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
Claims 55-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 September 2025.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 26 September 2025. Claims 68-72 are pending in the application. Claims 55-67 are cancelled. Claims 68-72 are being examined herein.
Status of the Objections and Rejections
The rejections of claims 68-72 under 35 U.S.C. § 112(b) are withdrawn in view of amendments.
The rejections of claims 68, 71, and 72 under 35 U.S.C. § 103 in view of Brown (US 200202164820 A1) in view of Hoffman, et. al. (US 20160281156 A1) are withdrawn in view of amendments.
The rejections of claims 69 and 70 under 35 U.S.C. § 103 in view of Brown (US 200202164820 A1) and Hoffman, et. al. (US 20160281156 A1) in further view of Wiktor (US 20160339427 A1) are withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see remarks starting at paragraph 03 of page 05 of the remarks, filed 26 September 2025, with respect to the rejection of claim 68 under Brown (US 200202164820 A1) in view of Hoffman, et. al. (US 20160281156 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Chaing, et. al. (US 20150275292 A1) in view of Hansen, et. al. (US 20110053151 A1). Chain in view of Hansen remedies the missing element of the “multiple primary reaction chambers” in newly amended claim 68.
Applicant offers no additional arguments for claims 69-72 outside of their dependence of claim 68 (remarks, pg. 06, par. 03-04).
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 “multiple primary reaction chambers” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Examiner believes hexagonal chambers 116 are representative of the multiple primary reaction chambers, but the “primary reaction chambers” as referenced throughout the specification of the instant application do not have a corresponding drawing label. A change is needed in the drawings, specification, and/or claims to clearly indicate what the primary reaction chambers are and if they correspond to the hexagonal chambers 116.
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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 68-69 and 71-72 are rejected under 35 U.S.C. 103 as being unpatentable over Chaing, et. al. (US 20150275292 A1) in view of Hansen, et. al. (US 20110053151 A1).
For claim 68, Chiang teaches a honeycomb tube comprising a fluidic path leading to a chamber with a plurality of wells that can perform multiplexing assays such as for nucleic acids (Abstract, par. 0002, 0046) (for identifying a plurality of nucleic acid molecules in a sample). Chiang teaches the honeycomb tube 100 is a cartridge and comprises a fluidic inlet 110 connected to a fluidic outlet 112 (Fig. 1A-B; par. 0061) (an inlet port) (an outlet port) (a cartridge fluidically coupling said inlet port and said outlet port and defining a space). Between the inlet 110 and outlet 112 of the honeycomb tube 100 is a fluidic path 114 with a pre-amplification chamber 122 and a well chamber 118 embedded in a planar frame 102 with a first planar substrate 104, second planar substrate 106, and a well substrate 120 that make up the cartridge (Fig. 1A-B; par. 0061-0062). The pre-amplification chamber 116 serves as a region for an initial reaction to occur before moving to the well chamber 118 and the pre-amplification chamber 116 can also be accessed by auxiliary chambers 132 (Fig. 1A-B; par. 0065-0066) (primary reaction chamber fluidically coupled to said inlet port to receive material from said inlet port and produce primary reaction chamber products from the material).
The well substrate 120, embedded in the planar frame 102 (par. 0071) and comprises an array of through-holes (Fig. 1A-B; par. 0062) (a product capture housing enclosing a solid support). Because the well substrate 120 can accommodate up to 1000 or more wells (through-holes) (par. 0062), primer material can be individually deposited into a well (Fig. 3A; par. 0080), and the primary goal of the device is to perform multiplexing assays (par. 0105), the wells within the well substrate 120 can further be divided can be set to perform different assays in replicate (par. 0129). As seen in Figure 12, provided below, each square represents a subdivision in a specificized row and column of the larger well substrate 120, and each subdivision further comprises a plurality of individual wells/through-holes. Further, each well can be coated in a hydrophilic material and the planer surface separating the wells can be coated in a hydrophobic material (par. 063) (with a plurality of product capture subdivisions configured in separate rows and columns, with each separate product capture subdivision comprising an array of a plurality of individual hydrophilic micro-pores) (wherein each of said individual hydrophilic micro-pores is separated by hydrophobic surfaces).
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Turning to Figure 2H to take a closer look at the wells (through-holes), the through-holes have a first (top) side that is wider in diameter than the second (bottom side) (cone shape) and open on both sides so "processing fluids can be exposed to both sides of the well-substrate" (par. 0078-0079) (and wherein each of said individual hydrophilic micro-pores has opposed first and second open ends with the first end having a large diameter and the second end having a diameter which is smaller than that of the first end). The well substrate 120 that holds the wells as depicted in Figure 2H has at least one fluid path on one side of the wells and a second fluid path on the second side of the wells (par. 0078) and all parts of the well are connected to the fluidic inlet 110 and outlet 112 (Fig. 1A-B) (said product capture housing comprising a plurality of fluid channels to permit material to pass from said inlet port through a column of the product capture subdivisions into contact with the array of micro-pores in those subdivisions, and to said outlet port, wherein the plurality of fluid channels are located above and below the solid support). The pre-amplification chamber 116 can include chemicals to produce a chemical reaction with the sample fluid before entering the well substrate 120 for analysis (par. 0091) (and wherein one or more of the primary reaction chamber products are further reacted to create array products which are detected in the micro-pores, wherein one or more of the rows and columns of separate product capture subdivisions receive material which has passed through one of said multiple primary reaction chambers).
Chaing is silent to multiple primary reaction chambers.
Hansen teaches a microfluidic device with a plurality of reaction chambers with a flow channel (Abstract). Hansen teaches the microfluidic device 100 comprises with an injection port 106 leading to a valve flow channel 102; valve flow channel 102 is further divided into injection port 104 connected to primary flow channel 103 and leads to valve 108 that opens to fill reaction chamber 114 by flow channels 105, 107, and 109 (Fig. 2a-c; par. 0076-0077). Each primary flow channel leads to a specific portion of an array (subdivision) and can be loaded with a fluid for a specific reaction to occur (par. 0076) (multiple primary reaction chambers). Hansen teaches the device allows for a large number of small-volume reactions in an array that is quick and easy to track and monitor (par. 0009) where the density and volume is not too small (par. 0017) and allows for more than one sample or reaction to be measured simultaneously (par. 0076).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the singular fluid path and pre-amplification chamber of Chaing to further include multiple other channels/chambers to hold and introduce reagents as taught by Hansen, in order to expand the types of assays/reactions that can be tested simultaneously. Because both devices utilize a cartridge with an array of reaction wells for testing nucleic acid-based assays, modifying a singular pre-reaction chamber to include multiple pre-reaction chambers as provided by Hansen, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
For claim 69, modified Chaing in view of Hansen teaches valves 108 that control the flow of fluid from injection port 104 and primary flow channel 103 that introduce reaction mixtures that are mixed with the samples in cascading flow channels 105, 107, and 109 (Fig. 2b; par. 0076-0077) (one or more valves for selectively introducing… reagents and/or reactants into… said product capture housing through said inlet port…).
For claim 71, Chaing teaches a method for preparing the well substrate 120 with a primer using a printing pin (Fig. 2H, 3A; par. 0078-0080) (for preparing a system for identifying a plurality of nucleic acid molecules in a sample). Modified Chaing in view of Hansen teaches the system of claim 68 (see above) (providing the system of claim 68). Chaing teaches nucleic acid primer material or probe is loaded and dried or sealed into the well for amplification and/or detection of a specific target (Fig. 2H, 3A; par. 0029, 0079-0080, 0093-0094) (applying capture oligonucleotide primers or probes to the micro-pores of the product capture subdivisions on the solid support within said product capture housing, whereby the capture oligonucleotide primers or probes are retained within the micro-pores).
For claim 72, modified Chaing teaches the primers/probed are loaded into the wells on the well substrate 120 and are sealed or dried into the wells before being liquified later during the reaction (par. 0080) (following said applying capture oligonucleotide primers or probes to the micro-pores). Once the well substate 120 is loaded with probes/primers 134, the honeycomb tube cartridge is then strategically filled with the sample fluid and a series of reagents and heated to promote a reaction (Fig. 4A-D"; par. 0081-0086) (conducting reactions in said system). The honeycomb cartridge 100 is then inserted into the sensor assembly for testing/measuring the assay, specifically PCR (par. 0087-0090) (detecting the presence of target nucleic acid molecules in the sample in the micro-pores based on said conducting the reactions).
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Chaing, et. al. (US 20150275292 A1) and Hansen, et. al. (US 20110053151 A1) as applied to claim 68 above, and further in view of Wiktor (US 20160339427 A1).
For claim 70, modified Chaing teaches the honeycomb cartridge 100, specifically the well substrate 120 is heated by being in contact with an external heating device (par. 0091) (one... heating element… proximate to said product capture housing).
Modified Chaing is silent to the heating element [being] in said cartridge.
Wiktor teaches a microreactor array platform for high-throughput parallel assays (par. 0025). Wiktor teaches a microarray platform 20 comprising a microreactor array 22 with plurality of microreactors 24 having a hydrophilic surface connected via channels (Fig. 3; par. 0057, 0060-0062), and an inlet port 50 that allows a reagent to be injected through a solenoid valve (par. 0069) and an outlet port 52 (Fig. 5). Wiktor teaches samples in the microreactors 24 within the microreactor array 22 undergo thermal cycling. Wiktor teaches heaters, like thermoelectric devices, built into the microreactor array platform (par. 0083) which houses the microreactors (heating elements in said cartridge proximate to said product capture housing). Adding an element that controls the temperature allows for control of the rate of reactions happening within the microreactors (par. 0083).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the cartridge capable of heat treating the wells in the well substrate of modified Chaing to include a heating element (thermoelectric device) as taught by Wiktor in order to have more control of the rate of reaction occurring the sample chambers. Because both systems heat the sample chambers to cause a reaction, adding heating element, as provided by Wiktor, to the cartridge as provided by modified Chaing, provide likewise sought functionality that would have reasonable expectation of success therein. MPEP § 2143(I)(G).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758