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 .
Response to Amendment
This FINAL office action is in response to the amended claims filed on August 14, 2025.
Claims 1, 5, and 7 have been amended.
Claims 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Eligibility Step 1 (Does the subject matter fall within a statutory category?)
Claims 1-6 are drawn to a method, claim 7-15 are drawn to a system, and claims 16-20 are drawn to a non-transitory computer readable medium and thus, are within the four statutory categories.
Eligibility Step 2A-1 (Does the claim recite an abstract idea, law of nature, or natural phenomenon?)
Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below:
The Examiner has identified independent method claim 1 as the claim that represents the claimed invention for analysis and is similar to independent claims 7 and 16.
Claim 1 recites a series of steps for generative an operative note, which, under the broadest reasonable interpretation, is an abstract idea that falls within the Certain Method of Organizing Human Activity grouping of abstract ideas such as managing behavior or relationships or interactions between people (i.e., following a set of rules or instructions).
Claim 1 (being representative) recites the following limitations which set forth the abstract idea:
Providing, […], a first query for a first list of one or more cases that are each associated with an operative note to be completed, the first query comprising […] and first fields […];
Providing, […] a second query for a second list of one or more cases that are each associated with an operative note to be completed, the second query comprising […] and second fields […], wherein the […] and the second list differs from the first list, and […] and the first fields and the second fields are based on stored electronic medical record data;
receiving, […], responsive to the first query, a first list of one or more cases that are each associated with an operative note to be completed;
receiving, […], responsive to the second query, a second list of one or more cases that are each associated with an operative note to be completed;
transmitting, […], selectable elements, the selectable elements comprising the first list of one or more cases and the second list of one or more cases;
in response to receiving a selection of an element associated with a case in the first list of one or more cases, transmitting a dictation […location…] and a selectable recording element;
responsive to receipt of a selection of the recording element, receiving audio input associated with the case […]
transmitting, […], the operative note by displaying, […] text generated based on the audio input;
finalizing the operative note responsive to receipt of a selection of a selectable element indicating provider approval of the operative note, wherein the provider approval is authorized based on an electronic medical record associated with a patient identifier; and
transmitting the finalized operative note to the electronic medical record.
Eligibility Step 2A-2 (Does the claim recite additional elements that integrate the judicial exception into a practical application?):
This judicial exception is not integrated into a practical application.
Claims 1, 7, and 16 recite the following additional elements:
A first practice management system of a first facility associated with medical procedures
A second practice management system of a second facility associated with medical procedures, wherein the second practice management system differs from the first
First and second application programming interfaces (API), wherein the second API differs from the first API
a provider device having a user interface and a dictation interface
one or more processors (claim 7)
memory encoding instructions, executed by one or more processors (claim 7)
one or more non-transitory computer readable media encoded with instructions, executed by one or more processors (claim 16)
The processor and memory/computer readable media elements are recited a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. The practice management system of a facility associated with medical procedures and responsive to APIs and provider device having interface elements merely “generally link” the abstract idea to a particular technological environment or field of use or alternately represent extra-solution data gathering or data outputting activity. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claim 1, 7, and 16 are directed to an abstract idea without a practical application.
The use of additional elements noted above as tools to implement/automate the abstract idea does not render claims 1, 7, and 16 to be patent eligible because it does not provide meaningful limitations and requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea.
Eligibility Step 2B (Does the claim amount to significantly more?):
Claims 1, 7, and 16 do not include additional elements that are sufficient to amount to significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements noted above to perform the generic computer functions amount to no more than mere instructions to apply the abstract idea using a generic computer component or generally link the claimed invention to a particular technological environment or field of use (or alternately represent extra-solution activity) (see MPEP 2106.05 (I)(A)). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Generally linking an abstract idea to a particular technological field of use cannot provide an inventive concept. And, alternately, transmitting and receiving data over a network cannot provide an inventive concept. Claims 1, 7, and 16 are, therefore, not patent eligible.
The dependent claims 2-6, 8-15, 17-20 further define the abstract idea that is present in their respective independent claims and hence are abstract for at least the reasons presented above.
Dependent claims 4-6, 8-15, and 17-20 do not recite any additional elements other than those identified in their respective independent claims.
Dependent claims 2 & 3 recite the following additional elements:
Image capture device
Cloud computing device
The image capture device and cloud computing device elements merely “generally links” the abstract idea to a particular technological environment or field of use. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claim 2 and 3 are directed to an abstract idea without a practical application.
The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the dependent claims are directed to an abstract idea. Claims 2-6, 8-15, 17-20 are, therefore, not patent eligible.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 5-6, 16, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanning (US 20160103810 A1), in view of Kade (US 20050154613 A1), and further, in view of White et al. (US 11610654 B1), hereinafter White.
Regarding claim 1, Hanning teaches a method for generating operative notes for medical procedures, the method comprising:
[…], transmitting a dictation interface to the provider device, the dictation interface configured to present information associated with the case and a selectable recording element ([0038] discloses a free text area in the surgical template where the surgeon can dictate freely. The surgeon can begin dictating by speaking a command that activates the VCS (voice-responsive control system));
responsive to receipt of a selection of the recording element, receiving audio input associated with the case from the provider device ([0038] discloses the surgeon can dictate freely after activating the VCS);
transmitting, to the provider device, the operative note by displaying, in the dictation interface, text generated based on the audio input ([0038] discloses the surgeon activates the voice responsive control system and dictates freely with the dictation being converted into dictated text and entered into the operative note template in the free text area);
finalizing the operative note responsive to receipt of a selection of a selectable element indicating provider approval of the operative note, wherein the provider approval is authorized based on the electronic medical record associated with a patient identifier ([0038] discloses the operative template includes a predetermined text area with patient information/URL to patients record online (interpreted as the EMR). [0040] discloses adding a digital signature to the operative note where the digital signature is the surgeon’s signature approving of the generated operative note. [0043] discloses the surgical operative note is completed and authenticated efficiently and simultaneously with completion of the surgery on the patient); and
Hanning may not explicitly teach the following limitation; however, Kade teaches:
providing, to a first practice management system of a first facility associated with medical procedures, a first query for a first list of one or more cases that are each associated with an operative note to be completed, the first query comprising a first application programming interface (API) and first fields of the first practice management system ([0018] discloses a database containing information regarding each patient and operative procedure that is performed and the surgery center management software communicating data (i.e., API). [0026] discloses the surgeon interacting with the program by clicking OpNotes button on the main menu toolbar, which presents the surgeon with a screen with two section, the first section displays the name of the doctor, the second section displays a list of patient cases for which operative notes need to be created, after the doctor has been selected);
…the first API, the first fields, […] are based on stored electronic medical record data ([0018] discloses a surgery center management software that stores information relating to patient scheduling, patient case history, reports, etc. within an SQL database containing information regarding each patient);
receiving, from the first practice management system responsive to the first query, the first list of one or more cases that are associated with an operative note to be completed ([0026] discloses a list of patient cases for which operative notes need to be created. The list of cases is created by accessing the database to determine all procedures recently performed by the surgeon and determining whether an operative note has been completed for that case.);
transmitting, to a provider device, a user interface configured to present selectable elements, the selectable elements comprising the first list of one or more cases [and the second list of one or more cases] ([0007] discloses displaying a list of patient cases for which operative notes need to be created. [0026] discloses the surgeon may select a single case or all cases and choose the create notes button.);
in response to receiving a selection of an element associated with a case in the first list of one or more cases, transmitting a […] interface to the provider device ([0027]-[0029] discloses upon choosing the create notes button on a case, the surgeon is shown a screen with relevant information about the patient and case and an option to choose a template where they can finish the operative note.),
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation method of Hanning to include selecting a case from a list of cases with operative notes to be completed as taught by Kade in order to more efficiently complete operative notes.
Hanning/Kade may not explicitly teach the following limitation; however, White teaches:
transmitting the finalized operative note to the electronic medical record associated with the patient identifier ([Col. 9, lines1-2] discloses the completed note is exported to the EHR system).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation method of Hanning/Kade to include transmitting the note to the EMR as taught by White in order to provide better accessibility of operative notes.
Hanning/Kade/White does not specifically disclose a second practice management system of a second facility and a second API that are different from the first practice management system of the first facility and the first API or a second list different from the first list, respectively.
That is, Hanning/Kade/White does not specifically disclose:
providing, to a second practice management system of a second facility associated with medical procedures, a second query for a second list of one or more cases that are each associated with an operative note to be completed, the second query comprising a second API and second fields of the second practice management system, wherein the second API differs from the first API the second facility differs from the first facility, the second practice management system differs from the first practice management system, and the second list differs from the first list,
receiving, from the second practice management system responsive to the second query, the second list of one or more cases that are each associated with an operative note to be completed;
… the second API and the second fields are based on stored electronic medical record data; (The Examiner, however, notes that the second query for a second list of a second practice management system of a second facility and the second API have no patentable significance because they produce the same results as the first query, the first list, the first practice management system of the first facility and the first API and such the results are predictable. The Examiner also notes that while the second list has been considered, it represents non-functional descriptive information and is therefore not given patentable weight.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate additional practice management systems and APIs and lists into Hanning/Kade/White because the mere duplication of parts has no patentable significance unless new and unexpected result is produced (see MPEP §2144.04 VI (B)).
Regarding claim 2, Hanning/Kade/White teach the method of claim 1. Hanning further teaches wherein transmitting the operative note further comprises:
adding, to the operative note, one or more images captured by a device during an appointment for a medical procedure ([0036] discloses capturing images from the video camera and inserting the images into the operative note template), wherein the one or more images are received from a cloud computing device ([0029] discloses a cloud storage retrievable through the network interface to allow functionality of the image capture device).
Regarding claim 5, Hanning/Kade/White teaches the method of claim 1. Hanning further teaches:
generating the dictation interface by identifying a plurality of dictation fields for inclusion in the dictation interface, wherein the plurality of dictation fields is identified based on a medical procedure associated with an appointment ([0034] discloses the operative note template is customized for the specific surgical procedure/particular surgeon performing the specific surgical procedure. The template includes fields for the surgical procedure information, images, annotations, free text, predetermined text, and signature).
Regarding claim 6, Hanning/Kade/White teaches the method of claim 5. Hanning further teaches wherein generating the dictation interface further comprises:
selecting default text for one or more of the identified dictation fields of the operative note based on the medical procedure associated with the appointment, wherein the dictation interface includes the default text and the plurality of dictation fields ([0038] discloses a text area for the predetermined text can be any text associated with the patient such as patient information obtained from the HIS or a link to patient’s record, the surgeon, the surgical procedure when the initiation information is first entered and/or billing codes automatically added based on the images/annotations inserted into the template).
Regarding claim 16, Hanning teaches one or more non-transitory computer readable media encoded with instructions to generate operative notes for medical procedures that, when executed by one or more processors of an operative note system ([0023] discloses one or more memory devices with software to be executed by one or more processors), cause the operative note system to perform operations comprising:
receiving a selection of a text field in the plurality of selectable text fields ([0007] discloses an electronic template of an operative note with text fields);
generating the operative note by providing text in the selected field, the text generated based on the audio input ([0007] discloses dictating information related to the specific surgical procedure and transferring the dictated information into free text and inserting the free text into the electronic template);
Hanning may not explicitly teach the following limitation; however, Kade teaches:
receiving, from a provider device, a first request to view a listing of cases associated with a provider, the first request comprising one or more first criteria to filter cases associated with the provider, the one or more first criteria comprising a period of time, a type of medical procedure, or a first medical facility, the first request comprising one or more data fields of a first practice management system associated with the provider ([0021] discloses the surgeon can access templates, OpNotes and actions. [0023] discloses selecting templates enables a surgery center staff to select a given credentialed surgeon in a first window to determine the procedures that the surgeon is authorized to perform at the facility. By next selecting a procedure, the software queries the database to determine whether any template for an operative note exists for the selected procedure and selected surgeon);
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation method of Hanning to include selecting a case from a list of cases with operative notes to be completed as taught by Kade in order to more efficiently complete operative notes.
The remaining claim limitations are analogous to the limitations in claim 1. As such, claim 16 is rejected for the same reasons given for claim 1.
As discussed in claim 1, Hanning/Kade/White do not specifically disclose the following limitations:
receiving, from a provider device, a second request to view a second listing of cases associated with a provider, the second request comprising one or more second criteria to filter cases associated with the provider, the one or more second criteria comprising a period of time, a type of medical procedure, or a second medical facility, the second request comprising one or more data fields of a second practice management system associated with the provider, and the second request differs from the first request, the second listing differs from the first listing, the second medical facility differs from the first medical facility, and the second practice management system differs from the first practice management system;
responsive to the second request, receiving, from the second practice management system, a second list of one or more cases that are associated with the one or more second criteria;
The Examiner, however, notes that the second a second practice management system of a second facility and the second API have no patentable significance because they produce the same results as the first practice management system of the first facility and the second API and such the results are predictable. The Examiner also notes that while the second list has been considered, it represents non-functional descriptive information and is therefore not given patentable weight.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate additional practice management systems and APIs and lists into Hanning/Kade/White because the mere duplication of parts has no patentable significance unless new and unexpected result is produced (see MPEP §2144.04 VI (B)).
Regarding claim 19, Hanning/Kade/White teaches the one or more non-transitory computer readable media of claim 16. Hanning further teaches wherein generating the operative note further comprises receiving, from the electronic medical record, patient data responsive to receipt, through the dictation interface, of audio data corresponding to a keyword associated with the patient data ([0038] discloses obtaining patient information from the hospital information system through the network to populate a predetermined text area after initiation information is received by voice from the surgeon. The Examiner notes that any location that stores patient information is considered an electronic medical record, this merely being a non-functional label.).
Regarding claim 20, Hanning/Kade/White teach the one or more non-transitory computer readable media of claim 16. Hanning further teaches generating the dictation interface by selecting a dictation template including default text and the plurality of selectable text fields ([0038] discloses the operative note template includes a text area for the predetermined text associated with the patient such as patient information obtained from the HIS or a link to patient’s record, the surgeon, the surgical procedure when the initiation information is first entered and/or billing codes automatically added based on the images/annotations inserted into the template), wherein the dictation template is selected based on a dictation keyword received as audio input from the provider device ([0034] discloses the operative note template is customized based on the initiation information obtained from the surgeon by voice).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanning (US 20160103810 A1), in view of Kade (US 20050154613 A1), in view of White et al. (US 11610654 B1), hereinafter White, and further in view of Laskin (US 20160098523 A1), hereinafter Laskin.
Regarding claim 3, Hanning/Kade/White teaches the method of claim 1. Hanning further teaches wherein transmitting the operative note further comprises:
adding, to the operative note, information related to an image captured by a device during an appointment for a medical procedure ([0037] discloses inserting annotations to the image into the operative note template);
Hanning/Kade/White may not explicitly teach the following limitation; however, Laskin teaches:
wherein the image is of an identifier related to a medical material used during the appointment and the information is related to the medical material ([0028] discloses a photo input of an object or photo of the packaging or label to be used as an identifier); and
the image is received from a cloud computing device ([0022] discloses operating via a cloud).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the image of Hanning to include the material identifier as taught by Laskin in order to provide a more detailed record of a medical procedure.
Regarding claim 4, Hanning/Kade/White/Laskin teaches the method of claim 3, wherein the medical material comprises an implant ([0017] discloses material used for implantation).
Claim(s) 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hussam et al. (US 20200227149 A1), hereinafter Hussam, in view of Kade (US 20050154613 A1), in view of White et al. (US 11610654 B1), hereinafter White, and further in view of Guan et al. (US 20020194029 A1), hereinafter Guan.
Regarding claim 7, Hussam teaches a system to generate operative notes for medical procedures ([0014] discloses a system for providing a physician with a surgical operative note template), the system comprising:
one or more processors ([0006] discloses one or more processors); and
memory encoding data fields of a plurality of practice management systems as electronic medical record (EMR) data ([0003] discloses a plurality of predefined data field for entry of medical data. [0020] discloses the system may pre-populate a predefined data field with medical data from the EMR record.); and
memory encoding instructions which, when executed by the one or more processors, cause the system to perform operations comprising ([0006] discloses a memory to store executable instructions):
transmitting a dictation interface configured to present a recording element ([0022] discloses sending a template to the client device with a predefined data field. [0023] discloses the user may enter data by speaking into microphone) and one or more elements that are rendered based on information received by the system from an electronic medical record using a patient identifier ([0018] discloses the system may use EMR record associated with the patient identifier to identify which template to use to generate the operative note);
responsive to receipt of a selection of the recording element, receiving audio input associated with the case from the provider device [0023] discloses the user may enter data by speaking into microphone);
generating the operative note by displaying, in the dictation interface, text generated based on the audio input ([0023] discloses the system populates the data field of the template using a speech recognition module to translate the words spoken by the user into text. [0028] discloses the system generates the surgical operative note for based on the populated template); and
Hussam may not explicitly teach the following limitation; however, Kade teaches:
providing, to a first practice management system of a first facility associated with medical procedures, a first query for a first list of one or more cases that are each associated with an operative note to be completed, the first query comprising a first application programming interface (API) and first fields of the first practice management system ([0018] discloses a database containing information regarding each patient and operative procedure that is performed and the surgery center management software communicating data (i.e., API). [0026] discloses the surgeon interacting with the program by clicking OpNotes button on the main menu toolbar, which presents the surgeon with a screen with two section, the first section displays the name of the doctor, the second section displays a list of patient cases for which operative notes need to be created, after the doctor has been selected);
receiving, responsive to the first query, the first list of one or more cases that are associated with an operative note to be completed; ([0018] discloses a database containing information regarding each patient and operative procedure that is performed and the surgery center management software. [0026] discloses a list of patient cases for which operative notes need to be created. The list of cases is created by accessing the database to determine all procedures recently performed by the surgeon and determining whether an operative note has been completed for that case.) ;
transmitting, to a provider device in communication with the system, a user interface configured to present the first list of one or more cases and [the second list of one or more cases] ([0026] discloses the surgeon may select a single case or all cases and choose the create notes button.);
in response to receiving a selection of an element associated with a case in the first list of one or more cases, transmitting a […] interface to the provider device ([0027]-[0029] discloses upon choosing the create notes button on a case, the surgeon is shown a screen with relevant information about the patient and case and an option to choose a template where they can finish the operative note.),
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation method of Hussam to include selecting a case from a list of cases with operative notes to be completed as taught by Kade in order to more efficiently complete operative notes.
Hussam/Kade may not explicitly teach the following limitation; however, White teaches:
transmitting the generated operative note to the electronic medical record associated with the patient identifier and […] ([Col. 9, lines1-2] discloses the completed note is exported to the EHR system).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation method of Hussam to include transmitting the note to the EMR as taught by White in order to provide better accessibility of operative notes.
Hussam/Kade/White may not explicitly teach the following limitation; however, Guan teaches:
transmitting the generated note to the practice management system ([0008] discloses edgemed.com is still another example of available automated medical practice systems, which includes stored diagnosis files, encounter and treatment notes).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation and transmission method of Hussam/White to include transmitting the note to the practice management system as taught by Guan in order to provide a more complete and accessible patient medical record.
Hussam/Kade/White/Guan do not specifically disclose the following:
providing, to a second practice management system of a second facility associated with medical procedures, a second query for a second list of one or more cases that are each associated with an operative note to be completed, the second query comprising a second API and second fields of the second practice management system, wherein the second API differs from the first API the second facility differs from the first facility, the second practice management system differs from the first practice management system, and the second list differs from the first list,
receiving, responsive to the second query, the second list of one or more cases that are each associated with an operative note to be completed;
The Examiner, however, notes that the second a second practice management system of a second facility and the second query have no patentable significance because they produce the same results as the first practice management system of the first facility and the first query and such the results are predictable. The Examiner also notes that while the second list has been considered, it represents non-functional descriptive information and is therefore not given patentable weight.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate additional practice management systems, facilities, queries, and lists into Hussam/Kade/White/Guan because the mere duplication of parts has no patentable significance unless new and unexpected result is produced (see MPEP §2144.04 VI (B)).
Regarding claim 8, Hussam/Kade/White/Guan teach the system of claim 7. Hussam further teaches wherein the memory encoding instructions further cause the system to perform operations comprising at least one of:
adding one or more images of a patient to the operative note, the one or more images of the patient captured during the medical procedure ([0005], [0021] disclose including a visualization related to the surgical procedure/portion of a body on which procedure is performed and labeling one or more portions of the visualization based on the medical information included in the patient’s records); or
adding information to the operative note, the information related to one of an implant or surgical materials used during the medical procedure ([0005] discloses receiving data indicative of a barcode associated with an implantable device that is used in the procedure, retrieving data associated with the barcode, and updating the surgical template with the data).
Regarding claim 9, Hussam/Kade/White/Guan teach the system of claim 7, wherein the dictation interface is further rendered to display a dictation template; and the memory encoding instructions further cause the system to perform operations comprising identifying the dictation template from a plurality of dictation templates based on data associated with an appointment for a medical procedure ([0020] discloses retrieving a surgical center template and pre-populating a pre-defined data field of the template with medical data from the EMR record. [0022] discloses sending the pre-populated template to the client device for presentation to the user).
Regarding claim 10, Hussam/Kade/White/Guan teach the system of claim 9. Hussam further teaches wherein the dictation template is rendered responsive to a dictation command received as audio input from the provider device ([0022]-[0023] discloses the user enters data into predefined data field of the template by speaking into a microphone).
Regarding claim 11, Hussam/Kade/White/Guan teach the system of claim 9. Hussam further teaches wherein the dictation interface includes at least one selectable field ([0005] discloses the template comprises a plurality of selectable fields for selection of an attribute of a patient or an attribute of the surgical procedure), and the memory encoding instructions further cause the system to perform operations comprising selecting text to fill the at least on selectable field from the electronic medical record ([0033]-[0037] disclose Fig. 2-3B where the system pre-selects fields based on contents of an EMR record or the user enters data pertaining to the surgery performed on the patient).
Regarding claim 12, Hussam/Kade/White/Guan teach the system of claim 9. Hussam further teaches wherein the dictation template is specific to the appointment for the medical procedure ([0020] discloses identifying the surgical center template as applicable to the surgical procedure to be performed on the patient).
Regarding claim 13, Hussam/Kade/White/Guan teach the system of claim 9. Hussam further teaches wherein and the memory encoding instructions further cause the system to perform operations comprising:
analyzing the data associated with the appointment to retrieve one or more of standard vocabulary, stock language, default descriptions, or defined texts related to the medical procedure associated with the appointment ([0017] discloses the system identifies an appointment of the patient and uses the appointment information to identify which surgical center templates are applicable to the surgical procedure. [0020] discloses retrieving contents from the EMR record).
populating the dictation template with the one or more of standard vocabulary, stock language, default descriptions, or defined texts ([0020] discloses the system pre-populates a predefined data field of the template with the medical data from the EMR record).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hussam et al. (US 20200227149 A1), hereinafter Hussam, in view of Kade (US 20050154613 A1), in view of White et al. (US 11610654 B1), hereinafter White, in view of Guan et al. (US 20020194029 A1), hereinafter Guan, and further in view of Bartelt et al. (US 20080288291 A1), hereinafter Bartelt.
Regarding claim 14, Hussam/White/Guan teach the system of claim 7. Hussam further teaches wherein transmitting the operative note further comprises […] a signature received by the system […] ([0041] discloses the surgical operative note includes an electronic signature of the physician).
Hussam/Kade/White/Guan may not explicitly teach the following limitations; however, Bartelt teaches
authenticating a signature using one or more of a credential of the provider device or a credential of a provider received from the provider device ([0082] discloses adding a digital signature to the note and biometrically authenticating the user. [0087] discloses a biometric device to authenticate the user).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the note generation of Hussam to include authenticating the signature of the physician as taught by Bartelt in order to maintain accurate documentation of a patient interaction (Bartelt, [0004]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hussam et al. (US 20200227149 A1), hereinafter Hussam, in view of Kade (US 20050154613 A1), in view of White et al. (US 11610654 B1), hereinafter White, in view of Guan et al. (US 20020194029 A1), hereinafter Guan, and further in view of Hanning (US 20160103810 A1), hereinafter Hanning.
Regarding claim 15, Hussam/Kade/White/Guan teach the system of claim 7. Hussam/Kade/White/Guan may not explicitly teach the following limitation; however, Hanning teaches wherein displaying, in the dictation interface, text generated based on the audio input received from the provider device includes selecting text based on a defined dictation shortcut received as audio input from the provider device ([0037] discloses the surgeon issues a voice command to directly call up one of the annotations from the index of annotations to annotate the image where the annotation is a text annotation).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the text generated based on audio input of Hussam to include selecting text based on a defined dictation shortcut as taught by Hanning in order to complete the surgical note more efficiently.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanning (US 20160103810 A1), hereinafter Hanning, in view of Kade (US 20050154613 A1), in view of White et al. (US 11610654 B1), hereinafter White, as applied to claim 16 above, and further in view of Hussam et al. (US 20200227149 A1), hereinafter Hussam.
Regarding claim 17, Hanning/Kade/White teach the one or more non-transitory computer readable media of claim 16. Hanning further teaches:
generating the dictation interface by identifying the plurality of selectable text fields for inclusion in the dictation interface, the plurality of selectable text fields are identified based on a medical procedure associated with the appointment ([0034] discloses the operative note template is customized for the specific surgical procedure/particular surgeon performing the specific surgical procedure. The template includes fields for the surgical procedure information, images, annotations, free text, predetermined text, and signature); and
Hanning/Kade/White may not explicitly teach the following limitation; however, Hussam teaches:
the plurality of selectable text fields are mapped to a plurality of fields of the electronic medical record associated with the patient identifier ([0020] discloses the system pre-populates a predefined data field of the template with the medical data from the EMR record).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the plurality of dictation fields as taught by Hanning to include mapping the fields to the EMR as taught by Hussam in order to ensure a thorough and accurate operative note.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanning (US 20160103810 A1), hereinafter Hanning, in view of Kade (US 20050154613 A1), in view of White et al. (US 11610654 B1), hereinafter White, as applied to claim 16 above, and further in view of Guan et al. (US 20020194029 A1), hereinafter Guan.
Regarding claim 18, Hanning/Kade/White teach the one or more non-transitory computer readable media of claim 16. Hanning further teaches wherein the transmitted operative note includes information correlating the operative note to an appointment with the medical provider using data about the practice management system ([0034] discloses the note is customized to particular hospital/specific surgical procedure). Hanning/Kade//White do not explicitly teach the following limitations; however, Bartelt teaches transmitting the finalized operative note to a practice management system of a facility associated with the provider ([0008] discloses a medical practice system that stores encounter and treatment notes).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the operative note generation and transmission method of Hanning/Kade/White to include transmitting the note to the practice management system as taught by Guan in order to provide a more complete and accessible patient medical record.
Response to Arguments
Claim Rejections - 35 USC § 112
Regarding the 112a rejection of claims 1-20, Applicant has provided on pages 10-12 of the Remarks support in the specification for the claim limitations that were previously deemed by the Examiner to not have sufficient support in the disclosure. As such, the 112a rejection has been withdrawn.
Claim Rejections - 35 USC § 101
Issue #1:
Applicant argues: Claims Do Not Recite Certain Methods of Organizing Human Activity. The term "certain" qualifies the "certain methods of organizing human activity" grouping as a reminder of several important points. First, not all methods of organizing human activity are abstract ideas. Second, this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances. (MPEP § 2106.04(a)(2)(II)). As explained in MPEP § 2106.04(a)(3), there may be rare circumstances in which an examiner believes a claim limitation should be treated as an abstract idea even though it does not fall within any of the groupings of abstract ideas, and this type of claim limitation is referred to as a "tentative abstract idea." However, the Office Action does not assert such a claim or reject a claim limitation based on this rare exception… The Office Action argues the identified claim elements represent a series of rules of instructions that a person or persons, with or without the aid of a computer, would follow to generate an operative note. However, the identified claim elements include, for example: transmitting ... selectable elements, the selectable elements comprising the first lost and the second list; responsive to receipt of a selection of the recording element, receiving audio input associated with the case; and transmitting ... the operative note by displaying ... text generated based on the audio input. Applicant submits the claim limitations do not represent a series of rules of instructions that a person or persons, with or without the aid of a computer, would follow to generate an operative note. The courts have used the phrases "managing personal behavior or relationships or interactions between people." to describe concepts relating to social activities, teaching, and following rules or instructions. The Office Action alleges the claims fall within the certain methods of organizing human activity grouping because the claims recite following a set of rules or instructions. (Office Action, page 4).
The Examiner respectfully disagrees. MPEP 2106.04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to generate a list of cases with operative notes to be completed, transmit the cases to the provider, transmit an interface for dictation, receive audio input, generating the operative note, and transmitting the finalized operative note to the patient’s record. Furthermore, the Examiner submits that healthcare itself inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to generate operative notes, the claimed invention is directed to an abstract idea.
Issue #2:
Applicant argues: Applicant respectfully submits the claim features discussed above with reference to Prong One also support a finding of eligibility at Prong Two because the claims, as a whole, integrate any abstract idea into a practical application. Specifically, the features discussed above recite a specific manner of generating operative notes. The features in the claims provide improvements to the process of generating operative notes. The features in the claims provide improvements in a technological process or field (see MPEP 2106.05(a)). In particular, the claims provide improvements to the generation of operative notes. For example, embodiments of the operative note system allow a provider to dictate operative notes related to an event (e.g. surgery or procedure) and immediately review and sign off on the operative note. The system provides access to multiple EMRs, practice management systems, and the like to both directly pull information for the operative note and transmit the completed operative notes directly from the provider device to, for example, the patient’s medical record (See e.g., Specification at [0023] - [0026]).
The Examiner respectfully disagrees for multiple reasons. Initially, there is no integration into a practical application. Applicant has not pointed to nor can the Examiner locate any practical application; the generation of the operative note is the abstract idea which cannot provide a practical application. The abstract idea is thereafter confined to a general-purpose computer (except for claim 1 which isn’t tied to any particular technological environment) that accesses multiple EMRs and systems to receive and transmit data, which cannot provide a practical application per Alice Corp.
Issue #3:
Applicant argues: Without conceding ineligibility of the claims at Step 2A, Applicant further submits the claims are eligible at Step 2B. At Step 2B, the Office considers whether the claims provide significantly more than the alleged judicial exception. (MPEP § 2106.05). In the present case, the claims provide significantly more than the alleged judicial exception. For example, amended independent claim 1 provides significantly more at least because it includes the features discussed above in relation to Step 2A. These features, when considered alone and in combination with other claim features, provide significantly more than the alleged judicial exception and amount to an inventive concept. For example, the features provide one or more improvements to technological processes (e.g., the generation of operative notes).
The Examiner respectfully disagrees. Regarding the “technology -based problem” argument, Applicant has not identified nor can the Examiner locate any particular problem cause by technological environment to which the claims are confined (a general-purpose computer). Applicant is invited to point to the technological problem they are solving; without that, eligibility is unlikely to be forthcoming.
Claim Rejections - 35 USC § 103 of CLAIMS 1-20
Regarding the prior art rejection of claims 1-20, the Examiner has considered the Applicant’s arguments in light of the present amendments and does not find them persuasive. Although Hanning and Hussam do not explicitly disclose receiving a second list from a second practice management system, the Examiner notes that the references need not explicitly disclose multiple lists from multiple practice management systems because of the duplication of parts rationale cited in the art rejection above. The Examiner further disagrees with the Applicant’s argument regarding Hanning being silent on APIs as Hanning communicates data regarding the operation between the facility management software and the database. The Examiner further disagrees with the Applicant’s argument regarding Kade being silent on APIs and receiving a list of cases from a practice management system as cited in [0018]. The communication between different programs is made possible using APIs even if not explicitly recited. The Examiner would also like to note that the claims receive and transmit a second list of cases, but receive a selection of an element associated with a case in the first list of cases only. The second list of cases is not utilized in any selections and have therefore been considered by the Examiner as non-functional descriptive data without any patentable weight.
The dependent claims have not been sufficiently amended and are therefore included in the prior art rejection above.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Gill et al. (US 20220148689 A1) teaches Automatically pre-constructing a clinical consultation note during a patient intake/Admission process.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALAK M NASSER whose telephone number is (703)756-4610. The examiner can normally be reached M-F 8:00 AM-5:00 PM.
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/MALAK M NASSER/Examiner, Art Unit 3687 /MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687