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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a medication injection device (claim 1, line 18; claim 11, line 15), a wearable pump (claim 2, line 1), imaging sensors, photoplethysmography sensors, electromyogram sensors, electroencephalogram sensors, and motion sensors (claim 10, lines 1-3; claims 20, lines 2-4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
In line 3, “their food sensitivity” should be changed to “a food sensitivity of the person”
In line 3, “the severity” should be changed to “a severity”
In line 4, “their reaction” should be changed to “a reaction of the person”
In line 6, “measurements” should be changed to “the measurements”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 15, 17, and 20 are objected to because of the following informalities:
In regards to claim 1, line 3, “a patient” should be changed to “the patient”.
In regards to claim 15, line 1, “determining” should be changed to “the determining”.
In regards to claim 17, line 1, “alerting” should be changed to “the altering”.
In regards to claim 20, line 1, “receiving” should be changed to “the receiving”.
In regards to claim 20, line 1, “at least one signal” should be changed to “the at least one signal”.
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 2, line 2 recites “epinephrine”. Claim 2 depends upon claim 1. Claim 1, line 18 recites “medication”. It is unclear whether the two recitations are the same or different.
In regards to claim 4, line 2 recites “a medication”. Claim 4 depends upon claim 1. Claim 1, line 18 recites “medication”. It is unclear whether the two recitations are the same or different.
In regards to claim 14, lines 1-2 recite “a medication”. Claim 14 depends upon claim 11. Claim 11, line 15 recites “medication”. It is unclear whether the two recitations are the same or different.
Claim Rejections - 35 USC § 102
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 Levine et al (US 2018/0333533).
In regards to claim 1, Levine et al teaches a system (Figures 22A-22F) for determining an allergic sensitivity of a patient, the system comprising:
at least one sensor (paragraph [0213]: sensing module) configured to measure one or more physiological parameters of a patient (paragraph [0014]: wearable sensor is for measuring a biological signal)
an input (paragraph [0014]: at least one controller) configured to receive:
at least one signal from the at least one sensor (paragraph [0014]: receive the biological signal from the wearable sensor)
at least partial user history of the patient (paragraph [0099]: taking into account historical trends)
one or more hardware processors (paragraph [0014]: at least one controller) configured to:
process the at least one signal from the at least one sensor (paragraph [0014]: process the biological signal in real-time) and the at least partial user history of the patient (paragraph [0099]: taking into account historical trends)
establish a baseline physiological state of the patient or a response to at least one first potential allergen (paragraph [0087]: historical or patient normal values)
identify a change in a physiological state of the patient or a response to at least one second potential allergen (paragraph [0087]: calculated severity significantly deviates from historical or patient normal values)
determine an allergic reaction of the patient based on the change in the physiological state of the patient or a difference between the response to the at least one first potential allergen and the response to the at least one second potential allergen (paragraph [0014]: determine if an anaphylaxis symptom is present)
a medication injection device (108/110/112) configured to inject the patient with medication in response to the allergic reaction (paragraph [0014]: in response to a determination that the anaphylaxis symptom is present, automatically cause the actuator to apply an actuator force on the needle, thereby causing at least a portion of the needle to move through the bend of the channel of the guide member such that (i) the needle is at least partially reshaped, the at least partially reshaped needle having a bent portion, and (ii) the needle is moved from the retracted position to an injecting position where at least a portion of the needle protrudes outside the housing and is configured to intramuscularly deliver a bolus of the epinephrine to a human body part)
In regards to claim 2, Levine et al teaches wherein the medication injection device is a wearable pump (108/110/112) configured to inject the patient with epinephrine (paragraph [0014]).
In regards to claim 3, Levine et al teaches wherein the at least partial user history is extracted from an electronic medical record or an electronic health record (paragraph [0099]).
In regards to claim 4, Levine et al teaches wherein the one or more hardware processors is further configured to instruct the patient to take a medication in response to the allergic reaction (paragraph [0014]).
In regards to claim 5, Levine et al teaches wherein the at least one sensor comprises at least one wearable sensor (paragraph [0014]).
In regards to claim 6, Levine et al teaches wherein the at least one wearable sensor comprises a smartwatch (paragraph [0092]).
In regards to claim 7, Levine et al teaches wherein the one or more hardware processors is configured to determine the patient has the allergic reaction when the difference between the response to the at least one first potential allergen and the response to the at least one second potential allergen is greater than an allergy threshold (paragraph [0099]).
In regards to claim 8, Levine et al teaches wherein the one or more hardware processors is configured to characterize a severity of the allergic reaction based on whether the difference between the response to the at least one first potential allergen and the response to the at least one second potential allergen is greater than one or more of a plurality of severity thresholds (paragraph [0099]).
In regards to claim 9, Levine et al teaches recording information about the allergic reaction to an electronic medical record or an electronic health record (paragraph [0274]).
In regards to claim 10, Levine et al teaches wherein the at least one sensor comprises acoustic sensors (paragraph [0117]).
In regards to claim 11, Levine et al teaches a method of determining an allergic sensitivity of a patient, the method comprising:
receiving at least one signal from at least one sensor configured to measure one or more physiological parameters of the patient (paragraph [0014]: receive the biological signal from the wearable sensor)
receiving at least partial user history of the patient (paragraph [0099]: taking into account historical trends)
processing the at least one signal from the at least one sensor (paragraph [0014]: process the biological signal in real-time) and the at least partial user history of the patient (paragraph [0099]: taking into account historical trends)
establishing a baseline physiological state of the patient or a response to at least one first potential allergen (paragraph [0087]: historical or patient normal values)
identifying a change in a physiological state of the patient or a response to at least one second potential allergen (paragraph [0087]: calculated severity significantly deviates from historical or patient normal values)
determining an allergic reaction of the patient based on the change in the physiological state of the patient or a difference between the response to the at least one first potential allergen and the response to the at least one second potential allergen (paragraph [0014]: determine if an anaphylaxis symptom is present)
injecting, with a medication injection device, the patient with medication in response to the allergic reaction (paragraph [0014]: in response to a determination that the anaphylaxis symptom is present, automatically cause the actuator to apply an actuator force on the needle, thereby causing at least a portion of the needle to move through the bend of the channel of the guide member such that (i) the needle is at least partially reshaped, the at least partially reshaped needle having a bent portion, and (ii) the needle is moved from the retracted position to an injecting position where at least a portion of the needle protrudes outside the housing and is configured to intramuscularly deliver a bolus of the epinephrine to a human body part)
In regards to claim 12, Levine et al teaches extracting the at least partial user history of the patient from an electronic medical record or an electronic health record (paragraph [0099]).
In regards to claim 13, Levine et al teaches wherein the medication is epinephrine (paragraph [0014]).
In regards to claim 14, Levine et al teaches instructing the patient to take a medication (paragraph [0014]).
In regards to claim 15, Levine et al teaches wherein determining the allergic reaction of the patient comprises determining that the difference between the response to the at least one first potential allergen and the response to the at least one second potential allergen is greater than an allergy threshold (paragraph [0099]).
In regards to claim 16, Levine et al teaches alerting the patient of the allergic reaction (paragraph [0099]).
In regards to claim 17, Levine et al teaches wherein alerting the patient of the allergic reaction comprises communicating information about the allergic reaction to a user device (paragraph [0099]).
In regards to claim 18, Levine et al teaches recording information about the allergic reaction to an electronic medical record or an electronic health record (paragraph [0274]).
In regards to claim 19, Levine et al teaches alerting an emergency service of the allergic reaction (paragraph [0099]).
In regards to claim 20, Levine et al teaches wherein receiving at least one signal from the at least one sensor comprises receiving at least one signal from acoustic sensors (paragraph [0117]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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