DETAILED ACTION
Claims 1-17, 19-27, and 76 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
Status of Claims
Claims 1-17, 19-27, and 76 are pending. Claims 1, 3, 9, and 27 have been amended. Claims 76 has been newly added.
Claims 1-17, 19-27, and 76 are under examination.
Withdrawn Claim Objections and/or Rejections
The rejection of claims 11-12, 20, and 22 under 35 USC 103 as being anticipated by Ramsey and Hu et al., as set forth on pp. 9-11 of the previous office action (mailed on 11/27/2024) has been withdrawn in view of the amended claims (filed on 12/29/2025).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1.Claims 1-17, and 19-27are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163 provides a procedure for evaluating the adequacy of written description to support the claim elements: a) determining what the claim covers as a whole, b) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and 3) determining whether there is sufficient written description to inform a skilled artisan that inventor was in possession of the claimed invention as a whole at the time the application was filed. The proscription against the introduction of new matter in a patent application serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 3232, 326 (CCPA 1981).
Claim 1 has been amended to recite “the sample passage slot having an opening that decreases in width from a bottom of the opening towards a top of the opening”.
A search of the originally filed specification shows no disclosure of a sample passage slot that has an opening that decreases in width from the bottom of the opening towards the top of the opening. The specification teaches that the sample passage slot is not rectangular and comprises a trapezoidal, triangular, or arched sample passage slot (see page 2 of specification). The specification teaches the sample passage slot could be an acute trapezoid, an isosceles trapezoid, an isosceles triangle, or a triangle with two acute angles (see page 37). The specification teaches the triangular shaped sample passage slot comprises a shape having an angle from 910179 degrees, a height that is from 2 to 15 mm and a base that has a length from 20 to 40 mm (see page 37). The specification does not provide support for the newly amended claim limitation. While the specification teaches potential measurements for the sample passage slot, it does not teach where the sample passage slot has an opening that decreases in width from a bottom of the opening towards a top of the opening.
Accordingly, the amendment to claim 1 constitute new matter. Claims 2-17 and 19-27 are included in this rejection as they depend on claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2.Claims 1, 3, 7-10, 13, 16-17, 19, 21, and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramsey et al., (US20130287650A1; published on 10/21/2014; effectively filed on 02/25/2013) (IDS filed on 11/01/2022).
Regarding claim 1, Ramsey teaches an assay device comprising:
a) a chamber configured for collecting and holding a sample (see [0006] “The present invention includes but is not limited to a specimen collection device that includes a chamber such that the chamber is capable of collecting or containing a specimen.”, see fig. 1), said chamber comprising an indication structure (see [0013] “The sample application zone being the region of the lateral flow detection device which is contacted first by the sample, the reagent zone being the region in which particular reagents for the desired assay are positioned such that they may migrate with an analyte along the device and the detection zone being the region in which the results of the assay are visualized or determined”, see [0042] “The test results observable at the detection zone are viewed through the indicator windows of the test device within the sealed reservoir”);
b) a reservoir comprising a test device (see [0006] “The reservoir contains a test device for testing the specimen for an analyte.”, see fig. 1); and
c) a non-rectangular sample passage slot fluidly connecting said chamber and said reservoir (see fig. 1, see [0007] “FIG. 1 depicts one aspect of a specimen collection and assay container of the present invention, which includes, but is not limited to, a chamber 101, a reservoir 300, a specimen passage slot 200, a chamber seal 400 a reservoir seal 306 and a test device 500. The arrow illustrates the flow of a sample, such as urine, from the chamber 101, through the specimen passage slot 200 and into the reservoir 300.”),
the sample passage slot having an opening that decreases in width from a bottom of the opening towards a top of the opening (see [0022] teaching that the chamber side wall and the specimen passage slot wall may be substantially tapered either outwardly from the top to the bottom of the side wall and the specimen passage slot wall or inwardly from the top to the bottom of the side wall).
Regarding claim 3, Ramsey teaches wherein said non-rectangular sample passage slot has a trapezoidal or a triangular shape (see fig. 1, see [0022] “The chamber 101 can have an upper opening 102 defined by the upper portion of the chamber 101 through which a specimen can be introduced into the interior of the chamber 101. In one embodiment of the present invention the chamber 101 can have a side wall 104, a bottom wall 106 and a specimen passage slot wall 202. The chamber side wall 104 and the specimen passage slot wall 202 may be substantially tapered either outwardly from the top to the bottom of the side wall 104 and the specimen passage slot wall 202 or inwardly from the top to the bottom of the side wall 104 and the specimen passage slot wall 202.”).
Regarding claims 4-6, and 8, Ramsey teaches the assay device of claim 1 as taught above. Ramsey’s figure 1 shows the trapezoidal shape, identical to the instant applications trapezoidal shape in figure 1B. The reference does not disclose the instantly claimed measurements, however, the instantly claimed invention and that of the prior art are identical such that the measurements are inherent.
Regarding claim 7, Ramsey teaches wherein said trapezoidal shape is an isosceles trapezoid (see fig. 1, see [0022] “The chamber 101 can have an upper opening 102 defined by the upper portion of the chamber 101 through which a specimen can be introduced into the interior of the chamber 101. In one embodiment of the present invention the chamber 101 can have a side wall 104, a bottom wall 106 and a specimen passage slot wall 202. The chamber side wall 104 and the specimen passage slot wall 202 may be substantially tapered either outwardly from the top to the bottom of the side wall 104 and the specimen passage slot wall 202 or inwardly from the top to the bottom of the side wall 104 and the specimen passage slot wall 202.”). Figure 1 appears to show an isosceles trapezoid shape.
Regarding claim 9, Ramsey teaches wherein said non-rectangular sample passage slot has a shape that is an arch, segment of a circle, or segment of an ellipse (see fig. 1, see [0022] “The chamber 101 can have an upper opening 102 defined by the upper portion of the chamber 101 through which a specimen can be introduced into the interior of the chamber 101. In one embodiment of the present invention the chamber 101 can have a side wall 104, a bottom wall 106 and a specimen passage slot wall 202. The chamber side wall 104 and the specimen passage slot wall 202 may be substantially tapered either outwardly from the top to the bottom of the side wall 104 and the specimen passage slot wall 202 or inwardly from the top to the bottom of the side wall 104 and the specimen passage slot wall 202. The chamber bottom wall 106 can take the form of a substantially level wall or may be angled thereby directing flow towards the specimen passage slot 200. The chamber 101 optionally includes a chamber orifice 108 communicatively connecting the inside and the outside of the chamber 101.”).
Regarding claim 10, Ramsey teaches a lid configured to seal said chamber (see fig.1, see [0023] “The chamber 101 can optionally include a chamber seal 400 to facilitate the closure of the chamber upper opening 102. A non-exclusive list of mechanisms and methods that can be used to form seals useful in the present invention includes thermal welding, ultrasonic welding, vacuum sealing, compressive gaskets, screw-top lids, snap-top lids, compressive ring gaskets, gluing, compressive latch mechanisms, compressive spring mechanisms, snap couplings, bayonet couplings, zipping, hook and loop fasteners, screws, nails, bolting mechanisms, elastic band or bands, string and twine, wire, sliding mechanisms, plug or plugs, compressive clips, twist lids, epoxying, and tamper resistant mechanisms.”, see [0025] “In a further alternative embodiment of the invention the chamber seal 400 can include a screw-lid 110.”).
Regarding claim 13, Ramsey teaches wherein said lid is a screw-lid (see [0025] “In a further alternative embodiment of the invention the chamber seal 400 can include a screw-lid 110.”).
Regarding claim 16, Ramsey teaches wherein said assay device does not comprise a membrane on the bottom wall of said assay device (see fig. 1, see [0022] “The chamber 101 can have an upper opening 102 defined by the upper portion of the chamber 101 through which a specimen can be introduced into the interior of the chamber 101. In one embodiment of the present invention the chamber 101 can have a side wall 104, a bottom wall 106 and a specimen passage slot wall 202.”). While Ramsey does not explicitly state that the assay device does not comprise a membrane on the bottom wall of the assay device, figure 1 does not show any membranes at the bottom of the wall of the assay device.
Regarding claim 17, Ramsey teaches wherein said chamber, said reservoir, and/or said test device comprises plastic (see [0028] “The materials from which the chamber 101 can be manufactured are varied. The possible materials include metal, silicon, glass, ceramic, plastic and synthetic and natural polymers and combinations and mixtures thereof.”, see [0031] “As with the chamber 101, the reservoir 300 can be manufactured using traditional manufacturing techniques known in the mechanical and manufacturing arts and may be constructed with various materials. These materials can include metal, silicon, glass, ceramic, plastic and synthetic and natural polymers or any combination thereof.”).
Regarding claims 19 and 21, Ramsey teaches that test strips are configured to test for the presence, absence, amount, and/or concentration of drugs of abuse (see [0013] “An “assaying device” or “assay device” is a device for detecting the presence and/or concentration of an analyte in a sample or specimen.”, see [0014] “An analyte can be but is not limited to a drug, a drug of abuse, a hormone, a protein, a nucleic acid molecule, an etiological agent, a specific binding member.”), drugs (see [0005] “These devices can be used for an assortment of purposes, including the detection of drugs or biological compounds such as glucose or hormones, antibodies or etiological agents.”), and/or drug metabolites (see [0009] “The present invention may assay for the presence or concentration of a variety of analytes such as but not limited to, a chemical, an organic compound, an inorganic compound, a metabolic product, a drug or a drug metabolite, an organism or a metabolite of such an organism, a nucleic acid, a protein, a hormone or a combination thereof.”).
Regarding claims 23 and 24, Ramsey teaches the assay device of claim 1 further comprising a sample of urine (see [0042] “A person in need of a drug of abuse test is given the present invention, referred to as “the urine cup” in this example. The person goes to the restroom. In the restroom, the person opens the top of the urine cup, urinates into the chamber of the urine cup, closes the urine cup, and gives the urine cup to a technician, which the technician then places on a counter. When the person urinates into the chamber of the urine cup, a portion of the urine flows into the reservoir through the specimen passage slot. The flow of urine pressurizes the air within the reservoir thereby limiting the influx of urine into the reservoir. After the urine flows into the reservoir, the urine comes into contact with the sample application zone of the test strip and migrates along the test strip.”).
Regarding claim 25, Ramsey teaches a reservoir seal providing an airtight seal for said reservoir (see [0030] “Alternatively the test device may be inserted between two halves of a reservoir and fused closed. IU another alternative embodiment of the present invention, the opening 314 of the reservoir 300 is hermetically sealed or sealed air tight with a reservoir seal 306.”).
Regarding claim 26, Ramsey teaches wherein said reservoir seal, in cooperation with said non-rectangular specimen passage slot, controls fluid passage from said chamber to said reservoir (see [0020] “The reservoir seal 306 controls the amount of sample added to the reservoir 300 by generally downward forces generated by air or gasses which compress upon entry of the sample to the reservoir 300.”).
Regarding claim 27, Ramsey teaches wherein said reservoir seal, in cooperation with said non-rectangular specimen passage slot, prevents excess influx of a sample into said reservoir upon introduction of said sample into said chamber (see [0018] “The reservoir seal prevents excess sample from entering the reservoir.”, see [0038] “The reservoir seal 306 prevents excess sample from entering the reservoir 300 by trapping air or a gas within the reservoir 300. The trapped air creates a downward pressure against the sample and therefore limits the amount of sample accessible through the specimen passage slot 200.”).
3.Claims 1, 3-11, 13, 16-26, and 76 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hu et al., (US20140046215A1) (IDS filed on 11/01/2022).
Regarding claim 1, Hu teaches an assay device (see claim 1 of ‘206) comprising:
a chamber configured for collecting and holding a sample, said chamber comprising an indication structure (see claim 1 of ‘206);
b) a reservoir comprising a test device (see figure 1 element 200, see [0043] teaching that element 200 is an assay chamber); and
c) a sample passage slot fluidly connecting said chamber and said reservoir (see figure 1 element 203, see [0043] teaching that element 200 is an assay chamber, see [0061] teaching the chamber opening is where the fluid sample can enter the collecting chamber), the sample passage slot having an opening that decreases in width from a bottom of the opening towards a top of the opening (see figure 1 of ‘206 showing the sample passage slot having an opening that decreases in width from the bottom of the opening towards the top of the opening. See the attached images below, showing the device of ‘206 (figure 1) and the device of the instant application (instant figure 1B)).
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Regarding claim 3, Hu teaches the sample passage slot having a trapezoidal or triangular shape (see figure 1 of ‘215 above showing the shape of the passage slot being the same shape as the passage slot in figure 1B of the instant application).
Regarding claims 4-6 and 8, Hu teaches the assay device of claim 1 as taught above. Hu’s figure 1 shows the trapezoidal shape, identical to the instant applications trapezoidal shape in figure 1B. The reference does not disclose the instantly claimed measurements, however, the instantly claimed invention and that of the prior art are identical such that the measurements are inherent.
Regarding claim 7, Hu teaches the shape of the sample slot being an isosceles trapezoid (see figure 1 of ‘215).
Regarding claim 9, Hu teaches the sample passage slot has a shape of an arch, segment of a circle, or segment of an ellipse (see figure 1 of ‘215).
Regarding claim 10, Hu teaches a lid configured to seal said chamber (see [0067] “For instance, the sound ‘pop’ the operator hears indicates the cover body has sealed the collecting chamber opening and the rotation can be stopped when the cover body is rotated into the specific position.”, see [0068] “In the invention, the conventional integrated structure of the collecting chamber opening and the assay chamber opening is innovated into split parts to ensure the sealing of collecting chamber.”).
Regarding claim 11, Hu teaches the indication structure is configured to produce a vibration when said lid is securely engaged with said chamber (see [0006] “This invention provides an assay device which is simple to operate and has an indication function. In particular, the device comprises a collecting chamber with an opening, test elements and an indication structure. The device indicates the operator through sound, in particular, by the vibration generated when the indication structure moves back to the original position after deformation. Preferably the vibration of indication structure attenuates naturally, not encountering any block or obstacle; therefore the sound generated by vibration is loud and lasting.”).
Regarding claim 13, Hu teaches the lid being a screw-lid (see figure 1 of ‘215 showing a screw lid).
Regarding claim 16, Hu teaches the assay device does not contain a membrane on the bottom wall of said assay device (see figure 1 of ‘215).
Regarding claim 17, Hu teaches the chamber, reservoir, and/or said test device comprises plastic (see [0012] “Both selectable resilient element and non-resilient element are made of plastic.”, see [0023] “The collecting chamber and the cover can be made of plastic such as ABS or PP.”).
Regarding claims 19 and 21, Hu teaches the test strips are configured to test for the presence, absence, amount, and/or concentration of drugs of abuse (see [0046] “Analytes can also be drug (drug of abuse), hormone, protein, DNA, RNA, nucleic acid molecule and pathogen. Drug of abuse (DOA) refers to use of drug for non-medical purposes (often for nerve paralysis). Abuse of these drugs can lead to physical and mental damage, drug dependence, drug addiction and/or death.”).
Regarding claim 20, Hu teaches wherein drugs of abuse are selected from the set
consisting of amphetamine, barbiturate, benzodiazepine, buprenorphine, cocaine,
tetrahydrocannabinol, ethyl glucuronide, methadone, methamphetamine, 3,4- methylenedioxy-
methamphetamine, opiate, oxycodone, phencyclidine, propoxyphene, 6-monoacetyl morphine,
morphine, fentanyl, tramadol, synthetic cannabinoids, and ketamine (see [0046] “ Abuse of these drugs can lead to physical and mental damage, drug dependence, drug addiction and/or death. These drugs include cocaine, amphetamine (e.g. black beauties, white amphetamine tablet, dextroamphetamine, dextroamphetamine tablet and Beans), methamphetamine (crank, meth, crystal and speed), barbiturate (Valium®, Roche Pharmaceuticals, Nutley and New Jersey), sedatives (sleep auxiliary drug), lysergide (LSD), inhibitors (downers, goofballs, barbs, blue devils, yellow jackets and methaqualone), tricyclic antidepressants (TCA, i.e. imipramine, elavil and doxepin); phencyclidine (PCP), tetrahydrocannabinol (THC, pot, dope, hash, weed and so on) and opiate preparations (morphine, opium, codeine, heroin and hydrocodone). The test strip can also be used for detection of drug that is applied to medical use but is easy to overdose, such as tricyclic antidepressants (imipramine or the similar) and acetaminophen.”).
Regarding claim 22, Hu teaches wherein said vibration provides an audio or haptic signal to a user of said assay device (see [0006] – [0007], see claim 1 of ‘215).
Regarding claims 23-24, Hu teaches the assay device comprising a sample, wherein the sample is urine, oral fluid, blood, serum, or spinal fluid (see [0045]).
Regarding claim 25, Hu teaches the reservoir seal providing an airtight seal for said reservoir (see [0003] “Therefore the sample container shall be sealed with a cover body before operation to avoid such risk. At present, a plurality of airtight devices have been invented”).
Regarding claim 26, Hu teaches wherein said reservoir seal, in cooperation with said specimen passage slot, controls fluid passage from said chamber to said reservoir (see [0054] “The assay device can further comprise an assay chamber 200 that has a test element. The liquid sample can flow freely or under control in the collecting chamber, and contact the test element in the assay chamber; the chemical reagent on the test element can detect if an analyte is present in liquid sample or determine the quantity of the analyte”, see [0048] “The samples are added into the sample feeding area and flow to the reagent area by a capillary tube. The sample will combine with the reagent if the analyte exist in the sample, and then flow to the test area.”).
Regarding claim 76, Hu teaches an assay device (see claim 1 of ‘215) comprising:
a chamber configured for collecting and holding a sample (see claim 1 of ‘215), said chamber comprising an indication structure (see claim 1 of ‘215);
b) a reservoir comprising a test device (see [0054] “the assay device can further comprise an assay chamber 200 that has a test element. The liquid sample can flow freely or under control in the collecting chamber, and contact the test element in the assay chamber; the chemical reagent on the test element can detect if an analyte is present in liquid sample or determine the quantity of the analyte.”); and
c) a sample passage slot fluidly connecting said chamber and said reservoir, the sample passage slot having a non-rectangular aperture configured to allow a portion of a sample collected in the chamber to flow into the reservoir (see [0054], see claim 1 of ‘215, see [0048] “the samples are added into the sample feeding area and flow to the reagent area by a capillary tube. The sample will combine with the reagent if the analyte exist in the sample, and then flow to the test area. For other reagents, the molecules of specifically binding analyte may be fixed in the test area. “, see [0054] “The assay device can further comprise an assay chamber 200 that has a test element. The liquid sample can flow freely or under control in the collecting chamber, and contact the test element in the assay chamber; the chemical reagent on the test element can detect if an analyte is present in liquid sample or determine the quantity of the analyte. The assay device 400 can further comprise the cover body 300 that is used for closing the collecting chamber opening 102. “). Claim Rejections - 35 USC § 102-Response to Arguments
The arguments filed on 12/29/2025 has been considered by the examiner.
On p. 7 of the previous office action applicants argue that Ramsey does not have a trapezoidal sample passage slot that has an opening that decreases in width from a bottom of the opening towards a top of the opening. Applicant argues that the previous office action does not point out the trapezoidal sample passage slot. Applicant argues that the citation of [0022] does not refer to the sample passage slot.
However, Ramsey’s figure 1 does teach the passage slot having a trapezoidal shape and decreasing in width from a bottom of the opening towards a top of the opening. The arrow below points to the sample passage slot. Further, Ramsey teaches that the sample passage slot may be tapered (see [0022]). It is known in the art that the term tapered means to reduce or decrease in size towards one end. [0022] explicitly teaches to the sample passage slot being tapered.
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
4.Claims 2, 4-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over
Ramsey et al., (US20130287650A1; published on 10/21/2014; effectively filed on 02/25/2013)
(IDS filed on 11/01/2022).
The teachings of Ramsey as applied to claims 1, 3, 7-10, 13, 16-17, 19, 21, and 23-27
are discussed in the 35 U.S.C. 102 above.
Regarding claim 2, Ramsey teaches the use of one or more test strips (see [0032] “In one embodiment of the present invention, the reservoir 300 will accept and engage either a test card or a test device 500 such as one or more test strips in a testably functional arrangement so as to permit the contact of the portion of the specimen with the appropriate sampling region or
regions on the bottom of the test card or test device.”, see [0041] “The one or more test strips can be used separately or can be arrayed on or in a common support such as a test card.”). The
selection of using 6 or more test strips would have been an obvious matter of choice absent
evidence of unexpected results.
Regarding claims 4-6, and 8, Ramsey teaches the assay device of claim 1 as taught
above. Ramsey’s figure 1 shows the trapezoidal shape, identical to the instant applications
trapezoidal shape in figure 1B. The reference does not disclose the instantly claimed
measurements, however, the instant application and the reference show identical trapezoidal
shapes. One of ordinary skill in the art would optimize such parameters based on the
requirements of the particular assay. Selection of such parameters would have been an obvious
matter of choice absent the evidence of unexpected results tied to said parameters.
It would have been obvious to one of ordinary skill in the art at the time of filing to
optimize such parameters based on the requirements of the particular assay and the samples
being tested. One of ordinary skill in the art would have been motivated to use one or more test
trips and the same measurements for the trapezoidal shape based on Ramsey’s success. Thus, claims 2, 4-6, and 8 are obvious to one of ordinary sill at the time of filing, especially in the
absence of evidence to the contrary.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al., (US20140046215A1) (IDS filed on 11/01/2022).
The teachings of Hu as applied to claims 1, 3-11, 13, 16-26, and 76 are discussed in the 35 U.S.C. 102 above.
Regarding claim 2, Hu teaches the use of two or more test strips (see [0054] “For example, the assay device comprises an indication structure, but the assay device comprises 2 or more indication structures are also obviously incorporated into the claims of this invention, and shall not be excluded. The assay device can further comprise an assay chamber 200 that has a test element.”). The selection of using 6 or more test strips would have been an obvious matter of choice absent evidence of unexpected results.
Regarding claim 12, Hu teaches a detection device that contains a lid that indicates the operator through sound, in particular, vibration (see [0006]). The lid is secured by rotation (see [0017]). While the reference does not explicitly state the torque of the lid must be of at least 21.3 pound-inch to produce the vibration the device Hu teaches has identical usage as the instant application. Absent evidence to the contrary, the lid mechanism for both the instant application and the prior art is identical, such that the torque of the lid being at least 21.3 pound-inch is inherent.
It would have been obvious to one of ordinary skill in the art at the time of filing to
optimize such parameters based on the requirements of the particular assay and the samples being tested. One of ordinary skill in the art would have been motivated to use six or more test strips and the torque of the lid being at least 21.3 pound-inch in order to produce the vibration of the device based on Hu’s success. Thus, claims 2 and 12 are obvious to one of ordinary skill in the art at the time of filing, especially absent of evidence to the contrary.
5.Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey as applied to claims 1, 3, 7-10, 13, 16-17, 19, 21, and 23-27, and in further view of Peace et al., “Performance evaluation of three on-site adulterant detection devices for urine specimens.” Journal of analytical toxicology vol. 26,7 (2002): 464-70. doi:10.1093/jat/26.7.464
The teachings of Ramsey as it pertains to claims 1, 3, 7-10, 13, 16-17, 19, 21, and 23-27
are discussed in the 35 U.S.C. 102 rejection above. Ramsey does not teach a sample validity test strip configured to test at least three sample characteristics such as pH, specific gravity, presence of creatinine, and presence of an oxidant.
Regarding claim 14, Peace teaches a sample validity testing strip configured to test for
at least three sample characteristics (see pg. 465 “Intect 7 assessed the presence of creatinine, nitrite, pH, specific gravity, glutaraldehyde, bleach, and PCC”).
Regarding claim 15, Peace teaches wherein said sample characteristics are pH, specific gravity, presence of creatinine, and presence of an oxidant (see pg. 465 “Intect 7 assessed the presence of creatinine, nitrite, pH, specific gravity, glutaraldehyde, bleach, and PCC”).
It would have been obvious to one of ordinary skill in the art at the time the application to
consider combining the methods of Ramsey with the teachings of Peace. Given the high level of
skill in the art as evidenced by Ramsey and Peace, one of ordinary skill in the art would have
considered combining Ramsey’s teachings of a specimen collecting device and assay container
with Peace’s teachings of urine integrity testing. Peace provides motivation by teaching that it is
a common practice in the art to run a urine integrity test when testing a urine sample as there is
an industry to invent ways to defeat drug tests (pg. 464). Peace teaches that it is a known
method in the art to run a validity test looking at levels of creatinine, pH, specific gravity, and
oxidants to determine if the sample has been adulterated. The artisan would have had
reasonable expectation of success based on the cumulative disclosures of these prior art
references at the time the instant application was filed.
Claim Rejections - 35 USC § 103-Response to Arguments
In the arguments filed on 12/29/2025 applicant did not present arguments to the 35 USC 103 Ramsey rejection, so therefore is maintained.
On p. 8 applicant argues that Peace does not remedy the deficiencies of Ramsey. However, Peace teaches a sample validity test strip configured to test for at least three sample characteristics including pH, presence of creatinine, nitrite, pH, specific gravity, glutaraldehyde, bleach, and PCC (see page 465).
Ramsey teaches a tapered sample passage slot (see figure 1, see [0022]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678