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 .
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.
Claim(s) 1, 3, 6, 7, 12 , 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tamir et al (US PGPub 2018/0021771).
Regarding Claim 1, Tamir et al teaches a diagnostic kit (illustrated in Figures 4a-c), in which a detection device (i.e. the test strip (elements 6-9) and a specimen collection tool (referred to as extraction chamber 4, in which a swab tip 2 is disposed) are integrated, for diagnosing a target material, the diagnostic kit comprising: a specimen collector (referred to as extraction chamber 4, in which a swab tip 2 is disposed) capable of collecting a specimen; a device comprising a housing (i.e. a casing 10) and a detection strip (embodied by elements 6-9) (see Figures 3-4 and [0068]); and a connector (referred to as stem 1) connecting the specimen collector with the device and moving a solution (see [0015], [0059] and [0069]), the connector having a bar shape (see Figures 1-2).
Regarding Claim 3, Tamir et al teaches that a head (tip) portion of the specimen collector comprises a sponge material (see [0074]).
Regarding Claim 6, Tamir et al teaches that the connector (i.e. stem 1 with swab tip 2) comprises a porous material, through which the solution is allowed to move (see [0015], [0050] and [0075]).
Regarding Claim 7, Tamir et al teaches that the connector comprises a catching protrusion, which protrudes outward from the connector (see [0069]).
Regarding Claim 12, Tamir et al teaches that the detection strip of the device comprises: a sample pad (8) absorbing a sample (see Figure 2 and [0069]); a conjugation pad (referred to a site on the strip where the analyte-specific labeled reagent has been incorporated (9)) located under the sample pad and comprising a source material that reacts with the target material (see [0064] and [0068]); and a membrane comprising a test line (referred to as capture zone 7), which is coated with the source material reacting with the target material, and a control line, which is coated with a source material used for a control group (see Figures 2-3 and [0064]).
Regarding Claim 15, Tamir et al teaches an absorption pad (6) capable of absorbing the sample that does not react in the conjugation pad and the membrane (see [0064] and [0068]).
Regarding Claim 16, Tamir et al teaches that the target material (i.e. the analyte) comprises a material extracted from a respiratory infection source (see [0003], [0047], [0057], [0064] and [0072]).
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) 2, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tamir et al as applied to claims 1 and 12 above, and further in view of Klapperich et al (US PGPub 2019/0062820).
Regarding Claim 2, Tamir et al teaches that the diagnostic tests its device performs may be used in assisting in the diagnosis of bacterial pharyngitis caused by group A streptococci (GAS) (an acute upper respiratory infection) (see [0002]-[0003]).
Tamir et al does not explicitly disclose that the specimen comprises a discharge inside a nasal cavity.
However, in the analogous art of molecular diagnostic devices, Klapperich et al teaches that the specimens used were obtained by extraction from inside a nasal cavity (see [0168]). It would have been obvious to one of ordinary skill in the art to modify the diagnostic kit of Tamir et al by utilizing a specimen also obtained by extraction from inside a nasal cavity (as taught by Klapperich et al) for the benefit of enabling various different infections (such as influenza A, coronavirus, respiratory infections) to be diagnosed in patients by swabbing the nasal cavity.
Regarding Claim 13, Tamir et al does not disclose that the source material is coupled with nano-sized nanoparticles and impregnated into the conjugation pad, and the nanoparticles comprise one or more of gold particles, silver particles, latex, cellulose, and fluorescent particles.
However, in the analogous art of molecular diagnostic devices, Klapperich et al teaches that the conjugate pad (of its diagnostic device) contains streptavidin-conjugated gold nanoparticles, a detection strip where the control and test lines are striped, and an absorbent pad to direct wicking. During amplification, loop primers tagged with FAM and biotin are incorporated into the amplicons, the biotin probe binds to the streptavidin conjugated beads, which can then aggregate at the test line (anti-fluorescein), forming a visible line to indicate a positive LAMP reaction. The control line (biotin) binds excess streptavidin beads, creating a visible positive control to show whether the flow strip worked properly (see [0149]). Further, Klapperich et al teaches that the streptavidin-conjugated gold nanoparticles (which are visible particles) bind the biotin probes on the LB primers within the amplicons. As the liquid continues to wick over the detection zone, amplicons that also contain the FITC probe on the LF primers will aggregate at the anti-FITC test line. Any excess streptavidin-conjugated gold nanoparticles will continue to wick through the LFD strip and bind the biotin control line, which confirms that the strip functioned properly. In this example, water was used as a negative control, thus only the control line appears on the strip (see [0223]). Thus, it would have been obvious to one of ordinary skill in the art to couple streptavidin-conjugated gold nanoparticles to the source material of Tamir et al for the benefit of enabling visible detection (through the gold nanoparticles, which are visible particles and which produce a line visible to the naked eye) and also ensuring that the test strip is functioning properly.
Regarding Claim 14, the combination of Tamir et al and Klapperich et al teaches that the conjugation pad comprises polyester (see [0073]-[0074] of Tamir et al) or a biocompatible or bioinert paper, PES, polycarbonate, cellulose, nitrocellulose, glass fiber, or glass fiber fusion papers), to facilitate holding a sufficient volume of sample (see [0067] of Klapperich et al).
Claim(s) 4, 8, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tamir et al as applied to claims 1 and 12 above, and further in view of Charlton et al (US PGPub 2022/0249073).
Regarding Claim 4, Tamir et al teaches that the dimensions of the specimen collector (i.e. the extraction chamber) may vary (see [0065]). In addition, Tamir et al discloses that an opposite portion of the specimen collector is open (see Figures 2-3).
Tamir et al does not explicitly disclose that the width of the opposite portion of the specimen collector is less than the width of the connector.
However, in the analogous art of sample collection devices, Charlton et al teaches a diagnostic device comprising a specimen collector (referred to as test device 103) and a connector (referred to as a stem, in connection with an absorbent sample pad), wherein the width of the opposite portion of the specimen collector (i.e. test device 103, with the opposite portion being 106) is less than the width of the stem (see Figure 1, [0040] and [0084]). It would have been obvious to one of ordinary skill in the art to have the width of the stem be greater than the width of the opposite end of the specimen collector for the benefit of ensuring the test device and specimen collector are able to be securely connected.
Furthermore, examiner Wecker notes that in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Regarding Claim 8, Tamir et al teaches diagnostic strip integration involving a casing made up of two matching, interlocking valves (10a,b). One such valve—the cover (10a)—is configured to clasp the swab tip (2) via its stem (1), while the other valve—the base (10b)—is configured to accommodate the test strip (6-9) and further teaches protrusions in the cover (13) that serve to firmly immobilize the swab stem within the casing cover (see [0069]).
Tamir et al does not explicitly disclose a catching groove, into which the catching protrusion is allowed to fit, is arranged inside the housing at one side of the housing.
However, in the analogous art of sample collection devices, Charlton et al teaches that the test device housing includes a catch, and the extension bar includes a catch counterpart (e.g., a depression or projection disposed in or on a side of the extension bar) disposed adjacent to the catch in the test device housing (see [0090]). It would have been obvious to one of ordinary skill in the art to modify the diagnostic kit of Tamir et al by incorporating a catching groove within the side of the test device housing (as taught by Charlton et al) for the benefit of enabling the protrusion of the connector to fit into the catching groove and secure these two components to one another, thereby ensuring the diagnostic kit is more secure and stable.
Regarding Claim 13, Tamir et al does not disclose that the source material is coupled with nano-sized nanoparticles and impregnated into the conjugation pad, and the nanoparticles comprise one or more of gold particles, silver particles, latex, cellulose, and fluorescent particles.
However, in the analogous art of sample collection devices, Charlton et al teaches a method for determining presence or absence and/or amount of an analyte in a sample that includes: detecting a detectable signal from a lateral flow strip through a window of a test device component of an assembly described herein, or an assembly prepared by a method described herein, and determining the presence or absence and/or amount of the analyte in the sample from the detectable signal. The detectable signal often is an optically detectable signal, which can be detected by an instrument or by eye. An optical signal can be detected with or without illumination (e.g., with or without dedicated illumination). Sometimes a signal detected optically is a signal emitted by nanoparticles (e.g., gold, latex, silver or carbon nanoparticles) (see [0087] and [0151]). It would have been obvious to one of ordinary skill in the art to couple gold, silver or latex nanoparticles (as taught by Charlton et al) to the source material of Tamir et al for the benefit of enabling visible detection (through the gold nanoparticles).
Regarding Claim 14, the combination of Tamir et al and Charlton et al teaches that the conjugation pad comprises polyester (see [0073]-[0074] of Tamir et al and [0085] and [0088] of Charlton et al) or glass (see [0085], [0088] of Charlton et al).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tamir et al and Charlton et al as applied to claim 4 above, and further in view of Tomer ( US 2008/0299648), as cited in the IDS.
Regarding Claim 5, the combination of Tamir et al and Charlton et al does not teach an elastic body is arranged on the opposite portion of the specimen collector.
However, in the analogous art of diagnostic kits, Tomer teaches a diagnostic kit in which a receptacle at an end of analysis test strip is held tightly against an elastic body by a sampling unit tip placed adjacent to the receptacle positioned on the closed end of a housing. The elastic body is adjacent on the opposite side to the housing wall. Accordingly, after the sampling unit is removed from the housing the receptacle is moved away from the elastic body into the centre of the closed end of the housing (see [0042]). It would have been obvious to one of ordinary skill in the art to modify the diagnostic kit of Tamir et al by incorporating an elastic body (as taught by Tomer) is placed at an end of the test strip for the benefit of tightly securing and supporting the test strip device within the housing.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tamir et al as applied to claim 1 above, and further in view of Hannant et al (US PGPub 2009/0208371).
Regarding Claim 9, Tamir et al does not teach that the housing comprises a support having a bar shape, at one end of the housing, the support extending from the one end of the housing to the outside of the housing and being capable of supporting the connector while contacting the outside of the connector.
However, in the analogous art of sample collection and testing devices, Hannant et al teaches that the sample collector at the first end of the housing is a swab, that is to say a small pad of liquid-absorbent material. The swab may for example be formed from a hydrophilic foam material such as a polyurethane foam, or it may for example be a fibrous swab, including a bonded fiber material such as FILTONA (registered trade mark). In certain alternative embodiments, the sample collector may comprise a biopsy punch, a pipette, or another mechanical sampling device. The sample collector is dimensioned to fit inside the cap on the swing arm. Suitably, the sample collector comprises, or is mounted on, a fitting for forming a liquid-tight seal with the cap so that sample and wash liquid do not leak from within the cap when the swing arm is in the sample analysis position. For example, the sample collector may be mounted on a collector support that is dimensioned to form a substantially liquid-tight seal with the open end of the cap on the swing arm, thereby enclosing the collector inside the cap when the cap is pushed down over the collector in the sample analysis configuration. Suitably, the collector support is a substantially tubular projection extending from the first end of the housing (see [0012]). It would have been obvious to one of ordinary skill in the art to modify the diagnostic kit of Tamir et al by incorporating a support having a bar shape, at one end of the housing (as taught by Hannant et al) for the benefit of enabling the sample collector to be securely mounted to form a substantially liquid-tight seal with the open end of the housing.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tamir et al as applied to claim 1 above, and further in view of Kato et al (US PGPub 2020/0038854).
Regarding Claim 10, Tamir et al does not teach that the specimen collector is inserted into a tube storing a developing solution, a test is performed by the device connected with the specimen collector via the connector.
However, in the analogous art of test strips, Kato et al teaches an immunochromatographic test strip, which comprises: a support having a detection region with an immobilized antibody (Antibody 1) that captures an analyte to be detected (antigen, etc.); a label region having a movable labeled antibody (Antibody 2); a sample pad to which a specimen is added; an absorbent pad that absorbs a developed specimen solution (see [0037]). Further, Kato et al teaches that an extracted sugar chain antigen is developed and moved together with an acidic developing solution to the neutralized reagent region 6, and the pH of the acidic developing solution containing the sugar chain antigen is neutralized and adjusted to the neutral range in the neutralizing reagent region 6 (see [0093]). It would have been obvious to one of ordinary skill in the art to modify the diagnostic kit of Tamir et al by inserting the specimen collector into a tube storing a developing solution (as taught by Kato et al) for the benefit of enabling the pH on the specimen collector to be neutralized such that the test strip detection rejection is accurate.
Regarding Claim 11, Tamir et al teaches an insertion portion at one side of the casing 10, the insertion portion having a cross-section of a polygonal shape (see Figures 3-4 of Tamir et al).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tamir et al as applied to claim 1 above, and further in view of Brenner et al (US PGPub 2018/0106799).
Regarding Claim 10, Tamir et al does not teach that the specimen collector is inserted into a tube storing a developing solution, a test is performed by the device connected with the specimen collector via the connector.
However, in the analogous art of test devices, Brenner et al teaches that the test device can be configured for a developing liquid to be used to transport the analytes and/or the labeled reagent to the test locations (see [0046]). Furthermore, Brenner et al teaches that analytes and/or the labeled reagent can be transported to the test locations by using a combination of a sample liquid and a developing liquid, used to transport the analytes and/or the labeled reagent to the test locations (see [0156]). The present test device can further comprise a liquid container. The liquid container can comprise any suitable liquid and/or reagent. For example, the liquid container can comprise a developing liquid, a wash liquid and/or a labeled reagent (see [0165]). It would have been obvious to one of ordinary skill in the art to modify the diagnostic kit of Tamir et al by inserting the specimen collector into a tube storing a developing solution (as taught by Brenner et al) for the benefit of enabling effective transport of the analytes to the test locations.
Regarding Claim 11, Tamir et al teaches an insertion portion at one side of the casing 10, the insertion portion having a cross-section of a polygonal shape (see Figures 3-4 of Tamir et al).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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, 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.
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.
/JENNIFER WECKER/Primary Examiner, Art Unit 1797