DETAILED ACTION
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 of claims 1-10 and 16-20 (Group I) in the reply filed on 02/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected election, there being no allowable generic or linking claim.
Claims 11-18 are canceled.
Claims 21-27 are added to the invention of Group I.
Claim 1-10 and 19-27 are being examined herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/11/2024 is being considered by the examiner.
Drawings
Figures 2a and 2b (p. 13, Fig. 2a and 2b are non-claimed nanochannels) should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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, 5-8, 10, and 21-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esmek et al. (“Sculpturing wafer-scale nanofluidic devices for DNA single molecule analysis.” Nanoscale, 2019, 11, 13620. Published on 02 July 2019).
Regarding claim 1, Esmek teaches a nanofluidic analysis device for the analysis of DNA molecules, comprising a detection nanochannel (the nanochannel shown in Fig. 3d or 3e), a supply channel (the microchannel that is connected to the inlet of the nanochannel, Figs. 1a and 1b) in fluid communication with an inlet (see annotated Fig. A)(Figs. 1a, 1b) for the detection nanochannel and a discharge channel (the microchannel that is connected to the outlet, Figs. 1a and 1b) in fluid communication with an outlet (see annotated Fig. A) for the detection nanochannel, so that a fluid comprising DNA molecules introduced into the supply channel may flow along a flow direction through the supply channel, via the inlet into the detection nanochannel, through the detection nanochannel, and out of the outlet out of the detection nanochannel into the discharge channel (interpreted as an intended use. The fluid comprising DNA molecules is not positively recited. The microchannels and the nanochannel meet the structural limitation of the intended use. Moreover, Fig. 6 and p. 13625, right col.), wherein a laser detector system is provided for analyzing the DNA molecules in the detection nanochannel (a laser detector system is not positively recited, and since the limitation is directed to the laser detector system, the limitation does not further limit the structure of the invention. For the purpose of compact prosecution, p. 13626 teaches a laser detector system can be provided for analyzing DNA molecules in the detection nanochannel), wherein both a width and a depth of the inlet and thereby a cross section of the inlet decrease along the flow direction and wherein both a width and a depth of the outlet and thereby a cross section of the outlet increase along the flow direction (Figs. 3d and 3e), wherein the detection nanochannel has a length of not more than 35 mm (the detection nanochannel is 20 mm, Fig. 3).
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Figure A. Annotated Figs. 3d-f of Esmek.
Regarding claim 2, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek wherein the width of the inlet decreases uniformly along the flow direction and wherein the depth of the inlet decreases uniformly along the flow direction (Fig. 3d and p. 13623, left column, “funnel-like inlet”).
Regarding claim 3, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the inlet and the outlet are of a symmetric configuration (Fig. 3d or 3e).
Regarding claim 5, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the detection nanochannel has a length of at least 1 mm (Fig. 3 and p. 13623, 1st para. on the right, nanochannel is 20 mm).
Regarding claim 6, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the detection nanochannel comprises a cross section of no more than 62,500 nm2 (Fig. 3 caption, the cross-sectional area of the nanochannel is its width x depth = 260 nm x 220 nm = 57,200 nm2 )
Regarding claim 7, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the laser detector system comprises a laser source for illuminating the DNA molecules inside the detection nanochannel and a detecting element for detecting fluorescent light emitted by the illuminated DNA molecules (a laser detector system is not positively recited, and since the limitation is directed to the laser detector system, the limitation does not further limit the structure of the invention. For the purpose of compact prosecution, p. 13626 teaches a laser detector system comprising a laser source and a photo counter for analyzing DNA molecules in the detection nanochannel).
Regarding claim 8, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the nanofluidic analysis device is comprising a control unit adapted to record a fluorescence signal of the DNA molecule and to retrieve a barcode of the DNA molecule in real-time (Fig. 7c, pp. 13626-13627 teaches the device record a fluorescence signal and retrieving a barcode and thus the device has a control unit to perform the limitation).
Regarding claim 10, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1.
With respect to “wherein a fluid comprising DNA molecules is introduced into the supply channel and flows spontaneously along the flow direction through the supply channel without the help of an external force, in particular without a voltage difference or a pressure difference being applied to the inlet and outlet,” the invention is an apparatus and the fluid is not positively recited, and thus this method step is interpreted as an intended use. In addition, p. 13629, right column, a DNA containing Trition X-100- buffer liquid is transported through the supply channel (microchannel) via capillary action.
Regarding claim 21, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the width of the inlet decreases in multiple gradual steps along the flow direction (Fig. 3e, see also annotated Fig. A above).
Regarding claim 22, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the depth of the inlet decreases uniformly along the flow direction (Fig. 3d, see also annotated Fig. A above).
Regarding claim 23, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek further teaches wherein the depth of the inlet decreases in multiple gradual steps along the flow direction (Fig. 3e, see also annotated Fig. A above).
Regarding claim 24, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek teaches wherein the width of the outlet increases uniformly along the flow direction (Fig. 3d, see also annotated Fig. A above).
Regarding claim 25, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek wherein the width of the outlet increases in multiple gradual steps along the flow direction (Fig. 3e, see also annotated Fig. A above).
Regarding claim 26, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek wherein the depth of the outlet increases uniformly along the flow direction (Fig. 3d, see also annotated Fig. A above).
Regarding claim 27, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1. Esmek wherein the depth of the outlet increases in multiple gradual steps along the flow direction (Fig. 3e, see also annotated Fig. A above).
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 4, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Esmek et al. (“Sculpturing wafer-scale nanofluidic devices for DNA single molecule analysis.” Nanoscale, 2019, 11, 13620. Published on 02 July 2019).
Regarding claim 4, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1.
Esmek does not teaches wherein pillars are arranged in the inlet and/or in the outlet.
However, Esmek teaches in nanochannel with smaller cross section, there is larger size mismatch between micro and nanostructures, and thus the harder for the DNA to overcome the entropic barrier and enter the nanochannel, and become especially problematic for very long molecules (e.g., genomic length DNA15), which often get entangled and clog the entrance of the nanochannels. Esmek further teaches pillars with gradually decreasing size can be patterned in the microchannels to ease the introduction of genomic DNA into nanochannels and pre-stretch the DNA and solve the problem of hairpin formation (p. 13620, Introduction, right column).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the supply channel (microchannel) of the nanofluidic analysis device with pillars arranged in the supply channel as taught on p. 13620, Introduction, right column because the pillars help ease the introduction of genomic DNA into nanochannels and pre-stretch the DNA and solve the problem of hairpin formation with a reasonable expectation of success (p. 13620, Introduction, right column.) (MPEP 2143)(I)(G).
In addition, modified Esmek discloses the claimed invention except for the rearrangement of the pillars to the inlet, which is the transition junction between the supply channel (microchannel) and the detection nanochannel (Figs. 1 and 3). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the pillars to the inlet from the supply channel, since it have been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. One would have been motivated to rearrange the pillars to the inlet for the purpose of the having pillars nearer to the entrance of nanochannel to help ease the introduction of genomic DNA into nanochannels which often get entangled (p. 13620, Introduction, right column). (In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). See MPEP 2144.04 (IV)(C).
Regarding claim 19, Esmek teaches all of the elements of the current invention as stated above with respect to claim 2.
Esmek teaches the outlet of the detection nanochannel has a width and a depth increase along the flow direction (see annotated Fig. A above).
Esmek teaches the width of the outlet increases uniformly along the flow direction ( embodiment in Fig. 3d) and thus fails to teach wherein the width of the outlet increases in multiple gradual steps along the flow direction and wherein the depth of the outlet increases in multiple gradual steps along the flow direction.
However Esmek teaches in the embodiment shown in Fig. 3e that the width of the outlet increases in multiple gradual steps along the flow direction and wherein the depth of the outlet increases in multiple gradual steps along the flow direction.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the outlet of embodiment in Fig. 3d with the embodiment in outlet of Fig. 3e which has the width of the outlet increases in multiple gradual steps along the flow direction and wherein the depth of the outlet increases in multiple gradual steps along the flow direction because one of ordinary skill in the art would accordingly have recognized whether the width and the depth are increasing uniformly or in multiple gradual steps along the flow direction would result in the predictable result of providing an outlet with a width and a depth increase along the flow direction.
Regarding claim 20, Esmek teaches all of the elements of the current invention as stated above with respect to claim 1.
Esmek teaches the inlet of the detection nanochannel has a width and a depth decrease along the flow direction, and the outlet of the detection nanochannel has a width and a depth increase along the flow direction (see annotated Fig. A above).
Esmek teaches the width and depth of the inlet decreases uniformly and the width and depth of the outlet increases uniformly along the flow direction ( embodiment in Fig. 3d and p. 13623, left column, “funnel-like inlet”) and thus Esmek fails to wherein the inlet and the outlet are of an asymmetric configuration.
However Esmek teaches in the embodiment shown in Fig. 3e that the width of the outlet increases in multiple gradual steps along the flow direction and wherein the depth of the outlet increases in multiple gradual steps along the flow direction.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the outlet of embodiment in Fig. 3d with the outlet of embodiment in Fig. 3e which has the width of the outlet increases in multiple gradual steps along the flow direction and wherein the depth of the outlet increases in multiple gradual steps along the flow direction because one of ordinary skill in the art would accordingly have recognized whether the width and the depth are increasing uniformly or in multiple gradual steps along the flow direction would result in the predictable result of providing the outlet with a width and a depth increase along the flow direction.
The teachings of modified Esmek would yield the inlet and the outlet are of an asymmetric configuration.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Esmek et al. (“Sculpturing wafer-scale nanofluidic devices for DNA single molecule analysis.” Nanoscale, 2019, 11, 13620. Published on 02 July 2019) in view of Ebenstein et al. (US 20190194755 A1).
Regarding claim 9, Esmek teaches all of the elements of the current invention as stated above with respect to claim 8.
Esmek teaches a device for DNA single molecule analysis, which is useful for early disease diagnosis, on personalized medicine and on effective cancer treatment.
Esmek does not explicitly teaches wherein the nanofluidic analysis device control unit is adapted to compare the retrieved barcode of the DNA molecule to theoretical barcodes.
However, Ebenstein teaches a method of diagnosing diseases based on DNA sequence (abstract). Ebenstein further teaches compare the retrieved barcode of the DNA molecule to theoretical barcodes (para. 0086, 0214) for data analysis and validation
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit taught by Esmek to include the function of the comparing the retrieved barcode of the DNA molecule to theoretical barcodes in order to analyze and validate data with a reasonable expectation of success (Ebenstein, paras. 0086 and 0214) (MPEP 2143)(I)(G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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