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 Group 1 (claims 1-2, 4, 7-9, 12-14, 16-17, and 19-21) in the reply filed on 27 February 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)).
Claims 26-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 February 2026.
Information Disclosure Statement
The information disclosure statement (IDS) filed 18 June 2025 is considered, initialed, and attached hereto.
Claim Status
Claims 1-2, 4, 7-9, 12-14, 16-17, 19-21, and 26-28 are pending.
Claims 1-2, 4, 7-9, 12-14, 16-17, and 19-21 are under examination.
Claims 26-28 are withdrawn.
Claims 3, 5-6, 10-11, 15, 18, 22-25, and 29-88 are canceled.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (Figures 6 and 7) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the term Thermopol, Therminator, Triton X, IsoLight, Maxima, Beckman Coulter, Ampure, JumpStart, Agilent, and BioAnalyzer, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claims 12-14 recite “[a/the] diameter of [a/the] CB capture moiety”. However, claim 1 on which claims 12-14 depend recites capture beads (CB) that have a diameter but does not recite the CB capture moiety having a diameter. In the instant specification [087-091], particularly [091], diameters are disclosed with regard to CBs, but not with regard to CB capture moieties. Therefore, where claims 12-14 recite “[a/the] diameter of [a/the] CB capture moiety”, for the purpose of applying prior art, the claims are broadly interpreted as referring to either the diameter of a CB or the diameter of a CB capture moiety that is sufficiently round to have a measurable diameter.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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.
Claims 12-14 and 19 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 12 recites the limitation "the first one of the two first regions" in both line 2 and line 3. There is insufficient antecedent basis for this limitation in the claim, so this is interpreted as referring to a specific first region of the at least one first regions.
Claim 13 recites the limitation "the second one of the two first regions" in both line 2 and line 3. There is insufficient antecedent basis for this limitation in the claim, so this is interpreted as referring to a specific first region of the at least one first regions.
Claim 14 recites the limitation "the diameter of the CB capture moiety" in lines 1-2 and lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitations "the first one of the first two regions" in line 2 and "the second one of the two first regions" in line 3. There is insufficient antecedent basis for these limitation in the claim, so these are interpreted as referring to a first and a second first region, respectively of the at least one first regions.
Claim 19 recites the limitation "the barcode sequence" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(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.
Claims 1, 4, 7-9, 12-14, 16, and 21 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ramsey et al. (U.S. Patent Application Cite No. 1 in IDS filed 18 June 2025)(US 2019/0054470, published 21 February 2019, effectively filed date 22 July 2015), herein Ramsey.
Regarding claim 1, Ramsey teaches a multiplex assay chip device configured for multiplexed analysis of biological material (“FIG. 6A shows that the microfluidic chip 50 can be configured so that the array of bead wells 10a occupy a footprint “F” (typically between 1 mm and 10 cm) with a dense array wells” [0108], the dense array of wells enables the chip for spatially separated multiplexing of reactions), the device comprising: a plurality of capture beads (CB) (“beads 25” [0107]; FIG. 6A), each bead including a CB capture moiety and having a diameter (“bead with a diameter” [0012]); a substrate having a plurality of chambers, each plurality of chambers including an open end arranged on a first side of the substrate (“bead wells of a bead well array can have sidewalls and a floor formed into one or more substrates to have an open top surface and a closed bottom surface with the sidewalls extending therebetween” [0079]; FIG. 6 described in [0107-0110]), at least one first region having a first length, a first width, and a first depth, wherein each of the first length, the first width, and the first depth is greater than the bead diameter (“the bead retention region 11 has a pocket or receptacle with an opening diameter that is between about 101-195% of the diameter of the bead 25, and may be between about 105% and 150% in some embodiments. The depth of the well in the bead retention region 11 can be between about 50% and 185% that of the bead diameter” [0101]), at least one second region having a second length, a second width, and a second depth, wherein at least one of the second length, the second width, and the second depth is less than the bead diameter (“the signal detection segment 15 can be configured as a narrow channel or “slit”, typically having a width that is 25%-75% less than a width of the bead retention segment 11” [0097], note that this teaches a second region, the signal detection segment, with width (w1) that is 75% less than the width of a first region (w2; w1 = 0.25*w2), the bead retention segment, and width/diameter of the bead retention segment may be 105% of the width/diameter of the bead (w3; w2 = 1.05*w3) per [0101] above, so this teaches an embodiment wherein w1 = 0.25*1.05*w3 = 0.2625*w3, so the second width, w1, is less than the bead diameter, w3); at least one CB arranged within the at least one first region of each of the plurality of chambers of the substrate (FIG. 6 described in [0107-0110]); and a surface removably couplable to the first side of the substrate, wherein each of the plurality of chambers is covered when the surface is removably coupled to the first side of the substrate (“top substrates, membranes or covers may be used. The top substrate, membrane or cover can seal, cover or otherwise close the upper surface of a fluidic channel(s) and/or array of reaction wells” [0079]; “The device 50 may comprise upper and lower substrates 50u, 50b (FIGS. 6B, 6C) that attach together” [0107]).
Regarding claim 4, Ramsey teaches the device of claim 1, wherein the at least one second region has a width of between 1 μm and 100 μm, a length of between 1 μm and 2000 μm, and a depth of between 1 μm and 100 μm (“The bead well segment on the left-hand side of the well is≈3.5-3.7 μm in diameter; the detection well segment on the right-hand side is≈2.1 μm diameter. The channel linking them is≈2.0-2.1 μm wide and 7.4 μm long. The depth can be about≈5 μm”[0117], the bead well segment is the first region and the detection well segment combined with the channel linking the segments is the second region).
Regarding claim 7, Ramsey teaches the device of claim 1, wherein the distance between adjacent ones of the plurality of chambers is between 0.01 μm and 10 μm (“Some or all of the neighboring wells 10 can have a separation distance of between 1 μm-10 mm, such as about 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm” [0093]).
Regarding claim 8, Ramsey teaches the device of claim 1, wherein the first width of the at least one first region is between 5 μm and 50 μm larger than the width of the second width of the at least one second region (“bead retention segment can be sized and configured to hold a microspherical bead with a diameter of between about 10 nm to about 1 mm, typically between about 100 nm to about 1 mm” [0012]; “bead retention segment can have a width that is between about 101% to about 195% of the diameter of a respective bead held therein” [0013]; “the signal detection segment 15 can be configured as a narrow channel or “slit”, typically having a width that is 25%-75% less than a width of the bead retention segment 11” [0097]; therefore, Ramsey teaches a range of embodiments including, for example, where the bead has diameter 25 μm, the bead retention segment [first region] has width 110% of the diameter of the bead, 27.5 μm, and the signal detection segment [second region] has width 75% less than the width of the bead retention segment, 27.5 - 0.75*27.5 = 6.875 μm, so the first width is 20.625 μm larger than the width of the second width). As there is no allegation of criticality of the claimed range, the overlapping range taught by Ramsey is sufficiently specific and anticipates the claimed range (see MPEP §2131.03).
Regarding claim 9, Ramsey teaches the device of claim 1, wherein the at least one first region is cylindrical and each of the first length and the first width are between 10 and 100 μm (FIGS. 2B, 3B, and 4B are side views showing that the bead retention segment 11, equivalent to the claimed first region, is cylindrical, also FIGS. 6A and 6B in combination with 6E show wells with flat bottoms and circular walls for the bead retention segment 11; “bead retention segment can be sized and configured to hold a microspherical bead with a diameter of between about 10 nm to about 1 mm, typically between about 100 nm to about 1 mm” [0012]; “bead retention segment can have a width that is between about 101% to about 195% of the diameter of a respective bead held therein” [0013]; therefore, Ramsey teaches a range of embodiments including, for example, where the bead has diameter 25 μm, so the bead retention segment [first region] has a width and length that falls within the claimed range of between 10 and 100 μm). As there is no allegation of criticality of the claimed range, the overlapping range taught by Ramsey is sufficiently specific and anticipates the claimed range (see MPEP §2131.03).
Regarding claims 12 and 13, Ramsey teaches the device of claim 1, wherein a diameter of a CB (see Claim Interpretation section) within a specific region of the at least one first regions (see rejection of claims 12 and 13 under 35 U.S.C. 112(b)) is between 0 μm and 50 μm smaller than a dimension of the specific region of the at least one first regions (“bead retention segment can be sized and configured to hold a microspherical bead with a diameter of between about 10 nm to about 1 mm, typically between about 100 nm to about 1 mm” [0012]; “bead retention segment can have a width that is between about 101% to about 195% of the diameter of a respective bead held therein” [0013]; therefore, Ramsey teaches a range of embodiments including, for example, where the bead has diameter 25 μm, the bead retention segment [first region] has width 110% of the diameter of the bead, 27.5 μm, so the bead has diameter 2.5 μm smaller than the width of the first region). As there is no allegation of criticality of the claimed range, the overlapping range taught by Ramsey is sufficiently specific and anticipates the claimed range (see MPEP §2131.03).
Regarding claim 14, Ramsey teaches the device of claim 1, wherein the diameter of the CB (see Claim Interpretation section) within a first first region is larger than the diameter of the CB within a second first region (FIGS. 14B-D, 11a is the first first region and 11b is the second first region; FIG. 15B, 11a or 11b is the first first region and 11c is the second first region; “The bead well retention segments 11a, 11b (11c) can be the same or different sizes as shown” [0129]).
Regarding claim 16, Ramsey teaches the device of claim 1, wherein the CB capture moiety is an oligonucleotide capture bead comprising a nucleic acid capture sequence tethered to the CB (“biotinylated primers that are attached to dye encoded, streptavidin-labeled, magnetic microspheres or beads […] the primers attached to the beads act as hybridization probes, capturing and purifying the nucleic acid sequence specific to that bead” [0113]).
Regarding claim 21, Ramsey teaches the device of claim 1, wherein the CB capture moiety comprises an antibody tethered to the CB (“beads labeled with anti-TNF-α antibodies” [0124]).
Therefore, claims 1, 4, 7-9, 12-14, 16, and 21 are anticipated.
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.
Claims 2, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey et al. (U.S. Patent Application Cite No. 1 in IDS filed 18 June 2025)(US 2019/0054470, published 21 February 2019, effectively filed date 22 July 2015), herein Ramsey, in view of Ng et al. (U.S. Patent Application Cite No. 2 in IDS filed 18 June 2025)(US 2019/0285626, published 19 September 2019), herein Ng.
Regarding claim 2, Ramsey teaches the device of claim 1. Ramsey also teaches that the shape of the wells they teach is advantageous because it enhances the signal to noise ratio for assays in the well (“Embodiments of the invention provide novel bead well geometries which can separate a respective bead from an adjacent region of solution in the well to enhance signal to noise for assay signal detection in the well” [0006]). However, Ramsey does not teach at least one substrate capture moiety attached to a surface of the at least one second region. This deficiency is made up for in the teachings of Ng.
Regarding claim 2, Ng teaches multiplexing assays (“The systems of the disclosure provides compositions and methods for the multiplexed analysis” [0004]) with reaction regions comprising at least one substrate capture moiety attached to a surface of the reaction region (“a surface comprising a plurality of capture agents operatively-linked thereto […]; a substrate comprising a plurality of chambers, wherein the substrate releasably couples with the surface and wherein each chamber of the plurality of chambers comprises at least one repeat of the repeating pattern of the plurality of capture agents of the surface” [0005]; see also Figure 15, [0038], and [0118]).
Regarding claim 17, Ramsey teaches the device of claim 16 and Ng teaches a bead composition in a chamber wherein the bead composition comprises a nucleic acid capture sequence comprising an individually unique chamber barcode sequence, a PCR handle, a unique molecular identifier (UMI), a barcode handle sequence, and a capture sequence (“at least one chamber comprises a bead, the bead composition comprises a bead and nucleic acid sequence encoding a barcode, wherein the barcode comprises a sequence encoding a barcode and a sequence encoding a barcode handle. In certain embodiments, the nucleic acid sequence encoding the barcode further comprises one or more of a sequence encoding a PCR handle, a sequence encoding a unique molecular identifier (UMI), […] and a sequence encoding a TSO hybridization site” [0045], the TSO hybridization site is considered a capture sequence since it captures a target via hybridization; “each bead of the plurality of chambers comprises a unique barcode” [0046], the unique chamber barcode sequence).
Regarding claim 19, Ramsey teaches the device of claim 16 and Ng teaches a bead composition in a chamber wherein the bead composition comprises a barcode sequence that is unique to each chamber of the plurality of chambers (“each bead of the plurality of chambers comprises a unique barcode” [0046]).
Regarding claim 20, the combination of Ramsey and Ng teach the device of claim 2 as discussed in the 35 U.S.C. 103 rejection above, and Ng teaches that the at least one substrate capture moiety is an antibody (“at least one capture agent of the plurality of capture agents comprises […] an antibody” [0016]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of the barcoded nucleic acid capture sequence taught by Ng for the primer that captures nucleic acid sequences taught by Ramsey. One of ordinary skill in the art could have performed the substitution and would expect the results of the substitution to be predictable because the substitution is of one oligonucleotide for another and both are performed in assays where the oligonucleotide is attached to a bead in a microwell. Additionally, one of ordinary skill in the art would be motivated to combine the teachings of Ramsey and Ng in order to improve the microwell-based assays taught by Ng with the advantage of enhanced signal to noise of the well geometry taught by Ramsey. Therefore, the invention as a whole of claims 2, 17, and 19-20 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 8, 16-17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 26, 28, and 135 of copending Application No. 18/035,037 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, claim 1 of ‘037 recites a multiplex assay chip device configured for multiplexed analysis of biological material, the device comprising: a plurality of capture beads (CB) each bead including a capture moiety; a substrate having a plurality of chambers, each of the plurality of chambers including an open end arranged on a first side of the substrate, and a length, a width, and a depth (the chambers are equivalent to the claimed second regions), a pocket P1 having a pocket diameter greater than the width of the chamber (the pocket P1 is equivalent to the claimed first regions), and a corresponding CB of the plurality of CBs arranged within the pocket P1 of the chamber (equivalent to “at least one CB arranged within the at least one first region of each of the plurality of chambers of the substrate” in instant claim 1), wherein each CB includes a CB diameter smaller than the pocket diameter of the pocket and larger than the width of the corresponding chamber, such that the CB fits within the pocket P1 of the chamber but no other portion of the corresponding chamber (the CB fitting with the pocket P1 is equivalent to each of the first length, the first width, and the first depth being greater than the bead diameter; the CB not fitting in any other portion of the corresponding chamber is equivalent to at least one of the second length, the second width, and the second depth being less than the bead diameter), and a surface configured to couple with the first side of the substrate and thereby enclose each chamber of the plurality of chambers (equivalent to “a surface removably coupled to the first side of the substrate, wherein each of the plurality of chambers is covered when the surface is removably coupled to the first side of the substrate). Therefore, claim 1 of ‘037 anticipates instant claim 1.
Regarding instant claim 4, claim 135 of ‘037 recites the device of claim 1 wherein each chamber has a width between 1 μm and 100 μm, a length of between 1 μm and 2000 μm, and a depth of between 1 μm and 100 μm (the recited chamber is equivalent to the second region). Therefore, claim 135 of ‘037 anticipates instant claim 1.
Regarding instant claim 8, claim 9 of ‘037 recites the device of claim 1 wherein the device of claim 1, wherein P1 has a pocket diameter of between 5 μm and 50 μm larger than the chamber width (equivalent to “the first width of the at least one first region is between 5 μm and 50 μm larger than the width of the second width of the at least one second region”). While claim 9 of ‘037 also recites in the alternative two additional limitations that limit the diameter of P1 or limit the difference in diameters of the CB and P1, such that instant claim 8 may be considered a species of the broader claim 9 of ‘037, one of ordinary skill in the art would “at once envisage the invention claimed in the examined application” (MPEP §804(II)(B)(2)). Therefore, claim 9 of ‘037 anticipates instant claim 8.
Regarding instant claim 16, claim 26 of ‘037 recites the device of claim 22 (itself reciting the device of claim 1) wherein the capture moiety is configured to capture nucleic acid sequences, and wherein the nucleic acid capturing CB is an oligonucleotide capture bead comprising a nucleic acid capture sequence tethered to a bead (equivalent to “wherein the CB capture moiety is an oligonucleotide capture bead comprising a nucleic acid capture sequence tethered to the CB”). Therefore, claim 26 of ‘037 anticipates instant claim 16.
Regarding instant claims 17 and 19, claim 28 of ‘037 recites the device of claim 26 (see above) wherein the nucleic acid capture sequence comprises an individually unique cell barcode, a PCR handle, a unique molecular identifier (UMI), a barcode handle sequence, and a capture sequence (the recited unique cell barcode is equivalent to the unique chamber barcode). This is also a more specific embodiment of instant claim 19. Therefore, claim 28 of ‘037 anticipates instant claims 17 and 19.
Claims 7, 9, 12-14, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/035,037 in view of Ramsey et al. (U.S. Patent Application Cite No. 1 in IDS filed 18 June 2025)(US 2019/0054470, published 21 February 2019, effectively filed date 22 July 2015), herein Ramsey.
This is a provisional nonstatutory double patenting rejection.
Regarding claims 7, 9, 12-14, and 21, Ramsey teaches the additional limitations of these claims as discussed in the 35 U.S.C. 102 rejections above. In view of Ramsey’s teaching that the well geometry they teach enhances signal to noise measurements, one of ordinary skill in the art would be motivated to combine Ramsey with the multiplex assay chip device claimed in claim 1 of ‘037. One of ordinary skill in the art would have a reasonable expectation of success in the combination of Ramsey and the device of claim 1 of ‘037 because both teach devices for analysis of biological samples in wells. Therefore, claims 7, 9, 12-14, and 21 are obvious variants of claim 1 of ‘037 in view of Ramsey.
Claims 2 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/035,037 in view of Ramsey et al. (U.S. Patent Application Cite No. 1 in IDS filed 18 June 2025)(US 2019/0054470, published 21 February 2019, effectively filed date 22 July 2015), herein Ramsey, and Ng (U.S. Patent Application Cite No. 2 in IDS filed 18 June 2025)(US 2019/0285626, published 19 September 2019), herein Ng.
This is a provisional nonstatutory double patenting rejection.
Regarding claims 2 and 20, Ng teaches the additional limitations of these claims as discussed in the 35 U.S.C. 102 rejections above. As discussed in the double patenting rejection of claims 7, 9, 12-14, and 21 above, the combination of claim 1 of ‘037 with Ramsey is obvious. As discussed in the rejection of claims 2, 17, and 19-20 under 35 U.S.C. 103 above, the combination of Ng with Ramsey is obvious, so the combination of claim 1 of ‘037 with Ramsey and Ng is obvious. Therefore, claims 2 and 20 are obvious variants of claim 1 of ‘037 in view of Ramsey and Ng.
Conclusion
Claims 1-2, 4, 7-9, 12-14, 16-17, and 19-21 are rejected. Claims 26-28 are withdrawn. Claims 3, 5-6, 10-11, 15, 18, 22-25, and 29-88 are canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey Lawrence Bellah whose telephone number is (571)272-1024. The examiner can normally be reached M-Th, 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEFFREY BELLAH/Examiner, Art Unit 1683 /ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights