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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cartridge of claims 1-23 must be shown or the feature(s) canceled from the claims.
Figure 2 of Applicant’s disclosure provides a planar, schematic-type depiction of cartridge 200, and which does not show the recited positive elements of the plurality of electrodes, at least one magnet, and first and second surfaces of their recited functionality coincident therewith the electrodes and at least one magnet as claimed. Examiner notes par.[0038] of Applicant’s pre-grant publication US 2023/0253040 that provides some prophetic discussion thereof (such as in “…a plurality of electrodes and at least one magnet are disposed along various portions of the dielectric cartridge surface 214), and the drawings are without particular showings to such claimed elements.
The structural elements of the cartridge are relied upon throughout all of claims 1-23, and such elements are not shown as claimed.
Furthermore, likewise seen with respect to the cartridge of claim 22, wherein the first and second surface of the cartridge are different surfaces must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Figure 2 of the drawings provides a schematic, planar depiction that does not show a second surface different from the first surface (given in the specification as item ‘214’; the discussion in par.[0038] to “the dielectric cartridge surface 214 includes cartridge surfaces below the illustrated sample reservoir…” is prophetic and without particular showing in the drawings as it pertains to the claimed, second surface that is different from the first surface).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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 § 112
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.
Claim 15 is 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 limitation "the presence". There is insufficient antecedent basis for this limitation in the claim. It appears that Applicant intends to recite “a presence.”
Claims 21-23 is 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.
The metes and bounds of the structural constitution of the sought cartridge for its operative embodiment are indefinitely defined herein.
The claimed first and second surfaces of the cartridge are indefinitely defined herein.
It is not clear what structure begets such surfaces.
Are these surfaces “of the cartridge” drawn to surfaces of the plurality of electrodes, at least one magnet, a combination thereof?
Does Applicant intend to provide a supporting substrate to any, all of the plurality of electrodes and at least one magnet and such a supporting substrate provides/begets these claimed first and second surfaces?
Clarification is required.
Claim 22 is 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 2 recites the limitation "the same surface". There is insufficient antecedent basis for this limitation in the claim. It appears that Applicant intends to recite “a same surface.”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 20-23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Pamula et al. (US 2007/0243634), hereafter Pamula-2.
Pamula-2 discloses a non-transitory computer readable medium, having stored thereon program instructions that, upon execution by a controller, cause a controller to perform a set of operations (pars.[0466-0470) comprising transporting, via a plurality of electrodes of a cartridge (pars.[0178,0205,0391,0495], a droplet on a surface of the cartridge (pars.[0157,0160,0347]), wherein the plurality of electrodes is configured to transport the droplet on the surface of the cartridge (pars.[0157,0347,0375-0382]), and immobilizing, via at least one magnet of the cartridge, the droplet on the surface of the cartridge (pars.[0157,0160,0347]), wherein the at least one magnet (i.e. 1204; fig. 12) is configured to immobilize the droplet on the surface of the cartridge (pars.[0044,0154,0182,0205,0347,0355]). Relatedly thereto from the above citations within Pamula-2, Pamula-2 discloses the physical cartridge (given as the microactuator 100; fig. 1, for example) comprising a plurality of electrodes, at least one magnet, and a first surface 1203 for transporting a droplet (wherein the droplet itself is not a positively claimed element of the cartridge), wherein the plurality of electrodes is configured to transport the droplet on the first surface of the cartridge, and a second surface for immobilizing the droplet (i.e. a surface spaced away from the first surface and being the same surface as in cl. 22; and likewise as in a second surface different form the first surface as in cl. 23 by way of portions of the cartridge at the reservoir(s) that have a magnet for localizing the beads wherein such reservoir provides a second, lower surface; par.[0346] for example), via the at least one magnet, wherein the at least one magnet is configured to immobilize the droplet on the surface of the cartridge.
Claim(s) 20-23 is/are rejected under 35 U.S.C. 102a1 as being unpatentable over Masters et al. (US 2023/0279512), hereafter Masters
With regard to claim 21, Masters discloses a cartridge comprising a plurality of electrodes (EWOD array 100 with grid of electrodes 120), at least one magnet (e.g. a magnet, pair of magnets) (pars.[0236,0476], figs. 1A,B, 2A,B, 10A-I, 30A-B). Masters further discloses the cartridge comprises a first surface 130 for transporting a droplet, via the plurality of electrodes, on the first surface of the cartridge, wherein the droplet comprises a paramagnetic, bar-coded bead (Examiner notes that herein a droplet comprising a paramagnetic, bar-coded bead is drawn to an intended workpiece and is not a positively claimed element of the device wherein such recitation is drawn to the claimed first surface and claimed electrodes; further noting that Masters discloses magnetic beads comprising molecular barcodes; pars.[0022,0532,0533,0722]) and wherein the plurality of electrodes is configured to transport the droplet on the first surface of the cartridge (pars.[0022,0243,0351-0355], figs. 10A-I, for example), and a second surface for immobilizing the droplet (i.e. a surface spaced apart from the first surface, such as in fig. 10D for immobilizing a droplet, and being the same surface as in cl. 22), via the at least one magnet (pars.[0723,0726,0745,0747,0776], on the second surface, wherein the at least one magnet is configured to immobilize the droplet on the second surface of the cartridge. With respect to claim 23, Masters discloses that the first and second surfaces may be different surfaces (pars.[0428,0429]; wherein the array 100 includes different regions that perform EWOD 1410, dielectrowetting 1420, and dielectrophoresis 1430 wherein such differently-constituted surfaces as the EWOD surface includes a dielectric layer and the DEW surface does not, thereby providing first and second surfaces that are different. With regard to claim 20, Masters discloses a non-transitory computer-readable medium having stored thereon instructions that cause a controller to perform the operations, as recited therein and as discussed above in the cited portions of Masters (par.[0410,0411,0415,0417,0419]).
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.
Claim(s) 1-4, 8-15, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abate et al. (US 2017/0009274), hereafter Abate, in view of Pamula et al. (US 2020/0393452), hereafter Pamula.
With regard to claim 1, Abate discloses a method of manipulating a droplet on a surface of a cartridge (microfluidic device herein Abate), wherein the droplet comprises at least one magnetic bar-coded bead (pars.[0096,0114-0118,0285,0292]) comprising transporting, via a plurality of electrodes of the cartridge, the droplet on the surface of the cartridge, wherein the plurality of electrodes is configured to transport the droplet on the surface of the cartridge (pars.[0150,0389]), and immobilizing, via at least one magnet of the cartridge, the droplet on the surface of the cartridge, wherein the at least one magnet is configured to immobilize the droplet on the surface of the cartridge (pars.[0285]; and as in a magnetic bead of the cartridge to the “at least one magnet”; see also par.[0333] and application of a magnetic field to the microfluidic device [‘cartridge’ herein] and the surface of the cartridge is construed as the surface of microfluidic channel of the cartridge).
With regard to claim 1, Abate does not specifically disclose that the magnetic bead is paramagnetic (and such ‘paramagnetic’ aspect subsequently found within the dependent claims thereof).
With regard to claim 2, Abate discloses the bar-coded bead of the droplet comprise one or more unique bar codes (pars.[0087,0097,0163]), but does not specifically disclose that the magnetic bead is paramagnetic.
With regard to claim 3, Abate does not specifically that the bar-coded bead comprises at least one non-spherical bar-coded bead and that the at least one bar-coded bead is paramagnetic.
With regard to claim 4, Abate discloses that the width of the microchannels of the microfluidic device is 100 microns or less, and thus the droplet which is transported on the surfaces thereof the microchannel(s) is less than 100 microns in size (i.e. 0.1 to 100 microns) as in cl. 4, but does not disclose the at least one bar-coded bead is paramagnetic.
With regard to claim 8, Abate discloses immobilizing, via at least one magnet of the cartridge, comprises immobilizing the magnetic bar-coded bead of the droplet, but does not disclose being paramagnetic.
With regard to claims 9 and 10, Abate discloses analyzing the droplet while the droplet is transported or immobilized on the surface of the cartridge, and wherein analyzing comprises performing one or more assay procedures and during the one or more procedures determining a parameter of the droplet (pars.[0177,0260,0324,0341,0353,0356,0367]). Further, as in cl. 11, Abate discloses wherein determining a parameter of the droplet comprises identifying a particular feature of the at least one magnetic, bar-coded bead of the droplet (pars.[0324,0356,0367]; i.e. the number of biomarkers individually detected within the droplet by fluorescence response or dyes, the droplet’s composition, size, shape, buoyancy, etc.). With regard to claim 12, Abate discloses generating an image of the droplet on the surface of the cartridge as recited therein (as modified below for a paramagnetic bead) and based on the generated image, determining a parameter of the droplet (pars.[0366-0368]; detection means (b) as an optical imager for detecting droplets and their parameters such as in composition, size, shape, buoyancy, etc.). With regard to claim 13, Abate discloses determining comprises comparing the generated image of the droplet to a previously generated image of the droplet (pars.[0355-0356] prior fluorescent detection under various polarization conditions and different dyes for different target markers). With regard to claim 14, Abate discloses applying an ultraviolet light to the droplet while generating an image (pars.[0356-0358,0366-0368,0377]). With regard to claim 15, Abate discloses performing a plurality of assay procedures on the droplet and determining the presence of one or more analytes adhered to the bar-coded bead of the droplet (pars.[0341,0351,0353,0355-0358]).
With regard to claim 18, Abate discloses the droplet further comprises a solution for washing the magnetic, bar-coded bead of the droplet (pars.[0277,0292]). With regard to claim 19, Abate discloses the droplet further comprises a read buffer solution (pars.[0342,0437,1347,1364]).
Pamula discloses methods of manipulating droplets on a surface wherein the droplet comprises at least one paramagnetic bead (par.[0013]). Pamula discloses that the beads may be any of a wide variety of shapes such as generally spherical, egg shaped, disc shaped, cubical, spherical, and other three dimensional shapes (par.[0007]).
It would have been obvious to one of ordinary skill in the art to modify Abate to provide a droplet comprising at least one paramagnetic bar-coded bead and being non-spherical such as suggested by the analogous art of Pamula to methods of manipulating beads in droplets in which choosing of paramagnetic material represents an obvious alternative material of construction that affords the desired magnetically responsive bead and that would have a reasonable expectation of success in Abate, and wherein a choice of a shape as in non-spherical is seen as an obvious engineering design choice in which Pamula provides that it is known that such beads may be of many different shapes, including the variously-delineated non-spherical shapes and would remain to provide a likewise functionality and a reasonable expectation of success in Abate.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abate in view of Pamula as applied to claims 1-4, 8-15, 18, and 19 above, and further in view of Masters.
Abate/Pamula does not specifically disclose the surface of the cartridge comprises a dielectric material as recited in claim 5, and wherein the electrical current comprises a direct electric current as in cl. 6, and wherein the electrical current comprises an alternating electrical current as in cl. 7.
Masters discloses a cartridge comprising a plurality of electrodes (EWOD array 100 with grid of electrodes 120), at least one magnet (e.g. a magnet, pair of magnets) (pars.[0236,0476], figs. 1A,B, 2A,B, 10A-I, 30A-B). Masters further discloses the cartridge comprises a first surface, as in dielectric surface 130 for transporting a droplet, via the plurality of electrodes, on the first surface of the cartridge and wherein the plurality of electrodes is configured to transport the droplet on the first surface of the cartridge by applying an electrical current to the electrodes, wherein such electrical current may be an alternating current or direct current (pars.[0022,0243,0264,0351-0355], figs. 10A-I, for example).
It would have been obvious to one of ordinary skill in the art to modify Abate/Pamula to provide a dielectric material as the surface of the cartridge and applying an electric current, as in an alternating or direct current, to transport the droplet on the surface such as suggested by the analogous prior art of Masters to digital microfluidics for manipulating droplets in which such a surface-based dielectric electrowetting array actuated by alternating or direct current represents an obvious alternative arrangement for transporting droplets, as likewise desired in Abate/Pamula, to the microfluidic flow channel arrangement and would have a reasonable expectation of success therein.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abate in view of Pamula as applied to claims 1-4, 8-15, 18, and 19 above, and further in view of Pamula et al. (US 2007/0243634), hereafter Pamula-2.
With regard to claim 16, Abate/Pamula does not specifically disclose transmitting instructions to a GUI to display a graphical representation of the determined parameter of the droplet.
With regard to claim 17, Abate/Pamula does not specifically disclose generating a composite image of the droplet, as claimed, and based on the generated composite image, determining a parameter of the droplet.
Pamula-2 discloses droplet-based surface modification, washing, and droplet manipulation(abstract). Pamula-2 discloses transmitting instructions to a GUI to display a graphical representation of the determined parameter of the droplet (pars.[0479,0483,0500,0525,0526], and Pamula-2 discloses generating a composite image of the droplet and determining a parameter of the droplet therefrom (pars.[0368,0500,0526]; which includes real-time imaging and superposition of images in determining a droplet parameter).
It would have been obvious to one of ordinary skill in the art to modify Abate/Pamula to transmit instructions to a GUI to display a graphical representation of the determined parameter of the droplet and generate a composite image of the droplet to determine a parameter of the droplet such as suggested by the analogous art of Pamula-2 to droplet-based surface modification and droplet manipulation in order to afford a user the ability and flexibility to control and easily visualize, assess, and provide results of the droplet under investigation.
Pamula discloses methods of manipulating droplets on a surface wherein the droplet comprises at least one paramagnetic bead (par.[0013]). Pamula discloses that the beads may be any of a wide variety of shapes such as generally spherical, egg shaped, disc shaped, cubical, spherical, and other three dimensional shapes (par.[0007]).
It would have been obvious to one of ordinary skill in the art to modify Masters to provide a droplet comprising at least one paramagnetic bar-coded bead such as suggested by the analogous art of Pamula to methods of manipulating beads in droplets in which choosing of paramagnetic material represents an obvious alternative material of construction that affords the desired magnetically responsive bead as in Masters and that would have a reasonable expectation of success in Masters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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