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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/10/2026 has been entered.
Status of Claims
Claims 1-2 have been amended. Claims 1-20 are pending and examined.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-3 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,405,216.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claims 1-3 and 5, Patent 216 recites a method, kit and apparatus comprising comprising:(a) a first plate and a second plate; each, on its surface, having a sample contact area for contacting the sample that contains or is suspected of containing an analyte, wherein the two plates are movable to different configurations including an open configuration and a closed configuration, the first plate is flexible and has a plurality of spacers on its surface, wherein the spacers are pillars; and(b) a staining solution that stains the analyte; wherein the distance between the two sample contact areas and the concentration of the staining solution in the thin layer are selected to make, during an imaging by an imager, the stained analyte in the thin layer is distinguishable from the rest of thin layer, wherein in the open configuration, the first and second plates are completely or partially separated apart, the spacing between the first and second plates is not regulated by the spacers; and wherein in the closed configuration, at least part of the sample is between the two plates, a layer of at least part of the staining solution is between the at least part of the sample and the first plate, and the spacing between the plates is regulated by the first and second plates and the spacers (see patent claims 1-3).
While Patent 216 does not specifically teach the sample contact areas of the plates confine the sample into a thin sample layer; wherein the thin sample layer has a thickness confined by the gap, the staining reagent stains the targeted cell, and the capture agent binds specifically to the non-cell analyte; wherein the gap has a size configured to make a targeted cell having a monolayer in the thin sample layer and wherein in the monolayer, the targeted cells do not have significant overlap, such limitation is drawn to intended use of the devices and therefore the prior art only needs to be capable of performing the recited intended use. So long as the inventions of Patent 216 are capable of confining the sample and staining the cell, it reads on the claims Patent 216 teaches the same structural limitations as recited in the claims, therefore it is considered capable of performing the same intended use.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 17, 19-31 of U.S. Patent No. 11,692,927.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claims 1-2 and 19, Patent 927 recites a method for assaying a targeted cell and a non-cell analyte in a sample, comprising: (a) obtaining two plates facing each other and separated by a gap, wherein each of the plates has a sample contact area for contacting a sample; (b) obtaining a cell staining reagent, a capture agent, and a sample that contains or is suspected of containing a targeted cell and a non-cell analyte; (c) confining the cell staining reagent, and the capture agent, and the sample between the sample contact areas of the two plates, forming a thin sample layer, wherein, the sample has a thickness confined by the gap, wherein the cell staining reagent stains the targeted cell, and the capture agent specifically captures the non-cell analyte; and (d) imaging, after (c), the thin sample layer to (i) detect and count the targeted cell that is stained by the cell staining reagent, and (ii) detect the non-cell analyte that is captured by the capture agent; wherein the gap has a size configured to make the targeted cell have a monolayer in the thin sample layer and wherein, in the monolayer, the targeted cells do not have significant overlap (patent claim 1), wherein the capture agent is coated on one or both of the sample contact areas (patent claim 2), wherein the staining agent is coated on one or both of the sample contact areas (patent claim 3), wherein the staining agent and the capture reagent are coated on one or both of the sample contact areas (patent claim 4), wherein the method is performed by a device comprising: (a) the two plates facing each other and separated by the gap; and (b) the cell staining reagent and/or capture agent, are coated in one or both of the sample contact area (patent claim 5), wherein the method is performed by a device comprising: (a) the two plates facing each other and separated by the gap; (b) a microstructure that is between the sample contact areas of the two plates; and (c) the cell staining reagent and/or capture agent coated either on the surface of the microstructure or in one or both of the sample contact area (patent claim 6), further comprising placing a microstructure between the sample contact areas of the two plates (patent claim 8), wherein the two plates are movable relative to each other, wherein the gap between the two plates are regulated by spacers, wherein at least one of the spacers is in the sample contact area (patent claim 11), wherein the two plates comprise a first plate and a second plate, and the device further comprises a plurality of spacers fixed to at least one of the first plate and the second plate; and wherein the plurality of spacers have (i) a pillar shape, (ii) a substantially flat top surface, (iii) a substantially uniform height, and (iv) a constant inter-spacer distance, wherein the sample contact areas are configured to hold a sample that contains or is suspected of containing a first analyte and a second analyte, and wherein the sample contact areas further comprise: a detection reagent on the sample contact area, wherein the detection reagent is configured to be diffusible in the sample and bind to the complex (patent claim 31).
Additionally, patent claim 7 reads on instant claim 3, patent claim 9 reads on instant claim 4, patent claim 10 reads on instant claim 4, patent claim 11 reads on instant claim 5, patent claim 17 reads on instant claim 6, patent claim 19 reads on instant claim 7, patent claim 20 reads on instant claim 8, patent claim 21 reads on instant claim 9, patent claim 22 reads on instant claim 10, patent claim 23 reads on instant claim 11, patent claim 24 reads on instant claim 12, patent claim 25 reads on instant claim 13, patent claim 26 reads on instant claim 14, patent claim 27 reads on instant claim 15, patent claim 28 reads on instant claim 16, patent claim 29 reads on instant claim 17, and patent claim 30 reads on instant claim 18.
Claims 1-3, 11-12 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 and 16-17 of U.S. Patent No. 11,940,443.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claims 1-3, 11-12 and 19, Patent 443 recites a device for assaying a target cell and a non-cell analyte in a sample, comprising: a first plate, a second plate, a plurality of spacers, a plurality of particles, and a capture agent, wherein: a) the first and second plates are movable relative to each other into different configurations, including an open configuration and a closed configuration; b) each of the plates has, on its respective surface, a sample contact area for contacting a sample that contains or is suspected of containing one or more target cells and a non-cell analyte; c) the spacers comprise an array of pillars that have a predetermined inter-spacer distance and a uniform height of 150 μm or less and are fixed on the first plate; d) the particles have a size of 0.2 μm to 100 μm, are equal to or less than the height of the spacers, and are, in an open configuration, distributed in one of the sample contact areas; and e) the capture agent is attached on the particles, wherein the capture agent binds the non-cell analyte; wherein in the open configuration, the two plates are separated apart, and the sample is deposited on one or both plates; wherein in the closed configuration, which is configured after a sample is deposited in the open configuration, a relevant sample volume is compressed by the first and second plates into a layer of substantially uniform thickness and is substantially stagnant relative to the first and second plates, and the thickness of the layer is confined by the first and second plates and is regulated by the first and second plates and the spacers; wherein the relevant sample volume is a portion of the sample containing or suspected of containing the non-cell analyte and the target cells to be analyzed; and wherein the height of the spacers and the geometry of the particles are configured to make, in the closed configuration, no significant overlaps between the one or more target cells, between the particles, and between the target cells and the particles, further comprising a staining reagent (patent claim 16), further comprising a labeled detection agent that is dry coated on one of the sample contact areas (patent claim 17), and further comprising an imager for obtaining an image of a relevant sample volume of the sample (patent claim 8).
While Patent 443 does not specifically teach the sample contact areas of the plates confine the sample into a thin sample layer; wherein the thin sample layer has a thickness confined by the gap, the staining reagent stains the targeted cell, and the capture agent binds specifically to the non-cell analyte; wherein the gap has a size configured to make a targeted cell having a monolayer in the thin sample layer and wherein in the monolayer, the targeted cells do not have significant overlap, such limitation is drawn to intended use of the devices and therefore the prior art only needs to be capable of performing the recited intended use. So long as the inventions of Patent 443 is capable of confining the sample and staining the cell or capturing the non-cell analyte, it reads on the claims. Patent 443 teaches the same structural limitations as recited in the claims, therefore it is considered capable of performing the same intended use.
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.
Claim(s) 1-6, 8-11, 13-14 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chou et al. (WO2017/027643, IDS, with US 2018/0202903 as the corresponding citation document).
Regarding claims 1-2, Chou teaches throughout the publication an assay device for assaying a targeted cell (paragraph 0107 or 0108), comprising:(a) two plates facing each other and separated by a gap (paragraph 0053 and Figure 8, plates and enclosed spacers for sample thickness regulation), wherein each of the plates have a sample contact area for contacting a sample (paragraph 0618, sample deposited on both plates), the sample contact areas of the plates confine the sample into a thin sample layer; wherein the thin sample layer has a thickness confined by the gap (paragraph 0053); (b) a microstructure that is between the sample contact areas of the two plates (paragraph 0227 and for example, paragraph 0077), (c) a dissolvable cell staining reagent (paragraph 1216, staining dyes are deposited on the inner surface for mixing with the sample; paragraph 0137, reagents dissolvable in the sample) or a dissolvable capture agent (paragraph 0042; paragraph 0137, reagents dissolvable in the sample) are coated on one or both of the sample contact area, wherein the gap has a size configured to make a targeted cell having a monolayer in the thin sample layer and wherein in the monolayer, the targeted cells do not have significant overlap (for example, paragraph 0334, sample is confined in the spacing and target cells do not overlap).
While Chou does not explicitly teach the staining reagent is capable of staining the targeted cell, and the capture agent is capable of binding specifically to the non-cell analyte, such limitation is drawn to intended use of the devices and therefore the prior art only needs to be capable of performing the recited intended use. So long as the device of Chou is capable of staining the cell or capturing an analyte, it reads on the claims. Chou teaches the same structural limitations as recited in the claims such that the functions of staining or capturing could be conducted, Chou is considered capable of performing the same intended use.
Regarding claim 3, Chou teaches the device further comprising an imager that takes one or more images of the layer (paragraph 0855).
Regarding claim 4, Chou teaches the device further comprising a detection agent, (paragraph 0042). While Chou does not specifically teach the detection agent binds specifically to the non-cell analyte, such limitation is drawn to intended use of the devices and therefore the prior art only needs to be capable of performing the recited intended use. So long as the device of Chou is capable of detection analytes, it reads on the claims. Chou teaches the same structural limitations as recited in the claims, therefore it is considered capable of performing the same intended use.
Regarding claim 5, Chou teaches the device wherein the two plates are movable relative to each other, wherein the gap between the two plates are regulated by spacers, wherein at least one of the spacers is in the sample contact area (paragraph 0164).
Regarding claim 6, Chou teaches the device wherein the capture reagent is an antibody, a nucleic acid, or an aptamer (paragraph 0091).
Regarding claim 8, Chou teaches the device wherein the microstructure is conjugated with antibody (paragraph 0227).
Regarding claim 9, Chou teaches the device wherein the microstructure is a plurality of beads (for example, paragraph 0077).
Regarding claim 10, Chou teaches the device wherein the plurality of beads is made of polystyrene (for example, paragraph 0416).
Regarding claim 11, Chou teaches the device wherein the plurality of bead has a diameter of 2 to 30 um (paragraph 0077, 4 microns).
Regarding claim 13, Chou teaches the device wherein the detection reagent is an antibody (paragraph 1212).
Regarding claim 14, Chou teaches the device wherein the antibody is a monoclonal antibody (paragraph 1179).
Regarding claim 16, Chou teaches the device wherein the detection agent is labeled with a fluorescent label (paragraph 1212).
Regarding claim 17, Chou teaches the device wherein the fluorescent label is FITC or rhodamine (paragraph 0921).
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.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (WO2017/027643, IDS, with US 2018/0202903 as the corresponding citation document), as applied to claims 1 and 9 above.
Regarding claim 12, while Chou teaches that the plurality of beads can have a diameter of 4 microns, the reference fails to specifically teach a diameter of 10 um. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 12 are for any particular purpose or solve any stated problem, and the prior art teaches that spacer size may be varied depending on the sample to be confined. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the spacers disclosed by the prior art by normal optimization procedures known in the assay device art.
Claim(s) 7, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (WO2017/027643, IDS, with US 2018/0202903 as the corresponding citation document), as applied to claims 1, 4, 13 above, and further in view of Robinson et al. (US 2016/0146799, Pub Date: 11/05/2015, hereinafter “Robinson”).
Regarding claims 7 and 15, although Chou does not specifically teach the device wherein the capture agent or the detection agent is a monoclonal antibody binds to a complex of the capture reagent and CRP, or a complex of the capture agent and SAA, Robinson teaches throughout the publication devices for enhanced fluorescence-based imaging assays (abstract). More specifically, Robinson teaches that reagents can include monoclonal antibodies (paragraphs 0073-0074) with desired analytes including CRP or SAA (paragraph 0068).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the capture/detection reagents device of Chou, the ability to bind to CRP or SAA as taught by Robinson because Chou is generic regarding the desired analyte that can be complexed and one skilled in the art would be motivated to choose the appropriate target based on the desired assay.
Regarding claim 18, while Chou does not specifically teach that the staining reagent is SYTO 9 or YOYO, Robinson teaches that a wide variety of fluorescent molecules can be used including YOYO-1 and YOYO-3 (paragraph 0051). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the staining reagent of Chou to include YOYO as taught by Robinson because Chou is generic regarding the staining reagent that can be used and one skilled in the art would have been motivated to choose the appropriate stain based on the desired sample to be visualized.
Response to Arguments
Applicant’s arguments filed 02/10/2026 have been considered but are not found to be persuasive. Applicant’s sole argument is that Chou does not teach or suggest that the staining reagent is capable of staining the targeted cell and that the capture agent is capable of binding the non-cell analyte, in addition to other features. This is not persuasive because these limitations are drawn to intended use as described above. Additionally, Chou teaches a cell staining reagent (paragraph 1216, staining dyes are deposited on the inner surface for mixing with the sample) or a capture agent (paragraph 0042), thus allowing the reagents of Chou to be capable of performing the recited intended uses of the claims. Since claims 1-2 clearly recites a cell staining reagent and/or a capture agent, then Chou teaching the presence of a staining reagent or a capture reagent reads on the structural limitations of the claims and the claims remain unpatentable.
Additionally, Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Conclusion
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677