DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
The preliminary amendment filed on 8/4/25 is entered. A restriction requirement was subsequently mailed on 6/1/26. Applicant’s election without traverse of Invention I (claims 1-2, 5-7, 9-10, 12, 14, 18, 21, 24, 27, 29, 30, and 32) in the reply filed on 6/18/26 is acknowledged. Accordingly, claims 39-42 are currently withdrawn from examination, and claims 1-2, 5-7, 9-10, 12, 14, 18, 21, 24, 27, 29, 30, and 32 are currently under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2 and 5, and the dependent claims thereof, are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 recites the limitation “the marker”. Claim 2 is dependent from claim 1 which recites “an injection site marker”. Based on the inconsistent terminology, it is unclear whether the recited marker of claim 2 is referring to the same injection site marker of claim 1 or another element. Therefore, claim 2 is indefinite.
The limitation of “the injection device” in claim 5 lacks sufficient antecedent basis in the claims.
Claim Rejections – 35 USC 102 (AIA )
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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, 2, 6, 7, 9, 10, 12, 14, 18, 27, and 29 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 10,748,450 B1 to OLEY.
Regarding claim 1, OLEY teaches An augmented reality (AR) injection training system for training a subject to administer injections (Abstract: An interactive augmented reality system for simulating medical procedures; col. 3, lines 35-45: augmented reality viewer and associated experience is enabled, which guides a child through a disease-care simulation; col. 6, line 63-col. 7, line 8: insulin pen), the system comprising:
an injection site marker (col. 3, lines 35-45: uniquely identifiable patterns; col. 3, lines 55-col. 4, lines 6: one or more uniquely identifiable patches),
an AR component (col. 3, lines 35-45: an augmented reality viewer; col. 4, lines 7-18: interactive augmented reality system 100 for simulating medical procedures for pediatric disease education can include a mobile device 110 such as a smart phone or tablet. The mobile device 110 can include one or more sensors and/or cameras (e.g., 120) configured to scan one or more of the uniquely identifiable patches 125 using a built-in visible light camera 120 of the mobile device 110. The mobile device 110 can include an interactive medical procedure simulation logic section 130 that is configured to produce the augmented reality experience to simulate medical procedure for pediatric disease education, as further described below), and
optionally a physical device for which training occurs (note: based on the use of the word “optionally”, the limitation that follows is not a required element of the claimed invention).
Regarding claim 29, OLEY teaches A method for using an AR injection training system by a subject in need (Abstract: An interactive augmented reality system for simulating medical procedures; col. 3, lines 35-45: augmented reality viewer and associated experience is enabled, which guides a child through a disease-care simulation; col. 6, line 63-col. 7, line 8: insulin pen) comprising
attaching a marker to an injection site (col. 3, lines 35-45: uniquely identifiable patterns; col. 3, lines 55-col. 4, lines 6: one or more uniquely identifiable patches can be placed on the plush toy 105 corresponding to key areas where the child will interact with the plush toy 105 to provide medical care),
using an AR component to detect the marker and the subject (col. 3, lines 35-45: an augmented reality viewer; col. 4, lines 7-18: interactive augmented reality system 100 for simulating medical procedures for pediatric disease education can include a mobile device 110 such as a smart phone or tablet. The mobile device 110 can include one or more sensors and/or cameras (e.g., 120) configured to scan one or more of the uniquely identifiable patches 125 using a built-in visible light camera 120 of the mobile device 110.),
conducting a virtual administration via the AR component (col. 3, lines 35-45: an augmented reality viewer; col. 4, lines 7-18: The mobile device 110 can include an interactive medical procedure simulation logic section 130 that is configured to produce the augmented reality experience to simulate medical procedure for pediatric disease education, as further described below),
optionally receiving corrections from the AR component (note: based on the use of the word “optionally”, the limitation that follows is not a required element of the claimed invention), and
optionally administering an injection device to the injection site indicated by the marker (note: based on the use of the word “optionally”, the limitation that follows is not a required element of the claimed invention).
Regarding claim 2, OLEY further teaches
wherein the marker comprises an attaching side that abuts tissue of the subject (col. 4, lines 7-18: In some embodiments, one or more of the uniquely identifiable patches 125 is an adhesive sticker, which can be moved from one location of the plush toy 105 to another location of the plush toy 105 by the user patient. The adhesive sticker can have a uniquely identifiable pattern printed on it so that it can be scanned and recognized by the mobile device 110, as further described below.),
wherein said attaching side optionally comprises an adhesive layer (note: based on the use of the word “optionally”, the limitation that follows is not a required element of the claimed invention).
Regarding claim 6, OLEY further teaches wherein the AR component comprises a computing device comprising a camera and screen (col. 4, line 55-col. 5, line 4: mobile device includes camera and a display screen).
Regarding claim 7, OLEY further teaches wherein the AR component is configured to display a virtual image overlay on the screen that facilitates establishing a proper viewing distance from the injection site (col. 6, lines 35-48: The interactive medical procedure simulation logic section 130 can cause an animation 305 to be superimposed on the camera feed around the patch 310 to indicate the uniquely identifiable patch 310 has been recognized).
Regarding claim 10, OLEY further teaches wherein the AR component tracks the injection site marker and the subject via the camera (col. 4, lines 55-col. 5, line 4: The mobile device 110 can include the visible light camera 120, which can capture a series of live images (e.g., 185 or 195) of the plush toy 105 having the one or more patches 125; col. 6, lines 35-48: the mobile device 110 can be used in a scan mode to scan a uniquely identifiable patch 310 from among the one or more patches 125).
Regarding claim 12, OLEY further teaches
wherein the AR content comprises a virtual injection device (col. 6, lines 63-col. 7, line 8: For example, a digital virtual disease care tool such as a digital virtual insulin pen 410 can be presented to the user patient through the touch-sensitive display screen 115), and
optionally, the AR component is programmed to provide audio content mimicking sounds that occur during injection (note: based on the use of the word “optionally”, the limitation that follows is not a required element of the claimed invention).
Regarding claim 14, OLEY further teaches
wherein the AR component is programmed to provide a virtual overlay on the screen to provide images onto a physical device that provides instructions on usage of the physical device, wherein the physical device is an actual injection device or a trainer device (col. 3, lines 35-45: augmented reality viewer and associated experience is enabled, which guides a child through a disease-care simulation; col. 5, line 60-col. 6, line 10: At 220, the interactive medical procedure simulation logic section 130 can cause an animation to be superimposed on a camera feed to indicate the uniquely identifiable patch 125 has been recognized, and that further interactive simulated medical procedures are available; col. 7, lines 53-63: The digital virtual medical tools logic section 140 can receive one or more dial gestures from the user patient via the touch-sensitive display screen 115 to cause the digital virtual dial 705 to show a digital virtual dosage (e.g., 2.5) of digital virtual insulin; col. 8, lines 39-50: confirmatory type message).
Regarding claim 18, OLEY further teaches wherein the AR component provides visual and/or auditory feedback to the subject during or after training to correct errors made while training (Abstract: Children learn how to manage their chronic illness by enabling them to practice their medical procedures and receive feedback related to correct and incorrect care; col. 8, line 65-col. 9, line 16: the interactive medical procedure simulation logic section 130 can include a pediatric disease simulation feedback logic section 145, which can provide audio or visual feedback to the user patient associated with the virtual medical care provided to the body of the plush toy 105).
Regarding claim 27, OLEY further teaches wherein the marker is made of a flexible material so as to facilitate pinching of the edges of the marker so as to pinch the underlying tissue (col. 3, line 55-col. 4, line 6: uniquely identifiable patches 125 can be made of cloth material).
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, 9, 21, 24, 30, and 32 is/are rejected under 35 U.S.C. 103 as being obvious over OLEY, as applied to claim 1 and 29, in view of US 2020/0206438 A1 to BAKER.
Regarding claim 5 and 32, OLEY further teaches the elements above, but does not disclose wherein, the marker comprises an opening to admit the injection device.
However, BAKER teaches an injection training device (par. 0064) including a positioning apparatus (i.e., marker) with a channel forming an opening to admit an injection device at target location (par. 0061-0062; 0064; 0089). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the positioning device comprising an opening at a target location, as taught by BAKER, for the patches of OLEY, in order to guide the medicament delivery device to deliver an injection at a target point at the target surface.
Regarding claim 9, OLEY further teaches when the marker is positioned on an injection site (col. 3, lines 35-45: uniquely identifiable patterns; col. 3, lines 55-col. 4, lines 6: one or more uniquely identifiable patches can be placed on the plush toy 105 corresponding to key areas where the child will interact with the plush toy 105 to provide medical care; col. 6, line 63-col. 7, line 8: location to use insulin pen), but does not expressly disclose the marker positioned on the subject. However, BAKER further teaches the device is used on a subject including a patient to guide the injection device to target tissue (par. 0060-0061). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further utilize the augmented reality system of OLEY on an actual human patient, as taught by BAKER, in order to provide further guidance to a user in proper medication administration during an actual medical procedure.
Regarding claim 21, OLEY further teaches the elements above, but does not disclose wherein the marker further comprises one or more medical sensors. However, BAKER further teaches the positioning device further includes a sensor, wherein the sensor 79 senses and records a use and/or a condition of the injection device 12 and/or of the positioning apparatus, e.g., a condition may include an orientation, a position, a location, a temperature, a use, or a combination thereof, of the housing, positioning apparatus, and/or the injection device 12 (par. 0090). BAKER teaches the purpose of the sensor is to allow the system to communicate to the user whether the angle at which an injection device is being positioned is correct or incorrect based on information obtained by the sensor (par. 0080). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further incorporate a sensor in the positioning device, as taught by BAKER, for the patches of OLEY, in order to communicate feedback to the user on the correctness of their actions during the medical procedure based on the information obtained by the sensor.
Regarding claim 24, OLEY further teaches the elements above, but does not disclose wherein the attaching side comprises an analgesic or anesthetic medication, a cold component and/or a vibration component. However, BAKER further teaches the positioning device further includes a vibration component in order to provide feedback to the user during use based on a condition detected, e.g., correct usage of the system (par. 0109). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further incorporate a vibration component in the positioning device, as taught by BAKER, for the patches of OLEY, in order to further communicate feedback to the user on the correctness of their actions during the medical procedure based on the information obtained by the sensor.
Regarding claim 30, OLEY further teaches the elements above, but does not disclose wherein the AR component is configured to provide narrated instructions to the user during the conducting step, wherein said narrated instructions optionally comprise information about the operation of a physical device (note: based on the use of the word “optionally”, the limitation that follows is not a required element of the claimed invention). However, BAKER further teaches an external device may provide instructions for using the injection device in a sequence of steps, and wherein the microprocessor is configured to control a provision of the instructions for using the injection device and/or the housing to the user in the sequence of steps and/or to provide an instruction to the user based on information detected and/or received by the information detecting and/or receiving component of the housing, and that the instructions may pertain to correct or incorrect angular positioning of the injection device relative to the target surface (par. 0109). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate output of instructions while the medical procedure is being performed, as taught by BAKER, through the AR device of OLEY, in order to further guide the user on the proper sequence of steps or technique to perform.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
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