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 .
Priority: the current application has the effective filing date of 02/06/2023.
Claim Objection
Claim 21 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 20. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1-2, 11 and 23 are objected to because of the following informalities:
To claims 1-2 and 11, the term “MAC address” should be defined to avoid incorrect interpretation of the abbreviation: MAC; based on the context of the claim, it is interpreted as ‘media access control.’
Further regarding claim 11, there should be a punctuation in line 11, following “MAC address”
To claim 22, the phrase “tracking real time” should be amended to “tracking in real time”
To claim 23, the abbreviation “EMR” should be defined to avoid incorrect interpretation; based on the context of the claim, it is interpreted as ‘electronic medical record.’
Appropriate correction is required.
Drawings
The drawings Figures. 4-8AA are objected to because these drawings are blurry, containing portions which are illegible. 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 use of the terms: Apple®, Apple Watch®, Garmin®, Bluetooth®, Zigbee®, Z-wave™, iPhone®, Android®, Chrome Book®, Windows®, MAC OS X ®, and Linux®, individually refer to a trade name or a mark used in commerce, has been noted in this application. These terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note: The Applicant is respectfully requested to scrutinize through the entire Disclosure for additional trade names and marks that the Examiner might have missed.
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 2-10, 13-22 and 26-27 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.
Claims 2-10 and 13-22 individually recite the term “the at least one device”; this term lacks proper antecedent basis in the claim because it is unclear whether this “one device” refers to the “at least one medical device” or the “at least one user interface device” recited in respective independent claims. For purposes of Examination, the Examiner interprets “the at least one device” to refer to “at least one medical device” recited in claim 1.
Regarding claims 9 and 10, and 19-21 recite “bandage”, “bandage readings”, “smart watch” and “watch readings”; these limitations are indefinite because these terms lack clear definition in the Specification and/or within the context of the claim. Currently, “bandage” refers to traditional bandages, and thus it is unclear as to what are considered “bandage readings”. As for “smart watch”, this refers to a watch with computer capabilities, as such it is unclear what type of data “watch readings” refers to.
Regarding claims 26 and 27, these claims recite “wherein patients are monitored… through White Label”, the term “White Label” is not defined in the claim and/or the Specification. For purposes of Examination, the Examiner interprets “White Label” as a form of masking a patient’s identity, or providing anonymity to the patient.
Claim Interpretation
Regarding the use of the term Bluetooth™ in the claim is deemed proper as it is not currently being used to identify or describe a particular material or product.
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.
(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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 8-13 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wexler et al. US 2017/0064363 A1 (hereinafter “Wexler”).
Regarding claim 1, Wexler discloses a system (system 200 as shown in Fig. 2) for monitoring in real time health data of an individual (monitored subject 100; [0005] health monitoring) comprising:
a cloud-based server (server 250) connected to a network (network 240), the cloud-based server (250) comprising a tangible, non-volatile memory ([0087]);
at least one medical device (wearable apparatus 110) wirelessly connected to the network (as shown in Fig. 2 and [0083, 0087] 110 wirelessly communicates with user’s device 120, and/or server 250), wherein the at least one medical device (110) is configured to generate health data from the individual ([0270] “Wearable apparatus 110 may thus include sensors to determine physiological parameters of user 100”), and the at least one medical device (110) having a unique MAC address that is associated with the individual ([0331] apparatus 110 transmits data which include its MAC address; also see [0334] MAC address to identify a user, a device, this is evident because apparatus 110 worn by another user also transmits data including a MAC address to identify said another user; see [0331] and Figs 33A-33C); and
at least one user interface device (computing device 120) connected to the network (240; as shown in Fig 2 and [0090]), wherein the server (120) is configured to store the health data and to allow the at least one user interface device to view the health data in real time ([0083, 0092-0093] stores, analyze, and provide feedback to the user based on detected data transmitted from 110) and associate the health data with the individual based on the unique MAC address ([0093] “Apparatus 110 can also connect to computing device 120 over network 240 via any known wireless standard (e.g., Wi-Fi, Bluetooth®, etc.)”).
Regarding claim 2, Wexler discloses the system according to claim 1, wherein the MAC address is a Bluetooth MAC address. ([0093] “Apparatus 110 can also connect to computing device 120 over network 240 via any known wireless standard (e.g., Wi-Fi, Bluetooth®, etc.)” and [0334] apparatus 110 transmits data with its own MAC address. When [0093] and [0334] are considered together, apparatus 110 wirelessly transmits over Bluetooth® connection, and the transmits data includes a MAC address, this is taken to encompass “Bluetooth MAC address” in the claim)
Regarding claims 3-10, the Examiner “the at least one device” to refer to “at least one medical device” recited in claim 1, which is taught by Wexler wearable 110 that is Bluetooth® enabled, see rejection to claim 1 and Wexler: [0093, 0274, 0302, 0328] which discusses Bluetooth® pairing.
Regarding claim 3, Wexler discloses the system according to claim 2, wherein the at least one device is a Bluetooth enabled thermometer and the health data includes temperature readings from the thermometer. ([0270] apparatus 110 detects physiological parameter from a user, e.g. temperature)
Regarding claim 8, Wexler discloses the system according to claim 2, wherein the at least one device is a Bluetooth enabled heart monitoring device and the health data includes heart readings from the heart monitoring device. ([0270] apparatus 110 detects physiological parameter from a user, e.g. heart activity, ECG)
Regarding claim 9, Wexler discloses the system according to claim 2, wherein the at least one device is a Bluetooth enabled bandage and the health data includes bandage readings from the bandage. (In this claim “bandage” is interpreted as wearable patch-type sensor, this is taught in [0270] which discloses wearable apparatus 110 being able to detect physiological parameters from the skin; also see [0296])
Regarding claim 10, Wexler discloses the system according to claim 2, wherein the at least one device is a Bluetooth enabled smart watch and the health data includes watch readings from the smart watch. ([0083] wearable 110 and smartwatch are incorporated as one device, thus, which is capable of detecting physiological parameters; these parameters are interpreted to encompass “watch readings” in this claim.)
Regarding claim 11, Wexler discloses a method of monitoring health data of an individual in real time (Abstract: system and method for using the same) comprising:
providing a system (system 200 as shown in Fig. 2) comprising a cloud-based server (server 250) connected to a network (network 240), the cloud-based server (250) comprising a tangible, non-volatile memory ([0087]);
at least one medical device (wearable apparatus 110) wirelessly connected to the network (as shown in Fig. 2 and [0083, 0087] 110 wirelessly communicates with user’s device 120, and/or server 250), wherein the at least one medical device (110) is configured to generate health data from the individual ([0270] “Wearable apparatus 110 may thus include sensors to determine physiological parameters of user 100”), and the at least one medical device (110) having a unique MAC address that is associated with the individual ([0331] apparatus 110 transmits data which include its MAC address; also see [0334] MAC address to identify a user, a device, this is evident because apparatus 110 worn by another user also transmits data including a MAC address to identify said another user; see [0331] and Figs 33A-33C); and
at least one user interface device (computing device 120) connected to the network (240; as shown in Fig 2 and [0090]), wherein the server (120) is configured to store the health data and to allow the at least one user interface device to view the health data in real time and associate the health data with the individual based on the unique MAC address ([0083, 0092-0093] stores, analyze, and provide feedback to the user based on detected data transmitted from 110) and associate the health data with the individual based on the unique MAC address ([0093] “Apparatus 110 can also connect to computing device 120 over network 240 via any known wireless standard (e.g., Wi-Fi, Bluetooth®, etc.)”);
using the user interface device (120) to remotely monitor the health data of the individual in real time ([0095]); and
storing the health data in the tangible, non-volatile memory ([0083, 0092-0093] stores data in server 250).
Regarding claims 12-13, these claims are rejected by Wexler under the same rationale as discussed to claims 2 and 3 above.
Regarding claims 18-21, these claims are rejected by Wexler under the same rationale as discussed to claims 7-9 above.
Claims 1-5, 7-9, 11-15, 17-19, 23-25 and 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Temkin et al. US 2022/0180075 A1 (hereinafter “Temkin”).
Regarding claim 11, Temkin discloses a method of monitoring health data of an individual in real time (Abstract: attachable system and method for using the same) comprising:
providing a system (system 100 as shown in Fig. 1) comprising a cloud-based server (servers 150, 160, 170, 180, 185) connected to a network (network 180), the cloud-based server (150, 160, 170, 180, 185) comprising a tangible, non-volatile memory ([0073] at least 150 and 185 are storage/database device);
at least one medical device (smart bandage 120) wirelessly connected to the network (as shown in Fig. 1 and [0065, 0069, 0073] 110 wirelessly communicates with servers via devices 130, 131 or 132), wherein the at least one medical device (120) is configured to generate health data from the individual ([0134-0135] bandage 120 comprises sensors and adapted for detecting physiological data), and the at least one medical device (120) having a unique MAC address that is associated with the individual ([0077] MAC address beacon, and [0116] MAC address); and
at least one user interface device (computing device 130, 131, 132) connected to the network (see Fig. 1 and [0066-0067, 0072]), wherein the server (150, 185) is configured to store the health data and to allow the at least one user interface device to view the health data in real time and associate the health data with the individual based on the unique MAC address and associate the health data with the individual based on the unique MAC address ([0066, 0072, 0076-0077]; also see Fig. 5 establishing Bluetooth® link for future communication associated with unique MAC address);
using the user interface device (130, 131, 132) to remotely monitor the health data of the individual in real time ([0063-0068] provides communication and data analysis and/or storage from bandage 120); and
storing the health data in the tangible, non-volatile memory ([0066] database 150 and 185 stores data in server 250).
Regarding claim 12, Temkin discloses the method according to claim 11, wherein the MAC address is a Bluetooth MAC address. ([0073] Bluetooth® beacon)
Regarding claim 13, Temkin discloses the method according to claim 12, wherein the at least one device is a Bluetooth enabled thermometer and the health data includes temperature readings from the thermometer. ([0134-0135] bandage 120 comprises sensors adapted to detect body temperature)
Regarding claim 14, Temkin discloses the method according to claim 12, wherein the at least one device is a Bluetooth enabled blood pressure monitor and the health data includes blood pressure readings from the blood pressure monitor. ([0134-0135] bandage 120 comprises sensors adapted to detect physiological parameters; see [0196] and Table 1: blood pressure, [0240: last sentence] blood pressure)
Regarding claim 15, Temkin discloses the method according to claim 12, wherein the at least one device is a Bluetooth enabled pill box and the health data includes a pill dispensed from the pill box. (see [0080, 0195] medication administration events, [0203] and Table 5 regarding medication dispensed, dispensed value and dispensed unit; these are all taken to encompass “a pill dispensed from the pill box” in this claim)
Regarding claim 17, Temkin discloses the method according to claim 12, wherein the at least one device is a Bluetooth enabled blood glucose device and the health data includes blood glucose readings from the blood glucose device. ([0134-0135] bandage 120 comprises sensors adapted to detect physiological parameters; see [0240: last sentence] sugar levels)
Regarding claim 18, Temkin discloses the method according to claim 12, wherein the at least one device is a Bluetooth enabled heart monitoring device and the health data includes heart readings from the heart monitoring device. ([0134-0135] bandage 120 comprises sensors adapted to detect heart rate.)
Regarding claim 19, Temkin discloses the method according to claim 12, wherein the at least one device is a Bluetooth enabled bandage and the health data includes bandage readings from the bandage. ([0062] smart bandage device 120, thus the “bandage” feature is taught inherently, all detected sensor data discussed in [0134-0135] is interpreted as “bandage readings”)
Regarding claim 23, Temkin discloses the method according to claim 12, comprising importing the health data into an EMR system. (server 150 and/or 185 are hospital based medical records database, this is taken to encompass “EMR system” in the claim; see [0091] and [0240] which discusses medical record tracking)
Regarding claim 24, Temkin discloses the method according to claim 12, comprising monitoring a plurality of patients wherein each patient has an associated at least one medical device, and each patient has an associated unique Bluetooth MAC address. (see [0089-0090, 0240] system 100 taught in Temkin is adapted to be used by plurality of patients in a hospital, see rejection to claims 11 and 12 regarding Bluetooth MAC address)
Regarding claim 25, Temkin discloses the method according to claim 24, wherein the patients are monitored in a nursing home. (see [0089-0090, 0240] system 100 taught in Temkin is adapted to be used by plurality of patients in a medical facility, this is taken to encompass “nursing home” in this claim, also see rejection to claims 11 and 12 regarding Bluetooth MAC address)
Regarding claim 28, Temkin discloses the method according to claim 12, comprising monitoring a plurality of soldiers wherein each soldier has an associated at least one medical device, and each soldier has an associated unique Bluetooth MAC address. (see [0089-0090, 0240] system 100 taught in Temkin is adapted to be used by plurality of soldiers in a battlefield and/pr a remote operation, also see rejection to claims 11 and 12 regarding Bluetooth MAC address)
Regarding claim 29, Temkin discloses the method according to claim 28, wherein the at least one medical device detects a gunshot in a soldier. ([0267] testing for the presence of blood or gun shot residue, this is taken to encompass “detects a gunshot in a soldier” in this claim).
Claim 1 is rejected by Temkin under the same rationale as discussed to claim 11 above.
As for claims 2-5 and 7-9, these claims are rejected by Temkin under the same rationale as discussed to claims 12-15 and 17-19 immediately above.
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.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Temkin as applied to claims 2 and 12 above, and further in view of Pal US 2015/0039327 A1.
Regarding claim 16, Temkin discloses the method according to claim 12, wherein the Bluetooth enabled bandage sensor 120 is adapted to detected a plurality of physiological parameters (see rejection to claim 12, and also see [0030-0031]), but does not disclose wherein the least one device is urinalysis device and the health data includes urinalysis readings from the urinalysis device.
Pal, a prior art reference in the field of remote health monitoring systems of clinical trial participants, discloses a system comprising providing a telemetric medical device for monitoring a health and with onboard communications capabilities for transmitting information wirelessly to a cloud-based server ([0083]). Pal provides that the medical device is a digital blood pressure instrument, glucometer, EKG, digital thermometer, blood analyzer or urine analyzer (see Claims 14-17). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Temkin to further include a urine analyzer in view of Pal; the motivation is to provide urine analysis provide s comprehensive health benefit insights.
Claim 6 is rejected by Temkin in view of Pal under the same rationale as discussed to claim 16 immediately above.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Temkin as applied to claim 12 above, and further in view of Jakobsson et al. US 2020/0394332 A1.
Regarding claims 26 and 27, Temkin discloses the method according to claim 24 which is adapted for monitoring patient remotely, and in a temporary medical facility (see Fig. 1 and [0003, 0089-0090]), but does not disclose wherein the patients are monitored in a doctor's office through White Label, and/or wherein the patients are monitored remotely through White Label.
However, Jackobsson, another prior art reference in the analogous art of IOT (internet of things) associated with individual user and a network server (see Abstract and Figs. 1-3); Jakobsson teaches a network system that provides anonymity, by using pseudonyms that are unique to individual users and/or connected sensor/device associated with said user ([0267, 0307, 0748]). It would have been obvious to a person of ordinary skill in the art at the time to modify Temkin’s communication system to provide the anonymity by using pseudonyms in view of Jakobsson; the motivation for doing so is to promote privacy and to protect end user’s identity when communicating sensitive personal health information (Jacoksson: [0267]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
November 28, 2025