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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/16/2026 has been entered.
Response to Amendment
Applicant amendments filed 03/16/2026 have been entered. Applicant amendments overcomes the previous claim objections in the Office Action mailed 11/28/2025, the previous claim objections are withdrawn. Applicant amendments do not overcome each and every 112(a) and 112(b) rejection set forth in the Office Action mailed 11/28/2025, please see 112 section below.
Status of Claims
Claims 1-2, 4-10, 13-20 remain pending in the application, with claims 1-2, 4-10, and 13 being examined and claims 14-20 being withdrawn pursuant to the election filed 03/23/2022.
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.
Claims 1-2, 4-10, and 13 are 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.
Claim 1 lines 9-11 recites “a detergent” where the instant specification only describes an anionic detergent which is still more specific than the currently claimed detergent. Line 10 was only amended to recite “adapted to” solubilize sample components, however it is understood that this is in reference to the overall extraction material itself. The claim is still reciting a general detergent and only has support for an anionic detergent.
It is suggested to amend lines 9-11 to recite “[[a]] an anionic detergent adapted to solubilize…” as this is what the instant specification has support for.
Claims 2, 4-10, 13 are rejected by virtue of being dependent on a rejected claim.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-10, 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 line 4 recites “deliver a predetermined volume of sample and solution into said tube” where it is unclear if the sample is the same or different from the sample described on lines 1-2, and further unclear if it is meant that the predetermined volume is both the sample and solution at the same time.
For examination, it will be interpreted that the sample is the same, and the solution is separate from the sample.
Therefore, it is suggested to amend line 4 to recite “deliver a predetermined volume of the sample and a predetermined volume of solution”
Lines 7-10 recites “an extraction material contained within said sample tube, wherein said extraction material comprises a mixture pre-loaded with a buffer material, at least one protein blocking agent, and a detergent” where this phrasing is unclear because how does the extraction material comprise a mixture pre-loaded with a buffer material, protein blocking agent, and detergent? How can a mixture be pre-loaded with those things?
For examination, it will be interpreted that the extraction material is within the sample tube, and the extraction material comprises a buffer material, at least one protein blocking agent, and a detergent.
Line 11 recites “a collected sample” where it is unclear if the collected sample is the same or different from the sample recited on line 2, and if it is the same or different from the predetermined volume of sample on line 4. For examination, it will be interpreted that they are all the same sample. It is suggested to keep the phrasing of the sample consistent such that it is clear they are all the same.
Lines 17-18 recites “a liquid solution” where it is unclear if this liquid solution is the same or different from the solution recited on line 4.
For examination it will be interpreted that they are the same.
Lines 25-26 recites “creating a sealed, integrated self-contained assembly” where it is unclear if this sealed, integrated self-contained assembly is the same or different from a single unit assay assembly described on line 1.
For examination, it will be interpreted that they are the same, and lines 25-26 should be amended to recite “creating the single unit assay assembly
Lines 28-29 recites “a visual intensity of a detectable signal in said test zone as compared to a visual intensity of a detectable signal in said control zone” where it is unclear if the detectable signal described is the same or different from the detectable signal described on line 23.
For examination it will be interpreted that they are the same.
It is suggested to amend lines 28-29 to recite “a visual intensity of [[a]] the detectable signal in said test zone as compared to a visual intensity of [[a]] the detectable signal in said control zone”
Claims 2, 4-10, and 13 are rejected by virtue of being dependent on a rejected claim.
Claim 5 recites “said particular analyte.” on line 4, there is insufficient antecedent basis for this limitation as no particular analyte has been recited prior.
Claim 1 does describe a target analyte on line 18. For examination, it will be interpreted that that particular analyte is the target analyte.
Claim 6 recites “said particular analyte” on line 4, where there is insufficient antecedent basis for this limitation, as there is no particular analyte recited prior.
It is noted that claim 1 does describe a target analyte on line 18. For examination, it will be interpreted that that particular analyte is the target 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.
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) 1-2, 4-10, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jabour (US-2014/0356978-A1) in view of Klapperich (US-2019/0025334-A1) and Reardon (US-2002/0182748-A1), and as evidenced by Parsons (US-2010/0129843-A1).
Regarding claim 1, Jabour teaches a single unit assay assembly for the analysis of a sample, said single unit self-contained assay assembly comprising:
c. a test strip comprising ([0020] see lateral flow test strips):
i. a solid backing support ([0026] see strip has additional strength that can be provided by a supplemental support such as a plastic backing upon which porous or bibulous strip components are attached), and
ii. a glass fiber membrane ([0026] see strip can be made of glass fiber filter), and
wherein said glass fiber membrane includes at least one control zone and at least one test zone having materials to produce a detectable signal in the presence of a target analyte ([0027] see one or more test zones and the various captured agents listed, [0028] see one or more optional control zones and the various capture agents listed, [0032]), and
wherein said assembly is configured such that at test completion, a user determines a test result based on a visual intensity of a detectable signal in said test zone as compared to a visual intensity of a detectable signal in said control zone by direct visual observation of said test strip without requiring an external reader, incubator, or auxiliary detection instrument ([0005] see steps of the method where there is no description of an incubator or incubation step, thus there is no incubator, [0030] see quantitative test, the extent of the difference between control zone and test zone can determine the test range detection level of an analyte, [0032] see “The signal intensities can be observed visually or measured by an electronic test instrument” thus observing visually is without use of a reader or auxiliary detection instruments).
While Jabour does describe in [0026] that the test strip can have additional strength provided by a plastic backing upon which the porous or bibulous strip components are attached, Jabour is not specific as to how the two components are attached.
In the analogous art of lateral flow assays, Klapperich teaches a lateral flow assay (Klapperich; [0003]).
Specifically, Klapperich teaches a device seen in Figure 1 that includes a sample pad 20, test line or zone 40, control line or zone 60, wick 80, and conjugate pad 90 (Klapperich; [0072]). It is further described in [0072] that the components can be mounted on a backing material that has pressure sensitive adhesive, where the backing provides structural support.
It would have been obvious to one skilled in the art to modify the test strip of Jabour such that the support and membrane are attached via an adhesive, because Klapperich teaches an adhesive is effective for attaching components of a lateral flow strip to a structural support (Klapperich; [0072]).
The limitation “adhered to said solid backing support via an adhesion material adapted to retain said membrane in a first dry storage position and a second substantially fluid submersion position wherein at least a portion of said glass fiber membrane is submerged in a liquid solution during assay activation, and wherein said glass fiber membrane is adapted to maintain adhesion following fluid submersion within said sample tube” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Jabour in view of Klapperich and the apparatus of Jabour in view of Klapperich is capable of retaining the membrane in a first dry storage position and second fluid submersion position, and maintaining adhesion following fluid submersion. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Jabour in view of Klapperich (see MPEP §2114).
See [0072] of Klapperich that describes where the lateral flow assembly has sample added using either an applicator or dipped in the sample solution.
Jabour teaches an extraction composition that has been previously dissolved in liquid that includes protein in buffered solution, where sodium phosphate is a provided example described in [0006] and an example of the protein is bovine serum albumin described in [0007]. BSA is a protein blocking agent, and it is evidenced by Parsons that sodium phosphate is a detergent (Parsons; [0084]). [0020]-[0021] of Jabour further describes where a sample extract can be mixed with a dilution buffer that allows a mobile phase to flow uniformly over the test strip, where an example of the dilution buffer is phosphate buffer or water.
[0019] of Jabour describes where extraction can take place by combining the sample with extraction composition and shaking the sample in a container. From [0006], [0007], [0020]-[0021] the container will have BSA (a protein blocking agent), sodium phosphate (a detergent), and a dilution buffer (a buffer material) in the container. However, Jabour is not specific as to the container used.
In the analogous art of assay devices that make use of chromatographic techniques in conducting specific binding assays, Reardon teaches a joint assay test device (Reardon; [0001], [0022]).
Specifically, Reardon teaches:
5a. a sample tube (reaction tube 15) having a releasable cap (cap 13) ([0026], Figure 1C);
It is seen in Figure 1C of Reardon that the reaction tube 15 (sample tube) has cap 13 (releasable cap) and line 14. [0026] of Reardon states that urine is added to line 14 to ensure proper amount of urine aliquot, and then the device 2 is placed back into the reaction tube 15 and the cap is “reapplied to reaction tube (15) and the test is allowed to run.” As such, the cap 13 of Reardon is releasable. It is further seen in Figure 1C of Reardon that there is device 1 placed inside along with liquid sample 16. [0024] of Reardon describes the device 1 as having a length of substrate material 3 upon which cellulosic membrane 4 is disposed, where cellulosic membrane has first reaction site 7 and second reaction site 8, as well as control reaction site 9.
Examiner further finds that the prior art contained a device/method/product (i.e., container) which differed from the claimed device by the substitution of component(s) (i.e., the container) with other component(s) (i.e., a sample tube with a cap), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., container of Jabour with the reaction tube and cap of Reardon), and the results of the substitution (i.e., holding liquid) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the container of reference Jabour with the reaction tube with cap of reference Reardon, since the result would have been predictable.
The limitation “said releasable cap is adapted to seal said tube, and deliver a predetermined volume of sample and solution into said tube using said releasable cap as a measuring device” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Reardon and the cap of Reardon is capable being used as a measuring device. As such, it is deemed that the claimed unit is not differentiated from device of Reardon (see MPEP §2114).
Instead of the fluid sample 16 held in the reaction tube 15 of Reardon will now be the extraction composition of Jabour. The test strip of Jabour may similarly be placed within the reaction tube 15 of Reardon, such that the test strip will be removably housed within the reaction tube, and the test strip will be removably positioned in physical proximity to the extraction composition. The reaction tube 15 of Reardon is understood to be capable of containing a solution including said extraction material. The test strip of Jabour modified with Klapperich to have adhesive attach the support and membrane and the container of Reardon teach a sealed, integrated self-contained assembly. Further, from [0026] of Reardon describing where there is a line 14 that ensures proper aliquot of urine where from Figure 1C this line appears on the outside of tube 15, and because [0026] describes where the cap 13 is reapplied to the reaction tube 15 and the test is allowed to run, where the cap 13 ensures a seal on the tube 15 that provides improved disposal of biological waste and reduces contact between the person using the kit and biological chemicals and waste within, it is understood that once the cap is reapplied to the reaction tube 15 it will not be reopened and thus results of device 2 will need to be visible from within the tube.
Please note that the limitations “said assembly is configured such that at test completion, a user determines a test result based on a visual intensity of a detectable signal in said test zone as compared to a visual intensity of a detectable signal in said control zone by direct visual observation of said test strip without requiring an external reader, incubator, or auxiliary detection instrument.” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Jabour and assembly of modified Jabour is capable of determining a test result based on visual intensity of a detectable signal in test and control zones without a reader, incubator, or auxiliary detection instrument. As such, it is deemed that the claimed unit is not differentiated from device of modified Jabour (see MPEP §2114).
Regarding claim 2, modified Jabour teaches the single unit assay assembly of Claim 1. Jabour further teaches wherein said glass fiber membrane comprises a glass fiber membrane substrate (Jabour; [0026]).
Regarding claim 4, modified Jabour teaches the single unit assay assembly of Claim 1. Jabour further teaches wherein said test strip includes two or more control zones and two or more test zones for multiple analytes (Jabour; [0027], [0028], [0031] see capture agents in different test areas can be targeted to separate receptors such as when the test strip is designed to detect multiple analytes).
Regarding claim 5, modified Jabour teaches the single unit assay assembly of Claim 1. Jabour further teaches wherein a greater visual intensity of the detectable signal in said test zone at test completion as compared to the visual intensity of the detectable signal in said control zone at test completion indicates a negative result for said particular analyte (Jabour; [0028] see control zone can be involved in an independent reaction that gives visual indicators for comparison to the test zone, [0030] see extent of the difference between control and test zone can determine the test range detection level of analyte, [0032] see intensities of the detectable signal in first and second test areas are measured to determine a result, and where during inhibition style test the intensity of signals are inversely related to concentration of analyte in the sample).
Please note the limitations of claim 5 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Jabour and the test and control zones of Jabour are capable of determining a test result depending on comparison of visual intensities of the detectable signals in test and control zones. As such, it is deemed that the claimed test and control zones are not differentiated from the test and control zones of Jabour (see MPEP §2114).
Regarding claim 6, modified Jabour teaches the single unit assay assembly of Claim 1. Jabour further teaches wherein a greater visual intensity of the detectable signal in said control zone at test completion compared to the visual intensity of the detectable signal in said test zone at test completion indicates a positive result for said particular analyte (Jabour; [0028], [0030], [0032]).
Please note the limitations of claim 6 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Jabour and the test and control zones of Jabour are capable of determining a test result depending on comparison of visual intensities of the detectable signals in test and control zones. As such, it is deemed that the claimed test and control zones are not differentiated from the test and control zones of Jabour (see MPEP §2114).
Regarding claim 7, modified Jabour teaches the single unit assay assembly of Claim 1. Reardon further teaches wherein said sample tube has said releasable cap (Reardon; [0026] see cap 13 is reapplied to reaction tube 15).
The limitations of claim 7 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Reardon and the cap of Reardon is capable of delivering a predetermined volume of sample to the tube. As such, it is deemed that the claimed cap is not differentiated from the cap of Reardon (see MPEP §2114).
Regarding claim 8, modified Jabour teaches the single unit assay assembly of Claim 7.
The limitations of claim 8 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Reardon and the cap of Reardon is capable of delivering a grain sample to the tube. As such, it is deemed that the claimed cap is not differentiated from the cap of Reardon (see MPEP §2114).
Regarding claim 9, modified Jabour teaches the single unit assay assembly of Claim 1. Reardon further teaches wherein said sample tube has said releasable cap (Reardon; [0026] see cap 13 is reapplied to the reaction tube).
The limitations of claim 9 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Reardon and the cap of Reardon is capable of being releasable and delivering a predetermined volume of solution to the tube. As such, it is deemed that the claimed cap is not differentiated from the cap of Reardon (see MPEP §2114).
Regarding claim 10, modified Jabour teaches the single unit assay assembly of Claim 1. Jabour further teaches wherein said single unit assay being adapted to screen for an aflatoxin (Jabour; [0005], [0027]).
Please note the limitations of claim 10 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Jabour and the apparatus of modified Jabour is capable of screening for an aflatoxin. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Jabour (see MPEP §2114).
Regarding claim 13, modified Jabour teaches the single unit assay assembly of Claim 1. Jabour further teaches wherein said single unit assay assembly being adapted to develop said analysis of said sample without incubation (Jabour; [0005] describes steps including: extracting the analyte from the sample to form an extract, contacting the extract with a labeled receptor to form a mobile phase, contact the mobile phase with a first test area, and measuring the intensity of the detectable signal. There is no description of an incubation step).
Please note the limitations of claim 13 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Jabour and the apparatus of modified Jabour is capable of developing said analysis of said sample without incubation. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Jabour (see MPEP §2114).
Response to Arguments
Applicant’s arguments filed 03/16/2026 have been fully considered but are not persuasive.
Applicant argues on page 6 that all claims now appear to be patentably distinguished over the cited references and allowance is requested.
It is respectfully noted that the amended claim language is still not supported in the specification, and there is unclear claim language. Please see 112 section supra.
The rejections under 35 USC 103 in view of Jabour, Klapperich, Reardon, and Parsons as evidence have been modified to address amendments to the claims.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Noffsinger (US-5663044-A) teaches where a filter paper carrier matrix, which may also be matted glass fibers, is affixed to a transparent polystyrene film and is secured using double faced adhesive where the matrix is immersed in a test sample and removed (Noffsinger; column 3 lines 62-63, column 10 lines 21-26, column 11 lines 13-25).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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