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 without traverse of Group I, claims 1 and 64-83 in the reply filed on 10/10/25 is acknowledged. Claims 32 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 and 64-68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nair et al. (WO 2021/011512) and characterized (US 2022/0258162). The Examiner notes that the WO document (WO 2021/011512) is prior art under 35 U.S.C. 102(a)(1). The US Publication (US 2022/0258162) contains the same information and is being cited to allow the Examiner to refer to Paragraphs of the US document disclosure. Nair teaches a device and a method of sampling for a target. The embodiments of the device most relevant to the instant claims are shown in Figures 1-6 and described in Paragraphs 0020-0062.
Regarding claim 1 – Nair teaches a sample preparation device (cartridge 200) and a method of processing a sample to detect a target. As shown in Figure 2, the device (cartridge 200) includes a lysis chamber (202) with a lysing means (beads 222 and magnetic bar 224) and a filter (212) that partitions the chamber and collects material. The device (cartridge 200) further includes a nucleic acid capture chamber (204) connected to the lysis chamber (202). The method includes flowing a sample through the cartridge to perform the steps of: filtering a fluid sample through one or more filter aid materials (filter 112/212), wherein at least some of a desired target, if present, disposed within the fluid sample remains within the one or more filter materials (sample flows to filter 212 where the target is retained) and; lysing (using the beads 222 and magnetic bar 224 to lyse collected material) the at least some of the desired target remaining within the one or more filter materials to release to release molecules from the one or more desired targets remaining within the one or more filter materials (212); and recovering the released molecules in sufficient yield for testing detection of the one or more desired targets (target flows through channel 218 where it is captured in nucleic acid capture chamber for later testing). See Figures 2-4 and Paragraphs 0025-0026
Regarding claim 64 – Nair teaches a sample preparation device (cartridge 200) and a method of processing a sample to detect a target. As shown in Figure 2, the device (cartridge 200) includes a lysis chamber (202) with a lysing means (beads 222 and magnetic bar 224) and a filter (212) that partitions the chamber and collects material. The device (cartridge 200) further includes a nucleic acid capture chamber (204) connected to the lysis chamber (202). The method includes flowing a sample through the cartridge to perform the steps of: extracting a fluid sample from a sample medium and/or filter aid materials disposed in an extraction bag or container by use of an extraction buffer (see Paragraphs 0051-0053 where Nair teaches placing the sample into a sample preparation container and mixing with an extraction buffer); transporting the extracted fluid sample to a filtration module and lysing by use of a lysis buffer (sample flows to filter 212 where the target is retained and then lysed using the beads 222 and magnetic bar 224); transporting the lysed filtered sample to a binding/mixing vessel and mixing with a binding buffer (sample is mixed with beads 222 as moved to from first lysis chamber section 214 to a second lysis chamber section 216 – see Paragraphs 0022-0023 and 0026); transporting the mixed fluid sample to nucleic acid affinity column and adding a washing buffer (sample is aspirated from second lysis chamber 216 to nucleic acid capture chamber 204 before adding a washing and elution buffer – See Paragraph 0026).
Regarding claims 65 and 68 – Nair recites sending the purified sample directly to a sample processing instrument with a detector for analysis in Paragraphs 0007, 0028, 0035, 0038 and 0062.
Regarding claims 66 and 67 – Nair discloses beads (222) having binding compounds in Paragraph 0024. The Examiner considers the beads 222 having binding compounds to be enrichment media. Nair further discloses heating the lysis chamber (202) in Paragraphs 0040-0044 and 0060-0061.
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 69-78 and 80-83 are rejected under 35 U.S.C. 103 as being unpatentable over Nair et al. (WO 2021/011512) and (US 2022/0258162) in view of Petersen et al. (US 2002/0042125). Nair teaches every element of claims 69-78 and 80-83 except for a waste receptacle, one or more vents, and a central controller.
Regarding claim 69 – Nair as described above in Paragraphs 5-9 teaches every element of claim 69 except for the waste receptacle. Petersen teaches a cartridge for treating a sample. The embodiment of the device most relevant to the instant claims is shown in Figures 2-7 and 12-18; and described in Paragraphs 0051-0164. As shown in Figure 2, the cartridge includes a micronetwork comprised of a plurality of chambers connected by channels for processing the sample, as well as flow controllers such as valves for controlling fluid flow in the cartridge. In Paragraphs 0051, 0069-0070, and 0101, Petersen teaches a waste chamber for the collection of waste in the cartridge. 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 waste chamber from Petersen with the device of Nair. One of ordinary skill in the art at the time would add the waste chamber to Nair to collect waste in the cartridge as taught by Petersen.
Regarding claims 70, 71, 72, 73 – Nair as described above in Paragraphs 5-9 teaches every element of claims 70-73 except for the vents. Petersen teaches a cartridge for treating a sample. The embodiment of the device most relevant to the instant claims is shown in Figures 2-7 and 12-18; and described in Paragraphs 0051-0164. As shown in Figure 2, the cartridge includes a micronetwork comprised of a plurality of chambers connected by channels for processing the sample, as well as flow controllers such as valves for controlling fluid flow in the cartridge. In Paragraphs 0020, 0066, and 0101-0105, Petersen further teaches the use of vents to allow for the release of gas or other fluids. 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 vents from Petersen with the device of Nair. One of ordinary skill in the art at the time would add the vents to Nair to allow for the release of gas from the cartridge as taught by Petersen. With respect to claim 72, Nair recites a cycle time of 15 minutes to 10 hours, preferably 1-4 hours in Paragraph 0062.
Regarding claims 74 and 81-83 - Nair teaches a sample preparation device (cartridge 200) and a method of processing a sample to detect a target. As shown in Figure 2, the device (cartridge 200) includes a lysis chamber (202) with a lysing means (beads 222 and magnetic bar 224) and a filter (212) that partitions the chamber and collects material. The device (cartridge 200) further includes a nucleic acid capture chamber (204) connected to the lysis chamber (202). The method includes flowing a sample through the cartridge to perform the steps of: fluidically coupling the cartridge (cartridge 200) within the sample treatment system, the cartridge (200) including a filtration unit (first lysis chamber section 214), binding/mixing vessel (second lysis chamber section (216), and nucleic acid affinity column, and the system including associated buffer reservoirs, the cartridge and system define a network of fluidic conduits and valves; operating the system by use of one or more vacuum sources and/or injection units (pump 402 - see Figures 4-7) so as to control facilitate controlled flow of fluid sample, buffers and any waste product through the network of fluidic conduits, thereby: extracting a fluid sample from a sample medium and/or filter aid materials disposed in an extraction bag or container by use of an extraction buffer (see Paragraphs 0051-0053 where Nair teaches placing the sample into a sample preparation container and mixing with an extraction buffer), transporting the extracted fluid sample to a filtration module and lysing by use of an in situ lysis buffer (sample flows to filter 212 where the target is retained and then lysed using the beads 222 and magnetic bar 224), transporting the lysed filtered sample to a binding/mixing vessel and mixing with a binding buffer (sample is mixed with beads 222 as moved to from first lysis chamber section 214 to a second lysis chamber section 216 – see Paragraphs 0022-0023 and 0026), transporting the mixed fluid sample to nucleic acid affinity column and adding a washing buffer, and eluting the fluid sample in the affinity column by use of an elution buffer so as to purify and concentrate the fluid sample; and dispensing the producing a purified, concentrated fluid sample from the cartridge into a sample test tube or container for testing (sample is aspirated from second lysis chamber 216 to nucleic acid capture chamber 204 before adding a washing and elution buffer – See Paragraph 0026). Nair recites containers for preprocessing in Paragraphs 0050-0055. Nair does not recite a waste receptacle.
Petersen teaches a cartridge for treating a sample. The embodiment of the device most relevant to the instant claims is shown in Figures 2-7 and 12-18; and described in Paragraphs 0051-0164. As shown in Figure 2, the cartridge includes a micronetwork comprised of a plurality of chambers connected by channels for processing the sample, as well as flow controllers such as valves for controlling fluid flow in the cartridge. In Paragraphs 0051, 0069-0070, and 0101, Petersen teaches a waste chamber for the collection of waste in the cartridge. 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 waste chamber from Petersen with the device of Nair. One of ordinary skill in the art at the time would add the waste chamber to Nair to collect waste in the cartridge as taught by Petersen.
Regarding claims 76, 77, 78 and 80 – Nair does not teach one or more vents and a central control unit. Petersen teaches a cartridge for treating a sample. The embodiment of the device most relevant to the instant claims is shown in Figures 2-7 and 12-18; and described in Paragraphs 0051-0164. As shown in Figure 2, the cartridge includes a micronetwork comprised of a plurality of chambers connected by channels for processing the sample, as well as flow controllers such as valves for controlling fluid flow in the cartridge. In Paragraphs 0020, 0066, and 0101-0105, Petersen further teaches the use of vents to allow for the release of gas or other fluids. 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 vents from Petersen with the device of Nair. One of ordinary skill in the art at the time would add the vents to Nair to allow for the release of gas from the cartridge as taught by Petersen.
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over Nair et al. (WO 2021/011512) and (US 2022/0258162) in view of Petersen et al. (US 2002/0042125), and further in view of Civel et al. (US 2016/0178490). Nair and Petersen teach every element of claim 79 except for pinch or clamp valve. Civel teaches a cell transfer device. The embodiment of the device most relevant to the instant claims is shown in Figure 7 and described in Paragraph 0068. In Paragraph 0068, Civel teaches closing the unit (100) through the use of a restriction device such as a clamp on the inlet and outlet tubing. 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 clam valve from Civel with the combined device of Nair and Petersen. One of ordinary skill in the art at the time would add the clam valve in order to open and close the tubing as taught by Civel.
Conclusion
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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/DWAYNE K HANDY/Examiner, Art Unit 1798 March 04, 2026
/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797