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 .
Response to Amendment
Applicant amendments filed 01/16/2026 have been entered. Applicant amendments overcomes the previous 112(b) rejection set forth in the Office Action mailed 10/16/2025, the previous 112(b) rejection is withdrawn.
Status of Claims
Claims 1-12, 14-15, 17-20, 23 remain pending in the application, with claims 1-3, 14-15, 17-20 being examined and claims 4-12 and 23 being withdrawn pursuant to the election filed 09/11/2025.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (US-6284550-B1) in view of Delahunt (US-2015/0111216-A1) and Arai (US-4540670-A).
Regarding claim 1, Carroll teaches a reaction test strip (test strip 10), comprising (column 3 lines 41-45, Figures 1-2, 4):
a base film layer structure with water absorbency, comprising a detection layer (membrane 40) (column 3 line 57, Figures 1-2, 4); and
a detection reagent, wherein the detection reagent is distributed in the detection layer (40), and is configured to change a color of the base film layer structure after reacting with a sample to be detected, the detection reagent is used to detect a content of fat in the sample to be detected (column 3 lines 51-55 see whole blood may be tested for other analytes such as LDH/HDL cholesterol, column 3 lines 65-67 see analyzing the color change in the membrane 40, column 7 lines 29-32 see membrane 40 holds a reagent and conditioning solution which together produces a color change in membrane 40 in response to the analyte of interest);
the base film layer structure comprises a multi-layer film structure (column 3 lines 55-57 see test strip 10 generally comprises a spreading layer 20, separating layer 30, and preconditioned membrane 40, where these three layers form the base film layer structure, Figure 1),
the multi-layer film structure comprises a water-absorbing layer (spreading screen 20) and the detection layer (40) which are stacked with each other (column 6 lines 13-17, Figures 1-2, 4), and
The limitation “the reaction test strip is used in cooperation with a detection chip and is accommodated in a detection groove of the detection chip, and the detection layer with less saturated water absorption is in contact with a bottom surface of the detection groove.” 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 Carroll and the apparatus of Carroll is capable of being used in cooperation with a detection chip. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Carroll (see MPEP §2114).
Layers 20, 30, and 40 make up the base film layer structure, where layer 40 (detection layer) will be capable of being in contact with a bottom surface of a detection groove.
Further, please note that the detection chip is not positively recited, and is therefore not a part of the claimed device. Presently, while not required, the lower support layer 13 of Carroll may be considered a detection chip as it has a reaction viewing port 18 that allows sample to be viewed (Carroll; column 4 lines 40-45).
Carroll does describe where the membrane 40 may be a polysulfone membrane, however Carroll does not teach wherein a material of the detection layer comprises cotton fiber or glass fiber.
In the analogous art of absorbent structures with an interior hydrophilic region, Delahunt teaches an absorbent structure that includes one or more layers of a porous material that can be glass fiber or polysulfone (Delahunt; [0066], [0070]).
Examiner further finds that the prior art contained a device/method/product (i.e., a membrane) which differed from the claimed device by the substitution of component(s) (i.e., material of the membrane being polysulfone) with other component(s) (i.e., material of the membrane being glass fibers), 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., polysulfone for glass fibers), and the results of the substitution (i.e., absorbing 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 polysulfone of reference Carroll with glass fibers of reference Delahunt, since the result would have been predictable.
Please note that [0070] of Delahunt also describes where the material can also include cotton.
Carroll does describe where a preferred screen 20 is a polyester medical screen (Carroll; column 6 lines 33-35), however Carroll does not teach a saturated water absorption of the detection layer is less than a saturated water absorption of the water-absorbing layer.
In the analogous art of multilayer analysis elements, Arai teaches a spreading layer (Arai; abstract).
Specifically, Arai teaches where a spreading layer can be made with natural fibers such as cotton or synthetic fibers such as polyesters (Arai; column 9 lines 58-65). A spreading layer refers to a layer having the capability of spreading al liquid sample which meters and distributes a definite volume of an applied liquid sample to a separate reagent layer (Arai; column 4 lines 19-23).
Examiner further finds that the prior art contained a device/method/product (i.e., a spreading screen) which differed from the claimed device by the substitution of component(s) (i.e., material of the spreading screen being polyester) with other component(s) (i.e., material of the spreading screen being natural fibers such as cotton), 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., polyester for cotton), and the results of the substitution (i.e., spreading 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 polyester of reference Carroll with cotton of reference Arai, since the result would have been predictable.
While Carroll in view of Arai does not address the relative saturated water absorption of the detection layer in comparison to that of the water-absorbing layer, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the glass fiber material of the detection layer and the cotton material of the spreading screen are different, the prior art is considered to have the same properties with respect to saturated water absorption as that is claimed. MPEP § 2112.01 (I-IV).
Please see [0087] of the instant specification which describes the water-absorbing layer “may include glass fiber, cotton fiber, composite fiber of glass fiber and cotton fiber, or the like, for example, cotton wool fiber or bonded glass fiber, or may also include other suitable water-absorbing materials, for example, a material having water absorbency of 25 mg/cm2 to 100 mg/cm2.”
Regarding claim 2, modified Carroll teaches the reaction test strip according to claim 1. Carroll further teaches wherein the detection reagent is used to detect the content of fat in the sample to be detected, and an initial color of the base film layer structure under action of the detection reagent is white (Carroll; column 7 lines 28-30 see membrane 40 should be optically white and hold reagent and conditioning solution that produces a color change in the membrane 40 in response to the analyte of interest).
The material of the membrane 40 has been modified by Delahunt to be glass fiber, where the glass fiber will similarly be optically white.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (US-6284550-B1), Delahunt (US-2015/0111216-A1), and Arai (US-4540670-A), and in further view of translated Hiroshi (JP-2000281650-A).
Regarding claim 3, modified Carroll teaches the reaction strip according to claim 2. Carroll does not teach wherein after the detection reagent used for detecting the content of fat in the sample to be detected reacts with the sample to be detected, a color of the base film layer structure changes to blue.
In the same problem solving area of detecting cholesterol concentration, Hiroshi teaches where first free and ester cholesterol in a sample are dissociated into lipid and protein by action of lipoprotein lipase and surfactant and then by the action of cholesterol esterase, where the produced cholesterol and endogenous cholesterol generate hydrogen peroxide by the action of cholesterol oxidase, where the hydrogen peroxide oxidizes the leuco dye by peroxidase and develops a blue color (Hiroshi; [0054]).
Carroll is silent with regards to specific reagents used for detecting cholesterol, therefore, it would have been necessary and thus obvious to look to the prior art for conventional reagents used to detect cholesterol. Hiroshi provides this conventional teaching showing that it is known in the art to use lipoprotein lipase, surfactant, cholesterol esterase, cholesterol oxidase to generate hydrogen peroxide which then oxidizes a leuco dye by peroxidase to develop a blue color. Therefore, it would have been obvious to one having ordinary skill in the art to use reagents as taught by Hiroshi because Hiroshi teaches that these reagents are effective for detecting the concentration of cholesterol in the sample.
Claim(s) 14-15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (US-6284550-B1), Delahunt (US-2015/0111216-A1), and Arai (US-4540670-A), and in further view of Chen (EP-0388782-A1).
Regarding claim 14, modified Carroll teaches the reaction test strip according to claim 1. Carroll further teaches wherein the multi-layer film structure further comprises a hydrophilic layer (separating layer 30) (Carroll; column 6 lines 41-45, Figures 1-2, 4),
the water-absorbing layer (20), the hydrophilic layer (30), and the detection layer (40) are stacked in sequence (Carroll; Figures 1-2, 4), and
Carroll does teach where a preferred fabric for separating layer 30 is polyester, cotton, or a 50/50 polyester-cotton blend (Carroll; column 6 lines 63-65), however Carroll does not teach a saturated water absorption of the hydrophilic layer is less than the saturated water absorption of the detection layer.
In the analogous art of multilayer analysis films for analyzing liquid samples, Chen teaches a filter layer (Chen; page 2 line 1, page 4 line 40).
Specifically, Chen teaches where a filter layer 11 separates formed components of the liquid sample such as whole blood sample, and allow the passage of only the fluid part to the underlying layers (Chen; page 4 lines 42-44). The filter layer is a sheet like filter material made of synthetic or natural fibers and glass fibers, where a specific example has the filter membrane being a hydrophilic nylon membrane (Chen; page 4 lines 44-45, page 5 lines 48-50).
Examiner further finds that the prior art contained a device/method/product (i.e., a separating layer) which differed from the claimed device by the substitution of component(s) (i.e., material of the separating layer being cotton) with other component(s) (i.e., material of the separating layer being nylon), 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., cotton for nylon), and the results of the substitution (i.e., separating 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 cotton of reference Carroll with nylon of reference Chen, since the result would have been predictable.
While Carroll in view of Chen does not address the relative saturated water absorption of the detection layer in comparison to that of the hydrophilic layer, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the glass fiber material of the detection layer and the nylon material of the separating layer are different, the prior art is considered to have the same properties with respect to saturated water absorption as that is claimed. MPEP § 2112.01 (I-IV).
Please see [0087] of the instant specification which describes the material of the hydrophilic layer may include nylon.
Regarding claim 15, modified Carroll teaches the reaction test strip according to claim 14. Carroll further teaches wherein a total saturated water absorption of the water-absorbing layer, the hydrophilic layer, and the detection layer ranges from 10 µL to 50 µL (Carroll; column 8 lines 28-32 see the invention can work well with a sample volume from 5 to 50 microliters of sample),
While modified Carroll in view of Delahunt and Chen does not address the saturated water absorption percentages of the water-absorbing layer nor detection layer, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the glass fiber material of the detection layer and the nylon material of the water-absorbing layer are different, the prior art is considered to have the same properties with respect to saturated water absorption as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 17, modified Carroll teaches the reaction test strip according to claim 14. Carroll further teaches wherein a planar shape of the water-absorbing layer (20), a planar shape of the hydrophilic layer (30), and a planar shape of the detection layer (30) are identical (Carroll; see Figure 2 where all the layers are a rectangle),
a size of the planar shape of the water-absorbing layer (20) is identical to a size of the planar shape of the hydrophilic layer (30) (Carroll; Figure 4), and
a size of the planar shape of the detection layer (40) is smaller than the size of the planar shape of the water-absorbing layer (20) and is smaller than the size of the planar shape of the hydrophilic layer (30) (Carroll; Figure 4).
Regarding claim 18, modified Carroll teaches the reaction test stirp according to claim 17.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to determine, through routine experimentation, the optimum single-edge size ratio of the planar shape of the detection layer to the planar shape of the water-absorbing layer, and the single-edge size ratio of the planar shape of the detection layer to the planar shape of the hydrophilic layer to a range of 0.8:1 to 0.95:1 which would allow for the separating layer to overlap the reaction membrane 40 and meet the lower mylar strip 13 at the glued surface to aid further in securing the separating layer 30 to the rest of the device (Carroll; column 5 lines 28-33) (MPEP § 2144.05 (II)).
The size/proportion of the membrane 40 is seen in Figure 4 to be smaller than the spreading layer 20 and separating layer 30, and as described above the membrane 40 will be changed to have a single-edge size ratio of the planar shape in a range of 0.8:1 to 0.95:1 in comparison to the spreading layer 20 and separating layer 30. Further, where when the only difference between the prior art and the claims is the recitation of relative dimensions of the claimed device, and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (see MPEP 2144.04 IV.A.).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (US-6284550-B1), Delahunt (US-2015/0111216-A1), Arai (US-4540670-A), and Chen (EP-0388782-A1), and in further view of Przybylowicz (US-3992158-A).
Regarding claim 19, modified Carroll teaches the reaction test strip according to claim 14. Carroll describes where the sample to be tested is whole blood, where the spreading screen receives and uniformly distributes the sample, and the membrane 40 and separating layer 30 are treated with reagents and/or conditioning solutions that removes red blood cells from the plasma so that red blood cells don’t interfere with the color reaction (Carroll; column 3 lines 57-65, column 6 lines 13-15). However, Carroll does not teach:
wherein a total thickness of the water-absorbing layer, the hydrophilic layer, and the detection layer ranges from 0.1 mm to 0.5 mm,
a thickness of the water-absorbing layer ranges from 0.1 mm to 0.4 mm,
a thickness of the hydrophilic layer ranges from 0.5 mm to 0.2 mm, and
a thickness of the detection layer ranges from 0.05 mm to 0.2 mm.
In the analogous art of integral analytical elements capable of use in the analysis of liquids such as blood, Przybylowicz teaches an element with a spreading layer and reagent layer (Przybylowicz; abstract, column 8 line 67).
Specifically, Przybylowicz teaches where a reagent layer has a thickness of about 10 to about 100 microns, where if there is a comparatively large amount of interactive material, it can be desirable to use slightly thicker reagent layers (Przybylowicz; column 9 lines 47-55). Przybylowicz further teaches a spreading layer that has a thickness of about 50 to about 300 microns, where the thickness of the spreading layer is variable and depends on the intended sample volume (Przybylowicz; column 10 lines 19-29). As seen in Figure 1, there is a support 10 with a reagent layer 12, reflecting layer 14, filtering layer 16, and sample spreading layer 18 (Przybylowicz; column 13 lines 38-45). In example 2 described in column 16 lines 8-12, a multilayered analytical element has a reagent layer formed, and then a filter material is laminated to it that has a thickness of 180 microns. It is further described by column 13 lines 14-16 that for whole blood, it can be applied directly to the element and the blood cells are filtered out through the action of a filtering layer so that the cells will not interfere with analysis. Additionally, in example 1 described in column 15 the test element has a reagent layer, a filtering and light reflecting layer, and a spreading layer, where column 15 lines 60-56 describes that the filter layer prevents blood cells from reaching the reagent layer.
It would have been obvious to one skilled in the art to modify the thickness of the spreading screen of Carroll to be about 50 to about 300 microns, the thickness of the separating layer of Carroll to be 180 microns, and the thickness of the membrane of Carrol to about 10 to about 100 microns as taught by Przybylowicz because Przybylowicz teaches that the thickness of a spreading layer is variable and depends on the intended sample volume, that the thickness of a reagent layer is variable depending on the amount of interactive material, and that a filtering layer with a thickness of 180 is an effective thickness for a filtering layer (Przybylowicz; column 9 lines 47-55, column 10 lines 19-29, column 16 lines 8-12).
Therefore, the total thickness will therefore be in the range of 240 microns to 580 microns.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (US-6284550-B1), Delahunt (US-2015/0111216-A1), and Arai (US-4540670-A), and in further view of Tatebe (US-2011/0062616-A1).
Regarding claim 20, modified Carroll teaches the reaction test strip according to claim 1. Carroll does not teach wherein the base film layer structure is a rhombus shape.
In the analogous art of test papers including a porous membrane carrying a reagent capable of reacting with a specified component of a sample to result in coloring, Tatebe teaches where the test paper can have shapes such as rectangular and rhombus (Tatebe; abstract, [0062]).
Examiner further finds that the prior art contained a device/method/product (i.e., membrane) which differed from the claimed device by the substitution of component(s) (i.e., rectangular shape of the membrane) with other component(s) (i.e., a rhombus shape of the membrane), 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., membrane having a rhombus shape instead of rectangular), and the results of the substitution (i.e., changing color in response to an analyte in a sample) 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 rectangular shape of the membrane of reference Carroll with a rhombus shape of reference Tatebe, since the result would have been predictable.
While Tatebe does not specifically describe a ratio of a long diagonal to a short diagonal ranging from 1:1 to 2:1, an acute inner angle ranging from 40° to 90°, the long diagonal being in the range of 1 mm to 20 mm and the short diagonal being in the range of 1 mm to 20 mm, it has been found 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 (see MPEP 2144.04 IV.A.).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hyun (US-2019/0310270-A1) teaches where a lower substrate 400 is coupled to an upper cover 200 and includes a recessed part 410 and lower opening window 420, where a measurement layer 300 is disposed on the recessed part 410 (Hyun; [0040], [0061], [0063], Figure 1).
Translated Zou (CN-110082517-A) teaches a reagent strip that includes a test strip and sampling ports, where a test strip slot for placing a test strip is provided with a lower clamping plate and fixing protrusions, and the fixing protrusions are located at both ends along the length direction of the test paper such that they hinder flow between different sample dispensing components as well as prevent test paper from deforming when it is wetted (Zou; [0015], [0028], [0030]).
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 9, filed 01/16/2026, with respect to the rejection(s) of claim(s) 1-2 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Carroll (US-6284550-B1) in view of Delahunt (US-2015/0111216-A1) and Arai (US-4540670-A).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Please note that with regards to technical feature (1) that “a material of a detection layer comprises cotton fiber or glass fiber” is met with Delahunt.
In response to applicant's argument that Carroll does not teach that the reaction test strip is used in cooperation with a detection chip and is accommodated in a detection groove of the detection chip, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Further, as noted above, the detection chip is not positively recited and is thus not a part of the claimed device.
With regards to applicant arguments that Carroll does not teach distinguishing technical feature (2), please note that Arai is used to meet the limitations regarding water absorption.
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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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759