received by the order processing server;
a dose preparation station for manual preparation of a
plurality of compounded doses by a human operator based on
received dose orders, the dose preparation station being in
bidirectional communication with the order processing server
and having an interface comprising a display for providing a
human operator with a protocol associated with each received
dose order in a human perceivable manner and specifying a set
of steps to prepare the compounded dose corresponding to the
dose order;
the dose preparation station being configured to present
the protocol using the display to the human operator in the human
perceivable manner for use by the human operator for manual
preparation of a compounded dose corresponding to the dose
order and having one or more data input devices operable by the
human operator to capture dose preparation information that
relates to at least one step of the protocol to prepare the
compounded dose to fill the dose order in accordance with the
protocol and communicate the dose preparation information to
the order processing server for association with the dose record,
wherein the dose preparation information includes confirmation
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data entered by the operator to confirm that the at least one step
of the protocol was successfully completed and further includes
indicia associated with the compounded dose that permits the
contents of the compounded dose to be confirmed, and wherein
the dose preparation information must be received prior to
advancing to a subsequent step of the protocol; and
a portal that is accessible remotely from the dose
preparation station and in communication with the database that
is configured to access the dose preparation information from the
dose record of the database for presentation of the dose
preparation information on a display to a remote user for
inspection of the prepared compounded dose by review of the
dose preparation information in order to verify whether the
compounded dose has been prepared in accordance with the
protocol, wherein the portal is configured to receive an approval
of the release of the compounded dose if the remote user
confirms that the dose has been prepared in accordance with the
protocol.
Rejection2
Claims 45-52 and 56-58 stand rejected under 35 U.S.C. § 101
because the claimed invention is directed to a judicial exception (i.e. a law of
nature, a natural phenomenon, or an abstract idea) without significantly
more. Non-Final Act. 2.
ANALYSIS
We review the appealed rejections for error based upon the issues
identified by Appellants, and in light of the arguments and evidence
2 Rather than repeat the Examiner's positions and Appellants' arguments in
their entirety, we refer to the above mentioned Appeal Brief, as well as the
following documents for their respective details: the Non-Final Action
mailed October 20, 2015 ("Non-Final Act."), the Examiner's Answer mailed
August 29, 2016 ("Ans."), and Appellants' Reply Brief filed October 26,
2016 ("Reply Br.").
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produced thereon. Exparte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential).
Section 101 defines patent-eligible subject matter as "any new and
useful process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof." 3 5 U.S. C. § 101. The Supreme Court has
"long held that this provision contains an important implicit exception[:]
Laws of nature, natural phenomena, and abstract ideas are not patentable."
Ass 'nfor Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589
(2013) (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66, 70 (2012)).
To distinguish "patents that claim laws of nature, natural phenomena,
and abstract ideas from those that claim patent-eligible applications of those
concepts," the Supreme Court has set up an analytical framework. Alice
Corp. v. CLS Bankint'l, 134 S.Ct. 2347, 2355 (2014) (citing Mayo, 566 U.S.
at 71-73). In the first step of the analysis, we determine whether the claims
at issue are "directed to" a judicial exception, such as an abstract idea. Alice,
134 S. Ct. at 2355. If not, the inquiry ends. Thales Visionix Inc. v. U.S., 850
F.3d 1343, 1346 (Fed. Cir. 2017); Enfzsh, LLC v. Microsoft Corp., 822 F.3d
1327, 1339 (Fed. Cir. 2016). If the claims are determined to be directed to
an abstract idea, then we consider under step two whether the claims contain
an "inventive concept" sufficient to "transform the nature of the claim into a
patent-eligible application." Alice, 134 S.Ct. at 2355 (citation omitted).
Noting that the two stages involve "overlapping scrutiny of the
content of the claims," the Federal Circuit has described "the first-stage
inquiry" as "looking at the 'focus' of the claims, their 'character as a
whole,"' and "the second-stage inquiry (where reached)" as "looking more
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precisely at what the claim elements add-specifically, whether, in the
Supreme Court's terms, they identify an 'inventive concept' in the
application of the ineligible matter to which (by assumption at stage two) the
claim is directed." Electric Power Grp, LLC v. Alstom S.A., 830 F.3d 1350,
1353 (Fed. Cir. 2016). In considering whether a claim is directed to an
abstract idea, we acknowledge, as did the Court in Mayo, that "all inventions
at some level embody, use, reflect, rest upon, or apply laws of nature, natural
phenomena, or abstract ideas." Mayo, 566 U.S. at 71. We, therefore, look
to whether the claims focus on a specific means or method that improves the
relevant technology or are instead directed to a result or effect that in itself is
the abstract idea and merely invoke generic processes and machinery. See
Enfish, 822 F.3d at 1336.
Step One: Whether the Claims Are Directed to a Patent-Ineligible
Concept (Abstract Idea)
Claim 45, which is representative of the claims before us, 3 is directed
to a "medication preparation system," including "an order processing server
executing software on a processor thereof," "a dose preparation station," and
"a portal" that is remote from the dose preparation station "for inspection of
the prepared compounded dose."
The Examiner concludes that the claims "are directed to the abstract
idea of comparing new drug preparation information with stored drug
preparation [information] and using rules to identify whether the drug has
been correctly made." Non-Final Act. 3. In particular, the Examiner
3 Appellants collectively argue the rejection of all claims with regard to the
Examiner's rejection of claim 45 under 35 U.S.C. § 101. See App. Br. 4--31.
Therefore, based on Appellants' arguments, we decide the appeal of all
pending claims based on claim 45 alone. See 37 C.F.R. § 41.37(c)(l)(iv).
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characterizes "[ c ]omparing new drug preparation information with stored
drug preparation [information] and using rules to identify whether the drug
has been correctly made" as an abstract idea "because it is analogous to
comparing new and stored information and using rules to identify options."
Id. The Examiner finds that "claim 45 in the present case is analogous to the
abstract idea identified in the Smartgene case." Id. at 6 (citing SmartGene,
Inc. v. Advanced Biological Labs., SA, 555 Fed. Appx. 950 (Fed. Cir. 2014)
( nonprecedential)).
We agree with and adopt the Examiner's findings and conclusion as
our own.
Appellants argue that the Examiner has mischaracterized what the
claims are directed to and has incorrectly analogized the claims here to those
in Smartgene. App. Br. 8-23. Appellants argue, for example, that, unlike
the claims in Smartgene, "the positive enforcement of a protocol such that
the user may only progress in a protocol upon receipt of confirmation data is
not capable of being provided by a human user who is inherently subject to
error." Id. at 20. We are not persuaded.
Claim 45 recites that "dose preparation information must be received
prior to advancing to a subsequent step of the protocol." This amounts to an
automated checklist or "comparing new and stored information and using
rules to identify options," as the Examiner finds. Non-Final Act. 6.
Specifically, the system of claim 45 prohibits the "option" to continue with
the protocol in the absence of "new information" (received data) satisfying a
condition when compared to "stored information." This is also similar to
running a mental checklist and advancing to the next item in the checklist
only after completing the prior one. A human is capable of mentally
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reinforcing a prohibition on advancing to a subsequent step in a checklist
only upon completing a current step.
Accordingly, we agree with the Examiner at step one of the Alice
analysis that the claims are directed to the abstract idea of "comparing new
and stored information and using rules to identify options." Non-Final
Act. 6.
Step Two: Whether Additional Elements Transform The Abstract Idea
Into Patent-Eligible Subject Matter
With respect to the question of whether additional elements transform
the abstract idea, the Examiner finds that "[t]his abstract idea is only
generally linked to a particular technological environment by reciting the
generic computer components that are well known in the art as
acknowledged by the [Appellants'] [S]pecification." Ans. 7. The Examiner
also finds that "[ w ]hile utilizing a computer to perform the abstract idea may
improve the efficiency of carrying out the abstract idea, the claims do not
result in any measurable improvements to the operations of the computer
hardware itself, such as reduced memory usage or increased processor
speed." Id. The Examiner also finds that"[ w ]hile the claims are directed to
manipulating and organizing data, they are not directed to a transformation
that changes the fundamental nature of the data." Id.
We agree with and adopt the Examiner's findings and conclusion.
In the Reply Brief, Appellants argue that "claim 45 presents
something more than the mere abstract idea of determining whether a dose is
correctly prepared" because "the system of claim 45 provides functionality
simply not possible without the utilization of a system such as that recited in
claim 45," namely, "an interlock that goes beyond the mental review of a
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user that is inherently subject to error." Reply Br. 3-9 (advancing
arguments of similar effect).
Appellants' arguments in this regard are unpersuasive because they
overstate the system's role in determining "whether a dose is correctly
prepared." Appellants' arguments imply that the system's interlock
produces infallibility, which is a desired outcome. We are not persuaded
that the system produces infallibility instead of merely following the rules it
is programmed to enforce. Moreover, the claim goes on to recite "a portal"
at which a "remote user confirms that the dose has been prepared in
accordance with the protocol," a superfluous component to the system if the
interlock produces the heretofore impossible desired outcome of infallibility.
In other words, Appellants' arguments that claim 45 transforms the abstract
idea into something more are based unpersuasively on the desired outcome
the system is intended to produce, rather than actual claim elements.
We have considered all of Appellants' remaining arguments and have
found them unpersuasive.
For the foregoing reasons, we are not persuaded the Examiner erred in
rejecting independent claim 45 under 35 U.S.C. § 101 as directed to patent-
ineligible subject matter, or in rejecting on the same basis dependent claims
44--52 and 56-58, which Appellants do not argue separately. App. Br. 4--31.
DECISION
For the reasons above, we affirm the Examiner's decision rejecting
claims 45-52 and 56-58.
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.
§ 41.50(f).
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AFFIRMED
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