CTNF 18/559,099 CTNF 98022 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 15, 22, 23 and 25 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 cross-sectional area of the trapping section in a manner that is dependent on the size of the particles in a fluid passing through the channel. Because claim 15 does not recite or otherwise limit the size of the particles other than in reference to the fluid, the cross-sectional area of the trapping section is indefinite. Claim 15 also recites “its inlet” and “its outlet” in lines 2 and 3 which limitations lack sufficient antecedent basis in the claim. In claim 22, the recitation “a course of cross-sectional area configured to separate a multiparticle mixture” in unclear. Claim 23 depends on claim 22. Claim 25 recites an optional use of the nanofluidic device that if not used, causes claim 25 not to recite any limitations. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA 1. Claim s 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 . 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. I.) As noted above Ramsey et al. in view of Dieguez et al. renders all the limitations of claim 13 obvious. Therefore, Ramsey et al. in view of Dieguez et al. renders claim 13 obvious. II.) Regarding applicant’s claim 14, as noted above Ramsey et al. in view of Dieguez 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. 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. renders claim 14 obvious. III.) Regarding applicant’s claim 15, as noted above Ramsey et al. in view of Dieguez et al. renders claim 13 obvious from which claim 15 depends. Claim 15 recites that a cross-sectional area of said trapping section is chosen to be at its inlet larger than a size of a biggest one of the particles to be trapped and at its outlet 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, the cross-sectional area of the inlet and outlet of the trapping section is 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. 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. renders claim 15 obvious. IV.) Regarding applicant’s claim 16, as noted above Ramsey et al. in view of Dieguez 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. 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. 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. renders claim 16 obvious V.) Regarding applicant’s claim 17, as noted above Ramsey et al. in view of Dieguez 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. 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. 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. renders claim 17 obvious. VI.) Regarding applicant’s claim 18, as noted above Ramsey et al. in view of Dieguez 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. renders claim 18 obvious. VII.) Regarding applicant’s claim 19, as noted above Ramsey et al. in view of Dieguez 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. 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. 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. 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. 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 pm 2 to 2000 pm 2 . Ramsey et al. in view of Dieguez et al. does not teach that the support columns have a cross-sectional area in a range from 10 pm 2 to 2000 pm 2 . 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. 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 pm 2 to 2000 pm 2 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. renders claim 21 obvious. X.) Regarding applicant’s claim 22, as noted above Ramsey et al. in view of Dieguez et al. renders claim 13 obvious from which claim 22 depends. Claim 22 recites that a course of cross-sectional area configured to separate a multiparticle mixture is separated 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. Therefore, Ramsey et al. in view of Dieguez et al. renders claim 22 obvious. XI.) Regarding applicant’s claim 23, as noted above Ramsey et al. in view of Dieguez 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 if Dieguez 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. 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. 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. 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. renders claim 24 obvious. XIII.) Regarding applicant’s claim 25, as noted above Ramsey et al. in view of Dieguez et al. renders claim 13 obvious from which claim 25 depends. Claim 25 recites that the nanofluidic device is preferably but not limited to 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. 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. 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 pm 2 to 70 pm 2 . Ramsey et al. in view of Dieguez et al. does not teach that the support columns have a cross-sectional area in a range from 20 pm 2 to 70 pm 2 . 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. 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 pm 2 to 70 pm 2 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. renders claim 26 obvious . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Application Publication No. 2014/0194313 to Craighead et al. teaches arrays of micropillars that have different cross-sectional areas as shown in Fig. 1 . 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798 Application/Control Number: 18/559,099 Page 2 Art Unit: 1798 Application/Control Number: 18/559,099 Page 3 Art Unit: 1798 Application/Control Number: 18/559,099 Page 4 Art Unit: 1798 Application/Control Number: 18/559,099 Page 5 Art Unit: 1798 Application/Control Number: 18/559,099 Page 6 Art Unit: 1798 Application/Control Number: 18/559,099 Page 7 Art Unit: 1798 Application/Control Number: 18/559,099 Page 8 Art Unit: 1798 Application/Control Number: 18/559,099 Page 9 Art Unit: 1798 Application/Control Number: 18/559,099 Page 10 Art Unit: 1798 Application/Control Number: 18/559,099 Page 11 Art Unit: 1798 Application/Control Number: 18/559,099 Page 12 Art Unit: 1798