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 .
This action is in response to the amendments filed on March 3, 2026. Claims 1-13 are pending and examined below.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rosenblatt, III et al. hereafter Rosenblatt (U.S. 2014/0204190).
With regard to claim 1, Rosenblatt teaches a method for determining approach and scope of human factors (HF) evaluation for medical devices ([abstract] methods and systems for providing guidance for a procedure with a device...analyzing the procedure performed on a patient...and protecting the privacy of person), the method comprising:
receiving, by a computing device, input information related to a medical device ([0014] the device may be at least one of a medical device, a telecommunications system device, a mechanical tool, a maintenance device, a diagnostic device, and chemical treatment device) via a Graphical User Interface (GUI) ([0006] guidance includes presenting a step-by-step workflow for a procedure on a user interface; [0053] The practitioner interface device may include a touch screen and an interface adapted to receive voice commands), wherein the input information comprises product launch information ([0253] This aspect may further include product out of bag that loads the application that is associated with the device; [0296] step-by-step device and procedure information, such as video, animations, product specifications), change history file ([0209] The patient data 316 may include information associated with a patient 112 who is the subject of a medical procedure, such as, but not limited to one or more diseases associated with the patient 112, a medical history associated with the patient 112, a drug history associated with the patient 112, a surgical history associated with the patient 112), human factors evaluation documentation of the medical device and similar devices ([0301] Use scenarios and applications associated with a procedure instruction system as described herein may further include parameter measurement/evaluation and feedback during a procedure);
extracting, by the computing device, the product launch information from the input information ([0242] On receiving the request from the user, the tablet device may extract the information associated with the request from the memory and display on the interface);
analysing, by the computing device ([abstract] analyzing the procedure performed on a patient; [0020] a data analyzer facility to associate the time-stamped information with data associated with at least one of the outcome of the procedure), the change history file to identify one or more changes in medical device interface and medical device usability ([0209] The patient data 316 may include information associated with a patient 112 who is the subject of a medical procedure, such as, but not limited to one or more diseases associated with the patient 112, a medical history associated with the patient 112, a drug history associated with the patient 112, a surgical history associated with the patient 112);
classifying, by the computing device, each of the one or more versions of the medical device as one of a legacy device or a new device based on the extracted product launch information ([0134] the current status of the medical device and the current statuses and versions of the application and the step-by-step workflow. In some embodiments, the storage server may be a file server that provides the current versions of the application and the step-by-step workflow; [0221] a device manufacturer might determine what versions of a device are easiest to use or most effective, what features of a device of a device are most difficult to use (such as based on the time it takes to complete a step using the device)) and the change history file analysis ([0209] The patient data 316 may include information associated with a patient 112 who is the subject of a medical procedure, such as, but not limited to one or more diseases associated with the patient 112, a medical history associated with the patient 112, a drug history associated with the patient 112, a surgical history associated with the patient 112);
identifying, by the computing device, a base version for documentation and subsequent versions till date for the medical device interface ([0134] the current status of the medical device and the current statuses and versions of the application and the step-by-step workflow. In some embodiments, the storage server may be a file server that provides the current versions of the application and the step-by-step workflow; [0221] a device manufacturer might determine what versions of a device are easiest to use or most effective, what features of a device of a device are most difficult to use (such as based on the time it takes to complete a step using the device));
determining, by the computing device, an HF evaluation approach for each of versions of the medical device interface based on the classification ([0134] the current status of the medical device and the current statuses and versions of the application and the step-by-step workflow. In some embodiments, the storage server may be a file server that provides the current versions of the application and the step-by-step workflow; [0221] a device manufacturer might determine what versions of a device are easiest to use or most effective, what features of a device of a device are most difficult to use (such as based on the time it takes to complete a step using the device)), the HF evaluation documentation ([0301] Use scenarios and applications associated with a procedure instruction system as described herein may further include parameter measurement/evaluation and feedback during a procedure. This aspect may further include parameters that may include size, configuration, surface characteristics, temperature, appearance, measured parameter), and incremental documentation requirement of the subsequent versions of the medical device interface ([0301] Use scenarios and applications associated with a procedure instruction system as described herein may further include parameter measurement/evaluation and feedback during a procedure. This aspect may further include parameters that may include size, configuration, surface characteristics, temperature, appearance, measured parameter…This aspect may further include the guidance based on information from other procedures using the medical device, information from procedures using other medical devices, information from procedures by the steps undertaken by other professionals, information from other procedures by the medical professional);
performing, by the computing device, a gap analysis for the base version and the subsequent version to identify documentation-related gaps ([0272] documenting the number of times a doctor used a particular procedure (e.g. for medical boards and societies), logging feedback from a surgeon, logging the timeout activities, and the like. This aspect may further include recording of additional equipment used that may include beginning log/record process upon taking equipment out of a box, automatically logging unboxing events, and the like); and
determining, by the computing device, a scope and plan corresponding to the version for HF evaluation activities based on the determined approach ([0134] the current status of the medical device and the current statuses and versions of the application and the step-by-step workflow. In some embodiments, the storage server may be a file server that provides the current versions of the application and the step-by-step workflow; [0221] a device manufacturer might determine what versions of a device are easiest to use or most effective, what features of a device of a device are most difficult to use (such as based on the time it takes to complete a step using the device)), and the identified documentation-related gaps ([0272] documenting the number of times a doctor used a particular procedure (e.g. for medical boards and societies), logging feedback from a surgeon, logging the timeout activities, and the like. This aspect may further include recording of additional equipment used that may include beginning log/record process upon taking equipment out of a box, automatically logging unboxing events, and the like).
With regard to claim 2, the limitations are addressed above and Rosenblatt teaches wherein the product launch information comprises information corresponding to one or more versions of the medical device ([0134] the current status of the medical device and the current statuses and versions of the application and the step-by-step workflow. In some embodiments, the storage server may be a file server that provides the current versions of the application and the step-by-step workflow; [0221] a device manufacturer might determine what versions of a device are easiest to use or most effective, what features of a device of a device are most difficult to use (such as based on the time it takes to complete a step using the device)), and a launch date ([0142] an initial schedule may be created before the workflow begins and generating the schedule based on the projected completion time comprises generating an updated schedule based on the projected completion time and based on the initial schedule) and change information of each of the one or more versions ([0209] The patient data 316 may include information associated with a patient 112 who is the subject of a medical procedure, such as, but not limited to one or more diseases associated with the patient 112, a medical history associated with the patient 112, a drug history associated with the patient 112, a surgical history associated with the patient 112).
With regard to claim 3, the limitations are addressed above and Rosenblatt teaches wherein:
when the launch date of a version of the medical device is prior to the predefined date the medical device is classified as the legacy device ([0188] This prior notification of about to be completed workflow may assist the second practitioner to prepare in advance for the one or more steps of his workflow; [0230] the user may also be able to navigate backwards in the step-by-step guidance, for example to review a prior step, to complete a missed step, or to change the order in which a step is performed), wherein the predefined date is as per a set of medical device regulatory standards for human factors and usability ([0037] providing real-time guidance on the use of a medical device in an operating room… the method may include providing a step-by-step guidance through the steps required to complete a medical procedure utilizing the medical device. The method may include displaying on the system medical device reference material associated with a medical device and accessible to a medical practitioner to assist the medical practitioner in the use of the medical device.), and
when the launch date of the version of the medical device is after the predefined date the medical device is classified as the new device ([0249] This aspect could be for procedures that do not include a medical device. This aspect may further include optional steps in a given procedure (such as for example irrigation), modify the order of some steps, modify how some steps are performed, and/or add new steps (e.g. using a marking pen to mark the hernia mesh in the middle to keep it symmetric)).
With regard to claim 4, the limitations are addressed above and Rosenblatt teaches wherein the change history file comprises impact of change information anticipated for an interface of the medical device ([0209] The patient data 316 may include information associated with a patient 112 who is the subject of a medical procedure, such as, but not limited to one or more diseases associated with the patient 112, a medical history associated with the patient 112, a drug history associated with the patient 112, a surgical history associated with the patient 112).
With regard to claim 5, the limitations are addressed above and Rosenblatt teaches further comprising identifying the base version of the medical device ([0100] methods and systems of a procedure instruction system may be enabled to guide a practitioner host to use a medical device in a procedure environment, where the procedure instruction system may be comprised of a tablet device, a system for logging time stamp data about steps undertaken during a procedure using the medical device on a patient, and a communication system. The medical device may be a stent, a shunt, a catheter, a delivery device, an implant, a vascular assist device, a pump, a monitoring device, an imaging device, a prosthetic or some other medical device; [0114] the communication system may be associated with a step-by-step workflow for using the medical device in the medical procedure).
With regard to claim 6, the limitations are addressed above and Rosenblatt teaches further comprising rendering the scope and plan corresponding to the version to the computing device through the GUI ([0224] the scheduler identify a resource needed for each of the procedures planned for patients 112A-C, and schedule the procedures so that the procedure in environment 104A get the resource first and is done with the resource before the procedure in environment 104B needs the resource, which is, in turn, done with the resource before the procedure in environment 104C needs the resource).
With regard to claim 7, Rosenblatt teaches a Graphical User Interface (GUI) client ([0006] guidance includes presenting a step-by-step workflow for a procedure on a user interface; [0053] The practitioner interface device may include a touch screen and an interface adapted to receive voice commands) on a computing device ([0014] the device may be at least one of a medical device, a telecommunications system device, a mechanical tool, a maintenance device, a diagnostic device, and chemical treatment device) for determining approach and scope of human factors (HF) evaluation for medical devices ([abstract] methods and systems for providing guidance for a procedure with a device...analyzing the procedure performed on a patient...and protecting the privacy of person), the GUI client is configured to:
receive input information related to a medical device ([0014] the device may be at least one of a medical device, a telecommunications system device, a mechanical tool, a maintenance device, a diagnostic device, and chemical treatment device), wherein the input information comprises product launch information ([0253] This aspect may further include product out of bag that loads the application that is associated with the device; [0296] step-by-step device and procedure information, such as video, animations, product specifications);
render a change history file based on the product launch information ([0209] The patient data 316 may include information associated with a patient 112 who is the subject of a medical procedure, such as, but not limited to one or more diseases associated with the patient 112, a medical history associated with the patient 112, a drug history associated with the patient 112, a surgical history associated with the patient 112);
receive HF evaluation documentation of a base version of the medical device ([0301] Use scenarios and applications associated with a procedure instruction system as described herein may further include parameter measurement/evaluation and feedback during a procedure; [0134] the current status of the medical device and the current statuses and versions of the application and the step-by-step workflow. In some embodiments, the storage server may be a file server that provides the current versions of the application and the step-by-step workflow; [0221] a device manufacturer might determine what versions of a device are easiest to use or most effective, what features of a device of a device are most difficult to use (such as based on the time it takes to complete a step using the device)); and
for each version from the base version to latest version of the medical device, render the scope and plan corresponding to the version to the computing device ([0224] the scheduler identify a resource needed for each of the procedures planned for patients 112A-C, and schedule the procedures so that the procedure in environment 104A get the resource first and is done with the resource before the procedure in environment 104B needs the resource, which is, in turn, done with the resource before the procedure in environment 104C needs the resource).
With regard to claim 8, the system claim corresponds to the method claim 1, respectively, and therefore is rejected with the same rationale.
With regard to claim 9, the system claim corresponds to the method claim 2, respectively, and therefore is rejected with the same rationale.
With regard to claim 10, the system claim corresponds to the method claim 3, respectively, and therefore is rejected with the same rationale.
With regard to claim 11, the system claim corresponds to the method claim 4, respectively, and therefore is rejected with the same rationale.
With regard to claim 12, the system claim corresponds to the method claim 5, respectively, and therefore is rejected with the same rationale.
With regard to claim 13, the system claim corresponds to the method claim 6, respectively, and therefore is rejected with the same rationale.
Response to Arguments
Applicant's arguments filed 3-3-2026 have been fully considered but they are not persuasive. Applicant states that the Rosenblatt reference fails to teach “an HF evaluation approach for each of versions of the medical device interface based on the classification, the HF evaluation documentation, and incremental documentation requirement of the subsequent versions of the medical device Interface”. Examiner respectfully disagrees with Applicant:
The Rosenblatt reference was used as it teaches providing guidance for a procedure with a device related to medical procedures ([abstract]; [0021]). The medical information can include information on a patient, a user, the device as well as the procedure [0017]. The medical procedure may also include the real-time guidance on the use of a medical device in an operating room and providing step-by-step guidance to complete medical procedures and access medical practitioners to assist in the use of medical devices [0037]. The system taught by Rosenblatt uses scenarios and applications associated with procedure instructions to include methods such as evaluation and feedback for further guidance [0301]. For instance, the system can include parameters such as size, configuration, surface characteristics, temperature, appearance, measured parameter (such as for example camera or other inspection fed to person guiding procedure), and so forth [0301]. The Human Factors (HF) evaluation in the medical field has capabilities and key phases of evaluation to maneuver certain tasks such as test devices in real simulated situations or clinical scenarios. Rosenblatt teaches the statuses of medical devices and versions of applications in a step-by-step workflow [0134]. Such step-by-step workflows can be considered as HF evaluation approach as it uses scenarios and applications associated with a procedural instruction system. Rosenblatt goes on to state that the procedures can be helpful to entities such as medical device companies like hospitals, health maintenance organizations, or the like [0221]. Rosenblatt mentions that a device manufacturer can determine which version of a device can be the most useful or helpful and the time it takes to complete tasks with each device [0221]. Each step can be classified based on which version is used or planned out by the application workflow. As mentioned previously, the use of scenarios and applications associated with a certain procedure instruction, can be considered a Human Factors (HF) evaluation. Furthermore, Rosenblatt teaches incremental or step-by-step workflow versions or documentation requirements of medical devices [0301]. According to Rosenblatt, the procedures can reference materials of text, audio, video, animations and still image content [0009]. The text information can be contextual information regarding the medical procedure [0055], or it can be a chatting capability in the step-by-step guidance procedure ([0072]-[0074]). The medical guidance procedures allow for certain documentation and versions of a medical device based on information required by the claim language. As such the Examiner asserts that the Rosenblatt reference teaches the claims. Applicant is welcomed to add more descriptive language to avoid the similarities taught in the Rosenblatt reference.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREA C. LEGGETT whose telephone number is (571)270-7700. The examiner can normally be reached M-F 9am-5pm.
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/ANDREA C LEGGETT/Primary Examiner, Art Unit 2171
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