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 .
Status of Claims
This action is in reply to the application filed on 11/29/24.
Claims 1-20 are currently pending and have been examined.
Priority/Continuity
Status of this application as a continuation of application 18/770,292 (filed on 07/11/2024), which is a continuation of application 18/056,164 (filed 11/16/2022), which is a continuation of application 15/865,023 (filed 01/08/2018), which claims the priority of provisional applications 62/445,182 (filed 01/11/2017) and 62/448,656 (filed 01/27/2017), is acknowledged. Accordingly, a priority date of 01/11/2017 has been given to this application.
IDS
The information disclosure statement (IDS) submitted on 01/13/2025 and 04/18/2025 have been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 20 does not fall within at least one of the four categories of patient eligible subject matter because it encompasses a transitory computer readable storage medium given the claim’s broadest reasonable interpretation in light of paragraph [0458] of specification, and therefore encompasses signals per se. Such media have been held to be ineligible subject matter under 35 U.S.C. 101. See In re Nuijten, 500 F.3d 1345, 1356-57 (Fed. Cir. 2007). It is suggested that Claim 20 be amended to recite “non-transitory computer-readable storage media” to overcome this rejection. For purposes of conducting a full subject matter eligibility analysis, Examiner is interpreting Claim 20 to be within a statutory class.
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.
Claim(s) 1-5, 7-9, 11-15, 17-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cork et. al. (US Publication 20170039423A1).
Regarding Claim 1, Cork discloses:
A wearable display system for interacting with a medical device, the wearable display system comprising (Abstract, teaching on a head-mounted display device for interface with a medical device configured to perform an invasive procedure on a patient):
a head-mounted display configured to present virtual content to a user while providing the user a view of an environment proximal to the display ([0017] teaching on a display driven by processing circuit to display data to a user; display may disposed directly in front of the eye of the user; display 18 may be an optical headmounted display configured to provide images to a user and allow the user to at least partially see through the display or a portion thereof (interpreted as providing virtual content while providing a view of the environment proximal to display); [0039] further teaches on “an augmented reality display” being used with the claimed system to overlay indicators, text, highlighting, etc. (“virtual content”) over one or more portions of a medical device as seen from a field of view of the user of the device);
one or more sensors configured to obtain data associated with the environment (Para. [0015]/Fig. 1, teaching on the structure of the optical head-mounted display device 10; [0019] camera 22 is configured to acquire light in the form of images and video to provide to processing circuit; camera 22 may be a forward-facing camera configured to acquire images from behind the user; acquired images/video/sounds may be stored in memory; [0020] teaches on transceiver 26 which transmits and receives data between the wearable device 10 and other devices; [0021] teaches on microphone 24 for receiving audible signals from near device 10 and spoken commands from the user (wearer); [0022] teaches on any variety of sensors 28 configured to provide input to the wearable device 10; Sensors 28 may comprise one or more of an accelerometer, gyroscope, magnetometer, ambient light sensor, proximity sensor, etc. which are configured to provide input to device 10 regarding “surroundings, movement, location or other characteristics of device 10”); and
a hardware processor in communication with the display and the one or more sensors, the hardware processor programmed to ([0016] teaches on processing circuit 14 comprising analog/digital electrical components to perform any functions described; Processing circuit 14 may comprise one or more microprocessors, microcontrollers, application-specific integrated circuits, programmable logic devices, etc.; per Fig. 1 the processor is interpreted as being in communication with the display and sensors):
receive the data obtained by the one or more sensors ([0019]-[0022] teach on receiving various types of sensor data, e.g., [0019] receiving image data from camera; [0021] receiving audible signals/spoken commands from near device 10; [0022] various sensors, e.g., proximity sensors, configured to provide input to device 10 regarding “surroundings, movement, location or other characteristics of device 10”; [0114] teaches on the head-mounted device monitoring being activated by determination it is within proximity of a medical device – receiving proximity sensor data);
based at least partly on the data, identify the medical device in the environment ([0035] teaches on processing circuit 303 of head-mounted display device receiving input data in the form of a “ping” or message comprising notification data from device 304 (per [0034], “device 304 is a medical device configured to perform an invasive procedure on a patient, in this case an infusion of a medication into a patient); Examiner interprets input data pertaining to device 304 as “identifying” the medical device (e.g., medical device 304) in the environment if it is in communication range; [0035] further teaches on using an image acquired by the display device to determine a make, model or type of the medical device – also interpreted as identifying the medical device in the environment based at least partly on the data);
establish a connection to wirelessly communicate with the medical device ([0020] teaches on the transceiver of device display 10 having “wireless transceiver circuits” for transmitting and receiving data with other devices; [0032] teaches on network 122 being any form of computer network that relays information between a medical device and the head-mounted display device 10; networks may include internet, WAN, LAB, cellular network, satellite network; [0035] teaches on medical device 304 sending a “wireless message” to the display device which is interpreted as indicating that the wireless connection has been established); and
instruct the display to present virtual content including a user interface (UI) that permits the user to control the medical device using the connection ([0041] teaches on head-mounted display device comprising a sensor configured to sense a motion or eye position of the person wearing the display device and generate control signals for controlling the medical device based on sensed motion or eye position; the display device can calculate the approximate location of a user’s eye gaze on a display screen of the device; display device 300 can be configured to execute commands associated with an input device (e.g., menu option, “OK” and “back” buttons) currently displayed at a screen location so the user can interact with the connected device 304 by looking at an appropriate sequence of menu options displayed on the screen – Examiner interprets the actual display of commands (Menu, OK, Back) for the user to interact with gaze tracking to indicate that the display has been instructed to present the virtual content (display of commands) via a user interface (the display itself) in order to control the medical device; per Fig. 2 this controlling is understood to occur over network 122/via communication link 112, e.g., the wireless communication per [0032], [0035]).
Regarding Claim 2, Cork discloses the limitations of Claim 1. Cork further discloses wherein the hardware processor is further programmed to instruct the display to present virtual content that indicates a location of the medical device in the environment ([0040] teaches on the system utilizing indicator 428 which may be a graphical indicator such as an indicator which a 2D shape such as an icon or other visual graphic such as an arrow shown immediately adjacent to a location where 3 kits of medical product are located; [0045] teaches on receiving information regarding a location of medical product in a medical facility via a wireless transceiver, e.g., Room 101 on first floor, a location within a room, e.g., Closet A or B; [0050] teaches on a distance indicator and arrow pointing on the display to show where a medical product is located; as the view is changed, the display indicator is continually updated with a new relative position, e.g., 20, 15, 10 feet; see Fig. 4A shows “Room 101” and “Left 20 feet” which are both interpreted as indicating a location of medical device in the environment; Examiner interprets ‘medical product’ as reading on ‘medical device’ – [0051] teaches on ‘medical product’ being a kit including a blood bag, tubing and other components for a blood donation; a blood bag is understood to be a medical device).
Regarding Claim 3, Cork discloses the limitations of Claim 2. Cork further discloses wherein the virtual content that indicates a location of the medical device includes semantic information associated with the medical device (see Fig. 4A shows “Room 101” and “Left 40 feet” which are both interpreted as semantic information associated with the medical product (e.g., the location), which is interpreted as semantic information associated with the medical product; Examiner interprets ‘medical product’ as reading on ‘medical device’ – [0051] teaches on ‘medical product’ being a kit including a blood bag, tubing and other components for a blood donation; a blood bag is understood to be a medical device).
Regarding Claim 4, Cork discloses the limitations of Claim 1. Cork further discloses wherein the data associated with the environment includes audio data ([0021] teaches on microphone 21 being part of the display device 10; microphone is configured to receive spoken commands from a user wear), and wherein identifying the medical device includes detecting sound in the audio data that indicates the medical device ([0048] teaches on a person speaking to the display device through a speech recognition engine to request information about a medical product (interpreted as a ‘medical device’).
Regarding Claim 5, Cork discloses the limitations of Claim 1. Cork further discloses wherein the data associated with the environment includes one or more images of the environment, and wherein identifying the medical device includes recognizing the medical device in the one or more images ([0063] teaches on display device using “image recognition” to identify an object in the camera’s field of view (objects in camera’s field of view are interpreted as “images of the environment”) that corresponds to the size, shape or other distinctive features of a blood transfusion bag; Examiner interprets a blood transfusion bag as reading on the broadest reasonable interpretation of “medical device”).
Regarding Claim 7, Cork discloses the limitations of Claim 1. Cork further discloses wherein the data associated with the environment includes one or more messages broadcast by the medical device ([0035] teaches on processing circuit of display device receiving a ping or message comprising notification data from medical device 304 indicating a condition or state of device 304, e.g., an occlusion has been detected by device 304, where device 304 is a medical device configured to perform an invasive procedure per [0034]), and wherein identifying the medical device is based on the one or more messages ([0035], teaching on medical device 304 pinging/messaging the display device to indicate an occlusion in device 304 – Examiner interprets this indication of a condition/state of device 304 to indicate the device has been identified as it provides data to the user regarding an occlusion detected in a line of the device).
Regarding Claim 8, Cork discloses the limitations of Claim 1. Cork further discloses wherein connection is established using a near field communication (NFC) interface of the wearable display system ([0020] teaches on using near-field communication for transceiver to receive and transmit device between device 10 and other devices; [0114] teaches on activating monitoring of medical device 1004 when it is within proximity of display device 1000).
Regarding Claim 9, Cork discloses the limitations of Claim 1. Cork further discloses wherein the hardware processor is further programmed to: access medical device data that is received from the medical device ([0093] teaches on the display device being worn by a clinician; the device may be configured to determine a characteristic of blood flowing through a component of the medical device from image data received and generate output based on that determination); and instruct the display to present virtual content that includes the medical device data ([0093] teaches out generating output of a characteristic of blood flowing through a component of a medical device; the output data may be a visual indication such as a message, alert, or alarm that the blood characteristic has exceeded a threshold or a text indicator of a measure of the characteristic).
Regarding Claim 11, Cork discloses a computer-implemented method for interacting with a medical device (Abstract, teaching on a head-mounted display device for interface with a medical device configured to perform an invasive procedure on a patient), the method performed by at least one hardware processor of a wearable display system (Fig. 1/[0015] – wearable display system; [0016] teaches on processing circuit 14 comprising analog/digital electrical components to perform any functions described; Processing circuit 14 may comprise one or more microprocessors, microcontrollers, application-specific integrated circuits, programmable logic devices, etc.), the method comprising: receiving data obtained by one or more sensors of the wearable display system ([0019]-[0022] teach on receiving various types of sensor data, e.g., [0019] receiving image data from camera; [0021] receiving audible signals/spoken commands from near device 10; [0022] various sensors, e.g., proximity sensors, configured to provide input to device 10 regarding “surroundings, movement, location or other characteristics of device 10”; [0114] teaches on the head-mounted device monitoring being activated by determination it is within proximity of a medical device – receiving proximity sensor data), the one or more sensors configured to obtain data associated with an environment proximal to a head-mounted display of the wearable display system (Para. [0015]/Fig. 1, teaching on the structure of the optical head-mounted display device 10; [0019] camera 22 is configured to acquire light in the form of images and video to provide to processing circuit; camera 22 may be a forward-facing camera configured to acquire images from behind the user; acquired images/video/sounds may be stored in memory; [0020] teaches on transceiver 26 which transmits and receives data between the wearable device 10 and other devices; [0021] teaches on microphone 24 for receiving audible signals from near device 10 and spoken commands from the user (wearer); [0022] teaches on any variety of sensors 28 configured to provide input to the wearable device 10; Sensors 28 may comprise one or more of an accelerometer, gyroscope, magnetometer, ambient light sensor, proximity sensor, etc. which are configured to provide input to device 10 regarding “surroundings, movement, location or other characteristics of device 10”), the display configured to present virtual content to a user of the wearable display system while providing the user a view of the environment proximal to the display ([0017] teaching on a display driven by processing circuit to display data to a user; display may disposed directly in front of the eye of the user; display 18 may be an optical headmounted display configured to provide images to a user and allow the user to at least partially see through the display or a portion thereof (interpreted as providing virtual content while providing a view of the environment proximal to display; [0039] further teaches on “an augmented reality display” being used with the claimed system to overlay indicators, text, highlighting, etc. (virtual content) over one or more portions of a medical device as seen from a field of view of the user of the device) based at least partly on the data, identifying the medical device in the environment ([0035] teaches on processing circuit 303 of head-mounted display device receiving input data in the form of a “ping” or message comprising notification data from device 304 (per [0034], “device 304 is a medical device configured to perform an invasive procedure on a patient, in this case an infusion of a medication into a patient); in the cited reference determining the notification data is from “device 304” is interpreted as identifying the medical device in the environment; [0035] further teaches on using an image acquired by wearable device to determine a make, model or type of the medical device – also interpreted as identifying the medical device in the environment); establishing a connection to wirelessly communicate between the wearable display system and the medical device ([0020] teaches on the transceiver of device display 10 having “wireless transceiver circuits” for transmitting and receiving data with other devices; [0032] teaches on network 122 being any form of computer network that relays information between a medical device and the head-mounted display device 10; networks may include internet, WAN, LAB, cellular network, satellite network; [0035] teaches on medical device 304 sending a “wireless message” to the display device which is interpreted as indicating that the wireless connection has been established); and instructing the display to present virtual content including a user interface (UI) that permits the user to control the medical device using the connection ([0041] teaches on head-mounted display device comprising a sensor configured to sense a motion or eye position of the person wearing the display device and generate control signals for controlling the medical device based on sensed motion or eye position; the display device can calculate the approximate location of a user’s eye gaze on a display screen of the device; display device 300 can be configured to execute commands associated with an input device (e.g., menu option, “OK” and “back” buttons) currently displayed at a screen location so the user can interact with the connected device 304 by looking at an appropriate sequence of menu options displayed on the screen – Examiner interprets the actual display of commands (Menu, OK, Back) for the user to interact with gaze tracking to indicate that the display has been instructed to present the virtual content (display of commands) via a user interface (the display itself) in order to control the medical device; per Fig. 2 this controlling is understood to occur over network 122/via communication link 112; per [0032] it is understood to occur over wireless connection).
Regarding Claim 12, Cork discloses the limitations of Claim 2. Claim 12 recites limitations that are substantially similar or the same as Claim 2, and the discussion above with respect to Claim 2 is equally applicable to Claim 12.
Regarding Claim 13, Cork discloses the limitations of Claim 3. Claim 13 recites limitations that are substantially similar or the same as Claim 3, and the discussion above with respect to Claim 3 is equally applicable to Claim 13.
Regarding Claim 14, Cork discloses the limitations of Claim 4. Claim 14 recites limitations that are substantially similar or the same as Claim 4, and the discussion above with respect to Claim 4 is equally applicable to Claim 14.
Regarding Claim 15, Cork discloses the limitations of Claim 5. Claim 15 recites limitations that are substantially similar or the same as Claim 5, and the discussion above with respect to Claim 5 is equally applicable to Claim 15.
Regarding Claim 17, Cork discloses the limitations of Claim 7. Claim 17 recites limitations that are substantially similar or the same as Claim 7, and the discussion above with respect to Claim 7 is equally applicable to Claim 17.
Regarding Claim 18, Cork discloses the limitations of Claim 8. Claim 18 recites limitations that are substantially similar or the same as Claim 8, and the discussion above with respect to Claim 8 is equally applicable to Claim 18.
Regarding Claim 19, Cork discloses the limitations of Claim 9. Claim 19 recites limitations that are substantially similar or the same as Claim 9, and the discussion above with respect to Claim 9 is equally applicable to Claim 19.
Regarding Claim 20, Cork discloses the limitations of Claim 11. Claim 20 recites limitations that are substantially similar or the same as Claim 11, and the discussion above with respect to Claim 11 is equally applicable to Claim 20. Claim 20 additionally recites the following which are also taught by Cork: Computer-readable storage media storing instructions which, when executed by at least one processor of a wearable display system, instruct the at least one processor to perform operations (Fig. 1; Paras. [0015], [0016] teaching on system architecture).
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) 6, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cork et. al. (US Publication 20170039423A1) as applied above to Claim 1 and Claim 11 respectively, and further in view of Djajadiningrat et. al. (US Publication 20170323062A1).
Regarding Claims 6 and 16, Cork discloses the limitations of Claim 1 and 11, respectively, but does not explicitly disclose the following. Djajadiningrat, which is directed to an augmented reality based user guidance system for multi-step medical procedures, teaches: wherein the hardware processor is further configured to execute at least one object recognizer that applies a computer vision algorithm to recognize the medical device ([0026] teaches on adding “computer vision and object recognition” to a real-life representation via augmented reality).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Cork with these teachings of Djajadiningrat to apply a computer vision algorithm to recognize a medical device, with the motivation of enabling the object itself to be recognized (color, shape, etc.) to allow recognizing and tracking objects without attaching distinct tags or labels to the objects (Djajadiningrat [0036]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cork et. al. (US Publication 20170039423A1) as applied to Claim 1 above, and further in view of McNamara (US Publication 20140003762A1).
Regarding Claim 10, Cork discloses the limitations of Claim 1 but does not disclose the following, but McNamara, which is directed to an augmented reality multiple depth plane 3D display, teaches: wherein the display is configured to present the virtual content with varying amounts of light ray divergence corresponding to a plurality of different depth planes ([0035]-[0036] teach on projecting light to simulate a 4D light field that would be produced by light reflecting from a real 3D object or scene; the multiple depth plane 3D display may project images (e.g., virtual content) into each eye of a user; [0046] teaches on the apparatus projecting multiple depth planes, each focused at a different radial distance with the corresponding spherical wavefront curvatures; [0058] teaches on a first and second beam; the first continues to a next microreflector while the second beam is reflected in a divergent pattern that is twice as great as that of a surface of the microreflector – interpreted as varying amounts of divergence).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Cork with these teachings of McNamara to configure a display to present virtual content with varying amounts of light ray divergence corresponding toa plurality of depth planes, with the motivation of using number and placement of virtual depth planes that are comparable to the depth resolution of the human vision system to mimic the psycho-physical effect produced by a real, continuous 3D object or scene (McNamara [0035]).
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20140266983A1, teaching on a head-mounted display for providing augmented reality display system to be used in accordance with medical devices and performance of medical treatments
US Publication 20160007937A1, teaching on systems and methods for wirelessly controlling medical devices
US Publication 20150088547A1, teaching on a wearable human interface module having an image delivery and display mechanism with augmented reality capabilities for use in healthcare applications such as a patient encounter
US Publication 20170186157A1, teaching on a method and system for outputting augmented reality information pertaining to a medical examination
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
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