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 Status
Claims 1, 3, 4, 7-10, 26, 28, and 33 are pending.
Claims 11-14, 16, 19, 20, 22, 25, 31, and 32 has been withdrawn.
Claims 2, 5, 6, 15, 17, 18, 21, 23, 24, 27, 29, 30 have been canceled.
Claims 1, 3, 4, 9 have been amended.
Claim 33 is new.
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.
Claims 1, 3, 4, 7-10, and 33 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Spero et. al. (WO 2018236833 A1).
Regarding claim 1, McMillan teaches “A micro fluidic” (Title, microfluidic systems); “reaction chamber comprising” (Figs. 2A and 2B, reaction chamber 105)- “a housing” (Figs. 2A and 2B, active surface device 100) “enclosing a chamber” (Paras, [0060] and [00101], FIG. 3A and FIG. 3B, microposts 122 and substrate 124 can be formed of an active surface material, for example PDMS. Any features can be integrated into the presently disclosed modular active surface devices 100.) “situated in the chamber” (Fig. 22A, antechamber 114) “the active surface comprising one or more actuable microposts” (Paras [0006] and [0060], microposts 122 and substrate 124, actuated surface-attached microposts) “and a dried reagent” (Para [00101], dried reagent 170) “deposited on the active surface” (Paras, [0060] and [00101], FIG. 3A and FIG. 3B, microposts 122 and substrate 124 can be formed of an active surface material, for example PDMS. Any features can be integrated into the presently disclosed modular active surface devices 100.); “and an opening” (Fig. 22A, includes fluid ports 112).
The recitation “suitable for flowing a liquid into and/or out of the chamber” is capability of the opening however taught within (Para [0053], Further, modular active surface device 100 includes fluid ports 112 (e.g., an input port and output port) in relation to reaction chamber 105.)
Additional recited capability is “wherein the one or more actuable microposts of the active surface are configured to resuspend the dried reagent, mix the liquid and the dried reagent within the chamber, or both,” which is taught within (Para [0012], the antechamber of the modular active surface device comprises dried reagent and/or a dried reagent pellet configured to dissolve when a sample fluid is added to the antechamber, thereby enabling a mixture of sample fluid and reagent to flow into the reaction chamber.).
The recitation “and wherein the one or more actuable microposts are configured to form a substantially homogenous mixture within the chamber” is a capability of the actutable microposts. Since Spero discloses the positively claimed structural elements of the actutable microposts as claimed, therefore the actutable microposts of Spero are fully capable of forming a substantially homogeneous mixture. As the actutable microposts of Spero comprise dried reagent and/or a dried reagent pellet that dissolves when a sample fluid is added to the antechamber, this enables a mixture of sample fluid and reagent to flow into the reaction chamber capable of being homogenous mixture in as much as positively claimed.
Further taught is homogeneous modification within (Para [00105], Other variations and features of the presently disclosed modular active surface devices 100 may include, but are not limited to, the following. Any surface in reaction chamber 105, including the microposts 122 themselves, can be modified, for example, to promote binding of a target analyte, to promote binding of something to select out for purifying the sample, modified like a microarray, and so on. There can be homogeneous modification or local modification (e.g., dots)).
Regarding claim 3, Spero teaches all of claim 1 as above in addition to “wherein the one or more actuable microposts form an active surface layer,” (Para [0006], The active surfaces of the modular active surface device are configured to manipulate a fluid inside the reaction chamber. The active surfaces comprise one or more elements selected from the group consisting of static surface-attached microposts, actuated surface-attached microposts, a microscale texture, a microscale topography); “and wherein the dried reagent coats some or all of the microposts.” (Para [00103] and [0090]- Using a freeze drying (lyophilization) process, dried reagents and be provided on the microposts 122 themselves.). Therefore, the dried reagents on the microposts which are within the reaction chamber teaches to the dried reagent coating some or all of the microposts.
Regarding claim 4, Spero teaches all of claim 1 as above in addition to “wherein the dried reagent comprises one or more spots of dried reagent, (Para [0012], the antechamber of the modular active surface device comprises dried reagent and/or a dried reagent pellet configured to dissolve when a sample fluid is added to the antechamber, thereby enabling a mixture of sample fluid and reagent to flow into the reaction chamber.); “and wherein the dried reagent coats a surface of the chamber.” (Para [00103], In another example, using a freeze drying (lyophilization) process, dried reagents and be provided on the microposts 122 themselves.). Therefor the microposts are a surface on the chamber and the dried reagent is coating the microposts.
Regarding claim 7, Spero teaches all of claim 1 as above in addition to “comprising a liquid in the chamber rehydrating the dried reagent.” (Paras [0012], the antechamber of the modular active surface device comprises dried reagent and/or a dried reagent pellet configured to dissolve when a sample fluid is added to the antechamber, thereby enabling a mixture of sample fluid and reagent to flow into the reaction chamber.).
Regarding claim 8, Spero teaches all of claim 1 as above in addition to “An instrument comprising” (Para [0040], For example, the actuation occurs by contacting cell processing chamber with the control instrument comprising elements that provide an actuation force, such as a magnetic or electric field. Accordingly, the control instrument includes, for example, any mechanisms for actuating the microposts (e.g., magnetic system), any mechanisms for counting the cells (e.g., imaging system), the pneumatics for pumping the fluids (e.g., pumps, fluid ports, valves), and a controller (e.g., microprocessor).; “the microfluidic reaction chamber of claim 1” (already taught within claim 1); “and an actuator arranged relative to the active surface of the active surface device in a spatial relationship” (Paras [0040] and [00103], Accordingly, the application of an actuation force actuates the movable surface- attached microposts into movement. For example, the actuation occurs by contacting cell processing chamber with the control instrument comprising elements that provide an actuation force, such as a magnetic or electric field. Accordingly, the control instrument includes, for example, any mechanisms for actuating the microposts (e.g., magnetic system), any mechanisms for counting the cells (e.g., imaging system), the pneumatics for pumping the fluids (e.g., pumps, fluid ports, valves), and a controller (e.g., microprocessor). The linear actuator.
The recitation “which permits the actuator to actuate the active surface.” is capability of the actuator. Spero discloses the positively claimed structural elements of the actuator as claimed, such actuator are said to be fully capable of the recited adaption in as much as recited and required herein. However an actuation is taught within Para [0040].
Regarding claim 9, Spero teaches “A microfluidic cartridge” (Para [0005}], and further wherein the modular active surface device is configured to integrate into a microfluidics cartridge.); comprising a recessed region, wherein the” (Para [0010], In another embodiment, the modular active surface device is configured to integrate into a microfluidics cartridge that comprises a recessed region configured to receive the modular active surface device.); “the microfluidic reaction chamber of claim 1” (already disclosed within claim 1); “fitted into the recessed region the microfluidic cartridge,” (Para [0010], as above);. The recitation “thereby causing fluid coupling between the opening and the microfluidic cartridge.” is capability of the cartridge however taught within (Para [0010], In another embodiment, the microfluidics cartridge further comprises fluid lines set to correspond to the fluid port, wherein when microfluidics device receives the modular active surface device, the microfluidics device and the modular active surface device are fluidly coupled.).
Regarding claim 10, Spero teaches all of claim 9 as above in addition to “An instrument comprising:” (Para [0040], above); “the micro fluidic cartridge of claim 9;” (already taught within claim 9); “and an actuator arranged relative to the active surface of the active surface device of the micro fluidic cartridge in a spatial relationship” (Paras [0040] and [00103], Accordingly, the application of an actuation force actuates the movable surface- attached microposts into movement. For example, the actuation occurs by contacting cell processing chamber with the control instrument comprising elements that provide an actuation force, such as a magnetic or electric field. Accordingly, the control instrument includes, for example, any mechanisms for actuating the microposts (e.g., magnetic system), any mechanisms for counting the cells (e.g., imaging system), the pneumatics for pumping the fluids (e.g., pumps, fluid ports, valves), and a controller (e.g., microprocessor. The linear actuator.).
The recitation “which permits the actuator to actuate the active surface.” is capability of the actuator. Spero discloses the positively claimed structural elements of the actuator as claimed, such actuator are said to be fully capable of the recited adaption in as much as recited and required herein. However an actuation is taught within Para [0040].
Regarding Claim 33, Spero teaches all of claim 1 as above. The recitation “wherein the one or more actuable microposts are configured to enhance the speed of rehydration of the reagent within the chamber.” is capability of the actuable microposts. Spero discloses the positively claimed structural elements of the actuable microposts as claimed, such actuable microposts are said to be fully capable of the recited adaption in as much as recited and required herein.
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.
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.
Claims 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Spero et. al. (WO 2018236833 A1) as applied to claim 1 above and in view of Mauk et. al. (US20090226911).
Regarding claim 26, Spero teaches all of claim 1 as but does not teach “wherein the microfluidic reaction chamber is separated by one or more dissolvable dried reagent barriers, wherein the dried reagent barriers comprise an inert reagent, and wherein the dried inert reagent barrier is dissolvable at a controlled rate, thereby acting as a valving mechanism within the active surface device.”.
Mauk teaches chambers within inlets which can be part of a larger integrated microfluidic system in addition to “wherein the microfluidic reaction chamber is separated by one or more dissolvable dried reagent barriers, wherein the dried reagent barriers comprise an inert reagent, and wherein the dried inert reagent barrier is dissolvable at a controlled rate, thereby acting as a valving mechanism within the active surface device.” (Abstract and Para [0018], a preloaded analysis modules, which modules comprise a chamber and a barrier material disposed within the chamber, the barrier material being immiscible with aqueous media, the barrier material being capable of being activated so as to release material disposed within the barrier material; and at least one reagent disposed within the barrier material. The reagent is suitably substantially inert to the barrier material. Disclosed are preloaded analysis modules comprising reagents disposed within a barrier material capable of liberating the reagents, at a time advantageous to a reaction scheme, when exposed to certain activation conditions or reagents.). The recitation “thereby acting as a valving mechanism within the active surface device” is capability of the dried inert barrier. Modified McMillan discloses the positively claimed structural elements of the dried inert barrier as claimed, such dried inert barrier are said to be fully capable of the recited adaption in as much as recited and required herein.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified over Spero to incorporate the teachings of Mauk wherein the microfluidic reaction chamber is separated by one or more dissolvable dried reagent barriers, wherein the dried reagent barriers comprise an inert reagent, and wherein the dried inert reagent barrier is dissolvable at a controlled rate, thereby acting as a valving mechanism within the active surface device. Doing so increases reaction control and allows for reactions to happen when needed and introduces reagents when needed.
Regarding claim 28, modified Spero teaches all of claim 26 as above. Further to Mauk teaches “comprising two or more of the dried inert reagent barriers dissolvable at different rates.” (Para [0027], the barrier material achieves upon activation a density different than that of aqueous media. In such cases, the barrier material may float upwards so as to avoid interference with a reaction proceeding within the chamber; other barriers may maintain or increase their density. Waxes are considered suitable materials for these embodiments.). Therefore, having more than one barrier, that have the dried reagent with it, which activate at different densities teaches to the dissolvable at different rates.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified over Spero to incorporate further teachings of Mauk having two or more of the dried inert reagent barriers dissolvable at different rates. Doing so increases the versatility of the device and allows more than one reagent to enter the chamber at different times which allows for optimization for the type of reaction needed.
Response to Amendments
Claim Amendments
Applicant’s amendments to independent claims pending claims have overcome the objection set forth in the non-final dated 7/23/2025. Claim 9 amendments have overcome the 112b rejection set forth in the non-final dated 7/23/2025.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered.
Applicant states McMillan fails to disclose all the features of the claims rejected under McMillan in the 102 rejection.
Applicant argues that McMillan does not describe any single chamber configuration for implementation of a dried reagent, and further does not disclose any active surface within a reaction chamber comprising one or more actuable microposts, where the actuable microposts are configured to resuspend the dried reagent and further configured to form a homogenous mixture, incorporating the resuspended reagent, within the chamber.
Examiner has withdrawn the rejection set forth in the non-final dated 7/23/2025 and made a new 102 rejection based on claim amendments. Examiner highlights that the recitation “actuable microposts are configured to resuspend the dried reagent and further configured to form a homogenous mixture, incorporating the resuspended reagent, within the chamber” is capability of the actuable microposts as discussed within the claim rejection.
Applicant argues McMillan specifically does not describe, teach, or suggest at least the features of "an active surface situated in chamber, the active surface comprising one or more actuable microposts and a dried reagent," and "wherein the one or more actuable microposts of the active surface are configured to resuspend the dried reagent, mix the liquid and the dried reagent within the chamber, or both, and wherein the one or more actuable microposts are configured to form a substantially homogenous mixture within the chamber."
Examiner has withdrawn the rejection set forth in the non-final dated 7/23/2025 and made a new 102 rejection based on claim amendments. Examiner highlights that “an active surface situated in chamber, the active surface comprising one or more actuable microposts and a dried reagent” is taught within the claims above. The recitation “wherein the one or more actuable microposts of the active surface are configured to resuspend the dried reagent, mix the liquid and the dried reagent within the chamber, or both, and wherein the one or more actuable microposts are configured to form a substantially homogenous mixture within the chamber.” is capability of the actuable microposts as discussed within the claim rejection.
Applicant submits that Spero does not teach or suggest at least the above-noted features, for instance, a micro fluidic reaction chamber comprising "an active surface situated in chamber, the active surface comprising one or more actuable microposts and a dried reagent," and "wherein the one or more actuable microposts of the active surface are configured to resuspend the dried reagent, mix the liquid and the dried reagent within the chamber, or both, and wherein the one or more actuable microposts are configured to form a substantially homogenous mixture within the chamber.".
Examiner disagrees and has made a new 102 rejection showing where Spero teaches and/ or is capable of the above capability of the claim as shown within the rejection.
Applicant submits Spero requires the reagent to be disposed in an antechamber separated from the reaction chamber and active surface so that the "[reagent] pellet [can] be stored in the module without risking physical damage to the active surface."
Examiner highlights that Spero teaches the dried reagent can be housed within the antechamber or along fluid path 116 or both. In addition, the claims do not structurally differentiate the claimed chamber from the antechamber 114 in Spero. The microposts are within chamber 105 as illustrated by ref. no. 110 which comprises the substrate and the microposts (see e.g., Fig. 2A ). Since the microposts are in the antechamber, in addition to the dried reagent, Spero meets the structural limitations of the claim.
Applicant submits Spero does not teach or suggest at least the features of "wherein the one or more actuable microposts of the active surface are configured to resuspend the dried reagent, mix the liquid and the dried reagent within the chamber, or both, and wherein the one or more actuable microposts are configured to form a substantially homogenous mixture within the chamber" and is instead concerned with a dried reagent separated from the active surface and resuspended prior to entering the reaction chamber, and further there is no teaching in Spero as to any configuration of achieving resuspension and homogeneity within the chamber itself.
Examiner highlights that the above recitations are capability of the actuable microposts and Spero is capable of such in as much as positively claimed.
Applicant submits no motivation to combine the microposts of Spero with the teachings of McMillan as it would not be obvious to pick that element out of the Spero reference and use it in the devices disclosed by McMillan.
Based on claim amendments the examiner has withdrawn the prior rejection using McMillan and made a new 102 rejection using Spero. Therefore the final rejection does not use McMillan in combination of Spero and therefore no additional motivation to combine needs to be shown.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798