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 .
Response to Amendment
The Amendment filed on 2/12/2026 has been entered. Claims 1-19 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection previously set forth in the non-final Office Action mailed 11/13/2025.
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.
Claim(s) 1-3, 5, 6, 12-15, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2007/106552, hereinafter Hunter.
Regarding claim 1, Hunter teaches a testing device for testing a swab sample (figure 6), the device comprising: a swab chamber (labeled in figure below) configured to receive the swab sample (intended use MPEP § 2114 (II) and is taught in figure 6); an elution source (pages 17-18, lines 36-5) configured to supply an eluent to the swab chamber through a chamber inlet (item 27) of the swab chamber (intended use MPEP § 2114 (II)), wherein the eluent is a liquid that interacts with the swab sample to produce an eluate indicative of a property of the swab sample (pages 17-18, lines 36-5); a discard channel (item 18) configured to receive a first portion of the eluate from a chamber outlet (the channel between items 12 and 13) of the swab chamber to be discarded (figure 6); an analysis channel (item 20) configured to receive a second portion of the eluate from the chamber outlet to be processed (figure 6); and a channel selector (item 14) configured to selectively direct the first portion into the discard channel and the second portion into the analysis channel (figure 6).
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Regarding claim 2, the swab head and break point are not positively claimed and therefore any limitation on the locations relative to the swab head and break point has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Hunter. The chamber inlet is able to be arranged closer to the tip of a swab head than the break point and the outlet being located farther from the tip than the break point based upon the length and positions of the swab head and break point to the rest of the device.
Regarding claim 3, Hunter teaches wherein the chamber inlet comprises a feature that prevents a swab from sealing the chamber inlet (the opening is spaced apart from where the swab is inserted and therefore wouldn’t seal).
Regarding claim 5, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Hunter and the apparatus of Hunter is capable of having the channel selector direct the first portion of the eluate into the discard channel before directing the second portion into the analysis channel. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Hunger (see MPEP §2114).
Regarding claim 6, Hunter teaches wherein the channel selector (item 14) comprises a junction between the discard channel, the analysis channel, and the chamber outlet from the swab chamber (figure 6).
Regarding claim 12, Hunter teaches wherein the analysis channel comprises a lysing section (pages 17-18, lines 36-5).
Regarding claim 13, Hunter teaches wherein the analysis channel comprises an amplification section for amplifying an analyte that is to be detected in the eluate (page 17, lines 31-35).
Regarding claim 14, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Hunter and the apparatus of Hunter is capable of being disposed of. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Hunter (see MPEP §2114).
Regarding claim 15, the swab head is not positively claimed and therefore any limitation on the sizing of the swab head relative to the opening of the swab chamber has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Hunter. The opening of the swab chamber is able to be smaller than a nonmail maximum radius of a swab head.
Regarding claim 18, Hunter teaches wherein the feature comprises a ledge (the opening item 27 is considered to have a ledge where the opening is).
Regarding claim 19, Hunter teaches wherein the chamber inlet (item 27) is arranged closer to a break point of a swab head than a tip of the swab head and the chamber outlet (the channel between items 12 and 13) is located farther from the break point of the swab head than the tip of the swab head (the examiner notes that the swab sample is not positively recited, nor is it stated at what point the swab head and swab break point are located in the specified locations, therefore, the swab sample could be located such that swab head and swab break point are located as specified when the swab is outside of the testing device, additionally, the location of the swab sample is considered to be the intended use (MPEP § 2114 (II)) of the device), so that the eluent impinges initially on a back end of the swab head and flows across the swab head towards the tip and then to the chamber outlet (intended use MPEP § 2114 (II) and the swab sample could be inserted into the swab chamber such that the swab break point encounters the eluent first and then back over and out through the outlet).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of United States Application Publication No. 2012/0107811, hereinafter Kelso.
Regarding claim 4, Hunter teaches all limitations of claim 1; however, Hunter fails to teach the elution source comprises a compressible external surface of the testing device.
Kelso teaches a liquid processing device in which the elution liquid is contained inside of a blister which is compressed and burst (Kelso, paragraph [0125]) so that multiple liquids can be burst in a specific sequence to prevent any cross-contamination (Kelso, paragraph [0123]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the elution source comprise a compressible external surface (blister) because it would allow for multiple liquids to be burst in a specific sequence to prevent any cross-contamination (Kelso, paragraph [0123]).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter.
Regarding claims 7 and 8, Hunter teaches all limitations of claim 6; however, Hunter fails to teach wherein, in the junction, an angle to redirect flow from the chamber outlet to the analysis channel is greater than an angle to redirect flow from the chamber outlet to the discard channel and the chamber outlet and the discard channel are arranged substantially opposite each other across the junction, and the analysis channel is arranged substantially at a right angle to the chamber outlet around the junction.
However, it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because it only involves the rotation of the valve 14 so that the chamber outlet and discard channel are arranged opposite each other and the analysis channel is at substantially a right angle to the chamber outlet around the junction.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of EP 3109618, hereinafter Anderson.
Regarding claim 9, Hunter teaches all limitations of claim 6; however, Hunter fails to teach the analysis channel comprises a hydrophobic surface.
Anderson teaches an assay cartridge which has vent ports as part of the chambers with a hydrophobic material covering the vent port so that they are porous to air but seal when they come into contact with the aqueous solution (Anderson, paragraph [0179]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a vent port covered by a hydrophobic surface because it would allow for air to pass through the hydrophobic membrane while sealing against the aqueous solution (Anderson, paragraph [0179]).
Regarding claim 10, Hunter teaches all limitations of claim 1; however, Hunter fails to teach the discard channel and/or the analysis channel comprises an air outlet and a hydrophobic filter arranged at the air outlet, such that the discard channel and/or the analysis channel can be initially filled with air, and the eluate replaces the air during use.
Anderson teaches an assay cartridge which has vent ports as part of the chambers with a hydrophobic material covering the vent port so that they are porous to air but seal when they come into contact with the aqueous solution (Anderson, paragraph [0179]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a vent port covered by a hydrophobic surface because it would allow for air to pass through the hydrophobic membrane while sealing against the aqueous solution (Anderson, paragraph [0179]).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/157170, hereinafter Eberwine in view of Anderson.
Regarding claims 10 and 11, Hunter teaches all limitations of claim 1; however, Hunter fails to teach the discard channel and/or the analysis channel comprises an air outlet, such that the discard channel and/or the analysis channel can be initially filled with air, and the eluate replaces the air during use and the air outlet is connected to a closed air chamber.
Eberwine teaches a microfluidic device which has a bubble trap which is connected to the analysis chamber with a degassing valve which can be manually opened and closed to release gas pockets and bubbles (Eberwine pages 8-9, lines 26-2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a bubble trap connected to the analysis chamber (with the opening from the channel to the bubble trap considered to be the air outlet and the chamber itself being the closed air chamber) because it would allow for gas pockets and bubbles to be release from the system (Eberwine pages 8-9, lines 26-2).
Hunter and Eberwine fail to teach a hydrophobic filter arranged at the air outlet.
Anderson teaches bubble traps which have an air-permeable but water-impermeable membrane to ensure the liquid is not expelled via the outlet (Anderson, paragraph [0173]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a hydrophobic filter at the air outlet because it would ensure the liquid is not expelled via the outlet (Anderson, paragraph [0173]).
Response to Arguments
Applicant's arguments filed 2/12/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the office cannot simply ignore the facts and allege that multiple distinct parts of the Hunter device are all part of one “swab chamber” is not found persuasive. The claim has not specified what can and cannot be part of the swab chamber and therefore the structure circled above in the rejection is together as a whole can be considered to be part of the “swab chamber.” Multiple distinct structures are able to be considered part of one item, just as the claim specifies a “testing device” and then lists multiple distinct structures and considers them all to be part of the testing device, the office is similarly able to consider multiple distinct structures as part of the swab chamber and based upon this interpretation, the swab chamber is considered to be the structures circled above in the rejection.
Regarding applicant’s argument that the claimed swab chamber requires a chamber inlet and a chamber outlet and that Hunter’s sample collection tube only has one port at the bottom is not found persuasive. As discussed above, the sample collection tube is not the only structure which is considered to be part of the claimed “swab chamber” and as such, the rejection above shows that the claimed chamber inlet is item 27 and the claimed chamber outlet is the channel between items 12 and 13. The use of the circled structure above is not incorrect as there is nothing in the claim which prevents this interpretation of the prior art to read on the instant limitations and also is considered to fall within the broadest reasonable interpretation of the claims and art therefore reading on the instant claims.
Regarding applicant’s argument that valve 14 cannot be considered to be a “channel selector configured to selectively direct the first portion into the discard channel and the second portion into the analysis channel” is not found persuasive. Firstly, what the channel selector is doing is considered to be the intended use of the channel and 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, item 14 is able to either direct the sample upwards towards item 14 or downwards towards item 18. Therefore, item 14 is able to direct different portions of the fluid either into a disposal chamber or into the analysis section of the device.
Regarding applicant’s argument that Hunter fails to include an “elution source” configured to supply an eluent to the swab chamber. An “elution source” does not necessarily mean that the elution fluid is stored on the device, but can also mean the place where the elution fluid comes from. In this case, the elution fluid is entering the device and as it is entering the device, this location is considered to be the “source” of the elution fluid thereby reading on the instant claims. A “source” does not have to be a reservoir or other chamber in which the elution is stored and therefore would be on the device, as applicants are seeming to allege.
Regarding applicant’s argument that adding the burstable blister liquid would be on the instrument of Hunter and not on the microfluidic cartridge is not found persuasive. Kelso is teaching a testing device which has the burstable blisters on the device itself. When one of ordinary skill in the art would have combined the device of Kelso with Hunter, they would have believed to have added the burstable blisters onto the microfluidic device of Hunter and not onto the instrument of Hunter as applicant’s allege.
Regarding applicant’s argument that Anderson’s bents are very different from an analysis channel that has a hydrophobic surface is not found persuasive. The claim has not specified what part of the analysis channel has the hydrophobic surface, but instead just states that there is a surface of the analysis channel which has a hydrophobic surface. Based upon the teachings of Anderson, one of ordinary skill in the art would have added hydrophobic vent ports onto the analysis channel of Hunter. These hydrophobic vent ports are considered to be part of the analysis channel. As these hydrophobic vent ports are considered to be part of the analysis channel, it can be said that one of the surfaces of the analysis channel has a hydrophobic surface, thereby reading on the instant claims.
Regarding applicant’s argument that Eberwine does not indicate that the valves are connected to a closed air chamber, as recited in claim 11 is not found persuasive. When the valves of the bubble traps are closed, the section of the bubble trap is considered to form a “closed air chamber,” thereby reading on the instant claims.
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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796