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 .
Specification
The abstract of the disclosure is objected to because the phrase “effects an opioid” in line 15 should read “effects of an opioid” for proper grammar. 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, 6, 12-13, and 15 are objected to because of the following informalities:
Regarding claim 1, the phrase “effects an opioid“ in the last line should read “effects of an opioid” for proper grammar,
Regarding claims 6, 13, and 15, the phrase “further including programming code positioned on the microprocessor enabling the microprocessor, at a predetermined interval” should read “furthering including programming code, wherein the microprocessor is programmed to execute the programming code to carry out the following instructions: at a predetermined interval…” to provide more clarity on the relationship between the code and the microprocessor,
Regarding claim 12, the phrase “effects an opioid” in the last line should read “effects of an opioid” for proper grammar,
Regarding claim 15, the phrase “effects an opioid” on the page labelled “14” lines 12-13 should read “effects of an opioid” for proper grammar,
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 5, 9-10 and 15 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.
Regarding claim 5, the phrase “a cartridge” in line 2 renders the claim indefinite because it is unclear. It is unclear whether this is a different cartridge or the aforementioned cartridge in claim 1. Examiner is interpreting it as the latter.
Regarding claim 9, the phrase “manipulated by a user” in line 3 renders the claim indefinite because it is unclear. It is unclear whether this is intended to mean a different user or the aforementioned user in claim 1. Examiner is interpreting this as the same user as the aforementioned user in claim 1.
Regarding claim 15, the phrase “a cartridge” in lines 27-28 renders the claim indefinite because it is unclear. It is unclear whether this is a different cartridge or the aforementioned cartridge. Examiner is interpreting it as the latter.
Regarding claim 10, this claim is rejected due to its dependency upon a rejected base claim.
Claim Rejections - 35 USC § 103
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 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) 1-3, 5, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sawyer et al. (U.S Patent Pub. No. 20230201463, “Sawyer”) in view of Biltagi (U.S Patent Pub. No. 20210093806 A1).
Regarding claim 1, Sawyer discloses the limitations (Claim 1) a vital sign monitoring and naloxone delivery device (100 in Fig. 1-2) comprising:
a housing (114 in Fig. 2A) defining an interior space (see Fig. 1 and para. 0057 – housing 114 defines interior space for storing each of the interior components);
a band (116 in Fig. 2A) attached to the housing (114) and being configured for selectively attaching the housing (114) to an arm of a user (see Fig. 2A and para. 0057); a battery (108 in Fig. 1) attached to the housing (114) and positioned in the interior space (see Fig. 1, para. 0057 for interior space, see para. 0061 for battery);
a microprocessor (106 in Fig. 1) attached to the housing (14, see Fig.1, see para. 0055-0056 – control module 106 comprises a microprocessor), positioned in the interior space (see para. 0057), and operationally engaged to the battery (106, see Fig. 1 and para. 0060);
a pulse oximeter (110 in Fig. 1) operationally engaged to the microprocessor (106, see para. 0063), wherein the pulse oximeter (110) is configured for measuring a blood oxygenation level of the user and for relaying the measurements to the microprocessor (106, see para. 0063), enabling the microprocessor (106) for determining an opioid overdose (see para. 0023 and 0063 – microprocessor 106 determines when blood oxygenation level is below a threshold which is indicative of an opioid overdose);
a pump (120 in Fig. 4A-4B) attached to the housing (114, see Fig. 2B-3 and para. 0065-0066), positioned in the interior space (see Fig. 2B-2C and para. 0065), and operationally engaged to the microprocessor (106, see para. 0066);
a cutout (115 in Fig. 2C) positioned in the housing (114, see Fig. 2C and para. 0065), wherein the cutout (115 in Fig. 2C) is configured for selective insertion of a cartridge (104) containing naloxone (see para. 0059 and 0065), such that the cartridge (104) is operationally engaged to the pump (120, see Fig. 3 and para. 0066 – pump 120 is operationally engaged with cartridge 104 as it is contained inside cartridge 104 and engaged with the remaining components of cartridge 104 as seen in Fig. 3); and
an injector (136 in Fig. 4A-4B) attached to the bottom of the housing (114) and operationally engaged to the pump (120) and the microprocessor (106, see Fig. 4A and para. 0072 – nozzle 136 injects medicament into skin and thus is positioned adjacent the skin at the bottom of the housing 114), wherein the microprocessor (106) is enabled for selectively actuating the pump (120) and the injector (136) upon determination of the overdose for injecting the user with naloxone to counter the effects an opioid (see Fig. 7 and para. 0089 and 0093).
While Sawyer discloses the pulse oximeter (110) which are commonly known to measure both blood oxygenation levels and pulse rate, there is no explicit teaching the pulse oximeter is configured for measuring a pulse rate of the user. Sawyer further fails to disclose the limitations of (Claim 1) a pulse oximeter attached to the bottom of the housing such that the pulse oximeter is in contact with skin of the arm upon attachment of the housing to the arm of the user.
Biltagi discloses a wearable, opioid overdose treatment assembly comprising vital sign monitoring and an inhalation drug delivery device. Biltagi teaches (Claim 1) a pulse oximeter (33 in Fig. 5) attached to the bottom of the housing (12) such that the pulse oximeter (33) is in contact with skin of the arm upon attachment of the housing (12) to the arm of the user (see Fig. 5, Fig. 7, and para. 0023 – pulse oximeter 33 is attached to a surface of the housing 12 that allows it to be in contact with the skin and thus this surface is interpreted as the bottom of the housing), wherein the pulse oximeter (33) is configured for measuring a blood oxygenation level and a pulse rate of the user and for relaying the measurements to the microprocessor (28, see para. 0023).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pulse oximeter taught by Sawyer to explicitly measure pulse rate and be attached to the bottom of the housing as taught by Biltagi. Biltagi teaches that by having the pulse oximeter in contact with the user’s skin during wear allows the pulse oximeter to sense blood oxygen levels as well as pulse rate (see para. 0023).
Regarding claim 2, modified Sawyer discloses the device of claim 1, as discussed above. In modified Sawyer, Sawyer discloses (Claim 2) wherein the band (116 in Fig. 2A) is resiliently stretchable (see para. 0057), wherein the band (116) is configured for stretching for insertion of the arm of the user and for rebounding for securing the housing (114) to the arm of the user (see para. 0057 – band 116 may be formed of a rubber material and is thus resiliently stretchable and configured for stretching and rebounding).
Regarding claim 3, modified Sawyer discloses the device of claim 2, as discussed above. In modified Sawyer, Sawyer discloses (Claim 3) wherein the band (116 in Fig. 2A) comprises rubber (see para. 0057).
Regarding claim 5, modified Sawyer discloses the device of claim 1, as discussed above. In modified Sawyer, Sawyer discloses (Claim 5) wherein the cutout (115 in Fig. 2C) is sized for insertion of a cartridge (104 in Fig. 2C) containing two doses of naloxone (see Fig. 6A-6B, para. 0023 and 0073 – cartridge 104 may be a dual medicament cartridge comprising two doses of medicament which may both be naloxone thus the cutout 115 is capable of being sized for insertion of a cartridge containing two doses of naloxone).
Regarding claim 7, modified Sawyer discloses the device of claim 1, as discussed above. In modified Sawyer, the embodiment of Fig. 3-4B of Sawyer disclose the injector (136) as a nozzle for a jet injector (see Fig. 4B and para. 0066).
However, modified Sawyer fails to disclose (Claim 7) wherein the injector comprises at least one needle.
An alternative embodiment of Sawyer teaches that the autoinjector can instead comprise a spring-loaded needle (see para. 0021).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the nozzle taught by the embodiment of Fig. 3-4B of modified Sawyer with a spring-loaded needle of the alternative embodiment of Sawyer. One of ordinary skill in the art could have substituted a known nozzle of a jet injector with a needle to form a spring-loaded, needle injector as explicitly disclosed in Sawyer (para. 0021), and the results of said substitution would have been predictable.
Regarding claim 12, Sawyer discloses the limitations of (Claim 12) a vital sign monitoring and naloxone delivery system (100 in Fig. 1-2) comprising:
a housing (114 in Fig. 2A) defining an interior space (see Fig. 1 and para. 0057 – housing 114 has interior space for storing each of the interior components);
a band (116 in Fig. 2A) attached to the housing (114) and being configured for selectively attaching the housing (114) to an arm of a user (see Fig. 2A and para. 0057);
a battery (108 in Fig. 1) attached to the housing (114) and positioned in the interior space (see Fig. 1, para. 0057 for interior space, see para. 0061 for battery);
a microprocessor (106 in Fig. 1) attached to the housing (14, see Fig.1, see para. 0055-0056 – control module 106 comprises a microprocessor), positioned in the interior space (see para. 0057), and operationally engaged to the battery (106, see Fig. 1 and para. 0060);
a pulse oximeter (110 in Fig. 1) operationally engaged to the microprocessor (106, see para. 0063), wherein the pulse oximeter (110) is configured for measuring a blood oxygenation level of the user and for relaying the measurements to the microprocessor (106, see para. 0063), enabling the microprocessor (106) for determining an opioid overdose (see para. 0023 and 0063 – microprocessor 106 determines when blood oxygenation level is below a threshold which is indicative of an opioid overdose);
a pump (120 in Fig. 4A-4B) attached to the housing (114, see Fig. 2B-3 and para. 0065-0066), positioned in the interior space (see Fig. 2B-2C and para. 0065), and operationally engaged to the microprocessor (106, see para. 0066);
a cartridge (104 in Fig. 2C) containing naloxone positioned through a cutout (115 in Fig. 2C) in the housing (114, see Fig. 2C and para. 0059 and 0065), such that the cartridge (104) is operationally engaged to the pump (120, see Fig. 3 and para. 0066 – pump 120 is operationally engaged with cartridge 104 as it is contained inside cartridge 104 and engaged with the remaining components of cartridge 104 as seen in Fig. 3); and
an injector (136 in Fig. 4A-4B) attached to the bottom of the housing (114) and operationally engaged to the pump (120) and the microprocessor (106, see Fig. 4A and para. 0072 – nozzle 136 injects medicament into skin and thus is positioned in contact with the skin at the bottom of the housing 114), wherein the microprocessor (106) is enabled for selectively actuating the pump (120) and the injector (136) upon determination of the overdose for injecting the user with naloxone to counter the effects an opioid (see Fig. 7 and para. 0089 and 0093).
While Sawyer discloses the pulse oximeter (110) which are commonly known to measure both blood oxygenation levels and pulse rate, there is no explicit teaching the pulse oximeter is configured for measuring a pulse rate of the user. Sawyer further fails to disclose the limitations of (Claim 12) a pulse oximeter attached to the bottom of the housing such that the pulse oximeter is in contact with skin of the arm upon attachment of the housing to the arm of the user.
Biltagi discloses a wearable, opioid overdose treatment assembly comprising vital sign monitoring and an inhalation drug delivery device. Biltagi teaches (Claim 12) a pulse oximeter (33 in Fig. 5) attached to the bottom of the housing (12) such that the pulse oximeter (33) is in contact with skin of the arm upon attachment of the housing (12) to the arm of the user (see Fig. 5, Fig. 7, and para. 0023 - pulse oximeter 33 is attached to a surface of the housing 12 that allows it to be in contact with the skin and thus this surface is interpreted as the bottom of the housing), wherein the pulse oximeter (33) is configured for measuring a blood oxygenation level and a pulse rate of the user and for relaying the measurements to the microprocessor (28, see para. 0023).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pulse oximeter taught by Sawyer to explicitly measure pulse rate and be attached to the bottom of the housing as taught by Biltagi. Biltagi teaches that by having the pulse oximeter in contact with the user’s skin during wear allows the pulse oximeter to sense blood oxygen levels as well as pulse rate (see para. 0023).
Claim(s) 4, 8, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sawyer in view of Biltagi as applied to claim 1 and 12 above, respectively, and further in view of Humphrey (U.S Patent Pub. No. 20200143657 A1).
Regarding claim 4, modified Sawyer discloses the device of claim 1, as discussed above.
While in modified Sawyer, Sawyer discloses a user can turn on the device (102) which powers on the battery (108) and microprocessor (106, see para. 0060 and para. 0085); however, modified Sawyer fails to disclose (Claim 4) a power button attached to the housing and operationally engaged to the battery and the microprocessor, wherein the power button is configured for depressing a first time for operationally engaging the microprocessor to the battery and for depressing a second time for disengaging the microprocessor from the battery.
Humphrey discloses a smart watch (10 in Fig. 1-2) for actively monitoring biological parameters of a user such as pulse rate and blood oxygen content (see Abstract and para. 0023), wherein Humphrey teaches (Claim 4) a power button (68 in Fig. 5) attached to the housing (16) and operationally engaged to the battery (22) and the microprocessor (24, see Fig. 5 and para. 0030), wherein the power button (68) is configured for depressing a first time for operationally engaging the microprocessor (24) to the battery (22) and for depressing a second time for disengaging the microprocessor (24) from the battery (22, see para. 0030 – examiner notes the power button 68 is configured to selective depression for operationally engaging the microprocessor 24 to the battery 22 and is thus capable of being configured to be depressed for disengagement thereof).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the user turning on the device to engage the microprocessor and battery of modified Sawyer to have a user selectively depress a button on the housing for engaging and disengaging the microprocessor and the battery as taught by Humphrey. Humphrey provides motivation that the power button allows for selective activation of the electronics module (see para. 0030), which would provide a tactile indication for the user that the device was powered on and off and allows for minimizing energy consumption.
Regarding claim 8, modified Sawyer discloses the device of claim 1, as discussed above. In modified Sawyer, Sawyer discloses the limitations of (Claim 8) further including a display panel (117 in Fig. 2A) attached to a top of the housing (114, see Fig. 2A, para. 0057).
However, Sawyer does not explicitly disclose the limitations (Claim 8) such that the microprocessor is enabled for selectively actuating the display panel for presenting the measurements of the blood oxygenation level and the pulse rate.
Humphrey discloses a smart watch (10 in Fig. 1-2) for actively monitoring biological parameters of a user such as pulse rate and blood oxygen content and having a display panel (32) attached to a top (34) of a housing (18, see Fig. 1-2, Abstract, para. 0020, and para. 0023), wherein Humphrey teaches (Claim 8) such that the microprocessor (24) is enabled for selectively actuating the display panel (32) for presenting the measurements of the blood oxygenation level and the pulse rate (see para. 0023-0024 – microprocessor 24 is enabled for selectively actuating display panel 32 to present measurements from the sensors 36 and 40 which may comprise a pulse oximeter).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display panel taught by modified Sawyer to be coupled with the microprocessor to enable selectively actuating the display panel for presenting the measurements of the blood oxygenation level and the pulse rate as taught by Humphrey to provide a visual indication to the user of the status of their respective biological parameters.
Regarding claim 11, modified Sawyer discloses the device of claim 1, as discussed above.
While Sawyer discloses that embodiments of the device are contemplated as being able to alert authorities or a physician that naloxone has been administered to the user (see para. 0094), modified Sawyer fails to disclose (Claim 11) further including: a receiver attached to the housing, positioned in the interior space, and operationally engaged to the microprocessor, the receiver being Global Positioning System enabled, wherein the receiver is configured for receiving positional coordinates of the user; and a transmitter attached to the housing, positioned in the interior space, and operationally engaged to the microprocessor, wherein the microprocessor is enabled for selectively actuating the transmitter for transmitting an overdose alert and the positional coordinates of the user.
Biltagi discloses a wearable, opioid overdose treatment assembly comprising vital sign monitoring and an inhalation drug delivery device, wherein Biltagi teaches (Claim 11) further including:
a receiver (46 in Fig. 1) attached to the housing (12), positioned in the interior space (see Fig. 1), and operationally engaged to the microprocessor (28, see para. 0026 – transceiver 46 functions as both the receiver and transmitter); and
a transmitter (46) attached to the housing (12), positioned in the interior space (see Fig. 1), and operationally engaged to the microprocessor (28, see para. 0026 – transceiver 46 functions as both the receiver and transmitter), wherein the microprocessor (28) is enabled for selectively actuating the transmitter for transmitting an overdose alert (see para. 0025-0026).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by modified Sawyer to have a receiver and transmitter for transmitting an overdose alert as taught by Biltagi to be able to notify emergency responders that the user is suffering from an opioid overdose (see para. 0025-0026).
However, modified Sawyer fails to disclose (Claim 11) the receiver being Global Positioning System enabled, wherein the receiver is configured for receiving positional coordinates of the user.
Humphrey discloses a smart watch (10 in Fig. 1-2) for actively monitoring biological parameters of a user such as pulse rate and blood oxygen content (see Abstract and para. 0023), wherein Humphrey teaches (Claim 11) the receiver (26 in Fig. 7) being Global Positioning System enabled (see para. 0021), wherein the receiver (26) is configured for receiving positional coordinates of the user (see para. 0021).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receiver taught by modified Sawyer to be GPS enabled as taught by Humphrey to be able to relay the location coordinates of the user to dispatch emergency personnel (see para. 0021).
Regarding claim 14, modified Sawyer discloses the system of claim 12, as discussed above.
While Sawyer discloses that embodiments of the system are contemplated as being able to alert authorities or a physician that naloxone has been administered to the user (see para. 0094), modified Sawyer fails to disclose (Claim 14) further including: a receiver attached to the housing, positioned in the interior space, and operationally engaged to the microprocessor, the receiver being Global Positioning System enabled, wherein the receiver is configured for receiving positional coordinates of the user; and a transmitter attached to the housing, positioned in the interior space, and operationally engaged to the microprocessor, wherein the microprocessor is enabled for selectively actuating the transmitter for transmitting an overdose alert and the positional coordinates of the user.
Biltagi discloses a wearable, opioid overdose treatment assembly comprising vital sign monitoring and an inhalation drug delivery device, wherein Biltagi teaches (Claim 14) further including:
a receiver (46 in Fig. 1) attached to the housing (12), positioned in the interior space (see Fig. 1), and operationally engaged to the microprocessor (28, see para. 0026 – transceiver 46 functions as both the receiver and transmitter); and
a transmitter (46) attached to the housing (12), positioned in the interior space (see Fig. 1), and operationally engaged to the microprocessor (28, see para. 0026 – transceiver 46 functions as both the receiver and transmitter), wherein the microprocessor (28) is enabled for selectively actuating the transmitter for transmitting an overdose alert (see para. 0025-0026).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by modified Sawyer to have a receiver and transmitter for transmitting an overdose alert as taught by Biltagi to be able to notify emergency responders that the user is suffering from an opioid overdose (see para. 0025-0026).
However, modified Sawyer fails to disclose (Claim 14) the receiver being Global Positioning System enabled, wherein the receiver is configured for receiving positional coordinates of the user.
Humphrey discloses a smart watch (10 in Fig. 1-2) for actively monitoring biological parameters of a user such as pulse rate and blood oxygen content (see Abstract and para. 0023), wherein Humphrey teaches (Claim 14) the receiver (26 in Fig. 7) being Global Positioning System enabled (see para. 0021), wherein the receiver (26) is configured for receiving positional coordinates of the user (see para. 0021).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receiver taught by modified Sawyer to be GPS enabled as taught by Humphrey to be able to relay the location coordinates of the user to dispatch emergency personnel (see para. 0021).
Claim(s) 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sawyer in view of Biltagi as applied to claims 1 and 12 above, respectively, and further in view of Insler et al. (U.S Patent Pub. No. 20170172522 A1, “Insler”).
Regarding claim 6, modified Sawyer discloses the device of claim 1, as discussed above. In modified Sawyer, Sawyer discloses the limitations of (Claim 6) further including programming code positioned on the microprocessor (106 in Fig. 7) enabling the microprocessor (106, examiner notes this limitation is being interpreted as the device comprises a programming code that is executed by the microprocessor to carry out the following functions, see para. 0056), actuating the pump (120) and the injector for injecting the user with a second dose of the naloxone (see Fig. 7, para. 0023, and 0090-0091 – the device is configured to have a dual medicament cartridge with two doses of naloxone which can be injected one after the other if the user’s condition hasn’t improved).
In modified Sawyer, Biltagi explicitly discloses the pulse oximeter (33) configured to measure blood oxygenation level and pulse rate of the user (see para. 0023), and further including programming code that is executed by the microprocessor (28) for comparing the measurement of the blood oxygenation level and pulse rate to predetermine levels (see para. 0027).
However, modified Sawyer fails to explicitly disclose (Claim 6) enabling the microprocessor at a predetermined interval after a first dose of the naloxone, for comparing the measurements of the blood oxygenation level and the pulse rate to predetermined levels and for selectively actuating the pump and the injector for injecting the user with a second dose of the naloxone should the measurements be lower than the predetermined levels.
Insler discloses a vital sign monitoring and naloxone delivery smart watch (see Fig. 2), wherein Insler teaches (Claim 6) further including programming code positioned on the microprocessor (200 in Fig. 2) enabling the microprocessor (200, see Fig. 2 and para. 0042, examiner notes this limitation is being interpreted as the device comprises a programming code that is executed by the microprocessor to carry out the following functions), at a predetermined interval after a first dose of the naloxone, for comparing the measurements of the blood oxygenation level and the pulse rate to predetermined levels and for selectively actuating the pump (203) and the injector (205) for injecting the user with a second dose of the naloxone should the measurements be lower than the predetermined levels (see para. 0050 for pump, see Fig. 3 and para. 0042 and 0047).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microprocessor taught by modified Sawyer to explicitly selectively actuate the pump and the injector for injecting the user with a second dose of naloxone should the measurements be lower than the predetermined levels at a predetermined interval after a first dose of naloxone as taught by Insler. Insler teaches that a second dose of naloxone useful during an overdose where individuals may require multiple doses of naloxone and in avoiding any vulnerable gaps between one opioid overdose reversal to the next while individuals wait to have their device refilled or replaced.
Regarding claim 13, modified Sawyer discloses the system of claim 12, as discussed above. In modified Sawyer, Sawyer discloses the limitations of (Claim 13) further including programming code positioned on the microprocessor (106 in Fig. 7) enabling the microprocessor (106, examiner notes this limitation is being interpreted as the device comprises a programming code that is executed by the microprocessor to carry out the following functions, see para. 0056), actuating the pump (120) and the injector for injecting the user with a second dose of the naloxone (see Fig. 7, para. 0023, and 0090-0091 – the device is configured to have a dual medicament cartridge with two doses of naloxone which can be injected one after the other if the user’s condition hasn’t improved).
In modified Sawyer, Biltagi explicitly discloses the pulse oximeter (33) configured to measure blood oxygenation level and pulse rate of the user (see para. 0023), and further including programming code that is executed by the microprocessor (28) for comparing the measurement of the blood oxygenation level and pulse rate to predetermine levels (see para. 0027).
However, modified Sawyer fails to explicitly disclose (Claim 13) enabling the microprocessor at a predetermined interval after a first dose of the naloxone, for comparing the measurements of the blood oxygenation level and the pulse rate to predetermined levels and for selectively actuating the pump and the injector for injecting the user with a second dose of the naloxone should the measurements be lower than the predetermined levels.
Insler discloses a vital sign monitoring and naloxone delivery smart watch (see Fig. 2), wherein Insler teaches (Claim 13) further including programming code positioned on the microprocessor (200 in Fig. 2) enabling the microprocessor (200, see Fig. 2 and para. 0042, examiner notes this limitation is being interpreted as the device comprises a programming code that is executed by the microprocessor to carry out the following functions), at a predetermined interval after a first dose of the naloxone, for comparing the measurements of the blood oxygenation level and the pulse rate to predetermined levels and for selectively actuating the pump (203) and the injector (205) for injecting the user with a second dose of the naloxone should the measurements be lower than the predetermined levels (see para. 0050 for pump, see Fig. 3 and para. 0042 and 0047).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microprocessor taught by modified Sawyer to explicitly selectively actuate the pump and the injector for injecting the user with a second dose of naloxone should the measurements be lower than the predetermined levels at a predetermined interval after a first dose of naloxone as taught by Insler. Insler teaches that a second dose of naloxone useful during an overdose where individuals may require multiple doses of naloxone and in avoiding any vulnerable gaps between one opioid overdose reversal to the next while individuals wait to have their device refilled or replaced.
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sawyer in view of Biltagi in view of Humphrey as applied to claim 8 above, and further in view of Nanikashvili et al. (W.O Patent Pub. No. 2007083315 A2, “Nani”).
Regarding claim 9, modified Sawyer discloses the device of claim 8, as discussed above.
However, modified Sawyer fails to disclose (Claim 9) further including a controller attached to the housing and operationally engaged to the microprocessor, wherein the controller is configured for being manipulated by a user for controlling a brightness of the display panel.
Nani discloses a portable, handheld vital sign monitoring device (10 in Fig. 1) comprising sensors such as a heart rate sensor for monitoring a patient’s physiological condition (see para. 0029). Nani teaches (Claim 9) further including a controller (54, 56 in Fig. 1) attached to the housing (33) and operationally engaged to the microprocessor (123, see para. 0047), wherein the controller (54, 56) is configured for being manipulated by a user for controlling a brightness of the display panel (20, see Fig. 1 and para. 0047 and 0060).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by modified Sawyer to have a controller for controlling a brightness of the display panel as taught by Nani to allow a user to adjust the brightness of the display to their preference (see para. 0060).
Regarding claim 10, modified Sawyer discloses the device of claim 9, as discussed above. In modified Sawyer, Nani discloses (Claim 10) wherein the controller (54, 56 in Fig. 1) comprises an increase button (54) and a decrease button (56, see Fig. 1 and para. 0060), wherein the increase button (54) and the decrease button (56) are configured for selective depression for increasing and decreasing the brightness of the display panel (20), respectively (see para. 0060 – increase button 54 and decrease button 56 are both push buttons indicating a user must press down on the buttons).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sawyer in view of Biltagi in view of Insler in view of Humphrey in view of Nani.
Regarding claim 15, Sawyer discloses the limitations (Claim 15) a vital sign monitoring and naloxone delivery device (100 in Fig. 1-2) comprising:
a housing (114 in Fig. 2A) defining an interior space (see Fig. 1 and para. 0057 – housing 114 has interior space for storing each of the interior components);
a band (116 in Fig. 2A) attached to the housing (114) and being configured for selectively attaching the housing (114) to an arm of a user (see Fig. 2A and para. 0057); the band (116 in Fig. 2A) being resiliently stretchable (see para. 0057), wherein the band (116) is configured for stretching for insertion of the arm of the user and for rebounding for securing the housing (114) to the arm of the user (see para. 0057 – band 116 may be formed of a rubber material and is thus resiliently stretchable and configured for stretching and rebounding) the band (116 in Fig. 2A) comprising rubber (see para. 0057);
a battery (108 in Fig. 1) attached to the housing (114) and positioned in the interior space (see Fig. 1, para. 0057 for interior space, see para. 0061 for battery);
a microprocessor (106 in Fig. 1) attached to the housing (14, see Fig.1, see para. 0055-0056 – control module 106 comprises a microprocessor), positioned in the interior space (see para. 0057), and operationally engaged to the battery (106, see Fig. 1 and para. 0060);
a pulse oximeter (110 in Fig. 1) operationally engaged to the microprocessor (106, see para. 0063), wherein the pulse oximeter (110) is configured for measuring a blood oxygenation level of the user and for relaying the measurements to the microprocessor (106, see para. 0063), enabling the microprocessor (106) for determining an opioid overdose (see para. 0023 and 0063 – microprocessor 106 determines when blood oxygenation level is below a threshold which is indicative of an opioid overdose);
a pump (120 in Fig. 4A-4B) attached to the housing (114, see Fig. 2B-3 and para. 0065-0066), positioned in the interior space (see Fig. 2B-2C and para. 0065), and operationally engaged to the microprocessor (106, see para. 0066);
a cutout (115 in Fig. 2C) positioned in the housing (114, see Fig. 2C and para. 0065), wherein the cutout (115 in Fig. 2C) is configured for selective insertion of a cartridge (104) containing naloxone (see para. 0059 and 0065), such that the cartridge (104) is operationally engaged to the pump (120, see Fig. 3 and para. 0066 – cartridge 104 includes pump 120 and is thus operationally engaged with pump 120); the cutout (115 in Fig. 2C) being sized for insertion of a cartridge (104 in Fig. 2C) containing two doses of naloxone (see Fig. 6A-6B, para. 0023 and 0073 – cartridge 104 may be a dual medicament cartridge comprising two doses of medicament which may both be naloxone thus the cutout 115 is capable of being sized for insertion of a cartridge containing two doses of naloxone); and
an injector (136 in Fig. 4A-4B) attached to the bottom of the housing (114) and operationally engaged to the pump (120) and the microprocessor (106, see Fig. 4A and para. 0072 – nozzle 136 injects medicament into skin and thus is positioned in contact with the skin at the bottom of the housing 114), wherein the microprocessor (106) is enabled for selectively actuating the pump (120) and the injector (136) upon determination of the overdose for injecting the user with naloxone to counter the effects an opioid (see Fig. 7 and para. 0089 and 0093);
programming code positioned on the microprocessor (106 in Fig. 7) enabling the microprocessor (106, examiner notes this limitation is being interpreted as the device comprises a programming code that is executed by the microprocessor to carry out the following functions, see para. 0056), actuating the pump (120) and the injector for injecting the user with a second dose of the naloxone (see Fig. 7, para. 0023, and 0090-0091 – the device is configured to have a dual medicament cartridge with two doses of naloxone which can be injected one after the other if the user’s condition hasn’t improved).
a display panel (117 in Fig. 2A) attached to a top of the housing (114, see Fig. 2A, para. 0057).
While the embodiment of Fig. 3-4B of Sawyer disclose the injector (136) as a nozzle for a jet injector (see Fig. 4B and para. 0066), Sawyer fails to disclose (Claim 15) wherein the injector comprises at least one needle. Sawyer further fails to disclose the limitations of a power button attached to the housing and operationally engaged to the battery and the microprocessor, wherein the power button is configured for depressing a first time for operationally engaging the microprocessor to the battery and for depressing a second time for disengaging the microprocessor from the battery; a pulse oximeter attached to the bottom of the housing such that the pulse oximeter is in contact with skin of the arm upon attachment of the housing to the arm of the user; the programming code enabling the microprocessor at a predetermined interval after a first dose of the naloxone, for comparing the measurements of the blood oxygenation level and the pulse rate to predetermined levels and for selectively actuating the pump and the injector for injecting the user with a second dose of the naloxone should the measurements be lower than the predetermined levels; the microprocessor is enabled for selectively actuating the display panel for presenting the measurements of the blood oxygenation level and the pulse rate; a controller attached to the housing and operationally engaged to the microprocessor, wherein the controller is configured for being manipulated by a user for controlling a brightness of the display panel, the controller comprising an increase button and a decrease button, wherein the increase button and the decrease button are configured for selective depression for increasing and decreasing the brightness of the display panel, respectively; a receiver attached to the housing, positioned in the interior space, and operationally engaged to the microprocessor, the receiver being Global Positioning System enabled, wherein the receiver is configured for receiving positional coordinates of the user; and a transmitter attached to the housing, positioned in the interior space, and operationally engaged to the microprocessor, wherein the microprocessor is enabled for selectively actuating the transmitter for transmitting an overdose alert and the positional coordinates of the user.
An alternative embodiment of Sawyer teaches that the autoinjector can instead comprise a spring-loaded needle (see para. 0021).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the nozzle taught by the embodiment of Fig. 3-4B of Sawyer with a spring-loaded needle of the alternative embodiment of Sawyer. One of ordinary skill in the art could have substituted a known nozzle of a jet injector with a needle to form a spring-loaded, needle injector as explicitly disclosed in Sawyer (para. 0021), and the results of said substitution would have been predictable.
While Sawyer discloses the pulse oximeter (110) which are commonly known to measure both blood oxygenation levels and pulse rate, there is no explicit teaching the pulse oximeter is configured for measuring a pulse rate of the user.
Biltagi discloses a wearable, opioid overdose treatment assembly comprising vital sign monitoring and an inhalation drug delivery device. Biltagi teaches (Claim 15)
a pulse oximeter (33 in Fig. 5) attached to the bottom of the housing (12) such that the pulse oximeter (33) is in contact with skin of the arm upon attachment of the housing (12) to the arm of the user (see Fig. 5, Fig. 7, and para. 0023 - pulse oximeter 33 is attached to a surface of the housing 12 that allows it to be in contact with the skin and thus this surface is interpreted as the bottom of the housing), wherein the pulse oximeter (33) is configured for measuring a blood oxygenation level and a pulse rate of the user and for relaying the measurements to the microprocessor (28, see para. 0023);
further including programming code that is executed by the microprocessor (28) for comparing the measurement of the blood oxygenation level and pulse rate to predetermine levels (see para. 0027);
a receiver (46 in Fig. 1) attached to the housing (12), positioned in the interior space (see Fig. 1), and operationally engaged to the microprocessor (28, see para. 0026 – transceiver 46 functions as both the receiver and transmitter); and
a transmitter (46) attached to the housing (12), positioned in the interior space (see Fig. 1), and operationally engaged to the microprocessor (28, see para. 0026 – transceiver 46 functions as both the receiver and transmitter), wherein the microprocessor (28) is enabled for selectively actuating the transmitter for transmitting an overdose alert (see para. 0025-0026).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pulse oximeter taught by modified Sawyer to explicitly measure pulse rate and be attached to the bottom of the housing as taught by Biltagi, and to have modified the device of modified Sawyer to comprise a receiver and transmitter for transmitting an overdose alert as taught by Biltagi. Biltagi teaches that by having the pulse oximeter in contact with the user’s skin during wear allows the pulse oximeter to sense blood oxygen levels as well as pulse rate (see para. 0023). Biltagi further teaches a receiver and transmitter allow the device to be able to notify emergency responders that the user is suffering from an opioid overdose (see para. 0025-0026).
Insler discloses a vital sign monitoring and naloxone delivery smart watch (see Fig. 2), wherein Insler teaches (Claim 15) further including programming code positioned on the microprocessor (200 in Fig. 2) enabling the microprocessor (200, see Fig. 2 and para. 0042, examiner notes this limitation is being interpreted as the device comprises a programming code that is executed by the microprocessor to carry out the following functions), at a predetermined interval after a first dose of the naloxone, for comparing the measurements of the blood oxygenation level and the pulse rate to predetermined levels and for selectively actuating the pump (203) and the injector (205) for injecting the user with a second dose of the naloxone should the measurements be lower than the predetermined levels (see para. 0050 for pump, see Fig. 3 and para. 0042 and 0047).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microprocessor taught by modified Sawyer to explicitly selectively actuate the pump and the injector for injecting the user with a second dose of naloxone should the measurements be lower than the predetermined levels at a predetermined interval after a first dose of naloxone as taught by Insler. Insler teaches that a second dose of naloxone useful during an overdose where individuals may require multiple doses of naloxone and in avoiding any vulnerable gaps between one opioid overdose reversal to the next while individuals wait to have their device refilled or replaced.
Humphrey discloses a smart watch (10 in Fig. 1-2) for actively monitoring biological parameters of a user such as pulse rate and blood oxygen content (see Abstract and para. 0023), wherein Humphrey teaches (Claim 15)
a power button (68 in Fig. 5) attached to the housing (16) and operationally engaged to the battery (22) and the microprocessor (24, see Fig. 5 and para. 0030), wherein the power button (68) is configured for depressing a first time for operationally engaging the microprocessor (24) to the battery (22) and for depressing a second time for disengaging the microprocessor (24) from the battery (22, see para. 0030 – examiner notes the power button 68 is configured to selective depression for operationally engaging the microprocessor 24 to the battery 22 and is thus capable of being configured to be depressed for disengagement thereof);
the microprocessor (24) is enabled for selectively actuating the display panel (32) for presenting the measurements of the blood oxygenation level and the pulse rate (see para. 0023-0024 – microprocessor 24 is enabled for selectively actuating display panel 32 to present measurements from the sensors 36 and 40 which may comprise a pulse oximeter); and
the receiver (26 in Fig. 7) being Global Positioning System enabled (see para. 0021), wherein the receiver (26) is configured for receiving positional coordinates of the user (see para. 0021).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the user turning on the device to engage the microprocessor and battery of modified Sawyer to have a user selectively depress a button on the housing for engaging and disengaging the microprocessor and the battery as taught by Humphrey, and to have modified the display panel taught by modified Sawyer to be coupled with the microprocessor to enable selectively actuating the display panel for presenting the measurements of the blood oxygenation level and the pulse rate as taught by Humphrey, and lastly to have modified the receiver taught by modified Sawyer to be GPS enabled as taught by Humphrey. Humphrey teaches that the power button allows for selective activation of the electronics module (see para. 0030), which would provide a tactile indication for the user that the device was powered on and off and allows for minimizing energy consumption. Humphrey further teaches the display panel provides a visual indication to the user of the status of their respective biological parameters, and the GPS enabled receiver provides the ability to relay the location coordinates of the user to dispatch emergency personnel (see para. 0021).
Nani discloses a portable, handheld vital sign monitoring device (10 in Fig. 1) comprising sensors such as a heart rate sensor for monitoring a patient’s physiological condition (see para. 0029). Nani teaches (Claim 15) a controller (54, 56 in Fig. 1) attached to the housing (33) and operationally engaged to the microprocessor (123, see para. 0047), wherein the controller (54, 56) is configured for being manipulated by a user for controlling a brightness of the display panel (20, see Fig. 1 and para. 0047 and 0060), the controller (54, 56 in Fig. 1) comprises an increase button (54) and a decrease button (56, see Fig. 1 and para. 0060), wherein the increase button (54) and the decrease button (56) are configured for selective depression for increasing and decreasing the brightness of the display panel (20), respectively (see para. 0060 – increase button 54 and decrease button 56 are both push buttons indicating a user must press down on the