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 1-12) in the reply filed on 08/04/2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2026.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 line 4, “the catheter unit”. It should be amended as “the disposable catheter unit”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dezfulian et al. (US 2020/0206471).
Regarding claim 1, Dezfulian discloses
A catheter insertion system (10, fig. 3 and par. 0065), comprising:
a disposable catheter unit (200, figs. 3 and 11-12B, pars. 0094-0095) comprising a needle (201) and a deployable catheter (202) disposed over the needle (see figs. 11-12B);
a detection unit (100, fig. 3 and par. 0065) coupled to the catheter unit (200), the detection unit (100) comprising circuitry (figs. 4) electrically coupled to the needle (see fig. 3) and a skin electrode (Examiner notes: the limitation “electrically coupled to … a skin electrode” is interpreted as functional limitation, and the limitation “a skin electrode” is not positively recited in claim 1. See pars. 0044-0117 and figs. 11-12B for the detection unit electrically coupled to electrodes 203/204) and configured to measure resistance between the needle and the skin electrode while the catheter unit is inserted or being prepared to be inserted into a patient and configured to determine an anatomical space within which an end portion of the catheter unit is located within the patient based on the measured resistance (Examiner notes: the limitation “configured to measure… and configured to determine… the measure resistance” is interpreted as functional limitation. See pars. 0044-0117 and figs. 11-12B for the function of the detection unit); and
an indicator interface (resistance of materials that the needle contacts as it is inserted, par. 0066) configured to send control instructions to an output device to present an indication of the anatomical space within which the end portion of the catheter unit is located within the patient (Examiner notes: the limitation “configured to send …within the patient” is interpreted as functional limitation, and the limitation “an output device” is not positively recited in claim 1. See par. 0066 for the resistance values)
Regarding claim 2, Dezfulian discloses
The system of claim 1, wherein the circuitry is configured to differentiate whether the end portion of the catheter unit is positioned in blood or in subcutaneous tissue based on the measured resistance (Examiner notes: the limitation “configured to differentiate...the measured resistance” is interpreted as functional limitation. See figs. 17A-25B and pars. 0100-0106 for three sets of tests using the device. See also par. 0110 for “the detection unit can differentiate between different materials encountered when placing a catheter”).
Regarding claim 3, Dezfulian discloses
The system of claim 1, wherein the anatomical space is mapped to an output state used to indicate a progress of the needle toward a target location (Examiner notes: the limitation “the anatomical space is mapped ... a target location” is interpreted as functional limitation. See par. 0012).
Regarding claim 4, Dezfulian discloses
The system of claim 3, wherein the target location is a vessel of the patient (see par. 0012).
Regarding claim 5, Dezfulian discloses
The system of claim 1, wherein the output device comprises a display (Examiner notes: the limitation “an output device” is not positively recited in claim 1, and this limitation is also not positively recited in claim 5).
Regarding claim 6, Dezfulian discloses
The system of claim 1, wherein the output device comprises a haptic feedback device (Examiner notes: the limitation “an output device” is not positively recited in claim 1, and this limitation is also not positively recited in claim 6).
Regarding claim 7, Dezfulian discloses
The system of claim 1, wherein the output device comprises a speaker system (Examiner notes: the limitation “an output device” is not positively recited in claim 1, and this limitation is also not positively recited in claim 7).
Regarding claim 9, Dezfulian discloses
The system of claim 1, wherein the detection unit is mounted on the skin electrode (Examiner notes: the limitation “a skin electrode” is not positively recited in claim 1 as well as claim 9. See fig. 3 for the detection unit 100 is attached/mounted to a disposable catheter unit 200 with electrodes 203/204. Therefore, 100 is capable to be mounted to a skin electrode).
Regarding claim 10, Dezfulian discloses
The system of claim 1, wherein the detection unit is mounted on the catheter unit (see fig. 3 for 100 being attached/mounted to 200).
Regarding claim 11, Dezfulian discloses
The system of claim 1, wherein the output device comprises one or more of a display, a haptic feedback device, or a speaker included in the detection unit (Examiner notes: the limitation “an output device” is not positively recited in claim 1 as well as claim 11. See fig. 6 and par. 0083 for detection unit with output interface such as speaker, LED or other light output, vibratory or other tactile interface, and/or LCD or other alpha numeric or graphical display).
Regarding claim 12, Dezfulian discloses
The system of claim 1, further comprising a wireless communication component (wireless communication component of 100, par. 0084) configured to communicate additional control instructions to a second output device remote from the detection unit (Examiner notes: the limitation “configured to communicate…the detection unit” is interpreted as functional limitation, and the limitation “a second output device” is not positively recited in claim 12. See par. 0084 for 100 with a wireless communication component to communicate wirelessly to a mobile device or a network or a computer).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dezfulian et al. (US 2020/0206471) in view of Imran et al. (US 2022/0080122).
Regarding claim 8, Dezfulian discloses the system of claim 1, wherein the detection unit (100, fig. 6) comprises a computing device (computing device of a mobile device disclosed in par. 0084), and wherein the skin electrode (Examiner notes: the limitation “a skin electrode” is not positively recited in claim 1 as well as claim 8) and an electrode on the needle (203 or 204) is connected to an interface of the computing device (interface of a mobile device disclosed in par. 0084).
Dezfulian discloses the system communicate wirelessly to a mobile device or a network or a computer such that the information is transferred to such device, computers, and/or networks (par. 0084). Dezfulian is silent about the external device being a wrist-worn device.
However, Imran teaches a system configured to transmit the information to an external device which is worn on a subject (par. 0192) and the device can be a wrist band, or a smart watch (pars. 0206-0207).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Dezfulian’s external device to be a smart watch, as taught by Imran, for the purpose of providing a communication/external device to be wearable by the user/subject (pars. 0192, 0206-0207 of Imran).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-5pm.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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