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 .
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, 10, 15, 16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,547,995. Although the claims at issue are not identical, they are not patentably distinct from each other. This rejection was applied to claim 1 in Paragraph 3 of the Non-Final Rejection mailed 10/01/25. Claims 1-12 of the ‘995 Patent recites “a base substrate; a plurality of sample processing regions defined at a broad surface of the base substrate, wherein the plurality of sample processing regions comprises at least two sample processing regions arranged as lanes, wherein each lane is configured to receive a separate sample such that multiple samples are processed in parallel, and wherein each of the plurality of sample processing regions comprises: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions” as recited in claims 1, 10 and 15 of the instant claims. In addition, claims 1-12 of the ‘995 patent further recite all of the features of the rejected dependent claims. Therefore claims 1-12 of the ‘995 Patent fully encompass the scope of the rejected instant claims.
Claims 1-5, 7-13 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,162,015. Although the claims at issue are not identical, they are not patentably distinct from each other. This rejection was applied to claim 1 in Paragraph 3 of the Non-Final Rejection mailed 10/01/25. This rejection was applied to claim 1 in Paragraph 3 of the Non-Final Rejection mailed 10/01/25. Claims 1-18 of the ‘015 Patent recites “a base substrate; a plurality of sample processing regions defined at a broad surface of the base substrate, wherein the plurality of sample processing regions comprises at least two sample processing regions arranged as lanes, wherein each lane is configured to receive a separate sample such that multiple samples are processed in parallel, and wherein each of the plurality of sample processing regions comprises: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions” as recited in claims 1, 10 and 15 of the instant claims. In addition, claims 1-12 of the ‘015 patent further recite all of the features of the rejected dependent claims. Therefore claims 1-12 of the ‘015 Patent fully encompass the scope of the rejected instant claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 11 recites the limitation "the cover substrate" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-3, 10, 12, 15, 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaye (US 3,787,290). Kaye teaches an assay apparatus. This rejection was applied to claim 1 in Paragraphs 7-8 of the Non-Final Rejection mailed 10/01/25. The rejection remains in effect for claim 1 and also includes new claims as listed above. Please also see Response to Arguments below.
Regarding claims 1-3, 10, 15 and 16 – As shown in Figures 5-7, Kaye teaches a base substrate (slide 52); and a set of sample processing regions (56/66) defined at a broad surface of the substrate, wherein each of the set of sample processing regions comprises: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary (60) separating each respective sample processing region from adjacent sample processing regions. See Examples IV and V in columns 10-11. The Examiner notes Figure 7 teaches an embodiment (tray 70) having wells in the subarray format shown in Figure 5. Figures 5 and 7 also show the base substrate (52/70) with three different sets of well sizes that increase in size when going from left to right with respect to the Figures such that each well set has a different dimension and footprint than the other well sets.
Regarding claims 12 and 19 – Kaye teaches the placement of solid media material (broth solids 26) in column 7, line 47 – column 8, line 40.
Claims 1-4, 10, 12, 15, 16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al. (US 2001/0024805). Williams teaches an assay apparatus. This rejection was applied to claim 1 in Paragraphs 9-10 of the Non-Final Rejection mailed 10/01/25. The rejection remains in effect for claim 1 and also includes new claims as listed above. Please also see Response to Arguments below.
Regarding claims 1, 10 and 15 – Regarding claim 1 - As shown in Figure 2, Williams teaches a base substrate (device 16); and a set of sample processing regions (18, 20, 22) defined at a broad surface of the substrate, wherein each of the set of sample processing regions comprises: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions. See Paragraph 0062.
Regarding claims 2, 3, and 16 – As shown in Figures 5 and 7, Williams teaches a substrate (16) with 3 different sets of well sizes that increase in size when going from top to bottom. Each well set has a different well dimension and total footprint than the other well sets.
Regarding claims 4 and 18 – Williams teaches a number of microwells between 10 and 100,000 microwells and an aggregate volume capacity from 0.01 to 10 ml in Paragraphs 0014, 0015, 0044, 0045 and 0062.
Regarding claims 12 and 19 – Williams teaches depositing dry reagents having colorimetric indicators in the assay zone in Paragraph 0073.
Claims 1-3, 5, 10-12, 15-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Broder et al. (US 2016/0053293). Broder teaches a multiwell sample testing plate. This rejection was applied to claim 1 in Paragraphs 11-12 of the Non-Final Rejection mailed 10/01/25. The rejection remains in effect for claim 1 and also includes new claims as listed above. Please also see Response to Arguments below.
Regarding claims 1, 10 and 15 – As shown in Figures 1A-6B, Broder teaches a base substrate (sample tray 140); and a set of sample processing regions (144, 146, 148) defined at a broad surface of the substrate, wherein each of the set of sample processing regions comprises: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions.
Regarding claims 2, 3 and 16 – As shown in Figures 1A-3B, Broder teaches a substrate (140) with 3 different sets of well sizes (144, 146, 148) that increase in size when going from right to left in Figure 1A. Each well set has a different well dimension and total footprint than the other well sets.
Regarding claims 5, 11, and 17 – Broder teaches a base substrate having wells of reduced thickness to provide permeability in Paragraphs 0082 and 0086.
Regarding claims 12 and 19 – Broder teaches dried media (3500) in the sample regions in Figure 4B and Paragraphs 0090-0093.
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Broder et al. (US 2016/0053293) in view of Han et al. (US 2016/0108459). Broder as described in Paragraphs 17-21 teaches every element of claims 6 and 14 except for the oil layer over the sample. Han teaches a kit for isolation and reaction of nucleic acids. The kit may include a cartridge that includes compartments preloaded with reagents. The compartment further includes a layer of mineral oil for preventing evaporation of contamination of the preloaded reagents. See Paragraphs 0025-0046 and 0059. The Examiner submits it would have been obvious to one of ordinary skill in the art to add the layer of oil from Han with the device of Broder. One of ordinary skill in the art would add the oil layer to Broder in order to protect materials in the wells from evaporation and contamination as taught by Han.
Claims 7-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Broder et al. (US 2016/0053293) in view of Dapprich (US 585,939). Broder teaches every element of claims 7-9 and 13 except for the cover substrate having a channel network. Broder teaches every element the claims except for the cover substrate having a channel network. Dapprich teaches a device having microstructures for processing and assaying a sample. The embodiments of the device most relevant to the instant claims are shown in Figures 2-4 and 7-9 and described in columns 7-12. In column 8, Dapprich teaches devices having cells (12) for holding samples or channels (14) as a base substrate. Then, in columns 9-11, Dapprich teaches multilayered structures comprised of a plurality of substrates with the layers having channels (14) that connect the cells (12) with the environment through sample ports that are connected to a covered network of channels. See column 9, lines 31 - column 10, line 54. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the additional layers having the channel network and fluid control structures from Dapprich with the device of Broder. Broder teaches a basic cover that seals the wells. One of ordinary skill in the art would add the additional layers having the fluid channel network to Broder in order to add and remove fluids from the wells without removing a cover as taught by Dapprich.
Regarding claims 8 and 9 – Broder teaches cover layers having gas permeability in Paragraphs 0075-0080.
Response to Arguments
Applicant’s arguments, filed 02/02/26, with respect to the rejection(s) of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Kaye (US 3,787,290), Williams et al. (US 2001/0024805), and Broder et al. (US 2016/0053293) have been fully considered but they are not persuasive. Applicant has amended claim 1 to recite “a base substrate; a plurality of sample processing regions defined at a broad surface of the substrate, wherein each of the plurality of sample processing regions is configured to receive a separate sample for parallel processing of multiple samples, and comprises: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions” and then argued the features of claim 1 are not taught by the cited prior art Kaye, Williams, and Broder. See pages 6-9 of Applicant’s Remarks. The Examiner respectfully disagrees and submits the following in rebuttal.
The Examiner notes Applicant’s argument from page 6:
Applicant respectfully submits that the claims are not anticipated. The independent claims recite "a plurality of sample processing regions where each region is configured to receive a separate sample for parallel processing of multiple samples, and where each region comprises its own set of microwell subarrays arranged in a gradient." The cited references fail to disclose a plurality of sample processing regions where each region is configured to receive a separate sample for parallel processing of multiple samples, and where each region comprises its own set of microwell subarrays arranged in a gradient. Instead, all three cited references report single-sample devices where different sized wells or zones collectively receive and process a single sample.
The Examiner submits Applicant is arguing an intended use of the device. Applicant intends to use the claimed device to provide each of the sample processing regions with a separate sample to be processed. The Examiner notes a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, each of the prior art devices – Kaye, Williams, and Broder – teach “a base substrate” with “a plurality of sample processing regions defined at a broad surface of the substrate, wherein each of the plurality of sample processing regions is configured to receive a separate sample for parallel processing of multiple samples”. The Examiner submits the operator of the device could divide a single sample into smaller portions that are place in the sample processing regions – or could also place any number of separate samples into different wells.
Applicant’s arguments, filed 02/02/26, with respect to the rejection(s) of claims under Double Patenting have been fully considered. The Examiner notes Applicant’s request that that the rejections be held in abeyance until the claims are otherwise in condition for allowance on page 9 of Applicant’s Remarks.
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 June 18, 2026
/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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