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 Arguments
Applicant’s arguments, see Remarks page 15, filed 02 February 2026, with respect to the 112(b) rejections of claims 6 – 28 and 31 – 35 have been fully considered. The rejections are moot in light of the canceled claims.
Applicant’s arguments, see Remarks page 15, filed 02 February 2026, with respect to the rejections of claims 1 – 35 under 102(a)(1) and 103 have been fully considered. The rejections are moot in light of the canceled claims.
Upon consideration of new claims 36 – 47, a new grounds of rejection is made in view of Bailey et al and further in view of Kang et al.
Status of Claims
Applicant's amendments to the claims filed 02 February 2026 have been entered. Applicant's remarks filed 02 February 2026 are acknowledged.
Claims 1 – 35 are canceled. Claims 36 – 47 are new.
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 36 – 48 re rejected under 35 U.S.C. 103 as being unpatentable over Bailey et al (US 20210031184 A1) in view of Kang et al (US 20230193931 A1, effectively filed 22 May 2020).
With regards to claim 36, Bailey et al teaches;
The claimed “a portable testing device” has been read on the taught ([0002], “The present invention relates to a device for collecting a fluid sample and an assay device…”);
The claimed “a detection device having at least one testing element capable of indicating presence of an analyte” has been read on the taught ([0134], “…a detection component and a collection component, wherein the detection component has a testing element 112…”);
The claimed “a collection device having a rod-like structure with an absorbing element at a distal end, the rod-like structure being connected at a proximal end to the detection device” has been read on the taught ([0136], “One end of the connecting rod 109 is connected to the absorbing element 107, and the other end thereof is connected to a connecting pipe or an input channel 1115 of the carrier 111…”);
The claimed “the rod-like structure defining a fluid passage along its length in fluid communication with the detection device” has been read on the taught ([0123], “The collector is connected to the connecting rod 109, and a channel 12 is arranged in the connecting rod…”);
The claimed “the collecting device being connectable to the detection device such that the fluid passage will be in fluid communication with a fluid inlet of the detection device” has been read on the taught ([0102], “For example, in the assay device 102 of the present invention, after the absorbing element absorbs a fluid sample or a liquid sample, the fluid can flow from the absorbing element 107 to the sample feeding area 1121 of the testing element 112…”);
Bailey et al further teaches that a diversion element which blocks or delays liquid entering the detection device; see [0116].
However, Bailey et al does not explicitly disclose a valve arrangement situated on the collection device, the valve arrangement including a movable valve element which provides selective fluid communication for fluid expressed from the absorbing element to enter the fluid passage.
In the analogous art of fluidic valve designs, Kang et al teaches;
The claimed “a valve arrangement situated on the collection device, the valve arrangement including a movable valve element which provides selective fluid communication for fluid expressed from the absorbing element to enter the fluid passage” has been read on the taught ([0005], “…an adjustable return check valve disposed between the directional control valve and the tank…”; [0009], “…the adjustable return check valve may include: a valve block having a path defined therein; a poppet opening or closing the path…”; The poppet reads on a movable valve element.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bailey et al with the valve as taught by Kang et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Bailey et al teaches a portable testing device. The prior art of Kang et al teaches a fluidic valve. One of ordinary skill in the art could have combined the elements according to known methods, with the testing element performing tests, and the valve limiting fluid flow. One of ordinary skill in the art would recognize that the combination yields a predictable result of a device which prevents fluid backflow or undesired fluid movement within the device.
With regards to claim 37, the device of claim 36 is obvious over Bailey et al in view of Kang et al.
Kang et al further teaches;
The claimed “wherein the valve arrangement includes a spring, the movable valve element being urged to a closed position by the spring” has been read on the taught ([0040], “The guide 67 may apply force to the poppet 63 via a spring 65 in a direction of closing the path.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bailey et al with the valve as taught by Kang et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Bailey et al teaches a portable testing device. The prior art of Kang et al teaches a fluidic valve. One of ordinary skill in the art could have combined the elements according to known methods, with the testing element performing tests, and the valve limiting fluid flow. One of ordinary skill in the art would recognize that the combination yields a predictable result of a device which prevents fluid backflow or undesired fluid movement within the device.
With regards to claim 38, the device of claim 37 is obvious over Bailey et al in view of Kang et al.
Kang et al further teaches;
The claimed “wherein the movable valve element is in the form of a piston” has been read on the taught ([0040], “The poppet 63 may move to open or close the path of the adjustable return check valve 60.”; Poppet 63 reads on a piston. See also Figure 3.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bailey et al with the valve as taught by Kang et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Bailey et al teaches a portable testing device. The prior art of Kang et al teaches a fluidic valve. One of ordinary skill in the art could have combined the elements according to known methods, with the testing element performing tests, and the valve limiting fluid flow. One of ordinary skill in the art would recognize that the combination yields a predictable result of a device which prevents fluid backflow or undesired fluid movement within the device.
With regards to claim 39, the device of claim 38 is obvious over Bailey et al in view of Kang et al.
Kang et al further teaches;
The claimed “wherein the piston has a piston column at one end and a piston bolt at another end, a piston limiting part being located axially between the piston column and the piston bolt” has been read on the taught (see annotated Figure 3, below);
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bailey et al with the valve as taught by Kang et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Bailey et al teaches a portable testing device. The prior art of Kang et al teaches a fluidic valve. One of ordinary skill in the art could have combined the elements according to known methods, with the testing element performing tests, and the valve limiting fluid flow. One of ordinary skill in the art would recognize that the combination yields a predictable result of a device which prevents fluid backflow or undesired fluid movement within the device.
With regards to claim 40, the device of claim 39 is obvious over Bailey et al in view of Kang et al.
Kang et al further teaches;
The claimed “wherein the spring is located coaxially of the piston bolt and engages the piston limiting part” has been read on the taught (See annotated figure 3 on page 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bailey et al with the valve as taught by Kang et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Bailey et al teaches a portable testing device. The prior art of Kang et al teaches a fluidic valve. One of ordinary skill in the art could have combined the elements according to known methods, with the testing element performing tests, and the valve limiting fluid flow. One of ordinary skill in the art would recognize that the combination yields a predictable result of a device which prevents fluid backflow or undesired fluid movement within the device.
With regards to claim 41, the device of claim 36 is obvious over Bailey et al in view of Kang et al.
With regards to the claimed, “wherein the movable valve element moves axially with respect to the rod-like structure,” this limitation is held to mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts does not distinguish a claimed invention from the prior art device, provided that the arrangement of parts does not modify the operation of the device; please see In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In the case of the claimed invention, the motion of the valve element does not modify the operation of the device. Accordingly, this limitation does not distinguish the claimed device from the prior art of Bailey et al in view of Kang et al.
With regards to claim 42, the device of claim 36 is obvious over Bailey et al in view of Kang et al.
With regards to the claimed “wherein the movable valve element moves transversely with respect to the rod-like structure,” this limitation is held to mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts does not distinguish a claimed invention from the prior art device, provided that the arrangement of parts does not modify the operation of the device; please see In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In the case of the claimed invention, the motion of the valve element does not modify the operation of the device. Accordingly, this limitation does not distinguish the claimed device from the prior art of Bailey et al in view of Kang et al.
With regards to claim 43, the device of claim 36 is obvious over Bailey et al in view of Kang et al.
With regards to the claimed “wherein the valve arrangement is located in an enlarged end portion of the collection device, the absorbing element being mounted on the end portion” this limitation is held to mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts does not distinguish a claimed invention from the prior art device, provided that the arrangement of parts does not modify the operation of the device; please see In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In the case of the claimed invention, the location of the valve element does not modify the operation of the device, given the single fluid passage claimed. Accordingly, this limitation does not distinguish the claimed device from the prior art of Bailey et al in view of Kang et al.
With regards to claim 44, the device of claim 36 is obvious over Bailey et al in view of Kang et al.
Bailey et al further teaches;
The claimed “wherein the collection device is detachably connected to the detection device” has been read on the taught ([0061], “In some embodiments, the collector and the assay device are detachably assembled.”).
With regards to claim 45, the device of claim 44 is obvious over Bailey et al in view of Kang et al.
Bailey et al further teaches;
The claimed “wherein the detection device has a plurality of parallel test strips” has been read on the taught ([0157], “…an assay device, comprising a carrier element 111, four grooves 1110, 1114, 11123, 11124 being arranged on the carrier element, and a lateral flow test strip being respectively arranged in the four grooves 1128, 1129, 1130, 1131, each of the test strip corresponding to a specific analyte.”; Figure 3 shows parallel test strips.).
With regards to claim 46, the device of claim 36 is obvious over Bailey et al in view of Kang et al.
Bailey et al further teaches;
The claimed “a receiving device including a receiving cup engageable with the detection device and a piercing element slidably movable in the receiving cup” has been read on the taught ([0137], “…the present invention further provides a receiving device used for receiving a part of the assay device…”; [0138], “…in an embodiment, the device comprises a chamber structure, which is similar to a cup or tube construction.”; [0047], “…the device comprising a chamber for accommodating a treatment solution and a piercing element that is movable in the device…”);
The claimed “the piercing element having a piercing structure at a distal end thereof so as to rupture a pierceable material and release a treatment solution” has been read on the taught ([0139], “In some embodiments, the piercing element comprises a piercing structure 1066, and chamber that is used to receive the treatment solution, i.e. the treatment solution from the first chamber of the receiving device. Therefore, after movement of the piercing element pierces the chamber containing the treatment solution, the released treatment solution enters into the chamber of the piercing element.”).
With regards to claim 47, the device of claim 46 is obvious over Bailey et al in view of Kang et al.
Bailey et al further teaches;
The claimed “wherein movement of the collection device relative to the receiving cup causes expression of fluid from the absorbing element” has been read on the taught ([0161], “…the absorbing element is compressed to release the saliva sample into the first chamber 1062 of the piercing element.”).
However, Bailey et al does not explicitly disclose wherein fluid pressure within a sealed space of the receiving device causes opening of the valve arrangement.
Kang et al further teaches;
The claimed “wherein fluid pressure within a sealed space of the receiving device causes opening of the valve arrangement” has been read on the taught ([0040], “The poppet 63 may move to open or close the path of the adjustable return check valve 60.”; A check valve reads on a valve arrangement which opens due to fluid pressure.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bailey et al with the valve as taught by Kang et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Bailey et al teaches a portable testing device. The prior art of Kang et al teaches a fluidic valve. One of ordinary skill in the art could have combined the elements according to known methods, with the testing element performing tests, and the valve limiting fluid flow. One of ordinary skill in the art would recognize that the combination yields a predictable result of a device which prevents fluid backflow or undesired fluid movement within the device.
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 ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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