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, 3-9, 13-16 and 19-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US 2004/0082078).
Regarding claim 1, Lin discloses a fluid sample testing apparatus comprising:
a fluid collector (fig. 1), wherein the fluid collector has an elongated stem (2) and an absorbent member (212) affixed to a first end (left side where cap 3 is placed) of the stem, the stem having an interior open channel (see fig. 1, stem 2 is hollow) extending from the first end of the stem to a distal second end (fig. 1 right side where stem cap 4 is placed) of the stem, the interior open channel having an opening to outside of the stem (see fig 1, distal end is open);
one or more lateral flow assay strips (5) positioned in the channel (hollow stem area as seen in fig. 1) of the stem and adapted for insertion into the interior open channel of the stem via the opening on the distal second end of the stem (this limitation does not further structurally limit the instant claims. Lin cap 4 is removable and therefore a test strip can be placed into the channel),
a stem cap (4) secured on the distal second end of the stem, wherein the stem cap covers the opening and seals the interior open channel in which the one or more lateral flow strips are positioned (see fig. 1, cap 4 is placed on step opening and seals the interior open channel where the strip 5 is placed)
wherein a sample reception member (slot 213 made in the member 212 to accept test strip; see fig. 1, absorbent member 212 is in contact with strip 5 to provide a sample to the strip) of each of the one or more lateral flow assay strips is in fluid communication with the absorbent member (see fig. 1),
wherein one or more test lines and a control line of the one or more lateral flow strips are visible through a window portion of the stem (stem 5 is transparent; para 13); wherein fluid introduced into the absorbent member reaches the sample reception member of the one or more lateral flow assay strips and a test result is perceptible by a user or instrument via the one or more test lines and the control line via the window portion of the stem (this limitation is drawn to a process/use limitation and does not further structurally limit the instant claims. Lin is structurally capable of performing the process as the absorbent member collects a sample and transfers the sample to the test strip for analysis; fig. 1).
Regarding claim 3, the apparatus of claim 1, wherein each of the one or more lateral flow assay strips are adapted to detect the presence or absence of one or more analytes (this limitation does not further structurally limit the instant claim because no specific analytes are positively claimed on the lateral flow assay strips).
Regarding claim 4, the apparatus of claim 3, wherein the one or more analytes comprise one or more drugs (this limitation does not further structurally limit the instant claim because no specific analytes are positively claimed on the lateral flow assay strips).
Regarding claim 5, the apparatus of claim 3, wherein the one or more analytes comprise an antigen or antibody corresponding to a virus (this limitation does not further structurally limit the instant claim because no specific analytes are positively claimed on the lateral flow assay strips).
Regarding claim 6, the apparatus of claim 5, wherein a first lateral flow assay strip tests for an antigen corresponding to the virus, wherein a second lateral flow assay strip tests for an antibody corresponding to the virus (this limitation does not further structurally limit the instant claim because no specific analytes are positively claimed on the lateral flow assay strips. Further the sample is not positively recited as being part of the device).
Regarding claim 7, the apparatus of claim 6, further comprising:
a housing with a fluid collector tube (see fig. 1); and a sample holding container (container in which a sample is collected or in an alternative interpretation, the cap 3 is a container) in fluid communication with the fluid collector tube; wherein the fluid collector 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 fluid collector 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 (this limitation does not further structurally limit the instant claims, the cap is a container that is structurally capable of holding a sample).
Regarding claim 8, the apparatus of claim 4, further comprising: a housing with a fluid collector tube (fig. 1); and a sample holding container (cap 3) in fluid communication with the fluid collector tube; wherein the fluid collector 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 fluid collector 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 (this limitation does not further structurally limit the instant claims, the cap is a container that is structurally capable of holding a sample).
Regarding claim 9, the apparatus of claim 1, further comprising: a housing with a fluid collector tube; and a sample holding container (cap 3) in fluid communication with the fluid collector tube; wherein the fluid collector 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 fluid collector into the sample holding container; a gasket (311) positioned in the fluid collector tube having an upper portion for engaging a wall of the fluid collector tube (2) 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 fluid collector into the fluid collector tube, wherein the gasket is positioned at a lower location in the fluid collector tube after insertion of the fluid collector into the fluid collector tube and at the lower location the gasket forms a seal with the sample holding container (see fig. 1), wherein air passes outside of the apparatus from the fluid collector tube before the gasket is positioned at the lower location (this limitation does not further structurally limit the instant claims, the cap is a container that is structurally capable of holding a sample).
Regarding claim 13, the apparatus of claim 1, wherein a fluid indicator strip is positioned in the channel of the stem (any of the sample pads changes colors when wetted by a sample. There is no structural limitations recited in claim 13 that would differentiate from the prior art).
Regarding claim 14. The apparatus of claim 1, further comprising: a housing with a fluid collector tube (cap 4) and one or more second lateral flow assay strips in fluid communication with the fluid collector tube; wherein the fluid collector 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 fluid collector, wherein the fluid is presented to the one or more second lateral flow strips, wherein the presence or absence of one or more analytes in the sample is detected based on the lateral flow assay strips in the channel of the stem and based on the second lateral flow assay strips.
Regarding claim 15, the apparatus of claim 1, wherein the channel has a first length (first length at 216), wherein the one or more lateral flow assay strips are of at least a second length, wherein the second length is greater than the first length (see fig. 1, strip 5 is longer than the channel portion having a first length).
Regarding claim 16, the apparatus of claim 1, wherein one or more of the lateral flow assay strips detect the presence or absence of a virus antigen, wherein one or more of the lateral flow assay strips have a sample pad in fluid communication with the absorbent member, wherein the sample pad includes an agent that facilitates antigen detection via the one or more lateral flow assay strips (para 14).
Regarding claim 19, Lin discloses fluid sample testing method, comprising:
affixing an absorbent member onto a first end of an elongated stem of a fluid collector (a test strip 5 is inserted into the stem 2 an attached to absorbent 212 at point 213); wherein the stem (2) has an interior open channel extending from the first end (cap side 3) of the stem to a distal second end (cap side 4) of the stem;
inserting one or more lateral flow assay strips into the interior open channel of the stem via an opening on the distal second end (end near cap 4) of the stem, wherein a sample reception member (213) of each of the one or more lateral flow assay strips (5) is in fluid communication with the absorbent member (212), wherein one or more test lines and a control line of the one or more lateral flow strips are visible through a window portion (para 13, stem is transparent to allow test strip visual result) of the stem sealing the opening on the distal second end of the stem with a stem cap (4) secured to the distal second end of the stem (fig. 1);
absorbing a fluid sample (para 13-18) to be tested on an absorbent member affixed to a first end of an elongated stem of a fluid collector (fig. 1);
wherein fluid introduced into the absorbent member reaches the sample reception member of the one or more lateral flow assay strips (fluid contacts 212 and flows to the test strips 5); the method further comprising determining a test result via visual user perception (visual results are view through the transparent barrel 2) or an instrument via the one or more test lines and the control line via the window portion of the stem (para 13).
Regarding claim 20, the apparatus of claim 1, wherein the stem cap secured on the distal second end of the stem is secured via one or more projections/indentations on the stem cap and stem (See fig. 1, stem cap 4).
Regarding claim 21, the apparatus of claim 1, wherein the stein cap secured on the distal second end of the stem is secured via threads correspondingly formed on the stem cap and stem (see fig 1).
Regarding claim 22, the method of claim 19, wherein the stem cap secured on the distal second end of the stem is secured via one or more projections/indentations on the stem cap and stem (see fig. 1).
Regarding claim 23, the method of claim 19, wherein the stem cap secured on the distal second end of the stein is secured via threads correspondingly formed on the stem cap and stem (see fig. 1).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2004/0082078) in view of Fuller et al. (US 2016/0121322).
Regarding claim 2, Lin teaches a testing device as seen in fig. 1.
Lin does not teach two lateral flow strips in the channel.
Fuller teaches test device that comprises an absorbent member connected to a stem which houses two test strips for analyzing different analyte within the same sample. It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Lin to employ two test strips which detect different analytes and provide them within the same testing device for rapid identification of multiple analytes within a sample as is taught by Fuller (fig. 1; para 9, 40).
Claim 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2004/0082078) in view of Sloweyet al. (US 2009/0306543).
Regarding claim 17 and 18, Lin teaches a testing device as seen in fig. 1.
Lin does not teach two lateral flow strips in the channel with lateral flow strips comprising detergent of Triton or TWEEN 20.
Slowey teaches a sample collection device and test system which comprises a channel having a test strip therein that test for various analytes within a sample. Slowey states the binding characteristics of various protein and other molecules to the absorbent pad is another important factor. This particular property influences the nature of the binding of a given material to absorbent pad materials and is carefully considered when choosing products for a given application. Materials with high-binding characteristics may in some instances be used to encourage removal of certain analytes from the oral cavity, which may be difficult to obtain using pad materials with lower binding characteristics. In these cases, release agents such as alcohols, Tween 20 and others may be used. Therefore it would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Lin to employ Tween 20 as a releasing agent in the lateral flow test strip as taught by Slowey (para 67).
Response to Arguments
Applicant’s arguments with respect to claims 1-9 and 13-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday, Tuesday, Thursday, Friday, 8-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758