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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 7-9, 11-16, 35 and 40-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pais et al. (US 2018/0372595).
Regarding claim 1, Pais discloses a sample collection device comprising an extraction tube body (fig. 3, 4) comprising a top end (top of container with lid), a central portion (middle portion of container), and a bottom end (lower portion that connects to microfluidic device), wherein said top end is configured to accept a top cap (a top cap is not positively recited. A top cap can be added to the top end of the extraction tube at a later time); said bottom end is configured to accept a bottom cap (a bottom cap is not positively recited. A bottom cap can be added to the top end of the extraction tube at a later time);
said bottom end comprises a dropper feature (the bottom end has an opening that is capable of providing a drop of liquid therefrom. A dropper feature does not provide any structurally difference from the prior art bottom opening; para 47); and
a swab device (swab as seen in fig. 3) for acceptance in said extraction tube body (see fig .3; para 22-29; 47),
wherein said swab device comprises a swab end and a swab handle having a first length, a second length, and a breakable junction (fig. 3, ref. 302; para 47) between the first length and the second length (See fig. 3, first length below 302, second length above), the first length being between the swab end and the breakable junction, such that a combined length of the broken swab device has a length that fits swab end and the first length is less than an internal length of the extraction tube body and the first length and the swab end fit completely inside the extraction tube body when the swab handle is broken at the breakable junction (this limitation does not further structurally limit the instant claim because the limitation is directed to a process/use limitation of breaking the swab; further, the prior art is structurally capable of performing this process as seen in fig. 3, which shows the first length which is below the breakable junction 302 fitting within the extraction tube body completely), wherein the breakable junction is a structurally weakened portion of the swab handle of the swab device (see fig. 3, scored breakpoint 302),
wherein said extraction tube body comprises a separation component (The instant claim does not recite what structure the separation component is, therefore the broadest reasonable interpretation is the sidewall of the extraction tube body can be the separation component. Pais extraction tube body is made of plastic and can be squeezed in order to break the swab device at the breakable junction. This is the same operation as the instant specification. The separation component of the instant specification is a sidewall of the extraction tube body that is capable of being squeezed which then interacts with the breakable junction. Without the process of squeezing/pinching the sidewall the operation of the breaking the swab device at the breakable junction will not occur. In an alternate interpretation, the top end is provided with an edge that is structurally capable of providing a breaking point along with the break junction 302, see fig. 3 for the steps. This inside edge is below the top end as the swab device would be angled against the inside edge during breakage) configured to interact with said breakable junction to facilitate breaking the swab device at the breakable junction (this limitation is drawn to a process/use limitation of breaking a swab at the breakable junction and does not further structurally limit the instant claim. The prior art provides these steps as seen in fig. 3); wherein the separation component is between said top end and said bottom end (the extraction tube body is made of plastic and can be squeezed in order to break the swab device at the breakable junction. This is the same operation as the instant specification. The separation component of the instant specification is a sidewall of the extraction tube body that is capable of being squeezed which then interacts with the breakable junction. Without the process of squeezing/pinching the sidewall the operation of the breaking the swab device at the breakable junction will not occur. In an alternate interpretation, the top end is provided with an edge that is structurally capable of providing a breaking point along with the break junction 302, see fig. 3 for the steps. This inside edge is below the top end as the swab device would be angled against the inside edge during breakage).
Regarding claim 3, the sample collection device of claim 1 wherein said swab device has a length that is longer than a length that is the length of the central portion plus the length of the top end (see fig. 3 swab which is not broken, step 2 and 3).
Regarding claim 7, the sample collection device of claim 1 wherein said extraction tube body comprises a fill line (markings and indicia are not given patentable weight, See MPEP 2111.05).
Regarding claim 8, the sample collection device of claim 7 wherein said fill line marks a volume of approximately 300 uL (markings and indicia are not given patentable weight, See MPEP 2111.05).
Regarding claim 9, the sample collection device of claim 1 wherein said swab device is flexible (a typical swab is inherently flexible due to the slender profile and length. Further due to the breakable junction flexibility is present in order to break).
Regarding claim 11, the sample collection device of claim 1 wherein said extraction tube body comprises a top cap (see fig. 3) sealing said top end and a bottom cap (a frangible seal in the first interpretation is provided at the bottom of the extraction tube body. Claim 11 has not provided threading for a cap that would structurally differentiate from a frangible sealing cap; in the second interpretation the microfluidic device shown in fig. 4 is a sealing cap because the extraction tube body is attached thereto) sealing said bottom end and at least a part of said the first length and the swab end of the swab device are sealed inside said extraction tube body (see fig. 3).
Regarding claim 12, the sample collection device of claim 1 wherein said extraction tube body comprises a top cap sealing said top end, and wherein said dropper feature is exposed (see fig. 3).
Regarding claim 13, the sample collection device of claim 1 wherein said dropper feature outputs droplets of approximately 50 ul (this limitation does not further structurally limit the instant claim. A droplet size can be determined by the amount of pressure applied to the sidewalls of the extraction tube body).
Regarding claim 14, the sample collection device of claim 1, wherein said sample collection device is made from polyethylene (para 61).
Regarding claim 15, the sample collection device of claim 1, wherein said sample collection device is made from high density polyethylene (para 61).
Regarding claim 16, Pais discloses a kit comprising: a) a swab device comprising: a swab end (fig. 3); and a swab handle having a proximal end and a distal end (fig. 3), wherein said distal end comprises said swab end; and wherein said swab handle comprises a breakable junction (302) between the swab end and the distal end of the swab handle (fig. 3), wherein the breakable junction is a structurally weakened portion of the swab handle (scored joint 302; para 47);
b) a sample collection device comprising (fig. 3): an extraction tube body comprising a top end (See fig. 3 where cap is positioned), a bottom end (bottom of extraction tube body), a dropper feature (bottom of extraction tube has an opening that is capable of dispensing a drop of fluid; a dropper feature does not structurally distinguish from the prior art opening) and a separation component configured to interact with said breakable junction to facilitate breaking the swab device at the breakable junction (The instant claim does not recite what structure the separation component is, therefore the broadest reasonable interpretation is the sidewall of the extraction tube body can be the separation component. Pais extraction tube body is made of plastic and can be squeezed in order to break the swab device at the breakable junction. This is the same operation as the instant specification. The separation component of the instant specification is a sidewall of the extraction tube body that is capable of being squeezed which then interacts with the breakable junction. Without the process of squeezing/pinching the sidewall the operation of the breaking the swab device at the breakable junction will not occur. In an alternate interpretation, the top end is provided with an inner edge that is structurally capable of providing a breaking point along with the break junction 302, see fig. 3 for the steps. This inside edge is below the top end as the swab device would be angled against the inside edge during breakage), wherein a length of the extraction tube body is at least a combined length of a portion of the swab handle between the swab end and the breakable junction (see fig. 3), and the swab and end the portion of the swab handle fit completely inside the extraction tube body when the swab device is broken at the breakable junction (this limitation is drawn to a process/use claim and does not further structurally limit the instant claim. Fig. 3 shows the lower swab portion fitting inside of the extraction tube once broken at the breakable junction); a top cap (see fig. 3); and a bottom cap (a frangible seal in the first interpretation is provided at the bottom of the extraction tube body. Claim 11 has not provided threading for a cap that would structurally differentiate from a frangible sealing cap; in the second interpretation the microfluidic device shown in fig. 4 is a sealing cap because the extraction tube body is attached thereto); and c) a buffer solution (para 45, buffer solution is provided in the extraction container).
Regarding claim 35, Pais discloses a method of collecting a sample, said method comprising: a) providing the kit of claim 16 (see above); b) adding at least a portion of the buffer solution to the extraction tube body to provide buffer solution in said extraction tube body (para 45); c) contacting the swab device with a sample (see fig. 3); d) placing the swab device into the extraction tube body with the proximal end of said swab handle extending above a top end of the extraction tube body and the swab end contacting said buffer solution in said extraction tube body (fig. 3, step 2); e) separating the swab end from at least a portion of the swab handle or compressing the swab device into the extraction tube (fig. 4-5); f) securing the top cap to the extraction tube body (step 5); g) removing a bottom cap from the extraction tube body (frangible seal is punctured in a first interpretation, or in a second interpretation the bottom of the extraction tube is placed onto a microfluidic device a; and h) dispensing from the dropper feature buffer solution comprising at least a portion of the sample (fig. 2-3).
Regarding claim 40, the kit of claim 16, wherein the separation component comprises a cutting edge or cutting ridge (the opening in the cap is a thin area which provides a cutting edge to the breakable junction 302, see fig. 3).
Regarding claim 41, the sample collection device of claim 1, wherein the separation component comprises a cutting edge or cutting ridge (the opening in the cap is a thin area which provides a cutting edge to the breakable junction 302, see fig. 3).
Regarding claim 42, the sample collection device of claim 1, wherein the breakable junction is a notched, serrated, or scored portion of the swab handle (see fig. 3, 302 which is scored, para 47).
Regarding claim 43, the kit of claim 16, wherein the breakable junction is a notched, serrated, or scored portion of the swab handle (see fig. 3, 302 which is scored, para 47).
Response to Arguments
Applicant's arguments filed 6/10/26 have been fully considered but they are not persuasive. Claim 1 and 16 have been amended to provide the separation component between the top end and the bottom end. Applicant argues, “Pais et al. does not disclose at least "separation component configured to interact with said breakable junction to facilitate breaking the swab device at the breakable junction, wherein the separation component is between said top end and said bottom end." Pais et al. describes "devices and methods for sample extraction from a swab during biological sample processing." (Pais et al. Abstract). Pais et al. states that "Step 1-the lid of the sample extraction container is opened." (Pais et al. para [0047]). "Step 2-the swab is inserted completely into the sample extraction container through the squeezing structure. Step 3-the swab is pulled up through the squeezing structure. (Pais et al. para [0047]). Pais et al. then states "After the swab is squeezed out, the shaft is broken at the scored breakpoint 302 in Step 4." (Pais et al. para [0047]). Pais et al. describes when the swab shaft is broken and does not describe that the swab shaft is broken by an interaction between the scored breakpoint and a separation component. Pais et al. likewise does not describe a separation component "between said top end and said bottom end" configured to "interact with said breakable junction to facilitate breaking the swab device at the breakable junction." Claim 1 and 16 are drawn to a device and not a method of use. Therefore the claims scope is directed to the structures contained within the claims and not the process or intended use limitation. Claim 1 and 16 recite a a separation component but does not specifically describe the structure. Therefore the broadest reasonable interpretation is the sidewall of the extraction tube body can be the separation component or the upper rim near the top end of the extraction tube body. Pais extraction tube body is made of plastic and can be squeezed in order to break the swab device at the breakable junction. This is the same operation as the instant specification. The separation component of the instant specification is a sidewall of the extraction tube body that is capable of being squeezed which then interacts with the breakable junction. Without the process of squeezing/pinching the sidewall the operation of the breaking the swab device at the breakable junction will not occur. In an alternate interpretation, the top end is provided with an inner edge that is structurally capable of providing a breaking point along with the break junction 302, see fig. 3 for the steps. This inside edge is below the top end as the swab device would be angled against the inside edge during breakage of the swab device.
Conclusion
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 SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
