DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending. Examiner notes that any citation to the instant disclosure will be in reference to the paragraph numbers found in the corresponding printed application, U.S. Pub. No. 2025/0006353 A1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are 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.
Step 1
Claims 1-12 are drawn to a system for managing medication dose orders and Claims 13-20 are drawn to workstation for managing medication dose order, construed as a device per the instant specification, which is within the four statutory categories (i.e. machine).
Step 2A | Prong One
Claim 1 of Group I (Claims 1-12) recite a system for managing medication dose orders, the system comprising:
a server storing a plurality of dose order records and protocols for preparing medication doses (MPEP § 2106.05(f), apply it and MPEP § 2106.05(g), insignificant extra solution activity), each protocol specifying sequential steps to prepare a different medication, at least some of the sequential steps requiring an input of dose preparation verification information; and
a workstation communicatively coupled to the server, the workstation including a pharmacy workflow management application configured to (MPEP § 2106.05(f), apply it):
receive information indicative of the plurality of dose order records from the server (MPEP § 2106.05(f), apply it),
display the received information indicative of the plurality of dose order records,
receive a selection of one of the plurality of dose order records,
transmit an indication of the selected dose order record to the server (MPEP § 2106.05(g), insignificant extra solution activity), the indication of the selected dose order record causing the server (MPEP § 2106.05(f), apply it) to determine a corresponding protocol and send the determined protocol to the workstation (MPEP § 2106.05(f), apply it),
receive the determined protocol from the server (MPEP § 2106.05(f), apply it),
cause a user interface to be displayed, the user interface including (MPEP § 2106.05(f), apply it):
(i) a medication product information section that provides information indicative of a medication related to the selected dose order record,
(ii) a current dose section that provides information indicative of a specific medication dose being prepared for a patient associated with the selected dose order record, and
(iii) a protocol section that lists sequential steps of the determined protocol for preparing the specific medication dose, each sequential step including an input prompt that is selectable by a user to indicate the sequential step has been completed or to enable the user to input dose preparation verification information, and
prevent input prompts from being displayed for at least some of the sequential steps of the determined protocol until at least one of:
(a) indications are received of prior steps being completed, or
(b) dose preparation verification information is received for the prior steps.
Claim 13 of Group II (Claims 13-20) recite a workstation for managing medication dose orders, the workstation comprising a pharmacy workflow management application configured to:
receive information indicative of a plurality of dose order records from a server (MPEP § 2106.05(f), apply it);
display the received information indicative of the plurality of dose order records;
receive a selection of one of the plurality of dose order records;
transmit an indication of the selected dose order record to the server (MPEP § 2106.05(g), insignificant extra solution activity), the indication of the selected dose order record causing the server (MPEP § 2106.05(f), apply it) to determine a corresponding protocol and send the determined protocol to the workstation (MPEP § 2106.05(f), apply it), the determined protocol specifying sequential steps to prepare a medication, at least some of the sequential steps requiring an input of dose preparation verification information;
receive the determined protocol from the server (MPEP § 2106.05(f), apply it);
cause a user interface to be displayed, the user interface including (MPEP § 2106.05(f), apply it):
(i) a medication product information section that provides information indicative of a medication related to the selected dose order record,
(ii) a current dose section that provides information indicative of a specific medication dose being prepared for a patient associated with the selected dose order record, and
(iii) a protocol section that lists sequential steps of the determined protocol for preparing the specific medication dose, each sequential step including an input prompt that is selectable by a user to indicate the sequential step has been completed or to enable the user to input dose preparation verification information; and
prevent input prompts from being displayed for at least some of the sequential steps of the determined protocol until at least one of:
(a) indications are received of prior steps being completed, or
(b) dose preparation verification information is received for the prior steps.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 2-12 and 14-20 include other limitations, for example Claims 2 and 17 recite wherein the medication product information section includes at least one of a medication name, a medication concentration, a medication quantity, or a medication weight, Claims 3 and 18 recite wherein the current dose section includes at least one of a patient name, a patient identifier, a final volume of the specific medication dose, an urgency indication, or a date/time when the specific medication dose is to be administered, Claims 4 and 19 recite wherein the dose preparation verification information includes at least one of: information from a barcode scan of a barcode on a container of a constituent component, a diluent, or an ingredient; an image recorded by a camera of a container of a constituent component, a diluent, or an ingredient; or an image recorded by a camera of the specific medication dose in a syringe or a medication container, Claims 5 and 20 recite wherein the dose preparation verification information includes information indicative of at least one of: a weight of a constituent component, a diluent, or an ingredient; or a weight of the specific medication dose in a syringe or a medication container, Claim 6 recites wherein the weight is received from a weight scale that is communicatively coupled to the workstation (MPEP § 2106.05(f), apply it), Claim 7 recites wherein the weight is input via the workstation, Claims 8 and 14 recite wherein the pharmacy workflow management application is configured to additionally prevent at least some text of the at least some of the sequential steps from being displayed until the indications are received of prior steps being completed or the input dose preparation verification information is received for the respective prior steps, Claims 9 and 15 recite wherein the pharmacy workflow management application is further configured to: store the input dose preparation verification information associated with the selected dose order record to a data record (MPEP § 2106.05(g), insignificant extra solution activity); and transmit the data record to the server (MPEP § 2106.05(g), insignificant extra solution activity) for pharmacist verification after the sequential steps of the determined protocol have been performed, Claims 10 and 16 recite wherein one of the sequential steps of the determined protocol specifies an acceptable weight range, and wherein the pharmacy workflow management application is configured to additionally prevent the input prompts from being displayed for the at least some of the sequential steps that are after the one of the sequential steps until the input dose preparation verification information associated with the one of the sequential steps includes a weight value that is within the acceptable weight range, Claim 11 recites wherein the user interface is configured to display numerical values for at least (i) and (ii) according to an Institute for Safe Medical Practice (“ISMP”) standard format, Claim 12 recites wherein the pharmacy workflow management application is a thick client (MPEP § 2106.05(f), apply it), but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 13.
Step 2A | Prong Two
Furthermore, Claims 1-20 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a server, application, workstation, user interface, a weight scale, and thick client, which amounts to merely invoking a computer or other machinery as a tool to perform the abstract idea, e.g. see paragraphs [0024-0025], [0081-0083], [0169], [0173-0174] and [0227] of the present Specification, see MPEP 2106.05(f); and
add insignificant extra-solution activity to the abstract idea – for example, the recitation of storing and transmitting data, which amounts to an insignificant application, see MPEP 2106.05(g).
Step 2B
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0024-0025], [0081-0083], [0169], [0173-0174] and [0227] of the Specification discloses that the additional elements (i.e. a server, application, workstation, user interface, a weight scale, and thick client) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions or use other machinery for its intended purpose (i.e. storing and transmitting data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention transmits the data to a server over a network, for example the Internet;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of dose order records and protocols for preparing medication doses and input dose preparation verification information data on a database and/or electronic memory; and
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing dose order records and protocols for preparing medication doses and input dose preparation verification information data in a database and/or electronic memory.
Dependent Claims 2-13 and 14-20 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than receiving or transmitting data over a network (e.g. the transmitting feature of dependent Claims 9 and 15), electronic recordkeeping (e.g. the storing feature of dependent Claims 9 and 15), and storing and retrieving information in memory (e.g. the storing feature of dependent Claims 9 and 15) or are recited at an “apply it” level (e.g., the weight scale and the application being a thick client).
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
The prior art of record, including Trible (U.S. Pub. No. 2010/0094653 A1), does not disclose or render obvious the combination of limitations found in claims 1 and 13. Trible discloses an automated medication dose order system (see at least paragraphs [0033] and [0035]) that prevents the processing of a dose order until verification is complete (see paragraph [0074]), but it fails to disclose or teach the particular of claims 1 and 13.
Claims 2-12 are also free from art as they depend from claim 1 and claims 14-20 are free from art as they depend from claim 13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
