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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-17) in the reply filed on 01/11/26 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/11/26.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 7-10 & 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cerman (US 2017/0266370).
Regarding claim 1, Cerman discloses an injection system 100 comprising:
a brace (including elements 105 & 150);
a needle 110 inside the brace in a retracted position;
a mechanism 112 operable to drive the needle from the retracted position (Fig. 1) to an extracted position (Fig. 2); and
a fluid 122 dispenser fluidly connected to the needle 110.
Regarding claim 5, wherein the brace further comprises: one or more sensors 153 to detect a position of the brace with respect to a body part (e.g., the sensor arrangement 153 is operable to detect a force that is provided on the strap 150 by the limb of the patient, para [0059]. It is noted that the sensor is configured to detect a force that provided on the strap is interpreted that the sensor is configured to detect a position of the brace on the body part) .
Regarding claim 7, wherein the needle is an intravenous needle.
Regarding claim 8, the injection device in Cerman includes a controller 101 that is configured to control operation of various components or controlling needle insertion through a skin and delivering drug into a patient. Therefore, the injection device includes a memory storing an application (software of controlling the insertion of the needle or drug delivery to a patient); and
a processor 101 which executes the application to: cause the mechanism to extract the needle, see Fig. 2, cause the injection system to administer a dosage through the needle, and cause the mechanism to retract the needle, see Fig. 1.
Regarding claim 9, wherein the brace further comprises: one or more sensors to detect a position of the brace with respect to a body part (e.g., the sensor arrangement 153 is operable to detect a force that is provided on the strap 150 by the limb of the patient, para [0059]. It is noted that the sensor is configured to detect a force that provided on the strap is interpreted that the sensor is configured to detect a position of the brace on the body part); and wherein the processor 101 which executes the application to cause the mechanism to extract the needle comprises:
the processor further executing the application to: determine whether to cause the mechanism to extract the needle based on the position of the brace (based monitoring force in or extension of the strap 150, the controller 101 and the sensing arrangement 153 are able to detect when the tissue of the patient adjacently in the injection site, para [0060]) with respect to the body part). For example: if the sensor arrangement 153 detects that the tissue is not swelling, then then continue delivery medicament (e.g., in other words, determine whether to cause the mechanism to extract/extend the needle).
Regarding claim 10, this claim is being rejected using same analysis as noted the above in the combination of claims 1 & 5. Please see the rejections of claims 1 & 5 above.
Regarding claims 15-17, please see the rejection in claims 7-9 above.
Claims 1, 4-5, 7-10, 13-14, 16-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gunay et al. (US 2023/0256159).
Regarding claim 1, Gunnay discloses an injection system 100, in Figs. 1-5, comprising:
a brace 15 (Note: the brace is interpreted as a frame or support the device and equivalent to a housing);
a needle 51 inside the brace in a retracted position;
a mechanism 50 operable to drive the needle from the retracted position (similar Fig. 14) to an extracted/extended position (when injecting into a skin); and
a fluid 30 dispenser fluidly connected to the needle.
Regarding claim 4, the brace further comprises a beacon (LED), para [0088].
Regarding claim 5, the brace further comprises: one or more sensor (skin sensor) to detect a position of the brace with respect to a body part (e.g., para [0089], cassette 100 comprises a skin sensor which senses whether the device is properly positioned against a patient's skin. In some embodiments, the cassette 100 may not actuate a needle assembly or deliver a medication if the skin sensor does not indicate that the device is positioned properly).
Regarding claim 7, the needle is an intravenous needle.
Regarding claim 8, further comprising: a memory 264 storing an application/instruction 265; and a processor 262 which executes the application to: cause the mechanism to extract the needle (extending a needle for drug delivery. Para [0063]), cause the injection system to administer a dosage through the needle, para [0063]), and cause the mechanism to retract the needle, see abstract.
Regarding claim 9, wherein the brace/housing further comprises: one or more sensors (skin sensor) to detect a position of the brace with respect to a body part; and wherein the processor which executes the application to cause the mechanism to extract the needle comprises: the processor further executing the application to: determine whether to cause the mechanism to extract the needle based on the position of the brace with respect to the body part (e.g., para [0089], cassette 100 comprises a skin sensor which senses whether the device is properly positioned against a patient's skin. In some embodiments, the cassette 100 may not actuate a needle assembly or deliver a medication if the skin sensor does not indicate that the device is positioned properly). For example: when the brace/cassette 100 is properly positioned against a patient’s skin, the processor executing the application to extend/extract the needle for deliver a medication.
Regarding claim 10, this claim is being rejected using same analysis as noted the above in the combination of claims 1 & 5. Please see the rejections of claims 1 & 5 above.
Regarding claims 13-14, 16-17, please see the rejection in claims 4-5 & 7-9 above.
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.
Claims 2 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cerman (US 2017/0266370) in view of Hogset et al. (US 2016/0199664).
Regarding claims 2 & 11, Cerman discloses all the claimed subject matter as required. Cerman discloses that the strap 150 is elastic. Therefore, the strap 150 by itself includes an adjustable fastener to secure the brace to a body part. In case, Applicant disagrees with Examiner’s statement above. Assuming the brace in Cerman does not include an adjustable fastener. The device in Cerman can be modified as below.
Hogset discloses an injection system 2 comprising: a brace 3a & 3b; an adjustable fastener (elements 4 & 5) to secure the brace to a body part.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the brace device of Cerman with including an adjustable fastener, as taught by Hogset, in order to secure the brace and the injection device to different locations of a body part in different sizes of patients.
Claims 3-4, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cerman (US 2017/0266370) in view of Peeters et al. (US 8,909,391).
Regarding claims 3-4 & 12-13, Cerman discloses all the claimed subject matter as required. The injection device in Cerman includes a controller 101 that is configured to control operation of various components or controlling needle insertion through a skin and delivering drug into a patient. Therefore, the injection device includes a memory storing an application (software of controlling the insertion of the needle or drug delivery to a patient); a beacon provided on/in the brace.
Cerman does not disclose the limitations that: an unmanned vehicle to carry and deploy the brace; a speaker; a microphone; and a processor which executes the application to: cause the speaker and microphone to operate as a communication device.
Peeters discloses a deployment system for an unmanned aerial vehicle (UAV) comprising: an unmanned vehicle (UAV) to carry and deploy a package (brace) for particular medical situation; a speaker; a microphone; a beacon (flashing a light); a memory storing an application (module) that is able to signal to a passerby for assistance in either reaching the specific location or delivering its medical support items to the medical situation, col. 14, lines 34-49; processor which executes the application/module to cause the speaker and microphone to operate as a communication device.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the injection system of Cerman with providing/including an unmanned vehicle to carry and deploy the brace; a speaker; a microphone; and a processor which executes the application to: cause the speaker and microphone to operate as a communication device; a beacon, as taught by Peeters, in order to deploy the medical package to provide medical support for patient who is currently in medical attention as needed.
Claims 6 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cerman (US 2017/0266370).
Regarding claims 6 & 14, Cerman discloses that wherein the needle is an intraosseous needle. Thus, a person skilled in the art would recognize that the needle 110 can be an intraosseous needle, as for intended use purpose in certain medical condition.
Claims 9 & 17 alternatively are rejected under 35 U.S.C. 103 as being unpatentable over Cerman (US 2017/0266370) in view of Gunay et al. (US 2023/0256159).
Note: incase Applicant still disagrees with Examiner about the rejection in claim 9 above, the claim 9 is alternatively being rejected as below.
Regarding claim 9, wherein the brace further comprises: one or more sensors to detect a position of the brace with respect to a body part (e.g., the sensor arrangement 153 is operable to detect a force that is provided on the strap 150 by the limb of the patient, para [0059]. It is noted that the sensor is configured to detect a force that provided on the strap is interpreted that the sensor is configured to detect a position of the brace on the body part);
Assuming that Cerman fails to disclose the limitation that: the processor further executing the application to determine whether to cause the mechanism to extract the needle based on the position of the brace with respect to the body part.
Gunay discloses an injection system comprising: a needle 51; a memory 264 storing an application; a processor 262, see Fig. 10; wherein one or more sensors, i.e. skin sensor to detect a position of the brace/housing with respect to a body part (e.g., the skin sensor which senses whether the device is properly positioned against a patient’s skin); and the processor which executes the application (software) to cause the mechanism to extract/extend the needle comprises: the processor further executing the application to determine whether to cause the mechanism to extract the needle based on the position of the brace with respect to the body part (e.g., para [0089], cassette 100 comprises a skin sensor which senses whether the device is properly positioned against a patient's skin. In some embodiments, the cassette 100 may not actuate a needle assembly or deliver a medication if the skin sensor does not indicate that the device is positioned properly. In other words, if the position of the brace/housing of the device is positioned incorrectly to the patient’s skin, the processor does not execute a needle assembly to deliver a medication. If the position of the brace/housing of the device is positioned correctly to the patient’s skin, then the processor further executing the application to cause the mechanism to extend/extract the needle to delivery drug into a patient’s skin).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the brace/housing device of Cerman with including a skin sensor to sense the injection needle being in positioned correctly with respect to the skin’s patient, as taught by Gunnay, in order to secure the brace of the injection device in correct position to deliver a drug into the patient.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783