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 with traverse of Group I in the reply filed on 06/18/26 is acknowledged. The claims 8, 11-13, 17, 19-23 were amended and depends on the claim 1. Therefore, the claims 8, 11-13, 17, 19-23 are being examined.
Currently, claims 1, 3-8, 11-13, 17, 19-23 are being examined in this office action.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1, 3, 5-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kilpadi et al. (US 2020/0197580).
Regarding claim 1, Kilpadi discloses a surgical drainage system comprising:
an assay device 106 operatively coupled to a surgical drainage tube 124; wherein the surgical drainage tube configured for implantation within a surgical bed 102/118 of a subject to drain surgical drain fluid out of the surgical bed, the assay device 106 configured to detect at least one analyte within the drainage fluid (e.g., the assay device or the sampling assessment system 106 has theranostic sampling elements 145-177, Fig. 1; para [0035], wherein the theranostic sampling elements 145-177 can be a testing or diagnostic in one or more of the sampling chamber, or can provide different testing and/or diagnostics);
wherein the analyte is indicative of a condition (for diagnostics of would fluid, para [0035]; numerous different conditions and diagnostics implemented with the theranostic, para [0046]; visual diagnostic and/or theranostic result indicators to indicate conditions of the fluid, para [0049]).
Regarding claim 3, wherein the assay device comprises a lateral flow antigen test (e.g., the sampling chambers 141-143 of the assay device 106 also includes a device for a lateral flow test, para [0052].
Regarding claim 5, wherein the at least one analyte comprises at least one biomarker (e.g., sensor/chemical) indicative of the presence of at least one of bacteria (bacterial detection component, bacteria enzyme, biofilm...), chyle, blood (glucose level or concentration, hemoglobin levels, and other testing), bile, and any combination thereof, paras [0046, 0047, 0059].
Regarding claim 6, wherein the at least one biomarker is selected from lipase, protease, peptidase, amylase, pepsin, trypsin, chymotrypsin, carboxypeptidase, elastase, phospholipase, lactase, maltase, sucrase, triglyceride, chylomicron, bilirubin, and any combination thereof, see para [0018].
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 4 & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpadi et al. (US 2020/0197580).
Regarding claim 4, as mentioned in the claim 3 above, the assay device 106 comprising a cartridge 140 housing the lateral flow antigen test in the chambers 141-143. The term “replaceable” is considered as intended use purpose for replacing the new cartridge as needed.
Regarding claim 7, wherein detection of the at least one analyte indicates a surgical bed condition selected from an infection within the surgical bed 102/118.
The limitation, i.e., a formation of a fistula, a chyle leak, a bile leak, an anastomotic leak, and any combination thereof, is a part of organ in the patient that recited in the device’s claim. Therefore, the limitation above is considered as functional limitation and only requires performing a function. In this case, Kilpadi states that the wound treatment site 102 includes connective tissue, tendons, ligaments, or any other tissue, para [0022]. Therefore, a person skilled in the art would recognize that the detection of the at least one analyte indicates a surgical bed condition from an infection within the surgical bed, and capable of detecting a formation of a fistula, a chyle leak, a bile leak, an anastomotic leak, and any combination thereof.
Claims 8, 11-13, 17, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpadi et al. (US 2020/0197580) in view of Ziebol et al. (US 9,352,142).
Regarding claims 8 & 11, Kilpadi discloses all the claimed subject matter as required except for the limitation that at least a portion of the inner lumen is coated with a nucleic acid preservation agent; wherein the nucleic acid preservation agent is selected from ethylene diamine tetra acetic acid (EDTA), sodium dodecyl sulfate (SDS), and any combination thereof.
Kilpadi discloses that the sampling chambers 145-147 includes stabilize, preserve, para [0047]. A person skilled in the art would recognize that the stabilize or preserve can be provided/coated in the inner lumen of the drainage tube and that considered as rearrangement parts.
Ziebol discloses that an antimicrobial catheter composition is provided and coated into the lumen of the catheter; wherein the antimicrobial composition includes ethylene diamine tetra acetic acid (EDTA), see abstract, col. 9, lines 15-19 & lines 38-40.
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 device of Kilpadi with providing an antimicrobial composition, i.e., ethylene diamine tetra acetic acid (EDTA) being coated in the inner lumen of the catheter (or drainage tube), as taught by Ziebol, in order to produce an effective antiseptic region, killing organism in the catheter (or drainage tube).
Regarding claim 12, Kilpadi in view of Ziebol discloses all the claimed subject matter as required. Kilpadi further discloses that a sample port 133 operatively connected to the inner lumen 130 of the surgical drainage tube 124, the sample port 133 comprising a valve 204/205 or 206/207 (Fig. 2) and a connection fitting (see marked-up Fig. 2 below), the sample port 133 configured to seal when the valve is in a closed position and to direct a sample of surgical drain fluid out of the lumen when the valve is in an open position, see Fig. 2 & para [0031].
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Regarding claim 13, Kilpadi in view of Ziebol discloses all the claimed subject matter as required. Kilpadi further discloses that further comprising an accessory reservoir 141-143 reversibly (e.g. can be attached and unattached) coupled to the connection fitting, wherein the accessory reservoir 141-143 is configured to receive the sample from the sample port 133.
Regarding claim 17, wherein the sample port 133 is further configured to reversibly couple and detach from the accessory reservoir 141-142 and at least one replacement accessory reservoir for serial sampling.
Regarding claim 21, further comprising at least one physiological sensor 145-147 (or visual theranostic result indicator, para [0050], another sensor/chemical, para [0059]) positioned at a proximal end of the surgical drain tube 124 (Note: the sensor #145-147 located near the proximal end of the tube 124; however, a person skilled in the art would recognize that the sensor #145-147 can be relocated at the proximal end of the surgical drain tube 124 and that considered as rearrangement parts); each physiological sensor configured to monitor a physiological condition of the surgical bed. (glucose level or concentration, hemoglobin levels, and other testing), paras [0046, 0047, 0059].
Regarding claim 22, wherein the physiological condition is selected from temperature, pH, pressure, hydration, oxygenation, and any combination thereof, paras [0046-0047, 0050, 0059-0060.
Regarding claim 23, further comprising the assay device 106 is operatively coupled to the lumen at proximal portion of the surgical drainage tube. However, a person skilled in the art would recognize that the assay device is positioned within the distal portion of the surgical drainage tube and that considered as rearrangement parts. Kilpadi further discloses that the assay device 106 configured to detect at least one analyte indicative of a surgical bed 102/118 condition within the drainage fluid.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpadi et al. (US 2020/0197580) in view of Ziebol et al. (US 9,352,142) and further in view of Cohn (US 5,101,804).
Regarding claims 19-20, Kilpadi in view of Ziebol discloses all the claimed subject matter as required except for the limitations in claims 19-20. However, Kilpadi further discloses that the sample elements 145-147 are temperature controlled. Therefore, a person skilled in the art would recognize that the system included a heat source so that the system can be set in desired/controlled temperature as needed.
Cohn discloses a biological fluid sample chamber comprising: a housing or reservoir 10; a heat source 22 configured to maintain the fluid at a desired temperature; wherein a thermal insulation material 28 enclosing at least a portion of the chamber (the accessory reservoir).
Note: Cohn discloses the heat source and the thermal insulation material are provided in the fluid sample chamber; however, a person skilled in the art would recognize that the heat source and thermal insulation material can be provided other location such as within an inner lumen of the catheter tube and that considered as rearrangement parts.
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 device of Kilpadi in view of Ziebol with providing a heat source and thermal insulation material, as taught by Cohn, in order to control the desired temperature as needed and the insulation material to prevent the heat loss.
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 M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
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