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 .
Status of Claims
This office action for the 19/322007 application is in response to the communications filed September 08, 2025.
Claims 1-20 were initially submitted September 08, 2025.
Claims 1-20 are currently pending and considered below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-20 of U.S. Patent No. 12,412,644. Although the claims at issue are not identical, they are not patentably distinct from each other.
As per claim 1,
U.S. Patent No. 12,412,644 teaches “A system for an automated exchange of healthcare information between an electronic medical record (EMR) system and a dose fulfillment client for fulfillment of dose orders, the system comprising:”:
(Claim 1 of U.S. Patent No. 12,412,644: “A method for an automated exchange of healthcare information between an electronic medical record (EMR) system and a selected dose fulfillment client for fulfillment of a dose order, the method comprising”)
U.S. Patent No. 12,412,644 further teaches “a platform interface module configured to:”:
(Claim 1 of U.S. Patent No. 12,412,644: “executing non-transitory machine-readable data for specifically configuring processors of a platform interface module, a transformation module, and a client router, execution of the non-transitory machine-readable data causing the processors to:”)
U.S. Patent No. 12,412,644 further teaches “receive a healthcare information data stream from the EMR system, wherein the healthcare information data stream comprises information including dose order metadata related to dose orders,”:
(Claim 1 of U.S. Patent No. 12,412,644: “receive a healthcare information data stream at the platform interface module via a network from the EMR system, wherein the healthcare information data stream comprises information including dose order metadata related to dose orders that is provided in a Health Level 7 (“HL7”) format;”)
U.S. Patent No. 12,412,644 further teaches “identify individual dose orders from the healthcare information data stream by identifying express delineators within the healthcare information data stream and identifying the dose order metadata corresponding to dose order data fields, wherein the express delineators mark separations between the dose orders in the healthcare information data stream,”:
(Claim 1 of U.S. Patent No. 12,412,644: “identify, via the platform interface module, individual dose orders from the healthcare information data stream by identifying express delineators within the healthcare information data stream and identifying the dose order metadata corresponding to dose order data fields, wherein the express delineators mark separations between the dose orders in the healthcare information data stream;”)
U.S. Patent No. 12,412,644 further teaches “parse the dose order metadata for each of the dose orders from the healthcare information data stream, wherein the dose order metadata comprises one or more dose characteristics associated with the respective dose order;”:
(Claim 1 of U.S. Patent No. 12,412,644: “parse, via the platform interface module, the dose order metadata for each of the dose orders from the healthcare information data stream, wherein the dose order metadata comprises one or more dose characteristics associated with the respective dose order;”)
U.S. Patent No. 12,412,644 further teaches “a transformation module communicatively coupled to the platform interface module, the transformation module configured to:”:
(Claim 1 of U.S. Patent No. 12,412,644: “executing non-transitory machine-readable data for specifically configuring processors of a platform interface module, a transformation module, and a client router, execution of the non-transitory machine-readable data causing the processors to:”)
U.S. Patent No. 12,412,644 further teaches “determine from the dose order metadata, a dose fulfillment client type, among a plurality of different dose fulfillment client types for fulfilling each of the dose orders,”:
(Claim 1 of U.S. Patent No. 12,412,644: “determine, via the transformation module from the dose order metadata, a dose fulfillment client type, among a plurality of different dose fulfillment client types for fulfilling each of the dose orders, the dose fulfillment client types including an automated dose preparation device, an automated total parenteral nutrition (TPN) compounder, and an automated dose dispensing cabinet;”)
U.S. Patent No. 12,412,644 further teaches “select a dose fulfillment client that matches the dose fulfillment client type for fulfillment of each of the dose orders,”:
(Claim 1 of U.S. Patent No. 12,412,644: “select, via the transformation module, a dose fulfillment client that matches the dose fulfillment client type for fulfillment of each of the dose orders;”)
U.S. Patent No. 12,412,644 further teaches “transform the dose order metadata into a predefined format dictated by the selected dose fulfillment client to generate transformed dose order metadata,”:
(Claim 1 of U.S. Patent No. 12,412,644: “transform, via the transformation module, the dose order metadata from the standardized intermediate format into a predefined format dictated by the selected dose fulfillment client to generate transformed dose order metadata,”)
U.S. Patent No. 12,412,644 further teaches “wherein the transforming is at least in part based on the respective predefined format of the selected dose fulfillment client;”:
(Claim 1 of U.S. Patent No. 12,412,644: “wherein the transforming is at least in part based on the respective predefined format of the selected dose fulfillment client”)
U.S. Patent No. 12,412,644 further teaches “a client router communicatively coupled to the transformation module, the client router configured to route the transformed dose order metadata to the selected dose fulfillment client to cause the respective dose order to be fulfilled automatically using the selected dose fulfillment client to provide a medication dose”:
(Claim 1 of U.S. Patent No. 12,412,644: “route, via the client router of the transformation module, the transformed dose order metadata to the selected dose fulfillment client via the network; and cause each of the dose orders to be fulfilled automatically using the selected dose fulfillment client based on the transformed dose order metadata to provide a corresponding medication dose.”)
As per claim 2,
U.S. Patent No. 12,412,644 teaches the limitations of claim 1.
U.S. Patent No. 12,412,644 further teaches “wherein the dose fulfillment client types include at least one of an automated dose preparation device, a pharmacy workflow management application for management of manual preparation of medication doses, an automated syringe filler, an automated total parenteral nutrition (TPN) compounder, and an automated dose dispensing cabinet.”:
(Claim 1 of U.S. Patent No. 12,412,644: “determine, via the transformation module from the dose order metadata, a dose fulfillment client type, among a plurality of different dose fulfillment client types for fulfilling each of the dose orders, the dose fulfillment client types including an automated dose preparation device, an automated total parenteral nutrition (TPN) compounder, and an automated dose dispensing cabinet;”)
As per claim 3,
U.S. Patent No. 12,412,644 teaches the limitations of claim 1.
U.S. Patent No. 12,412,644 further teaches “wherein the dose order metadata is provided in a Health Level 7 (HL7) format.”:
(Claim 1 of U.S. Patent No. 12,412,644: “receive a healthcare information data stream at the platform interface module via a network from the EMR system, wherein the healthcare information data stream comprises information including dose order metadata related to dose orders that is provided in a Health Level 7 (“HL7”) format;”)
As per claim 4,
U.S. Patent No. 12,412,644 teaches the limitations of claim 1.
U.S. Patent No. 12,412,644 further teaches “wherein the platform interface module is further configured to populate a staging table with the dose order metadata for each of the dose orders, wherein the staging table comprises a plurality of dose order data fields populated with corresponding respective portions of the dose order metadata parsed from the healthcare information data stream, and wherein the dose order metadata is populated in a standardized intermediate format, and wherein the transformation module is configured to transform the dose order metadata by transforming the dose order metadata from the standardized intermediate format into the predefined format.”:
(Claim 1 of U.S. Patent No. 12,412,644: “populate, via the platform interface module, a staging table with the dose order metadata for each of the dose orders, wherein the staging table comprises a plurality of dose order data fields populated with corresponding respective portions of the dose order metadata parsed from the healthcare information data stream, and wherein the dose order metadata is populated in a standardized intermediate format;”)
As per claim 5,
U.S. Patent No. 12,412,644 teaches the limitations of claim 4.
U.S. Patent No. 12,412,644 further teaches “wherein the staging table is independent of any of the plurality of dose fulfillment clients.”:
(Claim 3 of U.S. Patent No. 12,412,644: “wherein the staging table is independent of any of the plurality of dose fulfillment clients.”)
As per claim 6,
U.S. Patent No. 12,412,644 teaches the limitations of claim 4.
U.S. Patent No. 12,412,644 further teaches “wherein the transforming includes mapping the plurality of dose order data fields of the staging table to corresponding respective ones of a plurality of dose fulfillment client input fields for the selected dose fulfillment client, including at least: mapping one data field of the plurality of dose order data fields of the staging table to one data field of the plurality of dose fulfillment client input fields, and mapping at least two data fields of the plurality of dose order data fields of the staging table to one data field of the plurality of dose fulfillment client input fields.”:
(Claim 1 of U.S. Patent No. 12,412,644: “wherein the transforming includes mapping the plurality of dose order data fields of the staging table to corresponding respective ones of a plurality of dose fulfillment client input fields for the selected dose fulfillment client, including at least: mapping one data field of the plurality of dose order data fields of the staging table to one data field of the plurality of dose fulfillment client input fields, and mapping at least two data fields of the plurality of dose order data fields of the staging table to one data field of the plurality of dose fulfillment client input fields;”)
As per claim 7,
U.S. Patent No. 12,412,644 teaches the limitations of claim 6.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is further configured to update the staging table to indicate the dose order metadata for each of the dose orders that have been routed to the dose fulfillment client.”:
(Claim 11 of U.S. Patent No. 12,412,644: “updating the staging table to indicate the dose order metadata for each of the dose orders that have been routed to the dose fulfillment client.”)
As per claim 8,
U.S. Patent No. 12,412,644 teaches the limitations of claim 6.
U.S. Patent No. 12,412,644 further teaches “wherein the dose fulfillment client input fields are defined by a unique input format associated with the dose fulfillment client.”:
(Claim 4 of U.S. Patent No. 12,412,644: “wherein the dose fulfillment client input fields are defined by a unique input format associated with the dose fulfillment client.”)
As per claim 9,
U.S. Patent No. 12,412,644 teaches the limitations of claim 8.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is configured to further transform the dose order metadata by validating the dose order metadata of the plurality of dose order data fields with respect to the unique input format for corresponding ones of the dose fulfillment client input fields.”;
(Claim 5 of U.S. Patent No. 12,412,644: “wherein the transforming comprises: validating the dose order metadata of the plurality of dose order data fields with respect to the unique input format for corresponding ones of the dose fulfillment client input fields.”)
As per claim 10,
U.S. Patent No. 12,412,644 teaches the limitations of claim 9.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is configured to further validate the dose order metadata by correlating the dose order metadata of the plurality of dose order data fields to formulary records of the dose fulfillment client with respect to the corresponding respective ones of the dose fulfillment client input fields.”:
(Claim 6 of U.S. Patent No. 12,412,644: “wherein the validating comprises: correlating the dose order metadata of the plurality of dose order data fields to formulary records of the dose fulfillment client with respect to the corresponding respective ones of the dose fulfillment client input fields.”)
As per claim 11,
U.S. Patent No. 12,412,644 teaches the limitations of claim 10.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is further configured to generate an exception in response to an error associated with at least one of the mapping or validating.”:
(Claim 7 of U.S. Patent No. 12,412,644: “generating an exception in response to an error associated with at least one of the mapping or validating.”)
As per claim 12,
U.S. Patent No. 12,412,644 teaches the limitations of claim 11.
U.S. Patent No. 12,412,644 further teaches “wherein the exception comprises prompting a human user to resolve the error.”:
(Claim 8 of U.S. Patent No. 12,412,644: “wherein the exception comprises prompting a human user to resolve the error”)
As per claim 13,
U.S. Patent No. 12,412,644 teaches the limitations of claim 12.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is further configured to receive, from the human user, an input associated with the resolution of the error, wherein the input comprises at least one of a correct mapping between a dose order data field of the staging table and a corresponding respective one of a dose fulfillment client input fields or a correct correlation between a portion of dose order metadata and a formulary record of the dose fulfillment client.”:
(Claim 9 of U.S. Patent No. 12,412,644: “receiving, from the human user, an input associated with the resolution of the error, wherein the input comprises at least one of a correct mapping between a dose order data field of the staging table and a corresponding respective one of a dose fulfillment client input fields or a correct correlation between a portion of dose order metadata and a formulary record of the dose fulfillment client.”)
As per claim 14,
U.S. Patent No. 12,412,644 teaches the limitations of claim 13.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is further configured to update at least one of a mapping logic or a correlation logic for use in the mapping and correlating, respectively, based on the input received from the human user.”:
(Claim 10 of U.S. Patent No. 12,412,644: “updating at least one of a mapping logic or a correlation logic for use in the mapping and correlating, respectively, based on the input received from the human user.”)
As per claim 15,
U.S. Patent No. 12,412,644 teaches the limitations of claim 1.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is further configured to manage each of the dose orders prior to providing the dose order metadata in the predefined format to the dose fulfillment client”:
(Claim 12 of U.S. Patent No. 12,412,644: “managing each of the dose orders prior to providing the dose order metadata in a second form to the dose fulfillment client.”)
As per claim 16,
U.S. Patent No. 12,412,644 teaches the limitations of claim 15.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is configured to manage each of the dose orders by providing a user interface to allow a user to perform a management function relative to each of the dose orders.”:
(Claim 13 of U.S. Patent No. 12,412,644: “wherein the managing includes providing a user interface to allow a user to perform a management function relative to each of the dose orders.”)
As per claim 17,
U.S. Patent No. 12,412,644 teaches the limitations of claim 16.
U.S. Patent No. 12,412,644 further teaches “wherein the management function comprises at least one of modification of dose order metadata, cancellation of the dose order, organization of the dose order relative to other dose orders, or prioritization of the dose order relative to other dose orders.”:
(Claim 14 of U.S. Patent No. 12,412,644: “wherein the management function comprises at least one of modification of dose order metadata, cancellation of the dose order, organization of the dose order relative to other dose orders, or prioritization of the dose order relative to other dose orders.”)
As per claim 18,
U.S. Patent No. 12,412,644 teaches the limitations of claim 1.
U.S. Patent No. 12,412,644 further teaches “wherein the transformation module is further configured to perform logistical processing on each of the dose orders, wherein the logistical processing comprises performing an action relative to each of the dose orders in response to receipt of an EMR system message subsequent to the receipt of the respective dose order.”:
(Claims 15 and 16 of U.S. Patent No. 12,412,644: “performing logistical processing on each of the dose orders.” and “wherein the logistical processing comprises performing an action relative to each of the dose orders in response to receipt of an EMR system message subsequent to the receipt of the respective dose order.”)
As per claim 19,
U.S. Patent No. 12,412,644 teaches the limitations of claim 18.
U.S. Patent No. 12,412,644 further teaches “wherein the EMR system message comprises at least one of a dose order change message or a dose order discontinuation message.”:
(Claim 17 of U.S. Patent No. 12,412,644: “wherein the EMR system message comprises at least one of a dose order change message or a dose order discontinuation message.”)
As per claim 20,
U.S. Patent No. 12,412,644 teaches the limitations of claim 19.
U.S. Patent No. 12,412,644 further teaches “wherein the logistical processing comprises at least one of: determining when the dose order metadata has been provided to the dose fulfillment client; performing an action relative to each of the dose orders corresponding to the EMR system message for a dose order that has not yet been provided to the dose fulfillment client; and providing data to the dose fulfillment client related to the EMR system message for a dose order that has been provided to the dose fulfillment client.”:
(Claims 18-20 of U.S. Patent No. 12,412,644: “wherein the logistical processing comprises determining if the dose order metadata has been provided to the dose fulfillment client.”, “wherein the logistical processing comprises performing an action relative to each of the dose orders corresponding to the EMR system message for a dose order that has not yet been provided to the dose fulfillment client.”, and “wherein the logistical processing comprises providing data to the dose fulfillment client related to the EMR system message for a dose order that has been provided to the dose fulfillment client.”)
Allowable Subject Matter
Claims 1-20 contain subject matter free of prior art. The Examiner has conducted a thorough search of the prior art and could not find a single reference, or combination of references with adequate rationale to combine, to teach the limitations of “identify individual dose orders from the healthcare information data stream by identifying express delineators within the healthcare information data stream and identifying the dose order metadata corresponding to dose order data fields, wherein the express delineators mark separations between the dose orders in the healthcare information data stream,”. This limitation is substantially similar to the reasons for allowance of the parent case, Application 14/922,376. The closest prior art the Examiner was able to find was:
Alaimo et al. (US 2007/0038915; herein referred to as Alaimo): which teaches the use of data delineators such as filemarks, setmarks, and partition markers, which may similarly be numbered in the order of transmission from the host system. Other features common to sequential-access formats include the ability to append user data or delineators after any user data record or delineator, the ability to store compressed or encrypted user data, the ability to locate any data record or delineator with its assigned number, the ability to locate an end-of-data last object recorded on the medium, the ability to read content sequentially and determine the type and size of each data record or delineator as part of a self-describing format, and the like. On termination conditions, the sequential-access emulation system controller 102 does not need to add fill data to the current correction group size. Instead, it might only fill to a storage-medium block boundary. The sequential-access emulation system controller 102 may implicitly determine these conditions when reading the storage medium using the data descriptor information. This is in contrast to inline header formats that typically require all correction groups to be of the same size. The electronic hardware for implementing this format is also advantageously simpler than for an inline header format because no data-descriptor metadata needs to be inserted in the user data stream; the data descriptors are stored in a separate portion of the medium. Searching to an arbitrary position in the storage medium may proceed more quickly because the absolute position of the target object can be determined from the data descriptor information. However, Alaimo is deficient in teaching a data stream that includes data pertaining to individual dose orders. Looking to the previously cited prior art, it does not appear that there is sufficient evidence to support the position that one of ordinary skill in the art in possession of the combined teaching of Tribble, Mohapatra, Ranalletta, Lawless and Gunn would have looked to the teachings of Alaimo. While the combined teaching of Tribble, Mohapatra, Ranalletta, Lawless and Gunn includes data storage techniques, it would appear that there would need to be an obvious deficiency in its storage methods for one of ordinary skill in the art to look past the medication preparations methods in the combined teaching of Tribble, Mohapatra, Ranalletta, Lawless and Gunn into the error detection or correction archival format teachings of Alaimo. Such a deficiency does not appear to be readily apparent.
It can be seen that the prior art alone does not teach the limitations of claim 31, and by extension its dependents. Even if a combination of this prior art with previously cited prior art could have resulted in teaching the limitations of claim 1, such a combination would have only been possible through impermissible hindsight reasoning. Accordingly, claims 1-20 contain subject matter free of prior art.
Conclusion
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/CHAD A NEWTON/Primary Examiner, Art Unit 3681
