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 .
Information Disclosure Statement
The information disclosure statement (IDS) received on February 19, 2025 and September 10, 2025 has been considered by examiner.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claims are not directed to patent eligible subject matter.
Claims 1-20 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system) and a process (i.e., method).
Although claims 1-20 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 1-20 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity).
The identified limitations of independent claim 1 recite (in bold and italics):
a patient interface subsystem associated with a patient;
a patient communication module configured to enable the communication between the patient interface subsystem and a provider interface subsystem;
a patient processor operatively coupled to the patient interface subsystem and the patient communication module, and wherein the patient processor is configured to:
evaluate camera data that includes scene information of an external environment of the patient to confirm that a set of medical supplies are present in the external environment;
receive provider instructions of a remote healthcare provider from the provider interface subsystem via the patient communication module;
generate, in real time, one or more visual cues responsive to the received provider instructions;
cause display of a first graphic overlay with a patient augmented reality display module, wherein the first graphic overlay includes the generated one or more visual cues to be superimposed on a field of vision of the patient; and
evaluate additional camera data of either a given medical supply of the set of medical supplies or information regarding the patients
The identified limitations, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgement or opinion) but for the recitation of generic computer components. That is, other than reciting patient interface subsystem, patient communication module, and patient processor, nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompass a healthcare professional evaluating images of a patient to determine medical supplies needed for a medical procedure. The claim limitations fall within the Mental Processes groupings of abstract ideas. Thus, the claimed invention recites a judicial exception.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception.
This judicial exception is not integrated into a practical application. As a whole, the patient interface subsystem, patient communication module, and patient processor in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 2-13 and 15-20, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea.
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
PART II. DETERMINE WHETHER ANY ELEMENT, OR COMBINATION, AMOUNTS TO “SIGNIFICANTLY MORE” THAN THE ABSTRACT IDEA ITSELF
Under Part II, the steps of the claims, when considered individually and as an ordered
combination, do not improve another technology or technical field, do not improve the functioning of the
computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. As stated above in Prong Two, the patient interface subsystem, patient communication module, and patient processor in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 1-20, when considered
individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 2-13 and 15-20, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
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)(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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferro et al. (US 2022/0310253 A1).
Regarding claim 1, Ferro discloses a system comprising:
a patient interface subsystem associated with a patient (Paragraph [0225]);
a patient communication module configured to enable the communication between the patient interface subsystem and a provider interface subsystem (Paragraph [0225]);
a patient processor operatively coupled to the patient interface subsystem and the patient communication module (Paragraph [0225]), and wherein the patient processor is configured to:
evaluate camera data that includes scene information of an external environment of the patient to confirm that a set of medical supplies are present in the external environment (Fig. 2B; Paragraph [0096]: the user with augmented reality content including graphics and/or alphanumeric text conveying various information to the user while providing an aesthetically-pleasing enhanced user interaction experience. The information can include, for example: [0097] Information about the contents within the medical diagnostic test kit container);
receive provider instructions of a remote healthcare provider from the provider interface subsystem via the patient communication module (Paragraph [0114]: augmented reality content may be generated and displayed on the user device 110 that includes step-by-step visual instructions and/or infographics corresponding to the particular at-home medical diagnostic test);
generate, in real time, one or more visual cues responsive to the received provider instructions (Paragraph [0236]: the multi-session interfaces may comprise one or more visual cues to indicate to the proctor the status of each patient session and to alert the proctor if attention is needed for any given session.);
cause display of a first graphic overlay with a patient augmented reality display module, wherein the first graphic overlay includes the generated one or more visual cues to be superimposed on a field of vision of the patient (Paragraph [0286]: the system may utilize AR in order to further communicate the first aid guidance to the user. For example, instructions and/or other indicators can be overlayed onto images and/or video (whether live or prerecorded) captured using cameras on the user device); and
evaluate additional camera data of either a given medical supply of the set of medical supplies or information regarding the patient (Fig. 9D; Paragraph [0131]: The display may also include overlaid virtual content showing a box to guide the user as to what portion of the test kit to capture with a camera of the user device in order to capture the drug test results in the image. ).
Regarding claim 2, Ferro discloses the system of claim 1, wherein the provider instructions correspond to a virtual training session for the patient (Paragraph [0114]).
Regarding claim 3, Ferro discloses the system of claim 1, wherein the provider instructions are configured to guide the patient to find a particular one of the set of medical supplies (Paragraph [0097]).
Regarding claim 4, Ferro discloses system of claim 1, wherein the provider instructions are configured to virtually train the patient to perform a medical procedure (Paragraph [0114]).
Regarding claim 5, Ferro discloses the system of claim 4, wherein the medical procedure includes an injection operation (Paragraph [0287]: showing 3D visuals of how to use the appropriate knots to tie the stitching off, etc.), (B) how and where to inject an epinephrine autoinjector (“EpiPen”), including how to open the EpiPen case, where on the body or leg to inject it, indicate (potentially via a timer or countdown) how long to hold in place during the injection phase ).
Regarding claim 6, Ferro discloses the system of claim 1, wherein the one or more visual cues are selected from a cue set (Paragraph [0236]).
Regarding claim 7, Ferro discloses the system of claim 6, wherein the cue set further includes at least one audible cue or haptic cue (Paragraph [0226]: The session progress indicator 3002 may provide a visual and/or audible indicator of the progress of a testing session. ).
Regarding claim 8, Ferro discloses the system of claim 1, wherein the one or more visual cues include at least one of a dynamic visual cue or a static visual cue (Paragraph [0236]).
Regarding claim 9, Ferro discloses the system of claim 1, wherein the generated one or more visual cues to be superimposed on a field of vision of the patient are configured to guide a user to perform an injection (Paragraph [0287]).
Regarding claim 10, Ferro discloses the system of claim 1, wherein the evaluation of the additional camera data determines one or more variables to be monitored during a training session (Paragraph [0130]: a screen display in which textual instructions are provided to the user guiding the user as to what to do. A visual image is also displayed to visually show the user the step to complete. A box is overlaid on the image so that the user can fix his or her face within the box while performing the testing step of swabbing his or her mouth with a swab located in the drug test kit.).
Regarding claim 11, Ferro discloses the system of claim 1, wherein the set of medical supplies includes medical equipment (Paragraph [0079]).
Regarding claim 12, Ferro discloses the system of claim 1, wherein the evaluation of the additional camera data is used to track the given medical supply (Paragraph [0116]).
Regarding claim 13, Ferro discloses the system of claim 1, wherein the evaluation of the additional camera data is used to track the information regarding the patient (Paragraph [0131]).
Regarding claim 14, Ferro discloses a method comprising:
evaluating, by a patient processor, camera data that includes scene information of an external environment of a patient to confirm that a set of medical supplies are present in the external environment (Fig. 2B; Paragraph [0096]: the user with augmented reality content including graphics and/or alphanumeric text conveying various information to the user while providing an aesthetically-pleasing enhanced user interaction experience. The information can include, for example: [0097] Information about the contents within the medical diagnostic test kit container);
receiving, by the patient processor, provider instructions of a remote healthcare provider from a provider interface subsystem via a patient communication module (Paragraph [0114]: augmented reality content may be generated and displayed on the user device 110 that includes step-by-step visual instructions and/or infographics corresponding to the particular at-home medical diagnostic test);
generating, by the patient processor in real time, one or more visual cues responsive to the received provider instructions(Paragraph [0236]: the multi-session interfaces may comprise one or more visual cues to indicate to the proctor the status of each patient session and to alert the proctor if attention is needed for any given session.); and
causing, by the patient processor, display of a first graphic overlay with a patient augmented reality display module, the first graphic overlay including the generated one or more visual cues to be superimposed on a field of vision of the patient (Paragraph [0286]: the system may utilize AR in order to further communicate the first aid guidance to the user. For example, instructions and/or other indicators can be overlayed onto images and/or video (whether live or prerecorded) captured using cameras on the user device).
Regarding claim 15, Ferro discloses the method of claim 14, further comprising evaluating, by the patient processor, additional camera data of either a given medical supply of the set of medical supplies or information regarding the patient (Fig. 9D; Paragraph [0131].
Regarding claim 16, Ferro discloses the method of claim 15, wherein evaluating the additional camera data includes determining one or more variables to be monitored during a patient training session (Paragraph [0130]).
Regarding claim 17, Ferro discloses the method of claim 15, wherein evaluating the additional camera data is used to either track the given medical supply or track the information regarding the patient (Paragraph [0131]).
Regarding claim 18, Ferro discloses the method of claim 15, wherein the generated one or more visual cues to be superimposed on a field of vision of the patient are configured to guide a user to perform an injection(Paragraph [0287]).
Regarding claim 19, Ferro discloses the method of claim 18, wherein the user is the patient (Paragraph [0135]).
Regarding claim 20, Ferro discloses the method of claim 14, wherein the provider instructions are configured to either guide the patient to find a particular one of the set of medical supplies, or to virtually train the patient to perform a medical procedure (Paragraph [0287]).
Conclusion
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/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685