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 of group 3 in the reply filed on 12/08/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Further, please note that claims 1-2 corresponding to groups I and II have been cancelled.
Status of Claims
Claims 3-22 remain pending in the application.
Claim Objections
Claims 12, 14 are objected to because of the following informalities:
Claim 12 recites “where in the plurality of cross members engage with the absorbent tip of the swab stem.” where it appears that “where in” should instead be “wherein”
Claim 14 line 3 recites “an analyte test strip positioned in the on the at least one channel” where the phrasing is awkward. Is the test strip positioned in the channel or on the channel? Or is the claim saying that it could be either? Either “in the” or “on the” should be removed, alternatively the claim could be recited to state “positioned in the or on the”
Appropriate correction is required.
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.
Claims 3-22 are 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 3 recites “one or more analyte test strips” on line 12, where it is unclear if this is the same or different from “an analyte test strip” recited on lines 5-6.
It is suggested that the one or more analyte test strips be recited before the limitations of the test strip holder, as this would make clear that they are positively recited. One suggested amendment is the following:
one or more analyte test strips;
a test strip holder having one or more channels each adapted to hold the one or more analyte test strips, each such test strip testing for one or more analytes, wherein the test strip holder is adapted to slide into the top end of the swab stem and has one or more sealing members that upon full insertion of the test strip holder into the swab stem seals the interior cavity of the swab stem from the outside, wherein the test strip holder has an extending member that upon full insertion of the test strip holder into the swab stem engages the absorbent tip on the bottom end of the swab stem;
Line 15 recites “wherein the one or more analyte test strips contact fluid absorbed by the absorbent tip” where it is unclear if this fluid is the same or different from a fluid specimen recited on line 1.
For examination it will be interpreted that they are the same fluid.
It is suggested to amend line 15 to recite “the fluid specimen absorbed”
Claims 4-22 are rejected by virtue of being dependent on a rejected claim.
Claim 4 recites “wherein at least two analyte test strips are positioned in at least two channels of the test strip holder” on lines 1-2, where it is unclear if the analyte test strips are the same or different from the analyte test strips described in claim 3, further it is unclear if the channels are the same as the channel described in claim 3.
For examination, it will be interpreted that they are the same.
Further, line 3 recites “one or more analytes” where it is unclear if these one or more analytes are the same or different from the one or more analytes described on line 6 of claim 3.
It is suggested to amend claim 4 to recite “wherein at least two of the analyte test strips are positioned in at least two of the channels of the test strip holder, wherein each of the at least two analyte test strips are adapted to detect the presence or absence of the one or more analytes.”
Claim 5 recites “held in one or more channels of the test strip holder” on line 2, where it is unclear if the one or more channels are the same or different from the ones described in claim 3.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 2 to recite “held in the one or more channels of the test strip holder”
Further line 3 recites “one or more analytes” where it is unclear if these analytes are the same or different from the ones described in claim 3.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 3 to recite “the one or more analytes”
Claims 6-8 are rejected by virtue of being dependent on a rejected claim.
Claim 8 recites “a first analyte test strip” and “a second analyte test strip” on lines 1 and 2, where it is unclear if the first and second analyte test strip are the same or different from the analyte test strips described prior. Further, it is unclear if the antibody and antigen are the same or different from the ones described prior.
For examination, it will be interpreted that they are the same.
It is suggested to amend claim 8 to recite “wherein a first analyte test strip of the one or more analyte test strips tests for [[an]] the antigen corresponding to the virus, wherein a second analyte test strip of the one or more analyte test strips tests for [[an]] the antibody corresponding to the virus.”
Claim 9 recites “fluid” on line 6, where it is unclear if this fluid is the same or different from a fluid specimen described on line 1 of claim 3. Further, line 7 recites “fluid contained” where it is unclear if this fluid is the same or different from those recited prior.
For examination, it will be interpreted that they are all the same fluid.
It is suggested to amend both line 6 and line 7 to recite “the fluid”.
Claim 10 recites “fluid” on line 5, where it is unclear if this fluid is the same or different from a fluid specimen described on line 1 of claim 3.
For examination, it will be interpreted that they are the same fluid.
It is suggested to amend line 5 to recite “the fluid”
Claims 11-13 are rejected by virtue of being dependent on a rejected claim.
Claim 12 recites “a plurality of cross members” on lines 1-2, where it is unclear if these cross members are the same or different from the cross member described in claim 11.
As recited in the instant specification on page 56 lines 17-19 “… and the venting movable venting seal/gasket has a one and preferably a plurality of cross members traverse to the direction of swab/sponge insertion.” Therefore, for examination it will be interpreted that the plurality of cross members would include the cross member described in claim 11.
Further, line 2 of claim 12 recites “an interior portion of the gasket” where it is unclear if this interior is the same or different from the interior described in claim 11. For examination, it will be interpreted that they are the same interior.
It is suggested to amend claim 11 to recite “wherein the gasket includes [[a]] one or more cross members in an interior portion”, where then claim 12 would be amended to recite “wherein the gasket includes a plurality of the cross members that connect at a center point in [[an]] the interior portion of the gasket”
Claim 13 is rejected by virtue of being dependent on a rejected claim.
Claim 14 recites “wherein at least one channel of the test strip holder” on line 1, where it is unclear if this channel is the same or different from the channel recited in claim 3.
Further, lines 2-3 recites “an analyte test strip” where it is unclear if this analyte test strip is the same or different from the one described in claim 3.
It is suggested to amend claim 14 to recite “wherein at least one of the channels of the test strip holder has protrusions from a side wall of the at least one channel, wherein the protrusions engage [[an]] the analyte test strip positioned in the on the at least one channel.”
Claim 15 recites “in at least a first channel” on line 2, where it is unclear if the first channel is the same or different from one or more channels described in claim 3.
For examination, it will be interpreted that the first channel is one of the one or more channels.
It is suggested to amend claim 15 to recite “in at least a first channel of the one or more channels”
Claim 16 recites “to release fluid” on line 5, where it is unclear if this fluid is the same or different from the fluid specimen described in claim 3.
For examination, it will be interpreted that they are the same fluid.
It is suggested to amend line 5 to recite “the fluid”
Line 7 recites “one or more analytes” where it is unclear if these analytes are the same or different from the ones described in claim 3.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 7 to recite “the one or more analytes”
Line 8 recites “based on one or more analyte test strips” where it is unclear if these are the same or different from the test strips described in claim 3.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 8 to recite “based on the one or more analyte test strips”
Line 9 recites “the second lateral flow assay strips.” where there is insufficient antecedent basis for this limitation, as no second lateral flow assay strips have been described prior.
For examination, it will be interpreted that the second lateral flow assay strips are referring to the second analyte test strips described on line 2 of claim 16.
Claim 17 recites “wherein the test strip holder has n channels” on line 1, where it is unclear if these channels are the same or different from the one or more channels described in claim 3.
For examination, it will be interpreted that they are the same channels.
It is suggested to amend claim 17 to recite “wherein the one or more channels of the test strip holder has n channels”
Claim 18 recites “one or more analyte test strips” on line 1 and line 2, where it is unclear if the one or more analyte test strips is the same or different from the ones described in claim 3.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 1 and line 2 to recite “the one or more analyte test strips”
If the analyte test strips of claim 18 are the same as the ones described in claim 3, then it is unclear if the virus antigen is the same or different from the one or more analytes described in claim 3.
For examination, it will be interpreted that the virus antigen is the same as the one or more analytes described in claim 3.
Line 4 recites “facilitates antigen detection” where it is unclear if this antigen is the same or different from the virus antigen described on line 2.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 4 to recite “facilitates the antigen detection”
Line 4 recites “the one or more lateral flow assay strips.” where there is insufficient antecedent basis for this limitation, as no lateral flow assay strip has been recited prior.
For examination, it will be interpreted that the one or more lateral flow assay strips are referring to the one or more analyte test strips.
Claim 20 contains the trademark/trade name Triton and TWEEN 20. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a detergent and, accordingly, the identification/description is indefinite.
Claim 21 recites “at least one channel of the test strip holder includes an analyte test strip for the presence or absence of two analytes.” where it is unclear if the channel, the analyte test strip, and analytes are the same or different from the ones described in claim 3.
For examination, it will be interpreted that it is the same channel, same analyte test strip, and same analytes described in claim 3.
Claim 22 recites “at least two channels of the test stirp holder include an analyte test strip that tests for the presence or absence of two analytes.” where it is unclear if the channels, the analyte test strip, and analytes are the same or different from the ones described in claim 3.
For examination, it will be interpreted that it is the same channels, same analyte test strip, and same analytes described in claim 3.
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.
Claim(s) 3-8, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catteruccia (US-2015/0212081-A1) in view of Wan (WO-2010/101564-A1).
Regarding claim 3, Catteruccia teaches a test swab apparatus for testing a fluid specimen, comprising:
a swab stem (outer housing 21) having an absorbent tip (absorbent pad 27 and sample loading pill 30) on a bottom end of the swab stem, the swab stem (21) having an interior cavity open from a top end of the swab stem (21) to the bottom end of the swab stem (21) ([0041] and see absorbent pad 27 cut or sintered from absorbent material, [0048] see sample loading pill formed of an absorbent material, Figure 3, Figure 5b):
a test strip holder (inner support member 23) having one or more channels (grooves 24) each adapted to hold an analyte test strip (plurality of test strips 26), each such test strip (26) testing for one or more analytes, wherein the test strip holder (23) is adapted to slide into the top end of the swab stem (21), wherein the test strip holder (23) has an extending member (bottom most part of the inner support member 23) that upon full insertion of the test strip holder (23) into the swab stem (21) engages the absorbent tip (27 and 30) on the bottom end of the swab stem (21) ([0041], [0046], [0054], Figure 3);
one or more analyte test strips (26) positioned in the one or more channels (24) of the test strip holder (23), wherein upon full insertion of the test strip holder (23) into the swab stem (21) the test strips (26) are in fluid communication with the absorbent tip (27 and 30) ([0046], Figure 3);
wherein the one or more analyte test strips (26) contact fluid absorbed by the absorbent tip (27 and 30) and provide one or more test results via a transparent portion of the swab stem (21) ([0041] see outer tubular housing 21 is preferably molded in transparent rigid plastic material, [0046], [0050], Figure 3).
The limitation “wherein the test strip holder is adapted to slide into the top end of the swab stem” is 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 Catteruccia and the apparatus of Catteruccia is capable of having the test strip holder slide into the top end of the swab stem. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Catteruccia (see MPEP §2114).
While Catteruccia teaches that the inner support member 23 has a radially projecting head 25, where it is seen in Figure 4 that the radially projecting head 25 will fit within the outer tubular housing 21, it is unclear if the radially projecting head is a sealing member.
In the analogous art of analytical devices for collecting samples and determining the presence or absence and/or quantifying the amount of various analytes in the samples, Wan teaches a device with a sample collecting section, a sample accommodating section, and a sample analyzing section (Wan; [0002], [0007]).
Specifically, Wan teaches where the sample collection section 100 contains a lid 105 that includes a knob 101, an externally threaded portion 102, and an elongated shaft 103 where the externally threaded portion 102 is engagable with an internally threaded portion 502 of the sample accommodating section (Wan; [0023], Figure 2). [0025] of Wan describes that the sample accommodating section 500 may take on the shape of a cylinder and has an internally threaded portion 502 that engages with the externally threaded portion 102 of the sample collection section such that they may be coupled together. There may also be a rubber O-ring 200 provided between the lower rim of knob 101 and upper rim of internally threaded portion 502 that prevents leakage of collected sample (Wan; [0025], Figure 2).
It would have been obvious to one skilled in the art to modify the test chamber of Catteruccia such that it includes the externally threaded portion and O-ring as taught by Wan because Wan teaches that this coupling prevents the leakage of sample (Wan; [0025]).
The outer tubular housing 21 will have an internally threaded portion, which will correspond to the externally threaded portion of the inner support member, where one skilled in the art would find it obvious to place the O-ring on the inner support member. The threaded portion and O-ring are sealing members.
Regarding claim 4, modified Catteruccia teaches the apparatus of claim 3. Catteruccia further teaches wherein at least two analyte test strips (26) are positioned in at least two channels (24) of the test strip holder (23) wherein each of the at least two analyte test strips (26) are adapted to detect the presence or absence of one or more analytes (Catteruccia; Figure 3 showing four analyte test strips and that will correspond to four grooves 24 on the inner support member 23, [0054]).
Regarding claim 5, modified Catteruccia teaches the apparatus of claim 3.
The limitations of claim 5 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 modified Catteruccia and the apparatus of modified Catteruccia is capable of having each of the one or more test strips held in the one or more grooves of the inner support member detect the presence or absence of one or more analytes. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Catteruccia (see MPEP §2114).
Please see [0054] of Catteruccia which describes that the test strips 26 have a detection signal line 35 that becomes visible. Further, please see [0071] of Catteruccia describing an example of influenza A and B detection where if influenza A or B antigens are present, a specific red line together with a positive control line will appear, and if no antigens are present then just the positive control line will appear. And see [0075] that describes another example where drugs of abuse are detected.
Regarding claim 6, modified Catteruccia teaches the apparatus of claim 5.
The limitations of claim 6 are directed to the intended use of the apparatus, as described in claim 5 supra. Therefore, the limitation “wherein the one or more analytes comprise one or more drugs or alcohol.” is considered to be met.
However, please see [0075] of Catteruccia which describes an example where the target analytes consist of small molecules such as in the case of drugs of abuse.
Regarding claim 7, modified Catteruccia teaches the apparatus of claim 5.
The limitations of claim 7 are directed to the intended use of the apparatus, as described in claim 5 supra. Therefore, the limitation “wherein the one or more analytes comprise an antigen or antibody corresponding to a virus.” is considered to be met.
However, please see [0065] of Catteruccia which describes an example where influenza A and B are detected and [0071] where if influenza A or B antigens are present a specific red line and a positive control line will appear.
Regarding claim 8, modified Catteruccia teaches the apparatus of claim 7.
The limitations of claim 8 are directed to the intended use of the apparatus, as described in claim 5 and 7 supra. Therefore, the limitation “wherein a first analyte test strip tests for an antigen corresponding to the virus, wherein a second analyte test strip tests for an antibody corresponding to the virus.” is considered to be met.
Regarding claim 17, modified Catteruccia teaches the apparatus of claim 3. Catteruccia further teaches wherein the test strip holder (23) has n channels, wherein n equals 4 (Catteruccia; Figure 3 shows four test strips 26, and therefore there will be four grooves 24).
Claim(s) 9-10, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catteruccia (US-2015/0212081-A1) and Wan (WO-2010/101564-A1) and in further view of Loudermilk (US-2020/0376483-A1).
Regarding claim 9, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach further comprising:
a housing with a fluid collector tube; and
a sample holding container in fluid communication with the fluid collector tube;
wherein the swab stem is adapted for insertion into the fluid collector tube and upon insertion and penetration of the swab stem into the fluid collector tube pressure is generated to release fluid from the absorbent tip of the swab stem into the sample holding container;
wherein fluid contained in the sample holding container has sufficient volume for a confirmation test or a disease testing panel in a laboratory.
In the same problem solving area of substance collection and testing, Loudermilk teaches a housing provided with a vial (Loudermilk; [0002], [0041]).
Specifically, Loudermilk teaches that a housing 2 includes a vial 15 that is secured to the housing 2, where a swab assembly 5A is compressed in tube 2A of the housing 2 to release fluid into the vial 15 (Loudermilk; [0041], Figure 1).
It would have been obvious to one skilled in the art to modify the test chamber of Catteruccia such that it further comprises the housing of Loudermilk, where the test chamber is inserted into the tube of the housing of Loudermilk that is connected to the vial because Loudermilk teaches that the sample collected in the vial allows for confirmation testing to be performed (Loudermilk; [0040]).
The limitation “wherein the swab stem is adapted for insertion into the fluid collector tube and upon insertion and penetration of the swab stem into the fluid collector tube pressure is generated to release fluid from the absorbent tip of the swab stem into the sample holding container” is 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 modified Catteruccia and the test chamber of Catteruccia is capable of being inserted into the tube of Loudermilk. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Catteruccia (see MPEP §2114).
Regarding claim 10, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach further comprising:
a housing with a fluid collector tube; and
a sample holding container in fluid communication with the fluid collector tube;
wherein the swab stem is adapted for insertion into the fluid collector tube and upon insertion and penetration into the fluid collector tube pressure is generated to release fluid from the absorbent tip of the swab stem into the sample holding container;
a gasket positioned in the fluid collector tube having an upper portion for engaging a wall of the fluid collector tube and a lower portion of smaller diameter than the upper portion for insertion into an opening of the sample holding container, wherein the gasket is positioned at an upper location in the fluid collector tube upon insertion of the swab stem into the fluid collector tube, wherein the gasket is positioned at a lower location in the fluid collector tube after insertion of the swab stem into the fluid collector tube and at the lower location the gasket forms a seal with the sample holding container, wherein air passes outside of the apparatus from the fluid collector tube before the gasket is positioned at the lower location.
In the same problem solving area of substance collection and testing, Loudermilk teaches a housing provided with a vial (Loudermilk; [0002], [0041]).
Specifically, Loudermilk teaches a gasket 30 that is shaped like a funnel that extends into vial 32 and channels the flow of fluid into the vial 32 as swab 12A is compressed upon insertion into housing 2 (Loudermilk; [0054], Figures 9-10). [0056] of Loudermilk describes that the gasket 30 facilitates a linearly movable, two position valve/sealing implement where in a first unsealed, venting position in swab tube 2A air vents to the outside of the device, and then under pressure of swab compression the gasket moves down swab tube 2H to a second, sealed/non-venting position where fluid does not escape to the outside of the device.
It would have been obvious to one skilled in the art to modify the test chamber of Catteruccia such that includes the housing of Loudermilk, where the test chamber is inserted into the tube of the housing of Loudermilk that is connected to the vial, including the gasket, because Loudermilk teaches that the sample collected in the vial allows for confirmation testing to be performed (Loudermilk; [0040]).
The limitation “wherein the swab stem is adapted for insertion into the fluid collector tube and upon insertion and penetration into the fluid collector tube pressure is generated to release fluid from the absorbent tip of the swab stem into the sample holding container” is 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 modified Catteruccia and the test chamber of Catteruccia is capable of being inserted into the tube of Loudermilk. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Catteruccia (see MPEP §2114).
Regarding claim 15, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach wherein a fluid indicator strip is positioned in at least a first channel of the test strip holder.
In the same problem solving area of substance collection and testing, Loudermilk teaches a swab assembly (Loudermilk; [0002], [0045]).
Specifically, Loudermilk teaches where a swab assembly 5A has an indicator strip 27 that changes color when wet or saturated and is calibrated to serve as an indicator that a substantial and sufficient amount of saliva has been captured (Loudermilk; [0045], Figures 6A-C).
It would have been obvious to one skilled in the art to modify the test chamber of Catteruccia such that it included an indicator strip in one of the grooves of the inner support member because it is taught by Loudermilk that an indicator strip indicates if a substantial and sufficient amount of sample has been captured (Loudermilk; [0045]).
Regarding claim 16, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach further comprising:
a housing with a fluid collector tube and one or more second analyte test strips in fluid communication with the fluid collector tube;
wherein the swab stem is adapted for insertion into the fluid collector tube and upon insertion and penetration into the fluid collector tube pressure is generated to release fluid from the absorbent tip of the swab stem, wherein the fluid is presented to the one or more second analyte test strips, wherein the presence or absence of one or more analytes in the fluid specimen is detected based on one or more analyte test strips held by the test strip holder and based on the second lateral flow assay strips.
In the same problem solving area of substance collection and testing, Loudermilk teaches a housing that is provided with a strip cassette provided with a plurality of assay strips (Loudermilk; [0002], [0041]).
Specifically, Loudermilk teaches where a swab assembly 5B is inserted into swab tube 2B where saliva is released due to this insertion and the saliva is moved into chamber 2C of the housing (Loudermilk; [0042], Figure 3). Once the saliva is in chamber 2C the presence or absence of one or more target analytes is detected by the plurality of assay stirps 7 held in cassette 3 (Loudermilk; [0041]).
Examiner finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., inserted the test chamber of Catteruccia into the housing, specifically tube 2B connected to the cassette holding multiple assay strips, of Loudermilk), and that in combination, each element merely would have performed the same function as it did separately (i.e., detection of analytes), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the test chamber of reference Catteruccia with the housing of reference Loudermilk, since the result would have been predictable.
The limitation “wherein the swab stem is adapted for insertion into the fluid collector tube and upon insertion and penetration into the fluid collector tube pressure is generated to release fluid from the absorbent tip of the swab stem” is 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 modified Catteruccia and the test chamber of Catteruccia is capable of being inserted into the tube of Loudermilk. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Catteruccia (see MPEP §2114).
The test chamber of Catteruccia will now be inserted into the housing of Loudermilk, specifically the tube that is connected to chamber 2C that includes the plurality of assay strips 7.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catteruccia (US-2015/0212081-A1), Wan (WO-2010/101564-A1) and Loudermilk (US-2020/0376483-A1), and in further view of Engel (US-2019/0083069-A1).
Regarding claim 11, modified Catteruccia teaches the apparatus of claim 10. While Loudermilk does teach a gasket, Loudermilk does not teach wherein the gasket includes a cross member in an interior portion of the gasket that engages with the absorbent tip of the swab stem.
In the same problem solving area of compressing a sampling element with a sampler to express sample, Engel teaches an elevation 30 that has ridge-shaped elements 32 that promote the flow of sample down from the elevation 30 (Engel; [0107], Figures 3-4).
It would have been obvious to one skilled in the art to modify the gasket of Loudermilk such that it further includes an elevation with ridge-shaped elements as taught by Engel because Engel teaches that the ridge-shaped elements promote the flow of sample (Engel; [0107]).
The ridge-shaped elements are each a cross member.
Regarding claim 12, modified Catteruccia teaches the apparatus of claim 11. Engel further teaches wherein the gasket includes a plurality of cross members that connect at a center point in an interior portion of the gasket, where in the plurality of cross members engage with the absorbent tip of the swab stem (Engel; see Figure 3 where there is a plurality of ridge-shaped elements that connect at a center point).
Regarding claim 13, modified Catteruccia teaches the apparatus of claim 12. Engel further teaches wherein the plurality of cross members have a plurality of projections that engage with the absorbent tip of the swab stem.
The gasket of Loudermilk has been modified such that it further includes the ridge-shaped elements of Engel, where the ridge-shaped elements seen in Figures 3 and 4 are a plurality of projections.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catteruccia (US-2015/0212081-A1) and Wan (WO-2010/101564-A1) and in further view of Chen (US-2009/0068061-A1).
Regarding claim 14, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach wherein at least one channel of the test strip holder has protrusions from a side wall of the at least one channel, wherein the protrusions engage an analyte test strip positioned in the on the at least one channel.
In the same problem solving area of carriers with a series of grooves for holding a test strip, Chen teaches lugs (Chen; abstract).
Specifically, Chen teaches where a rectangular carrier has a series of grooves 24-28 that each hold a test strip, where each groove includes opposed lugs 32 that extend into the groove near the top and bottom ends of the grooves that squeeze the sides of test strips when installed to maintain the location of the test strips in its associated groove (Chen; [0028], Figures 1-2).
It would have been obvious to one skilled in the art to modify the grooves of Catteruccia such that they include the lugs as taught by Chen because Chen teaches that the lugs maintain the location of the test strips in their associated groove (Chen; [0028]).
Claim(s) 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catteruccia (US-2015/0212081-A1) and Wan (WO-2010/101564-A1) and in further view of Messmer (WO-2016/123105-A1).
Regarding claim 18, modified Catteruccia teaches the apparatus of claim 3. Catteruccia further teaches wherein one or more analyte test strips (26) detect the presence or absence of a virus antigen (Catteruccia; [0071] describing an example where if influenza A or B antigens are present, a specific red line will appear together with a positive control line).
However, Catteruccia does not teach wherein one or more analyte test strips have a sample pad in fluid communication with the absorbent tip, wherein the sample pad includes an agent that facilitates antigen detection via the one or more lateral flow assay strips.
In the analogous art of test devices for determining the quantity of a biologic in a sample, Messmer teaches where the device includes a sample pad (Messmer; abstract).
Specifically, Messmer teaches where a sample pad is a membrane that receives the biologic that is impregnated with agents that influence the flow rate of the sample that include protein detergents, where an example of a chemical agent that can be added includes Tween 20 (Messmer; [0021], [0022]). The sample pad is in fluid communication with a membrane that includes test lines (Messmer; [0020], Figure 1).
It would have been obvious to one skilled in the art to modify the test strips of Catteruccia such that they include the sample pad with impregnated agents, the agent being Tween 20, as taught by Messmer because Messmer teaches that the agents influences the flow rate of the sample and that the agents prevent the biologic from binding nonspecifically to any downstream materials or to modify the chemical nature of the biologic (Messmer; [0022]).
Regarding claim 19, modified Catteruccia teaches the apparatus of claim 18. Messmer further teaches wherein the agent comprises a detergent (Messmer; [0021], [0022]).
Regarding claim 20, modified Catteruccia teaches the apparatus of claim 19. Messmer further teaches wherein the detergent comprises TWEEN 20 (Messmer; [0021], [0022]).
Regarding claim 21, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach wherein at least one channel of the test strip holder includes an analyte test strip that tests for the presence or absence of two analytes.
In the analogous art of test devices for determining the quantity of a biologic in a sample, Messmer teaches where a test membrane comprises at least one test line (Messmer; abstract).
Specifically, Messmer teaches where a test line is a band or zone on the test membrane that contains at least one mimetope peptide, where after reaction with an antibody-detectable marker complex the band/zone produces an observable or measurable signal reflecting the presence or amount of biologic present in the sample (Messmer; [0028]). The test membrane may contain one, two, three, four, or more test lines, where the test lines contain the same or different immobilized mimetopes (Messmer; [0028]).
It would have been obvious to one skilled in the art to modify the test strips of Catteruccia such that they comprise multiple test lines as taught by Messmer because Messmer teaches that test strips with multiple test lines allows for multianalyte testing (Messmer; [0028]).
Regarding claim 22, modified Catteruccia teaches the apparatus of claim 3. Catteruccia does not teach wherein at least two channels of the test strip holder include an analyte test strip that tests for the presence or absence of two analytes.
In the analogous art of test devices for determining the quantity of a biologic in a sample, Messmer teaches where a test membrane comprises at least one test line (Messmer; abstract).
Specifically, Messmer teaches where a test line is a band or zone on the test membrane that contains at least one mimetope peptide, where after reaction with an antibody-detectable marker complex the band/zone produces an observable or measurable signal reflecting the presence or amount of biologic present in the sample (Messmer; [0028]). The test membrane may contain one, two, three, four, or more test lines, where the test lines contain the same or different immobilized mimetopes (Messmer; [0028]).
It would have been obvious to one skilled in the art to modify the test strips of Catteruccia such that they comprise multiple test lines as taught by Messmer because Messmer teaches that test strips with multiple test lines allows for multianalyte testing (Messmer; [0028]).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Esfandiari (US-2006/0134803-A1) teaches a sorbent material that supports a test line or test site with immobilized antigens or antibodies (Esfandiari; [0027], [0038]).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796