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 .
Remarks
This Office Action fully acknowledges applicant’s remarks filed 06/15/2026. Claims 13-26 are pending. Claims 13, 15 22 and 25 have been amended.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 fails to comply with 37 CFR 1.121(c) and is required to have a status identifier of ‘Currently Amended’ since the claim as originally filed has been amended.
Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
Appropriate correction is required.
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.
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.
1. Claims 13-26 are rejected under 35 USC 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0272958 to Ramsey et al. in view of U.S. Patent Application Publication No. 2019/0275522 to Dieguez et al. and U.S. Patent No. 10,753,920 to Pangarkar et al.
Ramsey et al. discloses a nanofluidic device that includes a channel 15e that, as shown in Fig. 5, has a decreasing cross-sectional area and a plurality of posts 16 (columns) that form a trapping section. [0024]-[0025], [0084]
Ramsey et al. does not teach that the posts support the channel wall from collapsing.
Dieguez et al. teaches a microscale cell filter for trapping sub-portions of cells (Abstract) that includes a plurality of post elements 8 that, as shown in Fig. 2 extend between cover 13 and substrate 12 with which the posts are integrally formed. [0059]
It would have been obvious to one of ordinary skill in the art to modify Ramsey et al. to form the posts 16 to extend between the bottom and top of the channel 15e as taught by Dieguez et al. as a matter of design choice.
Modifying Ramsey et al. so that the posts 16 extend between the bottom and top of the channel 15e would support the channel wall from collapsing.
The recitation of the columns being formed as a free-standing structure in claim 13 is directed to the process by which the columns are intermediately formed as shown in Fig. 1(c) which does not limit the final structure of the columns. The columns in the nanofluidic device, as shown in Fig. 1(d) after fabrication extend between the bottom and top of the channel, as do the posts in Ramsey et al. in view of Dieguez et al.
As to the newly recited limitation that “the trapping section having a decreasing channel height over the channel length in the flow direction,” Pangarkar et al. teaches positioning cells in a narrow channel for viewing (Abstract) and constraining cells in a small space for imaging (column 2, lines 11-18) and illustrates in Fig. 3D providing a small space for positioning cells by decreasing the height of channel 331.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Ramsey et al. in view of Dieguez et al. to decrease the height of the channel over the channel length in the flow direction as taught by Pangarkar et al. for purposes of trapping particles in the narrowed portions of the channel.
I.) As noted above, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders all the limitations of claim 13 obvious.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious.
II.) Regarding applicant’s claim 14, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that a distance between adjacent ones of said support columns is chosen to be larger than a size of a smallest one of the particles to be trapped.
The fluid containing particles is not a structural element of the nanofluidic device of claim 13. Accordingly, the distance between adjacent ones of the columns is not a limitation of the structure of the nanofluidic device absent the fluid.
Ramsey et al. teaches trapping cells and nanoparticles. [0078], [0098].
It would have been obvious to one of ordinary skill in the art to modify Ramsey et al. in view of Dieguez et al. and Pangarkar et al. to configure the distance between adjacent ones of the posts to be larger than a size of a smallest one of the particles to be trapped in any desired fluid.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 14 obvious.
III.) Regarding applicant’s claim 15, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 15 depends.
Claim 15 recites that the particles to be trapped contained in the fluid vary in size and a cross-sectional area of and inlet to said trapping section is larger than a size of a biggest one of the particles to be trapped and cross-sectional area of an outlet from said trapping section is smaller than a size of a smallest one of the particles to be trapped.
The fluid containing particles is not a structural element of the nanofluidic device of claim 13. Accordingly, neither the particle size to be trapped nor the cross-sectional area of the inlet and outlet of the trapping section are not structurally limited in claim 13.
Ramsey et al. teaches trapping cells and nanoparticles. [0078], [0098].
It would have been obvious to one of ordinary skill in the art to modify Ramsey et al. in view of Dieguez et al. and Pangarkar et al. to configure the cross-sectional area of the inlet of the trapping section to be larger than a size of a biggest one of the particles to be trapped and the cross-sectional area of the outlet to be smaller than a size of a smallest one of the particles to be trapped for particles in any desired fluid.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 15 obvious.
IV.) Regarding applicant’s claim 16, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 16 depends.
Claim 16 recites that the channel and said trapping section are configured to convey the fluid by capillary force.
Ramsey et al. in view of Dieguez et al. and Pangarkar et al. does not teach that the channel and said trapping section are configured to convey the fluid by capillary force.
Dieguez et al. teaches configuring channels in a microscale cell to effect capillary flow. [0042]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Ramsey et al. in view of Dieguez et al. and Pangarkar et al. to configure the channel and trapping section to effect capillary flow therethrough as taught by Dieguez et al.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 16 obvious
V.) Regarding applicant’s claim 17, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 17 depends.
Claim 17 recites that the channel is one of a plurality of channels each with a respective trapping section.
Ramsey et al. in view of Dieguez et al. and Pangarkar et al. does not teach that the channel is one of a plurality of channels each with a respective said trapping section.
It would have been obvious to modify Ramsey et al. in view of Dieguez et al. and Pangarkar et al. so that the channel is one of a plurality of channels each with a respective trapping section. Note, duplication of parts has no patentable significance unless a new and unexpected result is produced. (MPEP 2144.04(VI)(B))
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 17 obvious.
VI.) Regarding applicant’s claim 18, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 18 depends.
Claim 18 recites that the material of said channel wall is a thermoplastic.
Ramsey et al. teaches thermoplastics as a material for the nanofluidic device. [0096]
Dieguez et al teaches PMMA as a material for the microscale cell. [0015]
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 18 obvious.
VII.) Regarding applicant’s claim 19, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 19 depends.
Claim 19 recites that the column supports are generated by replication methods of a negative master pattern copy into a free-standing substrate thereby generating a patterned substrate.
Claim 19 recites how the column supports are fabricated, but does not further limit the structural limitations of claim 13.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 19 obvious as being dependent on claim 13.
VIII.) Regarding applicant’s claim 20, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 19 obvious from which claim 20 depends.
Claim 20 recites that the channel with said trapping section is generated by ultra-violate (UV)/O-assisted bonding of a patterned and an unpatterned substrate.
Claim 20 recites how the channel and trapping section are fabricated, but does not further limit the structural limitations of claim 13.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 20 obvious as being dependent on claim 19.
IX.) Regarding applicant’s claim 21, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 21 depends.
Claim 21 recites that the support columns have a cross-sectional area in a range from 10 pm2 to 2000 pm2.
Ramsey et al. in view of Dieguez et al. and Pangarkar et al. does not teach that the support columns have a cross-sectional area in a range from 10 pm2 to 2000 pm2.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Ransey et al. in view of Dieguez et al. and Pangarkar et al. to configure overall size of the device to process any desired volume of fluid having any size of target particles, including providing the posts with a cross-sectional area in a range from 10 pm2 to 2000 pm2 for processing a desired fluid with desired target particles. Note, changes in relative dimensions are not patentable if the resulting device would not perform differently. (MPEP 2144.04 (IV)(A))
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 21 obvious.
X.) Regarding applicant’s claim 22, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 22 depends.
Claim 22 recites that cross-sectional areas of said channel are configured to size-dependently separate a multiparticle mixture at distinct positions within said trapping section.
In Ramsey et al. teaches that the arrays of posts can have different sizes and configurations. [0101]. Claim 22 only requires a single array (course) of posts that separate a multiparticle mixture according to a single particle size.
Ramsay et al. in view of Dueguez et al. and Pangarkar et al. includes at least one cross-sectional area of the channel that is configured to size-denpendently separate a multiparticle mixture at distinct positions within the trapping section.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 22 obvious.
XI.) Regarding applicant’s claim 23, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 22 obvious from which claim 23 depends.
Claim 23 recites that each said trapping section is used to perform an on-bead immunoassay.
Claim 23 recites the use of the nanofluid device, but does not further limit the structure thereof.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 23 obvious as being dependent on claim 22.
XII.) Regarding applicant’s claim 24, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 24 depends.
Claim 24 recites that multiple inflows are provided to perform distinct immunoassays for different antigen targets.
Ramsey et al. in view of Dieguez et al. and Pangarkar et al. does not teach multiple inflows.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Ramsey et al. in view of Dieguez et al. and Pangarkar et al. to have multiple inflows for purposes of switching fluids to be processed and/or flushing the device with a cleaning fluid after or between use.
The recitation in claim 24 of performing distinct immunoassays for different antigen targets does not incorporate a structural limitation.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 24 obvious.
XIII.) Regarding applicant’s claim 25, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 25 depends.
Claim 25 recites that the nanofluidic device is configured to provide rapid and multiplexed serological antibody detection.
Claim 25 recites an optional use of the nanofluidic device that does not further limit claim 13.
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 25 obvious as being dependent on claim 13.
XIV.) Regarding applicant’s claim 26, as noted above Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 13 obvious from which claim 21 depends.
Claim 26 recites that the support columns have a cross-sectional area in a range from 20 pm2 to 70 pm2.
Ramsey et al. in view of Dieguez et al. and Pangarkar et al. does not teach that the support columns have a cross-sectional area in a range from 20 pm2 to 70 pm2.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Ransey et al. in view of Dieguez et al. and Pangarkar et al. to configure overall size of the device to process any desired volume of fluid having any size of target particles, including providing the posts with a cross-sectional area in a range from 20 pm2 to 70 pm2 for processing a desired fluid with desired target particles. Note, changes in relative dimensions are not patentable if the resulting device would not perform differently. (MPEP 2144.04 (IV)(A))
Therefore, Ramsey et al. in view of Dieguez et al. and Pangarkar et al. renders claim 26 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 13-26 have been considered but are moot because the new ground of rejection relies upon Pangarkar et al. as teaching positioning cells in a narrow channel and providing a small space for positioning cells by decreasing the height of channel, as necessitated by applicant’s amendments to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Patent Application Publication No. 2018/0372758 to Larsen discloses providing local sample volumes in a channel by decreasing the height of the channel.
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.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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