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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/8/2025 has been entered.
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.
Claims 14-17 and 19-29 are rejected under 35 U.S.C. 103 as being unpatentable over Naseri (WO 2016028497) (previously cited) (cited by Applicant) in view of Tariyal (WO 2016025332) (previously cited) (cited by Applicant) and Terbrueggen (WO 0243864).
Regarding claim 14, Naseri teaches a vaginal fluid monitoring device (Figure 3) embedded into a feminine sanitary pad (Paragraph [0088] feminine hygiene products with embedded biosensors and microelectronics 100 are illustrated in different formats, such as tampons 101, pads 102, panty liners 103 or menstrual cups 104), the device comprising: an absorbent layer (120) configured to be in proximity to, and collect, a vaginal fluid (Paragraph [0096]);
and a biosensing system (biosensor) in fluidic connection with the absorbent layer (120) (Paragraph [0096] there may be a channeling system (not shown) incorporated in pad 130 for channeling the fluid flow towards the inlets and the micro vaginal fluid (VF) collector 161. In one or more embodiments, the microfluidic channels are a paper-based fluidic system. Only VF, which is absorbed by 161, will be directed towards the biosensor platform 200, e.g., via capillary force in the case of paper-based biosensors), the biosensing system including,
a microfluidic chip (biosensor platform 200) configured to perform an immunoassay to detect a presence and/or a concentration of a target biomarker comprised in a vaginal fluid, (Paragraph [0113]),
a readout device (501, 502, 503) configured for providing a readout of the presence and/or the concentration of the target biomarker. (Paragraphs [0090]-[0091]).
However, Naseri does not specifically teach “the target biomarker indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk” and “a fluid-flow monitoring system comprising an electrode array located along a microfluidic path of the microfluidic chip and configured to detect and analyze a flow of the vaginal fluid by at least an impedance device, wherein the fluid-flow monitoring system is functionally distinct from the microfluidic chip and is configured to operate independently thereof for monitoring the fluid flow prior to and/or during the target biomarker analysis”.
Tariyal, in a related field of endeavor, teaches the target biomarker indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk. (Paragraphs [0009], [00118] fetal fibronectin).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naseri to provide a “target biomarker indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk” as taught by Tariyal. Doing so helps monitor and reduce the risk for preterm birth and infections such as yeast infections and Strep B. (Paragraph [0009]).
Terbrueggen, in a related field of endeavor, illustrates (Fig. 2A, 3C) a fluid-flow monitoring system comprising an electrode array (103) located along a microfluidic path of the microfluidic chip (biochip 105) and configured to detect and analyze a flow of the vaginal fluid, (Page 12, lines 5-8), by at least an impedance device (Page 36, line 17 impedance matching), wherein the fluid-flow monitoring system is functionally distinct from the microfluidic chip and is configured to operate independently thereof for monitoring the fluid flow prior to and/or during the target biomarker analysis. (Fig. 2A, 3C, electrode array 103 is functionally distinct from the biochip 105; Page 3, lines 27-28, array 103 is attached to surface 105; Page 31, lines 14-20 each electrode is independently addressable).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naseri to provide “a fluid-flow monitoring system comprising an electrode array located along a microfluidic path of the microfluidic chip and configured to detect and analyze a flow of the vaginal fluid by at least an impedance device, wherein the fluid-flow monitoring system is functionally distinct from the microfluidic chip and is configured to operate independently thereof for monitoring the fluid flow prior to and/or during the target biomarker analysis” as taught by Terbrueggen. Doing so may enable the conformation of the electrodes to be varied based on the detection method used. (Page 30, lines 23-28).
Regarding claim 15, Naseri teaches wherein the target biomarker is C- reactive protein (CRP) (Paragraphs [0084]-[0085]).
Regarding claim 16, Naseri teaches wherein the readout device (501, 502, 503) for providing the readout includes an optical readout and/or an electrochemical readout. (Paragraph [0090]).
Regarding claim 17, Naseri does not specifically teach “wherein the readout device for providing the optical readout includes an optical detector for detecting an optical signal generated by the immunoassay.”
Tariyal teaches wherein the readout device (assay reader 300) for providing the optical readout includes an optical detector (lens, sensor) for detecting an optical signal generated by the immunoassay. (Paragraphs [00184]-[00185]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naseri to provide “wherein the readout device for providing the optical readout includes an optical detector for detecting an optical signal generated by the immunoassay” as taught by Tariyal. Doing so provides an alternative mechanism to run and image assay results. (Paragraph [00184]).
Regarding claim 19, Naseri teaches wherein the absorbent layer (120) is configured to keep a constant flow of a vaginal fluid inside the microfluidic chip (200). (Paragraph [0096] vaginal fluid (VF) is collected in the center 120 of the top layer of the pad 110, where the pad is highly absorbent of VF. Pad 130 is in direct contact with a number of inlets, here illustrated with 4 inlets on a top protective layer 151, which seals the biosensor platform 200 as well as any microelectronics 300 embedded in the solution from the VF. There may be a channeling system (not shown) incorporated in pad 130 for channeling the fluid flow towards the inlets and the micro VF collector 161. In one or more embodiments, the microfluidic channels are a paper-based fluidic system. Only VF, which is absorbed by 161, will be directed towards the biosensor platform 200, e.g., via capillary force in the case of paper-based biosensors; Paragraph [0106] Inlets 160 leads to the micro VF collector 161 which then leads to a VF collecting central base 163 which collects the filtered/unfiltered fluid and leads it to a central fluid transporting core 164, leading to a plurality of receiver elements 171. The central fluid transporting core 164 further leads to a lower fluid transporting VF dispatcher 165, which allows for VF storage and dispatchment therefore providing continuous fluid flow continuous flow).
Regarding claim 20, Naseri teaches wherein the microfluidic chip (200) is configured to operate in a passive capillary regime. (Paragraphs [0096]-[0097]).
Regarding claim 21, Naseri teaches wherein the absorbent layer (120) includes a substrate (collecting pad 130) patterned with fluidic paths. (Paragraph [0116] fluid channeling system 150).
Regarding claim 22, Naseri teaches a microprocessor configured for processing a signal generated by the biosensing system. (Paragraph [0058]).
Regarding claim 23, Naseri teaches wherein the microprocessor is configured for processing a signal selected from an electrical impedance signal. (Paragraphs [0083], [0090], [0118]).
Regarding claim 24, Naseri illustrates wherein the absorbent layer (120) and the biosensing system (200) are arranged as layers of a stack. (See Figure 3).
Regarding claim 25, Naseri teaches a method for detecting a target biomarker in a vaginal fluid, (Paragraph [0031]), the method comprising:
allowing the vaginal fluid monitoring device to collect a vaginal fluid, (Paragraph [0031]), the vaginal fluid monitoring device including, an absorbent layer (120) configured to be in proximity to, and collect, the vaginal fluid, (Paragraph [0096]), and a biosensing system (biosensor) in fluidic connection with the absorbent layer (120), (Paragraph [0096] there may be a channeling system (not shown) incorporated in pad 130 for channeling the fluid flow towards the inlets and the micro vaginal fluid (VF) collector 161. In one or more embodiments, the microfluidic channels are a paper-based fluidic system. Only VF, which is absorbed by 161, will be directed towards the biosensor platform 200, e.g., via capillary force in the case of paper-based biosensors), the biosensing system including, a microfluidic chip (biosensor platform 200) configured to perform an immunoassay to detect a presence and/or a concentration of the target biomarker in the vaginal fluid, (Paragraph [0113]), a readout device (501, 502, 503) for providing a readout of the presence and/or the concentration of the target biomarker, (Paragraphs [0090]-[0092]), and obtaining the readout of the presence and/or the concentration of the target biomarker to determine the presence and/or the concentration of the target biomarker in the vaginal fluid. (Paragraphs [0090]-[0092]).
However, Naseri does not specifically teach “a fluid-flow monitoring device comprising an electrode array located along a microfluidic path of the microfluidic chip and configured to detect and analyze a flow of the vaginal fluid by at least an impedance device, wherein the fluid-flow monitoring device is functionally distinct from the microfluidic chip and is configured to operate independently thereof for monitoring the fluid flow prior to and/or during the target biomarker analysis”.
Terbrueggen, as previously discussed, illustrates (Fig. 2A, 3C) a fluid-flow monitoring device comprising an electrode array (103) located along a microfluidic path of the microfluidic chip (biochip 105) and configured to detect and analyze a flow of the vaginal fluid (Page 12, lines 5-8) by at least an impedance device (Page 36, line 17 impedance matching), wherein the fluid-flow monitoring device is functionally distinct from the microfluidic chip and is configured to operate independently thereof for monitoring the fluid flow prior to and/or during the target biomarker analysis. (Fig. 2A, 3C, electrode array 103 is functionally distinct from the biochip 105; Page 3, lines 27-28, array 103 is attached to surface 105; Page 31, lines 14-20 each electrode is independently addressable).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naseri to provide “a fluid-flow monitoring device comprising an electrode array located along a microfluidic path of the microfluidic chip and configured to detect and analyze a flow of the vaginal fluid by at least an impedance device, wherein the fluid-flow monitoring device is functionally distinct from the microfluidic chip and is configured to operate independently thereof for monitoring the fluid flow prior to and/or during the target biomarker analysis” as taught by Terbrueggen. Doing so may enable the conformation of the electrodes to be varied based on the detection method used. (Page 30, lines 23-28).
Regarding claim 26, Naseri does not specifically teach “wherein the presence and/or the concentration of the target biomarker is indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk.”
Tariyal, in a related field of endeavor, teaches wherein the presence and/or the concentration of the target biomarker is indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk. (Paragraphs [0009], [00118] fetal fibronectin).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naseri to provide “wherein the presence and/or the concentration of the target biomarker is indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk” as taught by Tariyal. Doing so helps monitor and reduce the risk for preterm birth and infections such as yeast infections and Strep B. (Paragraph [0009]).
Regarding claim 27, Naseri teaches wherein the target biomarker is C- reactive protein (CRP) (Paragraphs [0084]-[0085]).
Regarding claim 28, Naseri teaches wherein the electrode array is further configured to measure the conductivity of the vaginal fluid. (Paragraph [0096]).
Regarding claim 29, Naseri teaches wherein the electrode array comprise a plurality of sensing sites distributed along the microfluidic path of the microfluidic chip, each site consisting of a pair of electrodes. (See Fig. 13D illustrates multiple sensing sites, i.e., leftmost site comprising electrodes 320, 330 and rightmost site comprising electrodes 320, 330).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Naseri in view of Tariyal and Terbrueggen, further in view of Pangarkar (WO 2014018805) (previously cited).
Regarding claim 18, Naseri as modified does not specifically teach “wherein the optical detector comprises a laser light source coupled with a photodiode.”
Pangarkar, in a related field of endeavor, teaches image analysis of measurement of biological samples wherein the optical detector comprises a laser light source coupled with a photodiode. (Paragraph [0087]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naseri as modified to provide “wherein the optical detector comprises a laser light source coupled with a photodiode” as taught by Pangarkar. Doing so may reduce scattered light as compared to that which typically occurs with more diffuse light sources, and so may reduce the background in one channel by reducing light scattered into that channel from an adjacent channel) Thus, laser illumination can result in less trans-illumination background than would be expected from illumination by more diffuse light sources. (Paragraph [00285]).
Response to Arguments
Applicant's arguments filed 12/8/25 with respect to the rejections of claims 14-29 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Terbrueggen is relied upon for the amended feature.
Conclusion
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/OM PATEL/Examiner, Art Unit 3791 /JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791