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 .
Claim Objections
Claims 1, 5, 6, 9 and 10 is objected to due to the following informalities:
In claim 1, line 12, “the temperature of the interior of the syringe” should be corrected to “a temperature of the interior of the syringe” since this phrase was not previously introduced.
In claim 5, line 7, “the conduit” should be corrected to “a conduit” since this term was not previously introduced.
In claim 6, lines 5-6, “the insulin injection amount” should be corrected to “an insulin injection amount”
In claim 6, line 6, “the number of times of insulin injection” should be corrected to “number of times the insulin is injected”.
In claim 9, line 4, “electricity” should be corrected to “the electricity”.
In claim 10, line 1, the “a” at the beginning of “A auto-injectable smart insulin injection device” should be replaced with “an” for grammatical correctness.
In claim 10, line 3, “the lower end” should be corrected to “a lower end”.
In claim 10, line 10, “an oscillator cover” should be corrected to “the oscillator cover” since this phrase was previously introduced.
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.
Claim(s) 1-9 is/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.
Claim 1, line 6 recites “a cartridge housed inside the syringe in a state insulin of being stored”. It is unclear what the Applicant intended to refer to by “a state insulin of being stored”. In light of the Specification, it is being interpreted that line 6 is intended to recite “a cartridge housed inside the syringe in a state
Claims 2-9 are rejected by virtue of their dependency on claim 1.
Claim 3, line 3 recites “the temperature of the syringe”. Claim 3 depends on claim 1, however claim 1 does not recite “the temperature of the syringe”. Claim 1 however recites “the temperature of the interior of the syringe”, and therefore it is unclear if claim 3 is intended to refer to “the temperature of the interior of the syringe” or introduce a new temperature. For the sake of Examination, claim 3 is being interpreted to refer to ““the temperature of the interior of the syringe” of claim 1. Applicant is therefore suggested to amend claim 3 to overcome rejection.
Claim 6 in lines 6-7 and claim 7 in 3-4 recites “the temperature of the syringe” and therefore suffers from the same issues as claim 3. For the sake of Examination, claim 6 and 7 is being interpreted to refer to ““the temperature of the interior of the syringe” of claim 1. Applicant is therefore suggested to amend claim 3 to overcome rejection.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US 20230090661 A1), and further in view of Gomez et al. (US 20210069457 A1).
Regarding claim 1, Jensen discloses a thermostatically-storable smart insulin injection device (system 2 in Fig. 5; claim 1 does not positively recite that the device includes insulin, therefore the injection device simply has to be capable of use with insulin; Jensen reads on “insulin injection device” as claimed since Jensen discloses delivering fluid and insulin is known to be a fluid) comprising:
a casing (housing 6 in Fig. 7 and [0244]);
a syringe (autoinjector 4 in Fig. 5) installed inside the casing (auto injector comprises a housing 6 [0244]) and with a guide (contact member 1102 in Fig. 5) at a lower end to be in contact with skin during insulin injection (The contact member may be configured to be pressed against the injection site [0146]; contact member is interpreted to be located at lower end of device since contact member presses against injection site);
a cartridge (cartridge 700 in Fig. 5) housed inside the syringe in a state insulin of being stored (cartridge assembly 600 is received in auto injector 4 [0208]; cartridge assembly 600 comprises cartridge holder 800 which is configured for retention of cartridge 700 [0209]), and with a piston installed at an upper side (first stopper 708 in Fig. 4) and with a needle (needle 902 in Fig. 5) surrounded by the guide at the lower side (guide 1102 surrounds needle 902 in Fig. 5);
an insulin injection unit (plunger rod 400 in Fig. 5) pushing the piston of the cartridge (plunger rod 400 is configured to advance a first stopper of the cartridge 700 [0212]) to inject the insulin into skin through the needle (the medicament is expelled through the cartridge outlet 714 upon movement of the first stopper 708 [0200]; needle 902 extends through the cartridge outlet 714 [0210]; fluid is interpreted to inject through needle 902 via outlet 714); and
Jensen further discloses a Peltier module (autoinjector comprises a temperature control unit [0139]; temperature control unit comprises a thermoelectric element which is a Peltier element [0142]) to maintain the temperature of the interior of the syringe housed in a cartridge within a set temperature range (the heating or cooling element in the temperature control unit is configured to raise or lower the temperature of the cartridge [0140, 0141]), but failed to explicitly disclose supplying cold or warm air to the syringe.
However, Gomez teaches a cradle 200 attached to a thermoelectric module 212 coupled to fan 216 [0093]. One of ordinary skill in the art interprets the cradle 200 with its fan 216 is capable of providing cold or warm air and is to be configured to be attached with the Peltier module of Jensen as taught by Gomez.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen to include supplying cold or warm air to the syringe as taught by Gomez since such a modification enables the device of Jensen to provide a desired temperature [Jensen, 0056].
Regarding claim 2, Jensen as modified by Gomez disclosed all limitations of claim 1. Jensen further discloses wherein the insulin injection unit includes:
a drive motor (motor 502 in Fig. 5);
a screw shaft (inner plunger 402 with an outer thread in Fig. 5 and [0212]) connected to a motor shaft of the drive motor and rotating with the motor shaft (transmission 504 couples motor 502 to the inner plunger 402 [0213]); and
a piston pressing block (outer plunger rod 404 with inner thread in Fig. 5; outer plunger rod 404 is prevented from rotating [0212]) connected to the screw shaft (the thread of the inner plunger rod 402 is in engagement with the thread of the outer plunger rod 404) and pushing the piston of the cartridge by moving forward in the syringe (rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 40 which is configured to abut the first stopper of the cartridge 700, and to move the first stopper [0212]).
Regarding claim 3, Jensen as modified by Gomez disclosed all limitations of claim 1. Jensen further discloses wherein the Peltier module is configured with:
a temperature sensor measuring the temperature of the syringe (autoinjector comprises a temperature sensor to provide temperature signal indicative of the temperature of the cartridge [0135]);
a Peltier element (autoinjector comprises a temperature control unit [0139]; temperature control unit comprises a thermoelectric element which is a Peltier element [0142]) but fails to explicitly disclose the Peltier element generating the cold or warm air according to a value measured by the temperature sensor;
a conducting plate facing one side surface of the Peltier element and being in contact with the syringe to transfer the cold or warm air;
a heat sink plate facing the other side surface of the Peltier element; and
a blower fan providing airflow to the heat sink plate.
However, Gomez teaches a cradle 200 attached to a thermoelectric module 212 coupled to fan 216 [0093]. Gomez further teaches cradle comprises a metal plate shaped for the anesthetic cooling device to fit into on top of a thermoelectric plate with its own heat sink comprising a fan [0056]. One of ordinary skill in the art teaches the cradle 200 of Gomez comprising the heat sink, metal plate and fan is to be configured to be connected with the Peltier module of Jensen to perform the functions as required by claim 3.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen to include the Peltier element generating the cold or warm air according to a value measured by the temperature sensor; a conducting plate facing one side surface of the Peltier element and being in contact with the syringe to transfer the cold or warm air; a heat sink plate facing the other side surface of the Peltier element; and a blower fan providing airflow to the heat sink plate as taught by Gomez since such a modification enables the device of Jensen to provide a desired temperature [Jensen, 0056]
Claim(s) 4, 5, 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US 20230090661 A1), and further in view of Gomez et al. (US 20210069457 A1) and Traverso (US 20220346707 A1).
Regarding claim 4, Jensen as modified by Gomez disclosed all limitations of claim 4. However, Jensen as modified by Gomez failed to explicitly disclose further comprising a suction unit which, when the guide is contact with the skin, sucks the air between the cartridge and the syringe so that the skin is pulled up, to allow the skin to be automatically punctured by the needle.
However, Traverso teaches a vacuum chamber 128 in pen 100 of Fig. 1A which creates a vacuum by means of vacuum pump 112 when pen 100 is placed against a patient’s skin [0045]. The vacuum induces skin stretching at the lancing site [0047]. One of ordinary skill in the art teaches the injection device of Jensen to be configured to use the vacuum chamber of Traverso to pull skin to assist with needle puncture as taught by Traverso.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen as modified by Gomez to include a suction unit which, when the guide is contact with the skin, sucks the air between the cartridge and the syringe so that the skin is pulled up, to allow the skin to be automatically punctured by the needle as taught by Traverso since such a modification enables the device of Jensen to pull patient's skin to increase blood flow at the lancing site [Traverso, 0047].
Regarding claim 5, Jensen as modified by Gomez and Traverso disclosed all limitations of claim 4. However, Jensen as modified by Gomez failed to explicitly disclose wherein the suction unit is configured with:
a suction tube with one side end being connected to a space between the cartridge and the syringe;
a vacuum pump being connected to the other side end of the suction tube to suck air in the space between the cartridge and the syringe; and
a pressure sensor installed on the conduit of the suction tube or at the end of the suction tube to measure the pressure of the sucked air.
However, Traverso teaches a vacuum is created in the chamber 128 that is sealed against the patient’s skin via vacuum port 114 [0044]. Traverso further teaches pump 112 is fluidly coupled with the vacuum chamber via port [0054]. Traverso further teaches a pressure sensor is disposed inside the vacuum chamber 128 to measure the pressure and provide feedback [0047]. One of ordinary skill in the art teaches the vacuum port 114, vacuum pump 112 and pressure sensor of Traverso is to be configured to be incorporated into the injection device of Jensen to perform the functions as required by claim 5.
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen as modified by Gomez to include wherein the suction unit is configured with: a suction tube with one side end being connected to a space between the cartridge and the syringe; a vacuum pump being connected to the other side end of the suction tube to suck air in the space between the cartridge and the syringe; and a pressure sensor installed on the conduit of the suction tube or at the end of the suction tube to measure the pressure of the sucked air as taught by Traverso since such a modification enables the device of Jensen to provide vacuum pressure in order to pull patient's skin to increase blood flow at the lancing site [Traverso, 0047].
Regarding claim 6, Jensen as modified by Gomez and Traverso disclosed all limitations of claim 4. Jensen further discloses:
wherein a control unit (processing unit 20 in Fig. 7) is electrically connected to the insulin injection unit (processing unit 20 control the drive module 500 [0226]; it is set forth in [0213] the drive module 500 comprises motor 502 which actuates plunger rod 400), the Peltier module (processing unit is coupled to the temperature sensor to receive temperature signal; it is interpreted the processing unit is in communication with temperature control unit which is a Peltier element as set forth in [0142] due to receiving temperature signal from temperature sensor),
Jensen further discloses wherein the control unit displays information (user interface 1100 comprises a first output member 1110 which is a plurality of LEDs. The first output member 1110 may provide for a user output to a user [0196]; interface 1100 is coupled to the processing unit 20 [0225]), but fails to explicitly disclose the control unit is electrically connected to the suction unit, and
wherein the control unit displays information about the insulin injection amount, the number of times of insulin injection, and the temperature of the syringe, and transmits the information to a smartphone connected through a communication network.
However, Traverso teaches vacuum pump 112 is electrically coupled to a microcontroller [0047]. One of ordinary skill in the art teaches the vacuum pump of Traverso is to be configured to be coupled to the processing unit 20 of Jensen as taught by Traverso.
Traverso further teaches display 356 in pen 300 in Fig. 3A which displays operating parameters and calculated insulin doses [0058].
Traverso further teaches pen 100 wirelessly send measurement to a smartphone [0049]. One of ordinary skill in the art teaches the interface 1100 of Jensen is to be configured to display parameters and dose information as taught by Traverso and the device of Jensen is to be configured to communicate with a smartphone as taught by Traverso.
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen as modified by Gomez to include the control unit is electrically connected to the suction unit, and wherein the control unit displays information about the insulin injection amount, the number of times of insulin injection, and the temperature of the syringe, and transmits the information to a smartphone connected through a communication network as taught by Traverso since such a modification enables the device of Jensen to be configured as an easy-to-use device for users [Traverso, 0037].
Regarding claim 7, Jensen as modified by Gomez and Traverso disclosed all limitations of claim 6. However, Jensen as modified by Gomez failed to explicitly disclose wherein commanding the control unit so as to operate the Peltier module through the smart phone when the temperature of the syringe is outside the set temperature range.
However, Traverso teaches pen device is actuated using an external device like smartphone [0039]. One of ordinary skill in the art teaches the processing unit 20 of Jensen to be configured to be actuated by a smartphone to communicate with Peltier temperature control unit of Jensen.
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen as modified by Gomez to include wherein commanding the control unit so as to operate the Peltier module through the smart phone when the temperature of the syringe is outside the set temperature range as taught by Traverso since such a modification enables the device of Jensen to be configured as an easy-to-use device for users [Traverso, 0037].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US 20230090661 A1), and further in view of Gomez et al. (US 20210069457 A1), Traverso (US 20220346707 A1) and Edwards (US 20180304017 A1).
Regarding claim 8, Jensen as modified by Gomez disclosed all limitations of claim 4. Jensen as modified by Gomez discloses an end cap (see end cap in annotated Fig. 1 of Jensen below) installed at an upper end of the casing (end cap is located at upper end in annotated Fig. 1 below) but fails to explicitly disclose wherein the endcap with a plurality of air discharge holes discharging air sucked by the suction unit to the outside formed along the edge.
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Annotated Fig. 1 of Jensen
However, Edwards teaches a vent opening 4112 in proximal cap on medical injector 4000 of Fig. 9. Vent opening 4112 provides passageway through which pressurized gas is conveyed from gas chamber to outside of the injector 4000 [0135]. One of ordinary skill in the art interprets the injector device of Jensen to be configured to use the vent opening 4112 of Edwards on the cap of Jensen to convey pressurized air from the suction unit to the outside of the injector device as taught by Edwards.
Furthermore, one of ordinary skill in the art recognizes to replicate vent opening 4112 of Edward to incorporate a plurality of discharge holes on the cap of Jensen, since it has been held “that mere duplication of parts has no patentable significance unless a new and unexpected result is produced”. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04.VI.B. Further, Applicant places no criticality on multiple discharge holes.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen as modified by Gomez to include wherein the endcap with a plurality of air discharge holes discharging air sucked by the suction unit to the outside formed along the edge as taught by Edwards since such a modification enables the device of Jensen to release pressurized air from inside the device to outside [0182].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US 20230090661 A1), and further in view of Gomez et al. (US 20210069457 A1), Traverso (US 20220346707 A1), Edwards (US 20180304017 A1) and Neer (US 20100030153 A1).
Regarding claim 9, Jensen as modified by Gomez and Edward disclosed all limitations of claim 8. Jensen further discloses wherein a battery supplying electricity to the insulin injection unit (drive module 500 is connected to a battery for receiving electrical power [0213]) is installed inside the casing (The auto injector comprises a battery which is accommodated by the housing [0057]), and a charging hole supplying electricity to the battery to be stored (the battery is configured to be charged by connection of a charger [0057]) but fails to explicitly disclose the battery supplying electricity to the suction unit and the charging hole is formed in the end cap.
One of ordinary skill in the art interprets the vacuum pump of Traverso to be configured to be supplied with electricity from the battery of Jensen.
Furthermore, Neer teaches charging lead 332 located on the mechanical interface 315 at the upper end of the injector 306 in Fig. 6. One of ordinary skill in the art teaches the charging connection of Jensen to be configured to be located at the upper end (which is set forth as the cap in annotated Fig. 1 above) as taught by Neer.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the thermostatically-storable smart insulin injection device of Jensen as modified by Gomez, Traverso and Edwards to include the battery supplying electricity to the suction unit and the charging hole is formed in the end cap as taught by Neer since such a modification enables the device of Jensen to have a cordless feature [Neer, 0045].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US 20230090661 A1), and further in view of Blomquist (US 20100262078 A1).
Regarding claim 10, Jensen teaches a auto-injectable smart insulin injection device (Jensen reads on “insulin injection device” as claimed since Jensen discloses delivering fluid and insulin is known to be a fluid) wherein a cartridge (cartridge assembly 700 in Fig. 5) is configured with:
a cylinder (cartridge compartment 702 in Fig. 5) provided with a needle (needle 902 in Fig. 5) at the lower end (needle 902 is interpreted to be at lower end of cartridge since it is closest to the injection site);
a piston (first stopper 708 with plunger rod 400 in Fig. 8a) installed inside (stopper 708 is located inside compartment 702) and outside the cylinder (plunger rod 400 is located outside compartment 702) and able to be moved back (plunger rod 400 in retracted position in Fig. 8a [0248]) and forth (plunger rod 400 and stopper 708 moves forward in Fig. 8c);
but failed to explicitly disclose insulin stored in the cylinder;
an oscillator installed at a lower end of the piston to oscillate the insulin; and
an oscillator cover surrounding an outer surface of the oscillator and moves forward with an oscillator cover when the piston moves forward to pressurize the insulin.
However, Blomquist teaches an insulin pump 100 in Fig. 4 to containing insulin in an insulin cartridge [0044]. One of ordinary skill in the art teaches the injection device of Jensen to be configured to store insulin in cartridge as taught by Blomquist.
Blomquist further teaches pump 100 include a vibrating mechanism, which is configured to supplement the rapid forward and backward movement of the cartridge plunger [0119]. One of ordinary skill in the art teaches the vibrating mechanism of Blomquist to be configured to be incorporated into the injection device of Jensen as taught by Blomquist.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the auto-injectable smart insulin injection device of Jensen to include insulin stored in the cylinder; an oscillator installed at a lower end of the piston to oscillate the insulin; and an oscillator cover surrounding an outer surface of the oscillator and moves forward with an oscillator cover when the piston moves forward to pressurize the insulin as taught Blomquist since such a modification enables the device of Jensen to remove air bubbles within the insulin cartridge [0119].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20200390975 A1 (Bauer) related to an auto injector with air flow vent.
WO 2018231868 A1 (Chalberg) related to a delivery device with connection to smart device.
US 6290683 B1 (Erez) related to a needle assembly with thermoelectric cooling assembly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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