DETAILED ACTION
A complete action on the merits of pending claims 3-7, 9-21, 68, and 69 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
Claims 68 and 69 recite the limitation "the peripheral nerve". There is insufficient antecedent basis for this limitation in the claim.
Claim 68 recites the limitation "the cuff structure". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
Claims 3-7, 9-16, 19-21, and 68 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Monazami US 20210123641.
Regarding claim 3, Monazami teaches a microfluidic system configured to route a fluid comprising a liquid coolant and a dry gas (par. [0092] conversion of liquid nitrogen or carbon dioxide to gas) around the target region to change a local temperature of the target region so as to reversibly block activities of the target region, wherein the microfluidic system is operably in communication with the target region (par. [0038] cooling tissue to reduce pain); wherein the microfluidic system utilizes a liquid to gas phase transition as a cooling mechanism to change the local temperature of the target region (par. [0092] phase transition); and wherein the microfluidic system comprises a soft, flexible microfluidic layer configured to interface a target tissue/organ (par. [0060] contact member 110 can be rigid or flexible to conform to an ankle, shoulder, etc.).
Regarding claim 4, Monazami teaches wherein the microfluidic system comprises at least one fluidic chamber formed in a microfluidic layer (Fig. 1C chambers 150a-c).
Regarding claim 5, Monazami teaches wherein the at least one fluidic chamber has a length, a footprint and a volume, wherein the length defines a coverage angle of the microfluidic system when wrapping around the target region (Fig. 1C chambers 150a-c with microchannels 153).
Regarding claim 6, Monazami teaches wherein a cooled area in the target region is confined predominately to a surface directly associated with the at least one fluidic chamber (Fig. 1A).
Regarding claim 7, Monazami teaches fluid interconnects wherein the fluidic interconnects comprise: at least first and second input channels (par. [0047] one or more inlets 142), and at least one output channel (par. [0047] one or more outlets 144), each of which having a first end, and a second end fluidically connected to the at least one fluidic chamber, wherein the at least first and second input channels are configured to deliver the fluid to the at least one fluidic chamber, and the at least one output channel is configured to withdraw the fluid from the at least one fluidic chamber; and wherein the fluidic interconnects and the at least one fluidic chamber form a completely sealed microfluidic circuit having fluidic access only at the first ends of the at least first and second input channels and the at least one output channel (par. [0046] cycle of condenser 180, to 142, into working channels, to 144, and back to condenser 180).
Regarding claim 9, Monazami teaches wherein the at least one output channel is arranged colinearly with colinear to the at least first and second input channels (Fig. 1C input and output channels in the same line of the device).
Regarding claim 10, Monazami teaches wherein the first and second input channels have widths in ranges of about 50-150 µm and about 200-600 µm, respectively, and the output channel has a width in a range of about 200-600 µm (par. [0114] channels can be between 100 nanometers and a few hundred microns).
Regarding claim 11, Monazami teaches wherein the fluid comprises a liquid coolant and the dry gas (par. [0092] mixture of different materials and fluids including liquids and gases) being are operably transported into the at least one fluidic chamber via the first and second input channels, respectively (par. [0047] multiple fluid input channels).
Regarding claim 12, Monazami teaches wherein the microfluidic system is configured such that a simultaneous initiation of the liquid coolant and the dry gas flows into the at least one fluidic chamber prompts evaporation of the coolant at the microfluidic junction between the first and second input channels of the liquid coolant and the dry gas and along the at least one fluidic chamber (par. [0092] cooling by phase change).
Regarding claim 13, Monazami teaches wherein the at least one fluidic chamber comprises at least one serpentine microfluidic channel formed with a plurality of U-shaped turns over a region in the microfluidic layer (Fig. 1C U-shaped turns made by arrows F1-3).
Regarding claim 14, Monazami teaches wherein the at least one serpentine microfluidic channel operably routes a volume of the coolant to the target region where a flow of the dry gas triggers local and fully contained evaporation of the coolant (par. [0051] cooling through phase change going through U-shaped areas F1-3).
Regarding claim 15, Monazami teaches wherein mass flow rates of the coolant and the dry gas, and the length, the footprint and the volume of the at least one fluidic chamber determine magnitude and localization of the cooling effect (Fig. 1A and 6 device sitting on tissue area).
Regarding claim 16, Monazami teaches wherein the coolant is fluorocarbons (par. [0092] HFCs), and wherein the dry gas comprises any dry gas including N2, CO2, argon, or mixtures thereof (par. [0092] carbon dioxide that can be gas or liquid).
Regarding claims 19 and 20, Monazami teaches wherein the microfluidic system further comprises at least one first pump in fluidic communication with the at least first and second input channels for delivering the fluid to the at least one fluidic chamber to change the local temperature of the target region and wherein the microfluidic system further comprises at least one second pump in fluidic communication with the at least one output channel for withdrawing the fluid from the at least one fluidic chamber (par. [0091] pump for pumping fluid through inflow conduit and pump for pumping out evaporative fluid).
Regarding claim 21, Monazami teaches being configured such that a phase change prompts a temperature of the device in a planar (par. [0163]), uncurled configuration to drop to about -20°C within about 2 min or less after initializing flow in ambient, room temperature conditions (par. [0057]).
Regarding claim 68, Monazami teaches further comprising: an electronic system coupled with the microfluidic system for providing real time closed loop feedback, the electronic system comprising a bioresorbable, flexible temperature sensor embedded in the cuff structure and configured to measure the local temperature of the peripheral nerve and to control flow rates of the liquid coolant and the dry gas in the microfluidic system based on the measured local temperature (par. [0063] using temperature of the treated tissue in a feedback loop for temperature regulation).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Monazami in view of Barbut US 20060276552.
Regarding claim 17, Monazami does not explicitly teach wherein the coolant is a bioinert coolant including perfluoropentane (PFP). However, Monazami teaches where the coolant can be a fluorocarbon (par. [0092]).
Barbut, in a device seeking to cool portions of the body, teaches perfluoropentane is a fluorocarbon that can be used for phase transition cooling (par. [0128]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Monazami to use perfluoropentane, as in Barbut. It is a known fluorocarbon used in the art. It would yield the predictable result of mixing with gas to initiate a phase transition for cooling (Barbut par. [0226]).
Claims 18 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Monazami in view of Young US 20220331152.
Regarding claim 18, Monazami does not explicitly teach wherein the coolant is a non-bioinert coolant including diethyl ether.
Young, in an analogous thermal treatment device, teaches where the coolant can include diethyl ether (par. [0090]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Monazami to use diethyl ether, as in Young. It is a known fluid used for cooling in the art that is seen to preform equally as well as those used in Monazami. It would yield the predictable result of providing thermal therapy to the desired tissue area.
Regarding claim 69, Monazami teaches wherein the soft, flexible microfluidic layer terminates in a cuff structure configured to wrap around the peripheral nerve to provide a sutureless mechanical and thermal interface around the peripheral nerve.
Monazami does not explicitly teach wherein the liquid to gas phase transition occurs directly within the soft, flexible microfluidic layer via the liquid coolant and the dry gas intersecting at a microfluidic junction. However, Monazami teaches that a phase transition happens between the mingling of different fluids (par. [0092]).
Young, in an analogous thermal treatment device, teaches where the thermal device is inside of the flexible wearable layer (pars. [0033] and [0046] and Fig. 1D).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Monazami to have the phase transition happen in the flexible wearable element, as in Young. Integrating the phase changing area into the wearable prevents large heat buildup (Young par. [0030]).
Response to Arguments
Applicant's arguments filed 7/2/26 have been fully considered but they are not persuasive. The applicant argues that Monazami does not explicitly teach a flexible layer. They state that 110 is a rigid plate that contacts skin or a semiconductor surface. As shown above in par. [0092] contact 110 can be rigid or flexible. Therefore, the arguments presented by the applicant are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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