DETAILED ACTION
Notice of AIA Status
The present application, filed on 8/21/2025, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-2, 24-32 and 36-41 are rejected.
Claims 33-35 are objected to.
Response to Arguments
Applicant’s arguments with respect to claim 1 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. The objections to the specification is withdrawn.
Applicant’s arguments, see section IV - rejections under 35 U.S.C. §102 - on pages 6-7, filed 7/14/26, with respect to the rejection of claim 1 under 35 U.S.C §102 in view of Babu (US20130017559) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection under 35 U.S.C. §102, necessitated by the amendment dated 7/14/26, is made in view of Kirkegaard (US20070087450).
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.
Claim 41 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 41 recites “the sample release pad”. There isn’t sufficient antecedent basis for the “sample release pad” in the claim.
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.
Claims 1-2, 36 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirkegaard (US20070087450).
With respect to claim 1, Kirkegaard (US20070087450) teaches a device (assay platform 42 in [0031], see Fig. 2) for detecting an analyte (analyte in [0031], which recites “a color reaction, indicating the presence of … analyte. The presence and/or amount of analyte in the sample 10 may be determined by the visibility of a line formed by the capture reagent 12 a, specific for the analyte-label reagent conjugate being tested”)(see also [0049], which recites “If detection membrane strip 12 is detecting antigen as the analyte, the membrane 12 surface may be impregnated with antibody”) in a sample (sample 10 in [0031]), the device (assay platform 42) comprising:
a sample collection pad (sample receiving pad 13 in [0031], see Fig. 2) for contacting the sample (sample 10 in [0031], which recites “sample receiving pad …where the sample fluid 10 is initially applied)”); and
a conjugate release pad (lyophilized mobile conjugate pad 15 in [0031], see Fig. 2) arranged between (see Fig. 2) and in fluid communication with the sample collection pad (sample receiving pad 13) and a test strip (detection membrane strip 12 in [0031], which recites “sample fluid 10 flows out of the sample receiving pad or membrane 13 toward an adjacent dried or lyophilized mobile conjugate pad 15 and is along a flow path 20, composed of a fibrous membrane, where the sample 10 and mobile conjugate 22 has an opportunity to mix and flow through capillary migration into an elongated lateral flow analyte detection fibrous membrane strip 12 toward the direction of reservoir pad or membrane 14, located at the opposite end of the sample receiving pad or membrane 13 conjugate”), wherein:
the conjugate release pad (lyophilized mobile conjugate pad 15) includes at least one labelling reagent (dried conjugate 22 in [0031]),
the at least one labelling reagent (dried conjugate 22) is configured to be rehydrated by the sample (sample 10) (see [0031], which recites “sample 10 rehydrates the dried conjugate 22 along the flow path 20 at the conjugate pad or membrane 15, starting from the sample application area 16 b, flowing in the direction of the reservoir absorbent pad as shown at 20 in FIG. 2”) and comprises a component (test ligand in [0040]) configured to bind to the analyte at a first location (dried conjugate 22 carries a test ligand and the test ligand carried by the dried conjugate 22 reacts with the analyte in the conjugate release pad to form an analyte-conjugate complex, see [0040], which recites “when the sample 10 solution contacts the conjugate pad …, particle conjugate 22 is rapidly expressed into the sample 10 where the test ligand has opportunity to react with said conjugate particles 22”) (see also [0031], which recites “the sample 10 and mobile conjugate 22 has an opportunity to mix …pushing the reacted analyte conjugate complexes through flow path 20”),
the test strip (detection membrane strip 12 in [0031]) comprises a test line (region 12 a in [0031]) including a test antibody (antibody in [0005]) (see also [0031], which recites “immobilized capture reagent membrane at region 12 a of detection membrane strip 12”) (see also [0013], which recites “a porous capture material impregnated at a reaction site with a member of a specific binding pair such as an antibody”) (see also [0049], which recites “If detection membrane strip 12 is detecting antigen as the analyte, the membrane 12 surface may be impregnated with antibody”), and
the test antibody (antibody) is configured to bind the analyte at a second location (see [0031], which recites “Sample 10 and conjugate mixture 22 then continue to migrate to an immobilized capture reagent membrane at region 12 a of detection membrane strip 12, where the sample/conjugate mixture can bind or stick to the immobilized capture reagent, causing a color reaction, indicating the presence of a specific ligand or analyte. The presence and/or amount of analyte in the sample 10 may be determined by the visibility of a line formed by the capture reagent 12 a, specific for the analyte-label reagent conjugate being tested”).
With respect to claim 2, Kirkegaard (US20070087450) teaches the device of claim 1, wherein the test strip (detection membrane strip 12) comprises a cellulose membrane (see [0033], which recites “the detection membrane strip 12 … composed of … mixed cellulose esters”).
With respect to Claim 36, Kirkegaard teaches the device of claim 1 wherein the conjugate release pad comprises a blended cellulose membrane (see [0033], which recites “the detection membrane strip 12 … composed of a series of porous material pieces such as … mixed cellulose esters”).
With respect to claim 41, Kirkegaard teaches the device of claim 1, wherein the sample release pad is configured to receive a liquid as the sample (see [0031], which recites “a liquid sample 10 is applied through holes (cassette 16 openings) 16 b onto a sample receiving pad or membrane 13. The sample fluid 10 flows out of the sample receiving pad or membrane 13 toward an adjacent dried or lyophilized mobile conjugate pad 15 and is along a flow path 20, composed of a fibrous membrane, where the sample 10 and mobile conjugate 22 has an opportunity to mix and flow through capillary migration into an elongated lateral flow analyte detection fibrous membrane strip 12 toward the direction of reservoir pad or membrane 14, located at the opposite end of the sample receiving pad or membrane 13 conjugate. Sample 10 and conjugate mixture 22 then continue to migrate to an immobilized capture reagent membrane at region 12 a of detection membrane strip 12, where the sample/conjugate mixture can bind or stick to the immobilized capture reagent, causing a color reaction, indicating the presence of a specific ligand or analyte”).
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.
Claim 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450) in view of Lappalainen (WO2011051562).
With respect to claim 24, Kirkegaard (US20070087450) teaches the device of claim 2.
Kirkegaard fails to explicitly teach that the test strip includes no nitrocellulose materials.
In the analogous art of providing analytical devices, Lappalainen (WO2011051562) teaches a test strip includes no nitrocellulose materials (see page 5 of Lappalainen, which recites “compared to nitrocellulose membranes where flammability and poor mechanical strength is an issue, cellulose papers provide a much more viable solution to the production of such test strips”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard by employing the non-nitrocellulose test strip taught by Lappalaine such that the test strip includes no nitrocellulose materials with a reasonable expectation of success for the benefit of reducing the flammability concerns and poor mechanical strength associated with nitrocellulose while providing a more mechanically robust and less flammable test strip (see page 5 of Lappalainen).
Claims 25-28 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450 in view of Guo (US20040184954).
With respect to claim 25, Kirkegaard teaches the device of claim 1.
Kirkegaard fails to teach a sample collection reservoir configured to collect the sample and guide flow of the sample to the conjugate release pad.
In the analogous art of providing analytical devices, Guo (US20040184954) teaches a sample collection reservoir (sample application well 210 in [0052]) configured to collect the sample and guide flow of the sample to the conjugate release pad (see [0022], which recites “FIG. 7 is a cross-sectional view of the assembled liquid sample collection, testing and storage device of FIG. 1, illustrating some of the steps of expressing a sample from the absorbent application 120. Step 1 shows the absorbent applicator placed in the sample application well 210. Step 2 shows the absorbent applicator 120 pressed down into the sample application well 210, and liquid sample 710 simultaneously flowing into the reservoir interior 320 and onto a test strip 700”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard by incorporating the sample collection reservoir disclosed by Guo with a reasonable expectation of success for the benefit of collecting and storing sample fluid for performing a diagnostic test.
With respect to claim 26, Kirkegaard in view of Guo teaches the device of claim 25, wherein the sample collection reservoir (sample application well 210) is oval (see [0052] of Guo, which recites “the sample application well 210 can be of any geometric shape or dimension such as… oval”).
With respect to claim 27, Kirkegaard in view of Guo teaches the device of claim 25, wherein a length of the sample collection reservoir is greater than a width of the sample collection reservoir (see [0052] of Guo, which recites “the sample application well 210 can be of any geometric shape or dimension such as… oval”) (Oval indicates a length greater than a width).
With respect to Claim 28, Kirkegaard in view of Guo teaches the device of claim 25, further comprising a handle (housing 16 in [0037] of Kirkegaard) configured to receive the test strip (see [0037], which recites “the whole strip should be contained in a plastic or cardboard housing (cassette 16) to provide support and for ease of use”).
With respect to Claim 32, Kirkegaard in view of Guo teaches the device of claim 25, further comprising:
a coating (reservoir sealing means in claim 1 of Guo) coupled to the sample collection reservoir (sample application well 210), wherein the coating (reservoir sealing means) comprises one or more of sugar, gelatine or wax (see claim 1 of Guo, which recites “reservoir sealing means is … wax”).
Claims 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450) in view of Guo (US20040184954) as applied to claim 28 above, and in further in view of Young (US20110097250).
With respect to claim 29, Kirkegaard in view of Guo teaches the device of claim 28.
Kirkegaard in view of Guo teaches fails to teach that each of the handle and the sample collection reservoir consists of one or more biodegradable materials or one or more compostable materials or a combination thereof.
In the analogous art of providing analytical devices, Young (US20110097250) teaches each of the handle (handle 170) and the sample collection reservoir (receptable 110 in [0017]) consists of one or more biodegradable materials or one or more compostable materials or a combination thereof (see [0017], which recites “receptacle 110 is used for collecting urine, blood, saliva, or other liquid samples… receptacle 110 may be made of a recyclable or biodegradable material such as paper”) (see [0024], which recites “handle 170 may be an elongate member made of a recyclable and/or biodegradable material such as cardboard or paper”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard in view of Guo such that the handle and the sample collection reservoir comprise only biodegradable material as disclosed by Young with a reasonable expectation of success for the benefit of reducing environmental impact.
With respect to claim 30, Kirkegaard in view of Guo in view of Young teaches device of claim 29, wherein the biodegradable and/or compostable materials include at least one of unbleached wood pulp, vicose, potato, sugar cane, wheat straw fibres, banana fibres, corn-starch or cellulose (see [0017] and [0024] of Young).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450) in view of in Guo (US20040184954) as applied to claim 28 above, and in further in view of Edwards (US20180224436).
With respect to Claim 31, Kirkegaard in view of Guo teaches the device of claim 28, further comprising:
a backing (laminate 11 in [0031] of Kirkegaard) (see also backing in [0005] of Kirkegaard) coupled to a first surface of the test strip (test strip) opposite the sample collection pad (sample receiving pad 13) (see Fig. 2); and
Kirkegaard in view of Guo fails to teach a supporting material configured to provide rigid support to the handle and/or the backing, wherein the supporting material comprises one or more of sugar, gelatine or wax.
In the analogous art of providing analytical devices, Edwards (US20180224436) teaches a supporting material configured to provide rigid support to the handle and/or the backing, wherein the supporting material comprises one or more of sugar, gelatine or wax (see [0261], which recites “devices that utilize a non-woven support comprising, for example, gelatin”) (see [0256], which recites “water dispersible or otherwise dissolvable film (e.g., gelatine) is provided over opening or window (15) in support layer (20) to protect the test region and optionally enhance readability’).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard in view of Guo incorporating a supporting material configured to provide rigid support to the handle and/or the backing, wherein the supporting material comprises one or more of sugar, gelatine or wax as disclosed by Young with a reasonable expectation of success for the benefit of enhancing readability and facilitating disposal after reading.
Claim 37 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450) in view of McKee (US20190162717).
With respect to Claim 37, Kirkegaard teaches device of claim 1.
Kirkegaard fails to explicility teach that the sample collection pad comprises cellulose fibres.
In the analogous art of providing analytical devices, McKee (US20190162717) teaches cellulose fibers (see [0008], which recites “the wicking pad … formed … absorbent material … a cellulose fiber derivate”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Babu such that the sample collection pad comprises cellulose fibers disclosed by McKee with a reasonable expectation of success for the benefit of effectively driving flow through the pad in a controlled and rapid manner.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450) in view of Forman (US20220401082).
With respect to claim 38, Kirkegaard teaches the device of claim 1 further comprising a backing (laminate 11 in [0031]) (see also [0005]) coupled to a first surface of the test strip (test strip) opposite the sample collection pad (sample receiving pad 13) (see Fig. 2)
Kirkegaard fails to teach that the backing comprises at least one of: a gelatine material, a plant-based eco plastic or a non-woven fibre.
In the analogous art of providing analytical devices, Forman (US20220401082) teaches a backing comprising at least one of: a gelatine material, a plant-based eco plastic or a non-woven fibre (see [0004], which recites “a sample collection pad comprising: (a) a sample collection strip; and (b) a backing material having a larger surface area than the sample collecting strip is water soluble, said backing material comprising at least two layers, (i) a paper layer and (ii) a tissue layer, wherein the tissue layer is positioned between the paper layer and the sample collection strip…. tissue or paper layers comprise a plant-based nonwoven material”) (see [0049], which recites “the tissue or paper layer may comprise nonwoven fiber material. To enable biodegradability the fibers are preferably cellulosic”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard by forming the backing of a nonwoven fiber material as disclosed by Forman such that the backing is coupled to a first surface of the test strip opposite the sample collection pad, wherein the backing comprises at least one of: a gelatine material, a plant-based eco plastic or a non-woven fibre with a reasonable expectation of success for the benefit of effectively protecting the test strip, preventing cross contamination and enabling biodegradability of the device post use.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US20070087450) in view of Hall (US20180188247).
With respect to claim 39, Kirkegaard teaches the device of claim 1.
Kirkegaard fails to teach that the device is configured to dissolve in a fluid.
In the analogous art of providing analytical devices, Hall (US20180188247) teaches a device is configured to dissolve in a fluid (see [0005], which recites “a novel diagnostic test strip which dissolves in aqueous fluid. Consequently, the test strip may be flushed into the sewer system rather than being disposed of with biological waste”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard such that the device is configured to dissolve in a fluid as disclosed by Hall with a reasonable expectation of success for the benefit of enhancing user safety and disposal efficiency by enabling the device to dissolve in fluid thereby permitting direct flushing and eliminating the need for separate biohazard waste handling.
With respect to claim 40, Kirkegaard teaches the device of claim 1.
Kirkegaard fails to teach that the device is biodegradable.
In the analogous art of providing analytical devices, Hall (US20180188247) teaches a device is biodegradable (see [0008], which recites “With the components of the disclosed test strip dissolved, dispersed, and subject to biodegradation, there may be little or no recognizable remainder of the test strip in the sewer waste stream”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kirkegaard such that the device is biodegradable as disclosed by Hall with a reasonable expectation of success for the benefit of enhancing user test result privacy and disposal efficiency by enabling the device to dissolve in fluid.
Allowable Subject Matter
Claims 33-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to Claim 33, Kirkegaard teaches the device of claim 1 wherein the conjugate release pad comprises:
at least one horizontal fluid flow path (see Fig. 2)
Kirkegaard neither teaches nor reasonably suggests
at least one horizontal fluid flow path; and
a plurality of fabricated channels with borders, wherein the plurality of fabricated channels with borders are configured to control a speed and a direction of the sample flowing through the at least one vertical fluid flow path and the at least one horizontal fluid flow path.
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.
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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