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 .
Claim Status
Claims 1-20 are pending and under examination.
Response to Amendment
Applicant’s amendments to the claims, received 01/30/2026, have overcome the 112(b) rejection(s) previously set forth in the Non-Final Office Action mailed on 07/30/2025.
Based on the amended claims and remarks, the previous prior art rejection over Kochar has been withdrawn and a new prior art rejection set forth (see below).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/501,355, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 1 recites “a multi-vessel carrier target kit”. However, support for the claimed subject matter was not found in prior-filed application. Accordingly, claim 1-20 are not entitled to the benefit of the prior application.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 7-9, 12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kochar et al. (US 2022/0365106; already of record – hereinafter “Kochar”), in view of Luo et al. (US 2021/0278398 – hereinafter “Lou”), and Koster et al. (US 2002/0009394; already of record – hereinafter “Koster”).
Regarding claim 1, Kochar discloses an instrument for automatically carrying out a multiplexed immunoassay on a plurality of biological samples (Kochar; figs. 5-11, “assay system”, [0200-0203, 0206]), comprising:
1) a controller (Kochar; fig. 10a & 11b-c, #1009, “electronic enclosure configured to house a system control computer”, [0226, 0360-0366]);
2) a robotic gantry capable of moving in three degrees of freedom (Kochar; fig. 10b, #1022, “gantry”, [0226, 0234, 0253, 0300]);
3) a hotel capable of holding multi-vessel carrier plates that are accessible by a user and the robotic gantry (Kochar; fig. 10a-c, #1012, “platform”, [0226, 0231-0232]);
4) a mixer that operates as a mixer comprising multiple multi-vessel carrier plate platforms (Kochar; fig. 10a, #1006, “plate shaking subassembly”, [0226, 0267]);
5) a reader (Kochar; fig. 10a, #1003, “assay reader”, [0226]); and
6) positioned within the hotel (Kochar; fig. 10a, #1012, “platform”, [0226]),
a) a plurality of multi-vessel carrier plates, comprising a first plate comprising a plurality of first wells, a second plate comprising a plurality of second wells, a third plate comprising a plurality of third wells, a fourth plate comprising a plurality of fourth wells (Kochar; fig. 10a, #1004, “assay consumable storage unit … comprising a plurality of shelving units each sized to accommodate a multi-well assay plate … can comprise an M x N rectilinear array of storage units … 2x2, 3x3, 4x4, 5x6, 6x5”, [0231]) and a multi-vessel carrier assay plate comprising the plurality of biological samples (Kochar; figs. 15A & 15C-a – See “Materials Loaded onto Instrument” … “Sample Plate #1 (Hotel) ... Sample Plate #5 (Hotel) … Test Plate #1 (Hotel) … Test Plate #5 (Hotel)”, 0488]); and
b) a multi-vessel carrier target kit (Kochar; fig. 10a, 10g, 18a, 19d-h, #1018, “reagent troughs” and “V-PLEX kit”, [0226, 0268-0270, 0309, 0499-0530, 0711-0721, 0728-0730]).
Kochar does not teach a dual-capture and release multiplexed immunoassay or the multi-vessel carrier target kit comprising: a plurality of multiplexed paired-binding moieties, each of the plurality of multiplexed paired-binding moieties comprising different paired-binding moieties that are pre-selected to bind to a specific analyte in a plurality of different specific analytes in at least one of the plurality of biological samples, the paired-binding moieties comprising: i) a first moiety of the paired-binding moieties comprising a first antibody or a first antibody fragment that is pre-selected to bind the specific analyte, a first nucleic acid target label comprising a first identity that is analyte-specific to the specific analyte, and a first nucleic acid tag; and ii) a second moiety of the paired-binding moieties comprising a second antibody or a second antibody fragment that is pre-selected to bind the same specific analyte as the first antibody or antibody fragment of the first moiety of the paired-binding moieties, a second nucleic acid target label comprising a second identity that is analyte-specific to the specific analyte, and a second nucleic acid tag, wherein the first nucleic acid tag of the first moiety of the paired-binding moieties is preselected to bind to a first substrate that is the same for the plurality of multiplexed paired-binding moieties in the multiplex and the second nucleic acid tag of the second moiety of the paired-binding moieties is pre-selected to bind a second substrate that is the same for the plurality of multiplexed paired-binding moieties in the multiplex, wherein the second nucleic acid tag is preselected to bind to the second substrate after forming the binding complex with the specific analyte; or c) a multi-vessel carrier detection kit comprising: i) a first solution comprising the first substrate configured to bind to the first nucleic acid tag; and ii) a second solution comprising the second substrate configured to bind to the second nucleic acid tag.
However, Luo teaches the analogous art of a dual-capture and release multiplexed immunoassay (Luo; “MULISA immunoassay”; fig. 16, [0425, claim 285, 286]) and a multi-vessel carrier target kit comprising: a plurality of multiplexed paired-binding moieties, each of the plurality of multiplexed paired-binding moieties comprising different paired-binding moieties that are pre-selected to bind to a specific analyte in a plurality of different specific analytes in at least one of the plurality of biological samples (Luo; fig. 16, claims 285, 286, step 1), the paired-binding moieties comprising: i) a first moiety of the paired-binding moieties comprising a first antibody or a first antibody fragment that is pre-selected to bind the specific analyte, a first nucleic acid target label comprising a first identity that is analyte-specific to the specific analyte, and a first nucleic acid tag (Luo; fig. 16, claims 285, 286, step 1 (i)); and ii) a second moiety of the paired-binding moieties comprising a second antibody or a second antibody fragment that is pre-selected to bind the same specific analyte as the first antibody or antibody fragment of the first moiety of the paired-binding moieties, a second nucleic acid target label comprising a second identity that is analyte-specific to the specific analyte, and a second nucleic acid tag (Luo; fig. 16, claims 285, 286, step 1 (ii)), wherein the first nucleic acid tag of the first moiety of the paired-binding moieties is preselected to bind to a first substrate that is the same for the plurality of multiplexed paired-binding moieties in the multiplex (Luo; fig. 16, claims 285, 286, step 2) and the second nucleic acid tag of the second moiety of the paired-binding moieties is pre-selected to bind a second substrate that is the same for the plurality of multiplexed paired-binding moieties in the multiplex (Luo; fig. 16, claims 285, 286, step 5), wherein the second nucleic acid tag is preselected to bind to the second substrate after forming the binding complex with the specific analyte (Luo; fig. 16, claims 285, 286, steps 2-5); and c) a multi-vessel carrier detection kit comprising: i) a first solution comprising the first substrate configured to bind to the first nucleic acid tag (Luo; fig. 16, [0005], claims 285, 286, “in a solution”); and ii) a second solution comprising the second substrate configured to bind to the second nucleic acid tag (Luo; fig. 16, [0005], claims 285, 286, “in a solution”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the multi-vessel carrier target kit of Kochar with the multi-vessel carrier target kit and multi-vessel carrier detection kit as taught by Luo, because Luo teaches the multi-vessel carrier target kit and multi-vessel carrier detection kit can estimate early cancer detection of analytes at concentrations as low as 7 attomolar (Luo; [0004]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Kochar and Luo both teach systems and methods for conducting multiplexed immunoassays on biological samples.
Modified Kochar does not teach the mixer as magnetic bead processor.
However, Koster teaches the analogous art of a mixer (Koster; fig. 1, #172, [0098]) wherein the mixer operates as a magnetic bead processor and mixer (Koster teaches mixer 172 comprise magnets 202/302 configured to align with wells in a microtiter plate; figs. 2-3, #202, #302; [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mixer of Kochar with the mixer that operates as a magnetic bead processor and mixer, as taught in Koster, because Koster teaches the mixer as a magnetic bead processor and mixer concentrates magnetic beads 208 along the sides of the wells; fig. 2, [0099]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Kochar and Koster both teach mixers for multiwell plates.
Regarding claim 2, modified Kochar teaches the instrument of claim 1 above, wherein the controller comprises a processor and a non- transitory machine-readable storage medium comprising instructions executable by the processor to provide controlled operations of the components within the instrument (Kochar; figs. 10a & 11b-c, #1009, “electronic enclosure configured to house a system control computer”, [0226, 0360-0366]).
Regarding claim 3, modified Kochar teaches the instrument of claim 1 above, wherein the controller comprises a processor and a non-transitory machine-readable storage medium comprising preprogrammed instructions executable by the processor to execute the dual-capture and release multiplexed immunoassay (The modification of the multi-vessel carrier target kit of Kochar with the multi-vessel carrier target kit and multi-vessel carrier detection kit of Luo has previously been discussed in claim 1 above. Kochar teaches the instrument control system controls the workings of the robotic system 1002 and the operational and performance qualifications, as well as the reported errors; figs. 10a & 11b-c, #1009, “electronic enclosure configured to house a system control computer”, [0226, 0360-0366]).
Regarding claim 4, modified Kochar teaches the instrument of claim 1, wherein the instrument further comprises an incusealer comprising framed sealing film for sealing at least one multi-vessel carrier plate in the plurality of multi-vessel carrier plates (Kochar disclose mixer 1006 have heaters to maintain the assay plate temperature; [0267-0268], and lids 1032 with framed seal 1034 to prevent evaporation; figs. 10i-k, [0272]).
Regarding claim 7, modified Kochar teaches the instrument of claim 1 above, wherein the robotic gantry further comprises an end-effector (Kochar; fig. 10b, #1031, [0253]).
Regarding claim 8, modified Kochar teaches the instrument of claim 1 above, wherein the robotic gantry is capable of moving the end-effector in three degrees of freedom in X, Y and Z axes (Kochar; fig. 10b, #1031, [0253]).
Regarding claim 9, modified Kochar teaches the instrument of claim 7 above, wherein the end-effector further comprises a multi-vessel carrier plates gripper (Kochar; fig. 10b, #1031, [0253]).
Regarding claim 12, modified Kochar teaches the instrument of claim 1 above, wherein the reader is capable of identifying and/or quantifying nucleic acid reporters (Kochar teaches the reader is configured to detect the emission of luminescence, e.g., fluorescence, phosphorescence, chemiluminescence, and electrochemiluminescence (ECL), and is therefore capable of identifying and quantifying nucleic acid reports; [0211]).
Regarding claim 18, modified Kochar teaches the instrument of claim 1 above, wherein the first substrate comprise a first binding group that is capable of binding with the first nucleic acid tag, and wherein the second substrate comprise a second binding group that is capable of binding with the second nucleic acid tag (The modification of the multi-vessel carrier target kit of Kochar with the multi-vessel carrier target kit and multi-vessel carrier detection kit as taught by Luo, has previously been discussed in claim 1 above. Luo teaches the first substrate comprise a first binding group that is capable of binding with the first nucleic acid tag, and wherein the second substrate comprise a second binding group that is capable of binding with the second nucleic acid tag; fig. 16, [0425, claim 285, 286]).
Regarding claim 19, modified Kochar teaches the instrument of claim 18 above, wherein the first binding group comprises a nucleic acid sequence configured to hybridize with the first nucleic acid tag (The modification of the multi-vessel carrier target kit of Kochar with the multi-vessel carrier target kit and multi-vessel carrier detection kit as taught by Luo, has previously been discussed in claim 1 above. Luo teaches the first binding group comprises a nucleic acid sequence configured to hybridize with the first nucleic acid tag; fig. 16, [0425, claim 285, 286, step 2]).
Regarding claim 20, modified Kochar teaches the instrument of claim 1, wherein the first substrate comprises first magnetic beads, and wherein the second substrate comprises second magnetic beads (The modification of the multi-vessel carrier target kit of Kochar with the multi-vessel carrier target kit and multi-vessel carrier detection kit as taught by Luo, has previously been discussed in claim 1 above. Luo teach the first substrate comprises first magnetic beads, and wherein the second substrate comprises second magnetic beads; fig. 16, [0425, claim 285, 286, step 2 & step 5]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kochar, in view of Luo and Koster, and further in view of Beroth et al. (US 2009/0011954; already of record – hereinafter “Beroth”).
Regarding claim 5, modified Kochar teaches the instrument of claim 4 above.
Modified Kochar does not teach wherein the framed sealing film has one or more perforated lines that are configured to allow easy and complete separation of a film of the framed sealing film from a frame of the framed sealing film by tearing.
However, Beroth teaches the analogous art of sealing plates with a film (Beroth; fig. 1, [0025, 0050]), wherein the sealing film has one or more perforated lines that are configured to allow easy and complete separation of the film from the frame by tearing (Beroth teaches perforations on the film identical to the size and shape of the opening of the wells; [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the framed sealing film of modified Kochar to comprise perforated lines, as in Beroth, because Beroth teaches the perforated lines establish distinct wells in the surface of the lamination (Beroth; abstract).
Regarding claim 6, modified Kochar teaches the instrument of claim 4 above.
Modified Kochar does not teach wherein the framed sealing film is pierceable by a pipette tip.
However, Beroth teaches the analogous art of sealing plates with a film (Beroth; fig. 1, [0025, 0050]), wherein the framed sealing film is pierceable by a pipette tip (Beroth teach perforations on the film identical to the size and shape of the opening of the wells; [0050]. Further, a pipette tip with sufficient force would pierce the sealing film at the perforation around each well). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the framed sealing film of modified Kochar to comprise perforated lines able to be pierced by a pipette tip, as in Beroth, because Beroth teaches the perforated lines establish distinct wells in the surface of the lamination (Beroth; abstract).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kochar, in view of Luo, and Koster, and further in view of Friedman et al. (US 2013/0096718; already of record – hereinafter “Friedman”).
Regarding claim 10, modified Kochar teaches the instrument of claim 7 above.
Modified Kochar does not teach wherein the end-effector further comprises at least one laser position sensor.
However, Friedman teaches the analogous art of a robotic system comprising end effector (Friedman; 1A, #104, [0033]) wherein the end effector comprise at least one laser position sensor (Friedman; fig. 1A, #106, [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the end effector of modified Kochar to comprise at least one laser position sensor, as taught in Friedman, because Friedman teaches the laser position sensor are long range and emit multiple intersecting beams toward a target (Friedman; [0046]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kochar and Friedman both teach end effectors for positioning and moving objects.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kochar in view of Luo, Koster, and Friedman, and further in view of Bevirt et al. (US 2002/0150450; already of record – hereinafter “Bevirt”).
Regarding claim 11, modified Kochar teaches the instrument of claim 10 above.
Modified Kochar does not teach wherein the end-effector, further comprises a barcode scanner.
However, Bevirt teaches the analogous art of an end-effector (Bevirt; fig. 2, #8, [0029]) comprising a barcode scanner (Bevirt; fig. 2, #14, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the end effector of modified Kochar to comprise a barcode scanner, as in Bevirt, because Bevirt teaches the barcode scanner reads a barcode on the plates to allow a computer to monitor and track the plate (Bevirt; [0018]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kochar and Bevirt both teach end effector for positioning and moving plates.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kochar, in view of Luo and Koster, in further view of Ribbert et al. (US 2010/0183516; already of record – hereinafter “Ribber”).
Regarding claim 13, modified Kochar teach the instrument of claim 1 above, comprising the reader.
Modified Kochar does not teach wherein the reader comprises a qPCR unit.
However, Ribbert teaches the analogous art of carrying out an immunoassay on a biological sample (Ribbert; [0420]) wherein the immunoassay is read with a qPCR unit (Ribbert; [0421]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reader of modified Kochar to comprise a qPCR unit, as in Ribber, because Ribbert teaches the qPCR unit detects signal amplification from the immunoassay to determine a readout (Ribbert; [0421]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kochar and Ribbert both teach carrying out an immunoassay and detecting a signal with a reader.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kochar, in view of Luo, Koster, and Ribbert, in further view of O’Neill et al. (US 2019/0256546; already of record – hereinafter “O’Neill”).
Regarding claim 14, modified Kochar teach the instrument of claim 13 above, comprising the qPCR unit.
Modified Kochar does not teach wherein the qPCR is capable of preparing a pool library ready for next-generation sequencing (NGS).
However, O’Neill teaches the analogous art of characterizing a biological sample using a reader (O’Neill; fig. 20i; [0416]) wherein the reader comprise a qPCR capable of preparing a pool library ready for next-generation sequencing (NGS) (O’Neill teaches the sample is contacted with the ADAPT™ library pool 2022, Oligonucleotides that bound to isolated microvesicles are collected and identity is determined using NGS and qPCR; [0421]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reader of modified Kochar to comprise a qPCR capable of preparing a pool library ready for next-generation sequencing, as in O’Neill, because O’Neill teaches the reader comprising qPCR capable of preparing a pool library ready for next-generation sequencing identifies whether the bound oligonucleotides in from the patient sample contain a disease related to microvesicles (O’Neill; [0421]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kochar and O’Neill both teach characterizing a biological sample with a reader.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kochar, in view of Luo, in view of Koster, and further in view of O’Neill.
Regarding claim 15, modified Kochar teach the instrument of claim 1 above, comprising the reader.
Modified Kochar does not teach wherein the instrument is capable of detection of an analyte having a concentration of less than 50 attomolar.
However, O’Neill teaches the analogous art of characterizing a biological sample using a reader (O’Neill; fig. 20i; [0416]) wherein the reader comprise qPCR (O’Neill teach the sample identity is determined using NGS and qPCR; [0421]. NOTE: When the claimed invention and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. Accordingly, the qPCR of O’Neill would possess the claimed functionality as described in paragraphs [0030, 0064, 0075] of applicant specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reader of modified Kochar to comprise a qPCR reader, as in O’Neill, because O’Neill teaches the reader comprising qPCR capable of preparing a pool library ready for next-generation sequencing identifies whether the bound oligonucleotides in from the patient sample contain a disease related to microvesicles (O’Neill; [0421]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kochar and O’Neill both teach characterizing a biological sample with a reader.
Regarding claim 16, modified Kochar teach the instrument of claim 15 above, comprising the reader.
Modified Kochar does not teach wherein the instrument has a broad dynamic measurement range of up to 12 logs of concentration differences.
However, O’Neill teaches the analogous art of characterizing a biological sample using a reader (O’Neill; fig. 20i; [0416]) wherein the reader comprise qPCR (O’Neill teach the sample identity is determined using NGS and qPCR; [0421]. NOTE: When the claimed invention and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. Accordingly, the qPCR of O’Neill would possess the claimed functionality as described in paragraphs [0064, 0075] of applicant specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reader of modified Kochar to comprise a qPCR reader, as in O’Neill, because O’Neill teaches the reader comprising qPCR capable of preparing a pool library ready for next-generation sequencing identifies whether the bound oligonucleotides in from the patient sample contain a disease related to microvesicles (O’Neill; [0421]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kochar and O’Neill both teach characterizing a biological sample with a reader.
Regarding claim 17, modified Kochar teach the instrument of claim 15 above, wherein the instrument is capable of detection of an analyte having a concentration of less than 10 attomolar (The modification of the reader of modified Kochar to comprise a qPCR reader, as in O’Neill, has previously been discussed in claim 15 above. NOTE: When the claimed invention and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. Accordingly, the qPCR of O’Neill would possess the claimed functionality as described in paragraphs [0030, 0064, 0075] of applicant specification).
Response to Arguments
Applicant’s arguments, see pages 6-9 of their remarks, filed 01/30/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, and in view of the amended claim limitations, a new ground(s) of rejection is made in view of Luo.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/C.A.T./Examiner, Art Unit 1798
/P. Kathryn Wright/Primary Examiner, Art Unit 1798