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 claims 1-17 and 26-23 in the reply filed on 2/13/26 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15, 16 and associated dependent claims is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the MD membrane". There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the dependency to claim 11.
Claim 16 recites the limitation "the first flow channel". There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the dependency to claim 3.
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) 1-8, 11-15, 26-28, 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Carr”, US Patent 9119579, in view of “Shin”, WO2019054727.
Regarding claim 1, Carr discloses a microdialysis probe [fig.1] comprising:
a probe body that defines a first probe cavity and a second probe cavity [col.3, ll.20-31, col.3, l.59 to col.4, l.49: a frame having first and second longitudinal depressions or recesses, each open to the outside and receiving the supply and discharge lines], the first probe cavity defining a first orifice adapted to dispense a perfusate [col.6, ll.10-37: supply-line depression forming a channel for perfusion solution and opening in the probe region] and the second probe cavity defining a second orifice situated to receive a collection fluid responsive to the dispensation of the perfusate from the first orifice [col.1, ll.19-35: second depression / discharge line receiving fluid after perfusion and dialysis, i.e., the perfusion solution is returned via the discharge line]; and
a first tapered probe tip terminating the first probe cavity and a second tapered probe tip terminating the second probe cavity [col.3, ll.32-58; fig.2: distal tip structure is consistent with a probe having laterally separated flow paths terminating at the distal tapered end].
Carr does not disclose explicitly electroosmotic actuation [claim construction hereby gives full weight to preamble].
Shin teaches a similar microdialysis/perfusion-fluid delivery device comprising a membrane and first and second electrodes on opposite sides of the membrane, with alternating polarity generating suction force and expulsive force to move fluid [Abstract; fig. 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microdialysis probe of Carr with the electroosmotic pumping arrangement of Shin as it would be a mere substitution by replacing a perfusion-driving mechanism with a known electroosmotic source of fluid motion, yielding predictable results in the form of more stable controlled perfusate delivery through the Carr probe structure.
Regarding claim 2, Carr does not disclose details of the probe structure as related to paths for perfusion fluid and discharge.
Shin further teaches that the first probe cavity and the first tapered probe tip [e.g., 411] and the second probe cavity and the second tapered probe tip [e.g., 412] extend parallel to a common axis and the first probe tip and the second probe tip are displaced laterally in a direction perpendicular to the common axis [fig.4b; e.g., 411 displaced laterally from walls of 412].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microdialysis probe of Carr with the electroosmotic pumping arrangement with the paths for perfusion fluid and discharge as taught by Shin. The combination would result in the claimed configuration of first/second probe cavity/tip since it would be a mere substitution with a known microdialysis probe structure that has a known downstream fluid handling that works with the electroosmotic actuation for more stable perfusate delivery.
Regarding claim 3, Carr discloses wherein the first probe cavity defines a first reservoir and a first flow channel coupled to communicate the perfusate to the first orifice [supply-line depression forming a channel for perfusion solution and opening in the probe region ] and the second probe cavity defines a second flow channel coupled to receive the collection fluid from the second orifice [second depression / discharge line receiving fluid after perfusion and dialysis, i.e., the perfusion solution is returned via the discharge line] [col.1, ll.19-35; col.3, ll.20-31, col.3, l.59 to col.4, l.49; col.6, ll.10-37].
Regarding claim 4, Shin discloses the second tapered probe tip is more distal along the common axis than the first tapered probe tip [fig.4b: 412 is longer than 411].
Regarding claim 5, Carr discloses a first capillary situated in the first probe cavity and defining the first flow channel and a second capillary situated in the second probe cavity and defining the second flow channel [e.g., fig.2].
Regarding claim 6, Carr discloses the first capillary and the second capillary extend to be proximate the first tapered probe tip and the second tapered probe tip, respectively [e.g., fig.2].
Regarding claim 7, Shin discloses the first orifice is displaced along the common axis from the second orifice and the first orifice is situated to face toward the second flow channel [fig.4b].
Regarding claim 8, Shin discloses the second orifice is situated to face toward the first flow channel [fig.4b].
Regarding claim 11, Shin discloses the probe body defines a microdialysis (MD) cavity fluidically coupled to the second probe tip, the MD cavity defining a collection inlet and a collection outlet, and further comprising a dialysis membrane situated in the MD cavity [fig.4A-4C; perfusate is introduced into the probe, microdialyzed, and then discharged to the sensor via inlet passage 11a, discharge passage 11b, and semi-permeable membrane 403].
Regarding claim 12, Shin discloses the MD cavity includes a dialysis fluid inlet at a proximal end of the MD cavity and a dialysis fluid outlet at a distal end of the MD cavity [fig.4b].
Regarding claim 13, Shin discloses the MD cavity includes a flow channel defined in a wall of the MD cavity and extending along a length of the MD cavity [i.e., elongated fluid passages].
Regarding claim 14, Shin discloses the probe body defines a waste cavity coupled to the flow channel in the MD cavity [fig.1, 4A, 6-7; waste bag 17].
Regarding claim 15, Shin discloses first and second electrodes 201, 202 and an electroosmotic pump 13 that alternately generates suction force and discharge power. Shin further teaches that the pump drives perfusion fluid to the MD probe 11, and that fluid after microdialysis is directed to the sensor 16 and waste bag 17. [Abstract; fig. 1, 2D–2F, 3, 4A–4C, 6, 7].
Regarding claim 26, Carr discloses a microdialysis device comprising:
a probe body that defines probe cavity and a tapered probe tip terminating the probe body [col.3, ll.20-58; fig.1-2],
wherein the probe body defines an orifice adapted to dispense a perfusate [col.3, l.59 to col.4, l.49; fig.1: first and second depressions/recesses receiving supply and discharge lines for perfusion solution or supply-side opening corresponds to an orifice adapted to dispense perfusate].
Carr does not disclose explicitly electroosmotic actuation or details of the microdialysis probe to receive a collection fluid responsive to dispensation of the perfusate from the orifice.
Shin teaches the electroosmotic actuation as discussed above in reference to claim 1, and further teaches a microdialysis probe having an introduction path for perfusion fluid and a discharge path for perfusion fluid after microdialysis, thereby receiving collection fluid responsive to perfusate dispensation. [Abstract; fig. 4A, 4B].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microdialysis probe of Carr with the electroosmotic pumping arrangement with the paths for perfusion fluid and discharge as taught by Shin since it would be a mere substitution with a known microdialysis probe structure with known downstream fluid handling that works with the electroosmotic actuation for more stable perfusate delivery.
Regarding claim 27, Carr discloses at least a first capillary situated in the probe cavity and defining a flow channel [col.4, l.56 to col.5, l.42; fig.2: a hollow fiber arranged in the slit so that two stretches of hollow fiber come to lie next to one another].
Regarding claim 28, Carr discloses the first capillary extends beyond the probe body at a proximal end of the probe body [col.5, ll.15-42: if the slit starts in the probe body, the hollow fiber can emerge from the probe body and extend through the slit].
Regarding claim 30, Shin discloses a first electrode and a second electrode coupled to produce an electro-osmotic (EO) flow from the probe cavity to the MD probe [Abstract; fig. 2D, 2E-2F: first and second electrodes on both sides of membrane, with EO flow generated by voltage polarity changes].
Regarding claim 31, Shin discloses at least one current source coupled to the first and second electrodes and adapted to vary dispensation of the perfusate based on a variable current [fig.11-12; 401, 402].
Regarding claim 32, Carr discloses the probe body and the MD probe are secured to each other [fig.3]. Shin discloses the MD probe 11 connected to the transfer path portion 14, with fastening members and O-rings providing secure coupling [fig.2A].
Regarding claim 33, Shin discloses the orifice of the probe body faces the MD probe [fig.4b; perfusate delivery through the inlet passage 11a to the MD probe 11 and fluid return through the discharge path to the sensor, which inherently requires oriented fluid communication between the delivery opening and the receiving MD structure].
Claim(s) 9-10, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carr and Shin as applied to the associated claims above, and further in view of “Hoss”, US Patent 7169600.
Regarding claim 9, Carr and Shin did not disclose explicitly multiple reservoirs.
Hoss teaches a similar microdialysis device with at least two separate reservoirs for perfusion liquids with different glucose concentrations, including a first reservoir with glucose-free perfusion liquid and a second reservoir with glucose-containing perfusion liquid. Hoss further teaches that the flow mixer connects those reservoirs and the perfusate tube leading to the microdialysis probe. [col.2, ll.13-18; col.3, ll.32-51; col.4, ll.29-40; col.5, ll.33-50].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microdialysis probe of Carr and Shin with the multiple-reservoirs perfusate system teaching as of Hoss to allow selective perfusate composition while maintaining EO-driven transport.
Regarding claim 10, Shin discloses first and second electrodes 201, 202 coupled to the electroosmotic pump 13 and used to generate alternating suction and discharge forces by alternating polarity [fig. 2D–2F]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use SHIN’s EO electrode-based actuation in conjunction with Hoss’s separate reservoirs to control fluid delivery.
Regarding claim 16, Shin discloses the EO flow-generation mechanism using first and second electrodes 201, 202 and electroosmotic pump 13 as discussed above. Hoss teaches at least two separate reservoirs for perfusion liquids with different glucose concentrations and that the perfusate store may have a first reservoir containing glucose-free perfusion liquid and a second reservoir containing glucose-containing perfusion liquid. Hoss further teaches that the flow mixer connects to the reservoirs and the microdialysis probe. [col.2, ll.13-18; col.3, ll.32-51; col.4, ll.29-40; col.5, ll.33-50] It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microdialysis probe of Carr and Shin with multiple reservoirs perfusate system teaching as of Hoss to allow selective perfusate composition while maintaining EO-driven transport.
Regarding claim 17, Shin discloses a power supply unit that supplies a DC voltage to the first and second electrodes and alternates polarity at predetermined time intervals, thereby varying electroosmotic flow. Shin also explains that the flow rate can be adjusted by changing pulse voltage and pulse time [fig.2D–2F, 11–12].
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carr and Shin as applied to the associated claim above, and further in view of “Lalwani”, WO 2019136133.
Carr and Shin did not disclose explicitly details of the probe material.
Lalwani discloses a similar microneedle device comprising direct laser writing material [0125-127].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microdialysis probe of Carr and Shin with the laser direct writing teaching of Lalwani to efficiently design or define the probe cavity with a direct laser writing material that is cost efficient [Lalwani: 0126].
Conclusion
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/TSE CHEN/ Supervisory Patent Examiner, Art Unit 3791
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