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 .
Priority
This application’s status as a continuation of US applications 18/121,945 and 16/142,356 and corresponding claim of priority to provisional patent application 62/565,320 is acknowledged.
Status of the Claims
Claims 1-20 are currently pending and have been considered below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/3/2025 is in accordance with the provisions of 37 CFR 1.97 and is considered by the Examiner.
Claim Objections
Claims 13-20 are objected to because of the following informalities: claim 13 first introduces “a server” and then makes reference to “the server device” in line 19; the nomenclature of the server should be standardized such that it is consistently referenced as either the server or the server device for clarity. Examiner notes that claim 14 also references “the server device.” Claims 14-20 are also objected to on this basis because they inherit the objectionable language due to their dependence on claim 13. Appropriate correction is required.
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).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12020784 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined in the table below:
‘670 Claim #
‘670 Claim Language
Explanation
‘784 Claim Language
‘784 Claim #
1
A server computing system, comprising: one or more processors; memory configured for storing computing instructions;
identical
A server computing system, comprising: one or more processors; memory configured for storing computing instructions;
1
and a database of macro-based diagnoses;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
and a database of macro-based diagnoses, each macro-based diagnosis comprising an associated macro indicator and a plurality of elements of an accession having one or more corresponding specimens, each macro-based diagnosis including at least an initial diagnosis element;
wherein the computing instructions, when executed on the server computing system, implement a process for generating pathology lab diagnoses, the process configured to:
identical
wherein the computing instructions, when executed on the server computing system, implement a process for generating pathology lab diagnoses, the process configured to:
receive a macro indicator from a client device;
identical
receive a macro indicator from the client device;
identify a macro-based diagnosis in the database of macro-based diagnoses based on the received macro indicator;
identical
identify a macro-based diagnosis in the database of macro-based diagnoses based on the received macro indicator;
retrieve an initial diagnosis element from the identified macro-based diagnosis;
identical
retrieve the initial diagnosis element from the identified macro-based diagnosis;
transmit the initial diagnosis to the client device;
identical
transmit the initial diagnosis to the client device;
receive an edited version of the initial diagnosis from the client device;
identical
receive an edited version of the initial diagnosis from the client device;
combine the edited version of the initial diagnosis with one or more elements of an accession corresponding to the macro-based diagnosis into an accession specific macro-based diagnosis;
identical
combine the edited version of the initial diagnosis with each of the remaining plurality of elements of the accession of the macro-based diagnosis into an accession specific macro-based diagnosis;
store the accession specific macro-based diagnosis in the database of macro-based diagnoses for subsequent retrieval.
identical
store the accession specific macro-based diagnosis in the database of macro-based diagnoses for subsequent retrieval.
2
wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user;
identical
wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user;
2
and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user;
identical
and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user;
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
identical
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
and store the edited version of the initial diagnosis with a relation to the specific pathologist.
Identical
and store the edited version of the initial diagnosis with a relation to the specific pathologist.
3
wherein: the database of macro-based diagnoses is further configured such that each macro-based diagnosis includes additional fields for additional information;
Identical
wherein: the database of macro-based diagnoses is further configured such that each macro-based diagnosis includes additional fields for additional information;
3
and the process is further configured to: retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator;
identical
and the process is further configured to: retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator;
and transmit the additional information to the client device.
Identical
and transmit the additional information to the client device.
4
wherein the process is further configured to: receive an edited version of the additional information for at least one of the additional fields; and store the edited version of the additional information in the database of macro-based diagnoses for subsequent retrieval.
Identical
wherein the process is further configured to: receive an edited version of the additional information for at least one of the additional fields; and store the edited version of the additional information in the database of macro-based diagnoses for subsequent retrieval.
4
5
wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user;
identical
wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user;
5
and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user;
identical
and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user;
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
identical
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
identical
retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
store the edited version of the initial diagnosis with a relation to the specific pathologist;
Identical
store the edited version of the initial diagnosis with a relation to the specific pathologist;
store the edited version of the additional information with a relation to the specific pathologist.
Identical
store the edited version of the additional information with a relation to the specific pathologist.
6
wherein the additional fields in the database of macro-based diagnoses include options for Current Procedural Terminology (CPT) codes and options for International Classification of Diseases (ICD) codes.
Identical
wherein the additional fields in the database of macro-based diagnoses include options for Current Procedural Terminology (CPT) codes and options for International Classification of Diseases (ICD) codes.
6
7
A client computing system, comprising: one or more processors; and memory configured for storing computing instructions; wherein the computing instructions, when executed on the client computing system, implement a process for generating pathology lab diagnoses, the process configured to:
identical
A client computing system, comprising: one or more processors; and memory configured for storing computing instructions; wherein the computing instructions, when executed on the client computing system, implement a process for generating pathology lab diagnoses, the process configured to:
7
present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators;
identical
present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators;
receive via the user interface, a designation of a macro indicator associated with a macro-based diagnosis; transmit the designated macro indicator to a server;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
receive via the user interface, a designation of a macro indicator selected from a plurality of macro indicators, wherein each macro indicator is associated with a macro-based diagnosis; transmit the designated macro indicator to a server;
receive an initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
receive an initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator transmitted to the server and the macro-based diagnosis associated with the macro indicator;
receive via the user interface, one or more modifications to the initial diagnosis.
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
update the user interface to present the initial diagnosis in a diagnosis text box element of the accession; and receive via the user interface, one or more modifications to the initial diagnosis in the diagnosis text box element of the accession.
8
wherein the process for generating pathology lab diagnoses is further configured to transmit the edited entry from the diagnosis text box element to the server for storing in a database of macro-based diagnoses, wherein the stored edited entry is available for subsequent retrieval.
identical
wherein the process for generating pathology lab diagnoses is further configured to transmit the edited entry from the diagnosis text box element to the server for storing in a database of macro-based diagnoses, wherein the stored edited entry is available for subsequent retrieval.
8
9
wherein the process for generating pathology lab diagnoses is further configured to: receive additional information from the server responsive to the macro indicator; pre-populate one or more additional text boxes of the user interface with the additional information; and enable the user to edit the one or more additional text boxes.
identical
wherein the process for generating pathology lab diagnoses is further configured to: receive additional information from the server responsive to the macro indicator; pre-populate one or more additional text boxes of the user interface with the additional information; and enable the user to edit the one or more additional text boxes.
9
10
wherein the process is further configured to transmit edited text received in the one or more additional text boxes to the server for storing in a database of macro-based diagnoses, wherein the stored edited text is available for subsequent retrieval.
identical
wherein the process is further configured to transmit edited text received in the one or more additional text boxes to the server for storing in a database of macro-based diagnoses, wherein the stored edited text is available for subsequent retrieval.
10
11
wherein the one or more additional text boxes include text boxes for microscopic text and comment text.
Identical
wherein the one or more additional text boxes include text boxes for microscopic text and comment text.
11
12
wherein the user interface further includes one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes.
identical
wherein the user interface further includes one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes.
12
13
A computer-implemented method for generating pathology lab diagnoses, comprising: on a client device: present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators;
identical
A computer-implemented method for generating pathology lab diagnoses, comprising: on a client device: present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators;
13
receive via the user interface, a designation of a macro indicator selected from a plurality of macro indicators, wherein each macro indicator is associated with a macro-based diagnosis; and transmit the designated macro indicator to a server;
identical
receive via the user interface, a designation of a macro indicator selected from a plurality of macro indicators, wherein each macro indicator is associated with a macro-based diagnosis; and transmit the designated macro indicator to a server;
on a server: receive the designated macro indicator from the client device;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
on a server: store a database of macro-based diagnoses, each macro-based diagnosis comprising an associated macro indicator and a plurality of elements of an accession having one or more corresponding specimens, each macro-based diagnosis including at least an initial diagnosis element; receive a macro indicator from a client device;
identify a macro-based diagnosis based on the received macro indicator; retrieve an initial diagnosis element from the identified macro-based diagnosis;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
identify a macro-based diagnosis in the database of macro-based diagnoses based on the received macro indicator; retrieve the initial diagnosis element from the identified macro-based diagnosis;
transmit the initial diagnosis to the client device;
identical
transmit the initial diagnosis to the client device;
on the client device: receive the initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator transmitted to the server and the macro-based diagnosis associated with the macro indicator;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
on the client device: receive an initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator transmitted to the server and the macro-based diagnosis associated with the macro indicator; update the user interface to present the initial diagnosis in a diagnosis text box element of the accession;
and receive via the user interface, one or more modifications to the initial diagnosis;
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
and receive via the user interface, one or more modifications to the initial diagnosis in the diagnosis text box element of the accession;
on the server device: receive an edited version of the initial diagnosis from the client device; combine the edited version of the initial diagnosis with the macro-based diagnosis into an accession specific macro-based diagnosis; and store the accession specific macro-based diagnosis in a database of macro-based diagnoses for subsequent retrieval.
‘784 is narrower and includes all subject matter of ‘670; a species anticipates a genus
on the server device: receive an edited version of the initial diagnosis from the client device; combine the edited version of the initial diagnosis with each of the remaining plurality of elements of the accession of the macro-based diagnosis into an accession specific macro-based diagnosis; and store the accession specific macro-based diagnosis in the database of macro-based diagnoses for subsequent retrieval.
14
further comprising on the server device, transmitting to the client device additional information corresponding to one or more additional elements of the accession corresponding to the macro indicator.
identical
further comprising on the server device, transmitting to the client device additional information corresponding to one or more additional elements of the accession corresponding to the macro indicator.
14
15
further comprising on the client device, pre-populating one or more additional text boxes of the user interface with the additional information.
identical
further comprising on the client device, pre-populating one or more additional text boxes of the user interface with the additional information.
15
16
further comprising on the client device, enabling the user to edit the pre-populated text in the one or more additional text boxes.
identical
further comprising on the client device, enabling the user to edit the pre-populated text in the one or more additional text boxes.
16
17
wherein the one or more additional text boxes pre-populated with the additional information include text boxes for microscopic text and comment text.
identical
wherein the one or more additional text boxes pre-populated with the additional information include text boxes for microscopic text and comment text.
17
18
further comprising enabling the user to customize the microscopic text and the comment text.
Identical
further comprising enabling the user to customize the microscopic text and the comment text.
18
19
further comprising transmitting the customization of the microscopic text and the comment text from the client device to the server and storing the customized entries in the database of macro-based diagnoses.
Identical
further comprising transmitting the customization of the microscopic text and the comment text from the client device to the server and storing the customized entries in the database of macro-based diagnoses.
19
20
wherein the user interface further comprises one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes.
identical
wherein the user interface further comprises one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes.
20
Claims 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-12 of U.S. Patent No. 11972845 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined in the table below:
‘670 Claim #
‘670 Claim Language
Explanation
‘845 Claim Language
‘845 Claim #
7
A client computing system, comprising: one or more processors; and memory configured for storing computing instructions; wherein the computing instructions, when executed on the client computing system, implement a process for generating pathology lab diagnoses, the process configured to:
Functionally equivalent
A client computing system, comprising: one or more processors; and memory configured for storing computing instructions; wherein the computing instructions, when executed on the client computing system, implement a process for generating macro-based diagnoses from a database of macro-based diagnoses for a pathology lab, the process configured to:
7
present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators;
Functionally identical, but for inclusion of a plurality of elements of an accession in the user interface. However, claims 3 and 9 further show that additional information (functionally equivalent to a plurality of elements of an accession) may be presented on the user interface such that it would have been obvious to include this feature in claim 7
present a user interface to a user, the user interface including a diagnosis-based macro entry field for selection by the user of a diagnosis-based macro indicator from a plurality of available diagnosis-based macro indicators, each diagnosis-based macro indicator associated with one of the macro-based diagnoses;
receive via the user interface, a designation of a macro indicator associated with a macro-based diagnosis; transmit the designated macro indicator to a server;
Functionally equivalent because transmission of a selected macro indicator would first require receipt of the selection
transmit a selected diagnosis-based macro indicator to a server;
receive an initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
receive at least an initial diagnosis including a macro-based diagnostic suggestion associated with the initial diagnosis from the server responsive to the transmission of the selected diagnosis-based macro indicator; receive a Current Procedural Terminology (CPT) code and an International Classification of Diseases (ICD) code associated with the initial diagnosis responsive to the transmission of the selected diagnosis-based macro indicator; pre-populate a diagnosis text box on the user interface with the macro-based diagnostic suggestion; populate a CPT code selection field and an ICD code selection field with the received CPT code and the ICD code at a selection time of the selected diagnosis-based macro indicator;
receive via the user interface, one or more modifications to the initial diagnosis.
Functionally equivalent
enable the user to edit an entry in the diagnosis text box after it is pre-populated with the macro-based diagnostic suggestion.
8
wherein the process for generating pathology lab diagnoses is further configured to transmit the edited entry from the diagnosis text box element to the server for storing in a database of macro-based diagnoses, wherein the stored edited entry is available for subsequent retrieval.
Functionally identical
wherein the process is further configured to transmit the edited entry from the diagnosis text box to the server for storing in the database of macro-based diagnoses where it is available for subsequent retrieval.
8
9
wherein the process for generating pathology lab diagnoses is further configured to: receive additional information from the server responsive to the macro indicator; pre-populate one or more additional text boxes of the user interface with the additional information; and enable the user to edit the one or more additional text boxes.
Functionally identical
wherein the process is further configured to: receive additional information from the server responsive to the selected diagnosis-based macro indicator; pre-populate one or more additional text boxes on the user interface with the additional information; and enable the user to edit the one or more additional text boxes.
9
10
wherein the process is further configured to transmit edited text received in the one or more additional text boxes to the server for storing in a database of macro-based diagnoses, wherein the stored edited text is available for subsequent retrieval.
Functionally identical
wherein the process is further configured to transmit edited text in the one or more additional text boxes to the server for storing in the database of macro-based diagnoses where it is available for subsequent retrieval.
10
11
wherein the one or more additional text boxes include text boxes for microscopic text and comment text.
Identical
wherein the one or more additional text boxes include text boxes for microscopic text and comment text.
11
12
wherein the user interface further includes one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes.
Functionally identical
wherein the user interface is further configured to enable a user to: add new CPT codes, ICD codes, or both to the CPT code selection field and the ICD code selection field; and delete CPT codes, ICD codes, or both from the CPT code selection field and the ICD code selection field.
12
Claims 1-6 and 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11972845 B2 in view of Dobrean (US 20130339051 A1). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined in the table below:
‘670 Claim #
‘670 Claim Language
Explanation
‘845 Claim Language
‘845 Claim #
1
A server computing system, comprising: one or more processors; memory configured for storing computing instructions;
identical
A server computing system, comprising: one or more processors; memory configured for storing computing instructions;
1
and a database of macro-based diagnoses;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
and a database of macro-based diagnoses, each macro-based diagnosis associated with one or more elements of an accession, and one or more specimens associated with the accession;
wherein the computing instructions, when executed on the server computing system, implement a process for generating pathology lab diagnoses, the process configured to:
identical
wherein the computing instructions, when executed on the server computing system, implement a process for generating pathology lab diagnoses, the process configured to:
receive a macro indicator from a client device;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
provide a plurality of available diagnosis-based macro indicators to a client device, each diagnosis-based macro indicator associated with one of the macro-based diagnoses; receive a diagnosis-based macro indicator from the client device;
identify a macro-based diagnosis in the database of macro-based diagnoses based on the received macro indicator;
Functionally equivalent because both limitations identify and retrieve appropriate data associated with the selected macro
retrieve an initial diagnosis including a macro-based diagnostic suggestion associated with the initial diagnosis from the database of macro-based diagnoses responsive to the diagnosis-based macro indicator;
retrieve an initial diagnosis element from the identified macro-based diagnosis;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
retrieve a Current Procedural Terminology (CPT) code and an International Classification of Diseases (ICD) code associated with the initial diagnosis responsive to the diagnosis-based macro indicator;
transmit the initial diagnosis to the client device;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
transmit the initial diagnosis including the macro-based diagnostic suggestion to the client device; transmit the CPT code and the ICD code to the client device to apply the CPT code and the ICD code to the initial diagnosis at a selection time of the diagnosis-based macro indicator;
receive an edited version of the initial diagnosis from the client device;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
receive an edited version of the initial diagnosis from the client device including changes to the macro-based diagnostic suggestion;
combine the edited version of the initial diagnosis with one or more elements of an accession corresponding to the macro-based diagnosis into an accession specific macro-based diagnosis; and store the accession specific macro-based diagnosis in the database of macro-based diagnoses for subsequent retrieval.
Functionally equivalent but for the combining step. However, Dobrean teaches creating, editing, and storing clinical macros in association with procedure (i.e. accession)-specific parameters (Dobrean [0202]-[0219]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the edited and stored diagnoses of claim 1 such that they are combined with accession-specific elements in order to designate customized parameters for association with the diagnoses (as suggested by Dobrean [0206]-[0210]).
store the edited version of the initial diagnosis including the macro-based diagnostic suggestion in the database of macro-based diagnoses for subsequent retrieval.
2
wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user;
Functionally equivalent because both describe pathologist-specific macros being stored in the database
wherein: the database of macro-based diagnoses is further configured to include associations to one or more pathologist users;
2
and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
and the process is further configured to: receive the diagnosis-based macro indicator for a specific pathologist of the one or more pathologist users;
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
Functionally identical
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the diagnosis-based macro indicator for the specific pathologist;
and store the edited version of the initial diagnosis with a relation to the specific pathologist.
Identical
and store the edited version of the initial diagnosis with a relation to the specific pathologist.
3
wherein: the database of macro-based diagnoses is further configured such that each macro-based diagnosis includes additional fields for additional information;
Identical
wherein: the database of macro-based diagnoses is further configured such that each macro-based diagnosis includes additional fields for additional information;
3
and the process is further configured to: retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
and the process is further configured to: retrieve the additional information from the database of macro-based diagnoses responsive to the diagnosis-based macro indicator;
and transmit the additional information to the client device.
Identical
and transmit the additional information to the client device.
4
wherein the process is further configured to: receive an edited version of the additional information for at least one of the additional fields; and store the edited version of the additional information in the database of macro-based diagnoses for subsequent retrieval.
Identical
wherein the process is further configured to: receive an edited version of the additional information for at least one of the additional fields; and store the edited version of the additional information in the database of macro-based diagnoses for subsequent retrieval.
4
5
wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user;
Functionally equivalent because both describe pathologist-specific macros being stored in the database
wherein: the database of macro-based diagnoses is further configured to include associations to one or more pathologist users;
5
and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user;
Functionally equivalent
and the process is further configured to: receive the diagnosis-based macro indicator for a specific pathologist of the one or more pathologist users;
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the diagnosis-based macro indicator for the specific pathologist;
retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
retrieve the additional information from the database of macro-based diagnoses responsive to the diagnosis-based macro indicator for the specific pathologist;
store the edited version of the initial diagnosis with a relation to the specific pathologist;
Identical
store the edited version of the initial diagnosis with a relation to the specific pathologist;
store the edited version of the additional information with a relation to the specific pathologist.
Identical
store the edited version of the additional information with a relation to the specific pathologist.
6
wherein the additional fields in the database of macro-based diagnoses include options for Current Procedural Terminology (CPT) codes and options for International Classification of Diseases (ICD) codes.
Identical
wherein the additional fields in the database of macro-based diagnoses include options for CPT codes and options for ICD codes.
6
13
A computer-implemented method for generating pathology lab diagnoses, comprising: on a client device: present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators;
Functionally identical, but for inclusion of a plurality of elements of an accession in the user interface. However, claims 3 and 9 further show that additional information (functionally equivalent to a plurality of elements of an accession) may be presented on the user interface such that it would have been obvious to include this feature in claim 13
A computer-implemented method for generating pathology lab diagnoses, comprising: on a client device: presenting a user interface to a user, the user interface including: a macro entry field for selection by the user of a diagnosis-based macro indicator from a plurality of available diagnosis-based macro indicators; and one or more text boxes;
13
receive via the user interface, a designation of a macro indicator selected from a plurality of macro indicators, wherein each macro indicator is associated with a macro-based diagnosis; and transmit the designated macro indicator to a server;
Functionally equivalent because transmission of a selected macro indicator would first require receipt of the selection
and transmitting the diagnosis-based macro indicator;
on a server: receive the designated macro indicator from the client device;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
on a server: storing a database of macro-based diagnoses, each macro-based diagnosis associated with one or more elements of an accession, and one or more specimens associated with the accession; receiving the diagnosis-based macro indicator from the client device;
identify a macro-based diagnosis based on the received macro indicator; retrieve an initial diagnosis element from the identified macro-based diagnosis;
Functionally equivalent because retrieving a diagnosis would require identifying the diagnosis for retrieval
retrieving an initial diagnosis including a macro-based diagnostic suggestion associated with the initial diagnosis from the database of macro-based diagnoses responsive to the diagnosis-based macro indicator; retrieving a Current Procedural Terminology (CPT) code and an International Classification of Diseases (ICD) code associated with the initial diagnosis responsive to the diagnosis-based macro indicator;
transmit the initial diagnosis to the client device;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
transmitting the CPT code and the ICD code; and transmitting the initial diagnosis including the macro-based diagnostic suggestion;
on the client device: receive the initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator transmitted to the server and the macro-based diagnosis associated with the macro indicator;
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
and on the client device: receiving the initial diagnosis including the macro-based diagnostic suggestion; receiving the CPT code and the ICD code; pre-populating at least one of the one or more text boxes on the user interface with information including the macro-based diagnostic suggestion; populating a CPT code selection field and an ICD code selection field with the received CPT code and the ICD code at a selection time of the diagnosis-based macro indicator;
and receive via the user interface, one or more modifications to the initial diagnosis;
Functionally equivalent
and enabling the user to edit the pre-populated at least one of the one or more text boxes.
on the server device: receive an edited version of the initial diagnosis from the client device; combine the edited version of the initial diagnosis with the macro-based diagnosis into an accession specific macro-based diagnosis; and store the accession specific macro-based diagnosis in a database of macro-based diagnoses for subsequent retrieval.
Functionally equivalent to the limitations of claim 1 (but for the combining step) such that it would have been obvious to include the editing and storing functions to claim 13. Further, Dobrean teaches creating, editing, and storing clinical macros in association with procedure (i.e. accession)-specific parameters (Dobrean [0202]-[0219]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the edited and stored diagnoses such that they are combined with accession-specific elements in order to designate customized parameters for association with the diagnoses (as suggested by Dobrean [0206]-[0210]).
receive an edited version of the initial diagnosis from the client device including changes to the macro-based diagnostic suggestion; and store the edited version of the initial diagnosis including the macro-based diagnostic suggestion in the database of macro-based diagnoses for subsequent retrieval.
1
14
further comprising on the server device, transmitting to the client device additional information corresponding to one or more additional elements of the accession corresponding to the macro indicator.
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
receiving the CPT code and the ICD code; pre-populating at least one of the one or more text boxes on the user interface with information including the macro-based diagnostic suggestion; populating a CPT code selection field and an ICD code selection field with the received CPT code and the ICD code at a selection time of the diagnosis-based macro indicator;
13
15
further comprising on the client device, pre-populating one or more additional text boxes of the user interface with the additional information.
‘845 is narrower and includes all subject matter of ‘670; a species anticipates a genus
pre-populating at least one of the one or more text boxes on the user interface with information including the macro-based diagnostic suggestion; populating a CPT code selection field and an ICD code selection field with the received CPT code and the ICD code at a selection time of the diagnosis-based macro indicator;
13
16
on the client device, enabling the user to edit the pre-populated text in the one or more additional text boxes.
Functionally equivalent
and enabling the user to edit the pre-populated at least one of the one or more text boxes.
13
17
wherein the one or more additional text boxes pre-populated with the additional information include text boxes for microscopic text and comment text.
Functionally equivalent
wherein the pre-populated one or more text boxes include text boxes for microscopic text and comment text.
17
18
further comprising enabling the user to customize the microscopic text and the comment text.
Identical
further comprising enabling the user to customize the microscopic text and the comment text.
18
19
further comprising transmitting the customization of the microscopic text and the comment text from the client device to the server and storing the customized entries in the database of macro-based diagnoses.
Identical
further comprising transmitting the customization of the microscopic text and the comment text from the client device to the server and storing the customized entries in the database of macro-based diagnoses
19
20
wherein the user interface further comprises one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes.
Functionally equivalent
wherein the user interface is further configured to enable the user to: add new CPT codes, ICD codes, or both to the CPT code selection field and the ICD code selection field; delete CPT codes, ICD codes, or both from the CPT code selection field and the ICD code selection field; and replace previously populated CPT codes, previously populated ICD codes, or both from the one CPT code selection field and the ICD code selection field.
20
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the edited entry from the diagnosis text box.” There is insufficient antecedent basis for this limitation in the claim because there is no previously introduced “edited entry” element or “diagnosis text box” element. For purposes of examination, Examiner will interpret “the edited entry from the diagnosis text box” as “an edited entry from a diagnosis text box” newly introduced by the claim.
Claim Eligibility - 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 patent eligible. When considered as a whole using the 2-step framework outlined by the 2019 PEG and MPEP 2106, each of the claims satisfy Step 1 because they are directed to systems (i.e. machines, as in claims 1-12) and a method (i.e. a process, as in claims 13-20). When examining these claims under Step 2A – Prong 1, independent claims 1, 7, and 13 are not found to recite any of the judicial exceptions enumerated in MPEP 2106.04(a)(2). The instant claims are directed to client-server interactions for retrieving, editing, and storing macros for use in populating an electronic pathology report. Such subject matter does not recite any mathematical relationships, formulas, or calculations. Additionally, the claims do not recite a mental process because the steps are not practically performable in the human mind. Finally, none of these claims recite any method of organizing human activity such as a fundamental economic concept or managing interactions between people. Thus, independent claims 1, 7, and 13 are patent eligible because they do not recite a judicial exception, as are claims 2-6, 8-12, and 14-20 depending therefrom.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dobrean (US 20130339051 A1) in view of Safdi et al. (US 20100036676 A1).
Claim 1
Note: the descriptor of the diagnoses as being “pathology lab” diagnoses does not change or affect the structure or functioning of the claimed invention in any meaningful way because it merely describes the intended type of assessed diagnoses, such that they are interpreted as nonfunctional descriptive language. This descriptor is not further utilized in any particular analysis method unique to this type of diagnosis, and thus the diagnoses could be any types of diagnosis and the structure and functioning of the claimed invention (e.g. storing, retrieving, editing, and saving macro-based diagnoses while generating a clinical report) would remain unchanged. Accordingly, the “pathology lab” descriptor of the diagnoses is nonfunctional descriptive language and is not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean teaches a server computing system, comprising: one or more processors; memory configured for storing computing instructions; and a database of macro-based diagnoses; wherein the computing instructions, when executed on the server computing system, implement a process for generating (Dobrean [0030]-[0031], noting various computer hardware such as a server with processors executing instructions stored in memory to achieve the functions of the invention; see also [0036], [0094], noting a text macro database storing a plurality of text macros available for filling out medical procedure reports, which can have sections such as “findings” that outline diagnostic indications per Fig. 2, [0044], & [0047] and may define ‘normal’ diagnostic findings as in [0144]-[0145] such that the stored text macros are considered to include macro-based diagnoses for generating diagnoses), the process configured to:
receive a macro indicator from a client device (Dobrean [0040], [0051], [0100]-[0101], noting use of a user interface device to enter properties of a medical procedure for reporting, such as procedure type, body part, report structure, etc., which are associated with various stored macros per [0094]-[0096] such that the input properties are considered equivalent to macro indicators);
identify a macro-based diagnosis in the database of macro-based diagnoses based on the received macro indicator (Dobrean [0102], [0115], noting the stored macros are searched to identify those matching the entered properties for the report);
retrieve an initial diagnosis element from the identified macro-based diagnosis; transmit the initial diagnosis to the client device; (Dobrean [0052], [0065], [0103], [0107]-[0109], [0172], noting a selected macro is used to populate the structured report sections with text information on the user interface device, considered equivalent to an initial diagnosis when filling out the “findings” section as in Fig. 2 & [0047] or indicating normal results as in [0144]-[0145], for example);
receive an edited version of the initial diagnosis from the client device (Dobrean [0088], [0110], noting the populated or inserted macros may be edited via the user interface device);
combine the edited version of the initial diagnosis with one or more elements of an accession corresponding to the macro-based diagnosis into an accession specific macro-based diagnosis; and store the accession specific macro-based diagnosis in the database of macro-based diagnoses for subsequent retrieval (Dobrean [0202]-[0203], [0205]-[0219], noting new macros for addition to the database may be created during the reporting process by the user completing or editing reporting sections and saving the entries as a new macro in combination with defined macro parameters, such as procedure-specific parameters as in [0208] which are considered equivalent to one or more elements of an accession because they define the associated procedure type, body part, modality, etc. for the macro).
In summary, Dobrean teaches a structured reporting system that allows a user to select, edit, and save clinical macros for future use while generating clinical diagnostic reports. Dobrean further indicates that the system may be utilized for a variety of different clinical diagnostic modalities and procedures that necessitate findings reports with different structures and sections (see [0033], [0042]-[0043], [0048]-[0050]), but fails to explicitly disclose use of the system for generating pathology lab diagnoses. However, Safdi teaches use of a computerized system with structured reporting templates and automatic generation of text or sections for the specific field of pathology lab diagnostic reporting (Safdi [0149], [0241]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the procedure-agnostic structured reporting system of Dobrean to the specific field of pathology lab reporting as in Safdi because Safdi shows that pathology is a known clinical field that would benefit from automated reporting assistance for tissue analysis procedures (as suggested by Safdi [0149], [0241]). The result of such a combination would include the procedure-specific macros and reporting structures of Dobrean being customized to pathology-specific procedures like lab-based tissue analyses as in Safdi such that the reported findings auto-filled and/or edited by the user are related to pathology diagnoses by a pathologist user.
Claim 2
Dobrean in view of Safdi teaches the server computing system of claim 1, and the combination further teaches wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user; and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user; retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist; and store the edited version of the initial diagnosis with a relation to the specific pathologist (Dobrean [0097], [0121], [0209], noting each macro may have an associated user-specific parameter such that they may be retrieved, utilized, edited, and saved in association with input of a specific user property; the user would include a pathologist when considered in the context of the combination with Safdi).
Claim 3
Dobrean in view of Safdi teaches the server computing system of claim 1, and the combination further teaches wherein: the database of macro-based diagnoses is further configured such that each macro-based diagnosis includes additional fields for additional information; and the process is further configured to: retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator; and transmit the additional information to the client device (Dobrean [0055]-[0057], [0065]-[0088], noting each macro (e.g. procedure-specific macros identified responsive to input properties (i.e. macro indicators) as in [0051] & 0100]-[0102]) has associated text blocks with observation entry fields of various types, including database fields that automatically populate with additional information about the procedure from a database such as accession number, date, patient name, etc. for display and review at the user interface device).
Claim 4
Dobrean in view of Safdi teaches the server computing system of claim 3, and the combination further teaches wherein the process is further configured to: receive an edited version of the additional information for at least one of the additional fields; and store the edited version of the additional information in the database of macro-based diagnoses for subsequent retrieval (Dobrean [0088], [0110], noting the auto-populated fields may be edited and saved; e.g. as a new macro as in [0202]-[0210]).
Claim 5
Dobrean in view of Safdi teaches the server computing system of claim 3, and the combination further teaches wherein: a plurality of macro-based diagnoses in the database of macro-based diagnoses comprise a macro indicator associated with a specific pathologist user; and the process is further configured to: receive the macro indicator for a macro-based diagnosis associated with a specific pathologist user; retrieve the initial diagnosis from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist; retrieve the additional information from the database of macro-based diagnoses responsive to the macro indicator associated with the specific pathologist; store the edited version of the initial diagnosis with a relation to the specific pathologist; and store the edited version of the additional information with a relation to the specific pathologist (Dobrean [0097], [0121], [0209], noting each macro may have an associated user-specific parameter such that they may be retrieved, utilized, edited, and saved in association with input of a specific user property; the user would include a pathologist when considered in the context of the combination with Safdi).
Claim 6
Note: the descriptors of the additional fields do not change or affect the structure or functioning of the claimed invention in any meaningful way because they merely describe the intended content of the fields, such that they are interpreted as nonfunctional descriptive language. The descriptors of the fields as being “options for CPT codes” and “options for ICD codes” are not further utilized in any particular analysis method unique to these types of fields, and thus the fields could be configured to accept any type of data and the structure and functioning of the claimed invention (e.g. providing additional fields representing data in a pathology report) would remain unchanged. Accordingly, the “CPT codes” and “ICD codes” descriptors of the fields are nonfunctional descriptive language and are not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean in view of Safdi teaches the server computing system of claim 3, and the combination further teaches wherein the additional fields in the database of macro-based diagnoses include options for (Dobrean [0079], [0085], noting auto-filled fields of a macro may include ordered procedure code and performed procedure step code). Though the present combination contemplates a plurality of fields that are auto-populated for a procedure, including options for procedural codes, it fails to explicitly disclose options for specifically CPT codes and options for ICD codes. However, Safdi further teaches that CPT code and ICD code data may be stored in a database for each procedure and used in accordance with pathology reporting templates to populate pathology reports (Safdi [0098], [0127]-[0128], [0250]). It therefore would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the additional report fields of the combination (including procedure codes as in Dobrean) to specifically include options for CPT codes and ICD codes as in Safdi in order to incorporate basic data about each procedure in a known, standardized format in the generated pathology reports (as suggested by Safdi [0098], [0127]-[0128]).
Claim 7
Note: the descriptor of the diagnoses as being “pathology lab” diagnoses does not change or affect the structure or functioning of the claimed invention in any meaningful way because it merely describes the intended type of assessed diagnoses, such that they are interpreted as nonfunctional descriptive language. This descriptor is not further utilized in any particular analysis method unique to this type of diagnosis, and thus the diagnoses could be any types of diagnosis and the structure and functioning of the claimed invention (e.g. storing, retrieving, editing, and saving macro-based diagnoses while generating a clinical report) would remain unchanged. Accordingly, the “pathology lab” descriptor of the diagnoses is nonfunctional descriptive language and is not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean teaches a client computing system, comprising: one or more processors; and memory configured for storing computing instructions; wherein the computing instructions, when executed on the client computing system, implement a process for generating (Dobrean [0030]-[0031], [0040]-[0041], noting various computer hardware such a server and various client devices like a personal computer, laptop, cellular telephone, smartphone, tablet, etc. with processors executing instructions stored in memory to achieve the functions of the invention, e.g. in a client-server configuration as in [0041]; see also [0036], [0094], noting a text macro database storing a plurality of text macros available for filling out medical procedure reports, which can have sections such as “findings” that outline diagnostic indications per Fig. 2, [0044], & [0047] and may define ‘normal’ diagnostic findings as in [0144]-[0145] such that the stored text macros are considered to include macro-based diagnoses for generating diagnoses), the process configured to:
present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators; receive via the user interface, a designation of a macro indicator associated with a macro-based diagnosis (Dobrean [0040], [0051], [0100]-[0101], noting use of a user interface device to enter properties of a medical procedure (i.e. elements of an accession) for reporting, such as procedure type, body part, report structure, etc., which are associated with various stored macros per [0094]-[0096] such that the input properties are considered equivalent to macro indicators);
transmit the designated macro indicator to a server (Dobrean [0030], [0041], noting a client-server configuration of the system, such that the properties (i.e. macro indicators) input at the user interface device may be transmitted to the server to complete the macro identification/searching functions of [0102] & [0115]);
receive an initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator (Dobrean [0052], [0065], [0103], [0107]-[0109], [0172], noting a selected macro is used to populate the structured report sections with text information on the user interface device, considered equivalent to an initial diagnosis when filling out the “findings” section as in Fig. 2 & [0047] or indicating normal results as in [0144]-[0145], for example); and
receive via the user interface, one or more modifications to the initial diagnosis (Dobrean [0088], [0110], noting the populated or inserted macros may be edited via the user interface device).
In summary, Dobrean teaches a structured reporting system that allows a user to select, edit, and save clinical macros for future use while generating clinical diagnostic reports via a client device. Dobrean further indicates that the system may be utilized for a variety of different clinical diagnostic modalities and procedures that necessitate findings reports with different structures and sections (see [0033], [0042]-[0043], [0048]-[0050]), but fails to explicitly disclose use of the system for generating pathology lab diagnoses. However, Safdi teaches use of a computerized system with structured reporting templates and automatic generation of text or sections for the specific field of pathology lab diagnostic reporting (Safdi [0149], [0241]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the procedure-agnostic structured reporting system of Dobrean to the specific field of pathology lab reporting as in Safdi because Safdi shows that pathology is a known clinical field that would benefit from automated reporting assistance for tissue analysis procedures (as suggested by Safdi [0149], [0241]). The result of such a combination would include the procedure-specific macros and reporting structures of Dobrean being customized to pathology-specific procedures like lab-based tissue analyses as in Safdi such that the reported findings auto-filled and/or edited by the user are related to pathology diagnoses by a pathologist user.
Claim 8
Dobrean in view of Safdi teaches the client computing system of claim 7, and the combination further teaches wherein the process for generating pathology lab diagnoses is further configured to transmit the edited entry from the diagnosis text box element to the server for storing in a database of macro-based diagnoses, wherein the stored edited entry is available for subsequent retrieval (Dobrean [0202]-[0203], [0205]-[0219], noting new macros for addition to the database may be created during the reporting process by the user completing or editing reporting sections and saving the entries as a new macro; see also [0030] & [0041], noting a client-server configuration of the system such that the user-input modifications at the user interface would be transmitted to the server for storage and subsequent retrieval).
Claim 9
Dobrean in view of Safdi teaches the client computing system of claim 7, and the combination further teaches wherein the process for generating pathology lab diagnoses is further configured to: receive additional information from the server responsive to the macro indicator; pre-populate one or more additional text boxes of the user interface with the additional information; and enable the user to edit the one or more additional text boxes (Dobrean [0055]-[0057], [0065]-[0088], noting each macro (e.g. procedure-specific macros identified responsive to input properties (i.e. macro indicators) as in [0051] & 0100]-[0102]) has associated text blocks with observation entry fields of various types, including database fields that automatically populate with additional information about the procedure from a database such as accession number, date, patient name, etc. for display, review, and editing at the user interface device).
Claim 10
Dobrean in view of Safdi teaches the client computing system of claim 9, and the combination further teaches wherein the process is further configured to transmit edited text received in the one or more additional text boxes to the server for storing in a database of macro-based diagnoses, wherein the stored edited text is available for subsequent retrieval (Dobrean [0088], [0110], noting the auto-populated fields may be edited and saved, e.g. as a new macro as in [0202]-[0210]; see also [0030] & [0041], noting a client-server configuration of the system such that the user-input modifications at the user interface would be transmitted to the server for storage and subsequent retrieval).
Claim 11
Note: the descriptors of the text in the text boxes do not change or affect the structure or functioning of the claimed invention in any meaningful way because they merely describe the intended content of the text boxes, such that they are interpreted as nonfunctional descriptive language. The descriptors of the text as being “microscopic” and “comment” text are not further utilized in any particular analysis method unique to these types of text, and thus the text boxes could be configured to accept any type of text data and the structure and functioning of the claimed invention (e.g. providing text boxes for entering text into a pathology report) would remain unchanged. Accordingly, the “microscopic” and “comment” descriptors of the text are nonfunctional descriptive language and are not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean in view of Safdi teaches the client computing system of claim 9, and the combination further teaches wherein the one or more additional text boxes include text boxes for (Dobrean [0046], [0057], noting the populated report fields include various observation entry boxes (i.e. text boxes for comment text), e.g. performed procedure comment and description as in [0085]). Though the present combination contemplates a multitude of text-based data fields for generating a diagnostic report, it fails to explicitly disclose a text box for microscopic text. However, Safdi further teaches that text boxes for entering descriptions of microscopic examination of a tissue sample can be included as a field when generating a pathology report (Safdi [0239]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the various report text boxes of the combination to specifically include a text box for microscopic text as in Safdi in order to permit entry of microscopic examination data evaluated during the pathological tissue analysis (as suggested by Safdi [0239]).
Claim 12
Note: the descriptors of the selection fields do not change or affect the structure or functioning of the claimed invention in any meaningful way because they merely describe the intended content of the fields, such that they are interpreted as nonfunctional descriptive language. The descriptors of the fields as being “CPT codes” and “ICD codes” are not further utilized in any particular analysis method unique to these types of fields, and thus the fields could be configured to accept selection of any type of data and the structure and functioning of the claimed invention (e.g. providing selection fields representing data in a pathology report) would remain unchanged. Accordingly, the “CPT codes” and “ICD codes” descriptors of the fields are nonfunctional descriptive language and are not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean in view of Safdi teaches the client computing system of claim 7, and the combination further teaches that displayed and editable report fields at the user interface can include ordered procedure code and performed procedure step code (Dobrean [0079], [0085]). However, the present combination fails to explicitly disclose wherein the user interface further includes one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes. However, Safdi further teaches that a user may utilize a user interface to select CPT codes and ICD codes for pathology reporting templates (Safdi [0250]). Note that the system has knowledge of a plurality of ICD codes and a plurality of CPT codes as stored in tables (Safdi [0127]-[0128]) such that the selections of [0250] are considered to select codes from the plurality of known codes. It therefore would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the user interface of the combination to specifically include selection fields for ICD codes and/or CPT codes as in Safdi in order to permit a user to assign desired ICD and/or CPT codes for a given pathology reporting template so that known, standardized coding formats may be incorporated into the generated pathology reports (as suggested by Safdi [0127]-[0128] & [0250]).
Claim 13
Note: the descriptor of the diagnoses as being “pathology lab” diagnoses does not change or affect the structure or functioning of the claimed invention in any meaningful way because it merely describes the intended type of assessed diagnoses, such that they are interpreted as nonfunctional descriptive language. This descriptor is not further utilized in any particular analysis method unique to this type of diagnosis, and thus the diagnoses could be any types of diagnosis and the structure and functioning of the claimed invention (e.g. storing, retrieving, editing, and saving macro-based diagnoses while generating a clinical report) would remain unchanged. Accordingly, the “pathology lab” descriptor of the diagnoses is nonfunctional descriptive language and is not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean teaches a computer-implemented method for generating (Dobrean [0030]-[0031], [0040]-[0041], noting various computer hardware such a server and various client devices like a personal computer, laptop, cellular telephone, smartphone, tablet, etc. with processors executing instructions stored in memory to achieve the functions of the invention, e.g. in a client-server configuration as in [0041]; see also [0036], [0094], noting a text macro database storing a plurality of text macros available for filling out medical procedure reports, which can have sections such as “findings” that outline diagnostic indications per Fig. 2, [0044], & [0047] and may define ‘normal’ diagnostic findings as in [0144]-[0145] such that they are considered to be used for generating diagnoses), comprising:
on a client device: present a user interface to a user, the user interface comprising a plurality of elements of an accession and a macro entry field configured to receive a designation of a macro indicator selected from a plurality of macro indicators; receive via the user interface, a designation of a macro indicator selected from a plurality of macro indicators, wherein each macro indicator is associated with a macro-based diagnosis; and transmit the designated macro indicator to a server (Dobrean [0040], [0051], [0100]-[0101], noting use of a user interface device to enter properties of a medical procedure (i.e. elements of an accession) for reporting, such as procedure type, body part, report structure, etc., which are associated with various stored macros per [0094]-[0096] such that the input properties are considered equivalent to macro indicators; see also [0030], [0041], noting a client-server configuration of the system, such that the properties (i.e. macro indicators) input at the user interface device may be transmitted to the server to complete the macro identification/searching functions of [0102] & [0115]);
on a server: receive the designated macro indicator from the client device; identify a macro-based diagnosis based on the received macro indicator; retrieve an initial diagnosis element from the identified macro-based diagnosis; and transmit the initial diagnosis to the client device (Dobrean [0102], [0115], noting the stored macros are searched to identify those matching the properties for the report entered at the user interface; see also [0052], [0065], [0103], [0107]-[0109], [0172], noting a selected macro is used to populate the structured report sections with text information on the user interface device, considered equivalent to an initial diagnosis when filling out the “findings” section as in Fig. 2 & [0047] or indicating normal results as in [0144]-[0145], for example. Such operations are considered to occur via the client-server configuration of [0041] such that the server receives the indicator from the client device and performs the identifying and retrieving functions for transmission back to the client device for display);
on the client device: receive the initial diagnosis from the server, the initial diagnosis corresponding to the designated macro indicator transmitted to the server and the macro-based diagnosis associated with the macro indicator; and receive via the user interface, one or more modifications to the initial diagnosis (Dobrean [0088], [0107]-[0110], noting the report is populated at the user interface device via the macros for display and editing);
on the server device: receive an edited version of the initial diagnosis from the client device; combine the edited version of the initial diagnosis with the macro-based diagnosis into an accession specific macro-based diagnosis; and store the accession specific macro-based diagnosis in a database of macro-based diagnoses for subsequent retrieval (Dobrean [0202]-[0203], [0205]-[0219], noting new macros for addition to the database may be created during the reporting process by the user completing or editing reporting sections (e.g. via the user interface device as in [0088] & [0110]) and saving the entries as a new macro in combination with defined macro parameters, such as procedure-specific parameters as in [0208] which are considered equivalent to one or more elements of an accession because they define the associated procedure type, body part, modality, etc. for the macro. Such operations are considered to occur via the client-server configuration of [0041] such that the server receives the edited observation entries from the client device and performs the combining and storing functions for later retrieval from the database).
In summary, Dobrean teaches a structured reporting system that allows a user to select, edit, and save clinical macros for future use while generating clinical diagnostic reports in a client-server configuration. Dobrean further indicates that the system may be utilized for a variety of different clinical diagnostic modalities and procedures that necessitate findings reports with different structures and sections (see [0033], [0042]-[0043], [0048]-[0050]), but fails to explicitly disclose use of the system for generating pathology lab diagnoses. However, Safdi teaches use of a computerized system with structured reporting templates and automatic generation of text or sections for the specific field of pathology lab diagnostic reporting (Safdi [0149], [0241]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the procedure-agnostic structured reporting system of Dobrean to the specific field of pathology lab reporting as in Safdi because Safdi shows that pathology is a known clinical field that would benefit from automated reporting assistance for tissue analysis procedures (as suggested by Safdi [0149], [0241]). The result of such a combination would include the procedure-specific macros and reporting structures of Dobrean being customized to pathology-specific procedures like lab-based tissue analyses as in Safdi such that the reported findings auto-filled and/or edited by the user are related to pathology diagnoses by a pathologist user.
Claim 14
Dobrean in view of Safdi teaches the computer-implemented method of claim 13, and the combination further teaches on the server device, transmitting to the client device additional information corresponding to one or more additional elements of the accession corresponding to the macro indicator (Dobrean [0055]-[0057], [0065]-[0088], noting each macro (e.g. procedure-specific macros identified responsive to input properties (i.e. macro indicators) as in [0051] & 0100]-[0102]) has associated text blocks with observation entry fields of various types, including database fields that automatically populate with additional information about the procedure (i.e. accession) from a database such as accession number, date, patient name, etc. for display and review at the user interface device).
Claim 15
Dobrean in view of Safdi teaches the computer-implemented method of claim 14, and the combination further teaches on the client device, pre-populating one or more additional text boxes of the user interface with the additional information (Dobrean [0055]-[0057], [0065]-[0088], noting the various additional text fields may be auto-populated on the user interface with the additional information about the procedure (i.e. accession) such as accession number, date, patient name, etc.).
Claim 16
Dobrean in view of Safdi teaches the computer-implemented method of claim 15, and the combination further teaches on the client device, enabling the user to edit the pre-populated text in the one or more additional text boxes (Dobrean [0088], [0110], noting the auto-populated fields may be edited at the user interface device).
Claim 17
Note: the descriptors of the text in the text boxes do not change or affect the structure or functioning of the claimed invention in any meaningful way because they merely describe the intended content of the text boxes, such that they are interpreted as nonfunctional descriptive language. The descriptors of the text as being “microscopic” and “comment” text are not further utilized in any particular analysis method unique to these types of text, and thus the text boxes could be configured to accept any type of text data and the structure and functioning of the claimed invention (e.g. providing text boxes for entering text into a pathology report) would remain unchanged. Accordingly, the “microscopic” and “comment” descriptors of the text are nonfunctional descriptive language and are not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean in view of Safdi teaches the computer-implemented method of claim 15, and the combination further teaches wherein the one or more additional text boxes pre-populated with the additional information include text boxes for (Dobrean [0046], [0057], noting the populated report fields include various observation entry boxes (i.e. text boxes for comment text), e.g. performed procedure comment and description as in [0085]). Though the present combination contemplates a multitude of text-based data fields for generating a diagnostic report, it fails to explicitly disclose a text box for microscopic text. However, Safdi further teaches that text boxes for entering descriptions of microscopic examination of a tissue sample can be included as a field when generating a pathology report (Safdi [0239]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the various report text boxes of the combination to specifically include a text box for microscopic text as in Safdi in order to permit entry of microscopic examination data evaluated during the pathological tissue analysis (as suggested by Safdi [0239]).
Claim 18
Dobrean in view of Safdi teaches the computer-implemented method of claim 17, and the combination further teaches enabling the user to customize the microscopic text and the comment text (Dobrean [0088], [0110], noting the various observation entry fields (e.g. including microscopic text and comment text when considered in the context of the combination with Safdi) may be edited (i.e. customized) by a user).
Claim 19
Dobrean in view of Safdi teaches the computer-implemented method of claim 18, and the combination further teaches transmitting the customization of the microscopic text and the comment text from the client device to the server and storing the customized entries in the database of macro-based diagnoses (Dobrean [0088], [0110], noting the various observation entry fields (e.g. including microscopic text and comment text when considered in the context of the combination with Safdi) may be edited (i.e. customized) by a user at the user interface device and saved, e.g. as a new macro as in [0202]-[0210]; see also [0030] & [0041], noting a client-server configuration of the system such that the user-input modifications at the user interface would be transmitted to the server for storage and subsequent retrieval).
Claim 20
Note: the descriptors of the selection fields do not change or affect the structure or functioning of the claimed invention in any meaningful way because they merely describe the intended content of the fields, such that they are interpreted as nonfunctional descriptive language. The descriptors of the fields as being “CPT codes” and “ICD codes” are not further utilized in any particular analysis method unique to these types of fields, and thus the fields could be configured to accept selection of any type of data and the structure and functioning of the claimed invention (e.g. providing selection fields representing data in a pathology report) would remain unchanged. Accordingly, the “CPT codes” and “ICD codes” descriptors of the fields are nonfunctional descriptive language and are not patentably limiting in this case (see MPEP 2111.05). However, in the interest of compact prosecution, this limitation has been addressed with art below.
Dobrean in view of Safdi teaches the computer-implemented method of claim 13, and the combination further teaches that displayed and editable report fields at the user interface can include ordered procedure code and performed procedure step code (Dobrean [0079], [0085]). However, the present combination fails to explicitly disclose wherein the user interface further comprises one or more of an ICD selection field for selecting an ICD code from a plurality of ICD codes and a CPT selection field for selecting a CPT code from a plurality of CPT codes. However, Safdi further teaches that a user may utilize a user interface to select CPT codes and ICD codes for pathology reporting templates (Safdi [0250]). Note that the system has knowledge of a plurality of ICD codes and a plurality of CPT codes as stored in tables (Safdi [0127]-[0128]) such that the selections of [0250] are considered to select codes from the plurality of known codes. It therefore would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the user interface of the combination to specifically include selection fields for ICD codes and/or CPT codes as in Safdi in order to permit a user to assign desired ICD and/or CPT codes for a given pathology reporting template so that known, standardized coding formats may be incorporated into the generated pathology reports (as suggested by Safdi [0127]-[0128] & [0250]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kablotsky et al. (US 20130151286 A1) describes a clinical reporting system that utilize procedure-specific and user-specific templates with associated macros and standard diagnostic text. Martinez et al. (US 10872683 B1), Pressly (US 20020065854 A1), and Wang (US 20120084096 A1) describe clinical reporting systems that utilize procedure-specific and/or user-specific templates with default diagnostic text. Cervin et al. (Reference U on the accompanying PTO-892) describes automated pathology reporting systems to assist pathologists in generating pathology lab diagnoses.
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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684
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