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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al. (US 2017/0367654 A1).
With regard to claim 1, Cheng et al. teach a device for detecting an intravenous therapy (IV) infiltration event in a subject comprising: an adhesive patch, wherein the adhesive patch is formed from a pressure sensitive adhesive tape (Fig. 2A member 200, [0055], [0112]); and a sensor (Fig. 2A member 204), wherein the sensor is configured to detect changes in resistance based on length ([0047]), wherein the sensor is embedded in the adhesive patch, such that the sensor does not make direct contact with the subject ([0059], [0066] the electrode is printed on the patch and layered, as metal components are sandwiched between layers it is taken as embedded, [00110] metallic electrode material may also be embedded in the film).
With regard to claims 2-4, see [0079], audible or visual alerts may be triggered.
With regard to claims 5 and 6, see [0078] and [0080] data is wirelessly transmitted to a processor.
With regard to claim 8, a wired connection may be used ([0077]).
With regard to claim 9, see at least [0077] the device would necessarily be powered.
With regard to claim 10, see [0075] a plurality of electrodes are used which detect resistance ([0043]).
With regard to claim 11, see [0047]-[0049] swelling in the skin.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 2017/0367654 A1) as applied to claim 6 above, and further in view of Krupnick et al. (US 2020/0054279).
With regard to claim 7, the device of Cheng et al. is necessarily powered but Cheng et al. do not explicitly disclose a battery. However, Krupnick teaches a patch for detecting extravasation with a battery power source ([0004], [0013]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a battery in Cheng et al. as in Krupnick as this provides an art effective power source and would yield the same result of sensing.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 2017/0367654 A1) as applied to claim 1 above, and further in view of Banet et al. (WO 2022/035822).
With regard to claim 12, Cheng et al. teach sensing resistance and using a multimeter ([0106]) to transmit information but do not explicitly disclose voltage. However, Banet et al. teach an extravasation detection patch with embedded circuitry in which the change in resistance is reflected by voltage ([000159], [000164]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to output voltage in Cheng et al. as Banet et al. teach it is reflective of resistance and may also be used to effectively indicate extravasation.
Claim(s) 13-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 2017/0367654 A1) in view of Banet et al. (WO 2022/035822).
With regard to claims 13-16, Cheng et al. teach a device for detecting an intravenous therapy (IV) infiltration event in a subject comprising: an adhesive patch, wherein the adhesive patch is formed from a pressure sensitive adhesive tape (Fig. 2A member 200, [0055], [0112]); a sensor (Fig. 2A member 204), wherein the sensor is configured to detect changes in resistance based on length ([0047]), wherein the sensor is embedded in the adhesive patch, such that the sensor does not make direct contact with the subject ([0059], [0066] the electrode is printed on the patch and layered, as metal components are sandwiched between layers it is taken as embedded, [00110] metallic electrode material may also be embedded in the film); and a processor configured to receive data from the sensor such that changes in the data can be monitored, and wherein data greater than a threshold triggers an alert (see [0078]-[0080], audible or visual alerts may be triggered, data is wirelessly transmitted to a processor). Cheng et al. teach sensing resistance and using a multimeter ([0106]) to transmit information but do not explicitly disclose voltage. However, Banet et al. teach an extravasation detection patch with embedded circuitry in which the change in resistance is reflected by voltage ([000159], [000164]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to output voltage in Cheng et al. as Banet et al. teach it is reflective of resistance and may also be used to effectively indicate extravasation.
With regard to claim 18, a wired connection may be used ([0077]).
With regard to claim 19, see at least [0077] the device would necessarily be powered.
With regard to claim 20, see [0075] a plurality of electrodes are used which detect resistance ([0043]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 2017/0367654 A1) and Banet et al. (WO 2022/035822) as applied to claim 16above, and further in view of Krupnick et al. (US 2020/0054279).
With regard to claim 17, the device of Cheng et al. is necessarily powered but Cheng et al. do not explicitly disclose a battery. However, Krupnick teaches a patch for detecting extravasation with a battery power source ([0004], [0013]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a battery in Cheng et al. as in Krupnick as this provides an art effective power source and would yield the same result of sensing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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