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
The Amendment filed 08/07/2026 has been entered. Claims 1-21 remain pending in the application. Claims 18-19 are withdrawn. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 05/15/2026. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claim 6 is objected to because of the following informalities: In claim 6, line 2, “f” should read “of”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-6, 11-17, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barbedette et al. (WO 2021175909 A2; cited in the IDS filed 09/14/2023; see machine translation).
Regarding claim 1, Barbedette teaches a urine reagent containing device (Figs. 8-13,19, 24-28, 30 and [179]-[185]; interpreted as comprising housing 54, test strips 56, and cover 72; [150]-[151] teaches the test strips contain reagents for urine) for a urine analysis device cartridge (Figs. 8-13,19, 24-28, 30; rotatable holder 44), the urine reagent containing device comprising:
a carrier assembly (Figs. 24-26 and [221]-[224], band or separator 158; see below annotated Fig. 25) arranged to define a plurality of open chambers spaced next to one another (see below annotated Fig. 25, adjacent housings 54), wherein two adjacent open chambers (see below annotated Fig. 25, adjacent housings 54) are attached to one another at a rim portion of each open chamber by a bridge portion of the carrier assembly (see below annotated Fig. 25, adjacent housings 54 are attached at a rim portion, i.e. rim of the openings of the adjacent housings 54, by a bridge portion, i.e. portion including the structures between and around the adjacent open chambers that includes a different housing 54 and walls around the housing such as walls 54a,54b), wherein the bridge portion and the two adjacent open chambers define therebetween a gap (see below annotated Fig. 25, the bridge portion between two adjacent open chambers define therebetween a gap, i.e. one of the housings 54), the gap being a space that is free of material of the carrier assembly (see below annotated Fig. 25, the gap, i.e. one of the housings 54 between two adjacent housings 54, includes a space free of material of separator 158) and that is delimited at least in part by the bridge portion and by mutually facing walls of the two adjacent open chambers (see below annotated Fig. 25, the gap, i.e. one of the housings 54 between two adjacent housings 54, is delimited by a portion of bridge portion, i.e. the upper wall at label 58a, and the facing of walls of 54a,54b);
a plurality of lid assemblies (Figs. 9,11,24 and [179], interpreted as the cover 72 that covers each housing 54; therefore each housing has a lid assembly) arranged to cover the plurality of open chambers (Figs. 9,11,24 and [179]), each open chamber of the carrier assembly and each lid assembly defining a closed chamber (Figs. 9,11,24 and [179]); and
a urine reagent in the closed chamber (Figs. 9,11,24 and [179] teaches test strips with reagents are within each closed housing 54; [150]-[151] teaches the test strips contain reagents for urine), wherein the urine reagent containing device is flexible ([28], [53], [221]).
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Annotated Fig. 25 of Barbedette.
Regarding claim 4, Barbedette further teaches the urine reagent containing device of claim 1, comprising more than 20 closed chambers (Figs. 24, 27 and [54] teaches more than 20 closed housings 54).
Regarding claim 5, Barbedette further teaches wherein the urine reagent containing device is configured to be bent in a right cylinder shape (Figs. 24,27 and [53],[55],[221] teaches the separator 158 is flexible so as to be windable in a circle or right cylinder shape as shown in Fig. 24), wherein a maximum diameter of the right cylinder shape is between 3 cm and 10 cm (Fig. 9 and [163] teaches the outer diameter D44 of the rotary support is between 30 mm and 130 mm, preferably 60 mm, and therefore the housing 54, test strips 56, and cover 72, has a maximum diameter of between 3 cm and 10 cm, e.g. 6 cm).
Regarding claim 6, Barbedette further teaches wherein the lid assemblies are formed by a single lid assembly sheet covering at least two open chambers of the plurality of open chambers (Figs. 9,11,24 and [179]-[180], teaches cover 72 is a continuous film that covers at least two housing 54), wherein the single lid assembly sheet is attached at least to the bridge portion of the carrier assembly (Fig. 24 and [180] teaches the cover 72 is attached to the outer wall to cover the housings 54, therefore is attached to at least the bridge portion between the housings 54).
Regarding claim 11, Barbedette further teaches wherein the carrier assembly is shaped as a strip extending along a longitudinal axis (Figs. 24-27 teaches the separator 158 is shaped as a strip extending in a longitudinal axis L) and the open chamber (housings 54) extends along the width of the strip, perpendicular to the longitudinal axis (Figs. 24-27).
Regarding claim 12, Barbedette further teaches wherein the lid assembly (cover 72) is radially inward in a bent configuration of the reagent containing device (Fig. 24).
Regarding claim 13, Barbedette further teaches wherein the urine reagent containing device is configured to be manufactured in a flat configuration along a longitudinal axis and afterwards bent in a circular shape (Figs. 24-27 and [221] teaches the separator is flexible that is made in the form of a strip intended to be wound in receptacle 156 in a circular shape).
Regarding claim 14, Barbedette further teaches the urine reagent containing device of claim 1, comprising between 50 and 100 closed chambers (Figs. 24, 27 and [54] the separator including at least 50 strips; therefore, the taught range is sufficiently specific to teach the device comprising at between 50 and 100 closed chambers that includes the strips).
Regarding claim 15, Barbedette teaches a cartridge (Figs. 19, 24, rotary support 44) comprising the urine reagent containing device of claim 1 (Figs. 19, 24 comprises the urine reagent containing device of claim 1 as discussed above, i.e. the rotary support comprises the separator 158, housing 54, test strips 56, and cover 72), wherein the urine reagent containing device is arranged in a right circular cylinder shape, extending along at least 80% of a circle (Fig. 24).
Regarding claim 16, Barbedette further teaches wherein the lid assembly is arranged radially innermost (Fig. 24 teaches the cover 72 is arranged radially innermost).
Regarding claim 17, Barbedette teaches a urine analysis device (Figs. 1-4 and abstract, urinalysis device 12) for urine analysis (abstract) comprising:
the cartridge of claim 15 (see above claims 1 and 15; Figs. 19,24 teaches the urinalysis device 12 includes rotary support 44 with separator 158, housing 54, test strips 56, and cover 72);
a station (Figs. 2, 18-19, housing 22) configured to be positioned on a wall of a toilet bowl (Figs. 1-2), the station including
a case (Fig. 19, faces 25,26 of housing 22) comprising an annular housing (152) in which the cartridge is at least partially received and is rotatably mounted therein around a rotation axis ([157]-[160]),
an injector (Fig. 29, injector 46), configured to pierce the lid assembly of the urine reagent containing device of the cartridge and to inject urine onto the urine reagent ([232]), and
an analyzer (Figs. 8,20 and [283], analysis system 50; Fig. 30 and [223], light sources 176,178, optical sensor 99), configured to emit and receive light ([223],[283]), in relation with a closed chamber of the cartridge to detect a change of properties of the urine reagent ([223],[283]).
Regarding claim 21, Barbedette further teaches wherein the carrier assembly is shaped as a strip extending along a longitudinal axis (Figs. 25-27), the plurality of open chambers being spaced along the longitudinal axis (Figs. 25-27), and wherein a distance between two adjacent open chambers along the longitudinal axis is equal to or less than a width of an open chamber along the longitudinal axis (see above annotated Fig. 25 regarding claim 1; the distance between the adjacent open chambers along axis L is equal to the width of the housing 54 between the adjacent open chambers).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Barbedette as applied to claim 1 above, and further in view of List et al. (US 20120063970 A1).
Regarding claim 2, Barbedette further teaches wherein each open chamber (Figs. 24,26,30, housings 54) includes at least one aperture located at a bottom of the open chamber (holes 160).
Barbedette fails to teach: the urine reagent containing device further comprising a plurality of independent closing assemblies, wherein the at least one aperture of an open chamber is covered by a closing assembly of the plurality of independent closing assemblies extending at least partially over the gap, the plurality of closing assemblies being independent from one another, wherein each open chamber, each lid assembly and each closing assembly define a closed chamber.
Barbedette teaches a cover hermetically isolating the test strip from the external environment and neighboring housing, and therefore protecting the test strip reagents from possible contamination ([179]). Barbedette teaches a cover or seal to cover each housing can be a continuous film or can individually encapsulate each test strip ([180],[183]). Barbedette teaches the cover or seal is transparent to allow for performing colorimetric analysis through the seal ([185]). Barbedette teaches apertures or openings for optical measurement ([223]).
List teaches an analytical magazine comprising a plurality of chambers (abstract). List teaches the individual chambers are sealed by corresponding seals to ensure sterility ([0027]). List teaches plurality of openings of the chambers can be sealed individually ([0050]). List teaches if at least one measurement opening is provided, the at least one measurement opening can be sealed and be transparent to detection light and/or excitation light ([0051]). List teaches chambers are protected against ambient influences, in particular moisture, by sealing the openings; wherein measurement openings are sealed ([0172]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the urine reagent containing device comprising at least one aperture of Barbedette to incorporate Barbedette’s teachings of hermetically and individually sealing the chambers with a transparent cover, and the apertures are for optical measurement ([179], [180], [183], [185], [223]) and List’s teachings of individually sealing measurement openings of chambers ([0027],[0050]-[0051],[0172]) to provide: the urine reagent containing device further comprising a plurality of independent closing assemblies, wherein the at least one aperture of an open chamber is covered by a closing assembly of the plurality of independent closing assemblies extending at least partially over the gap, the plurality of closing assemblies being independent from one another, wherein each open chamber, each lid assembly and each closing assembly define a closed chamber. Doing so would have a reasonable expectation of successfully improving hermetically sealing and protection of the chamber from ambient influences while allowing for optical measurement of through the at least one aperture.
Regarding claim 3, modified Barbedette fails to teach: wherein the closing assembly is a closing assembly sheet, cut at a level of the gaps.
Barbedette teaches a cover hermetically isolating the test strip from the external environment and neighboring housing, and therefore protecting the test strip reagents from possible contamination ([179]). Barbedette teaches a cover or seal to cover each housing can be a continuous film or can individually encapsulate each test strip ([180],[183]). Barbedette teaches apertures or openings for optical measurement ([223]).
List teaches the individual chambers are sealed by corresponding seals to ensure sterility ([0027]). List teaches plurality of openings of the chambers can be sealed individually ([0050]). List teaches sealing films are known in the art ([0053]). List teaches if at least one measurement opening is provided, the at least one measurement opening can be sealed and be transparent to detection light and/or excitation light ([0051]). List teaches chambers are protected against ambient influences, in particular moisture, by sealing the openings; wherein measurement openings are sealed ([0172]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the urine reagent containing device comprising at least one aperture of Barbedette to incorporate Barbedette’s teachings of hermetically and individually sealing the chambers with a transparent cover, and the apertures are for optical measurement ([179], [180], [183], [185], [223]) and List’s teachings of individually sealing measurement openings of chambers with films ([0027],[0050]-[0051],[0053],[0172]) to provide: wherein the closing assembly is a closing assembly sheet, cut at a level of the gaps. Doing so would have a reasonable expectation of successfully improving hermetically sealing and protection of the individual chamber from ambient influences by providing individual closing assemblies cut at the level of the gaps.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Barbedette as applied to claim 1 above, and further in view of Harding et al. (US 20050233363 A1).
Regarding claim 7, Barbedette fails to teach: wherein a geometry of the carrier assembly, when laid out in a flat configuration, only includes draft angles, such that the carrier assembly is formable by molding with a mold moving along a single direction or by embossing along a single direction.
Harding teaches an array comprising reaction chambers and detecting signals from the reaction chambers (abstract). Harding teaches a plurality of wells includes draft angles, where the draft angle provides benefits including increased ease of manufacturing and minimizing shadowing ([0214]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier assembly of Barbedette to incorporate Harding’s teachings of chambers or wells with draft angles ([0214]) to provide: wherein a geometry of the carrier assembly, when laid out in a flat configuration, only includes draft angles, such that the carrier assembly is formable by molding with a mold moving along a single direction or by embossing along a single direction. Doing so would have a reasonable expectation of successfully improving increased ease of manufacturing and minimizing shadowing of the carrier assembly as taught by Harding ([0214]).
Note that “…such that the carrier assembly is formable by molding with a mold moving along a single direction or by embossing along a single direction” is interpreted as a product-by-process limitation (MPEP 2113). MPEP 2113 states even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. As discussed above, modified Barbedette provides “a geometry of the carrier assembly, when laid out in a flat configuration, only includes draft angles”, therefore, the product is the same as claimed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Barbedette as applied to claim 1 above, and further in view of Audino et al. (US 20020083686 A1).
Regarding claim 8, Barbedette further teaches wherein: the carrier assembly is made of at least two layers (Figs. 8-13,19, 24-28, 30 and [179]-[185]; interpreted as the layers of the housing 54 and cover 72), one of said layers being a moisture-proof layer ([179] teaches the cover hermetically isolates the test strips of each housing from the external environment; therefore, the cover is interpreted as being a moisture-proof layer since it hermetically seals the housings); and the closed chamber is moisture proof ([179] teaches the cover hermetically isolates the test strips of each housing from the external environment; therefore, the closed housings are moisture proof from the external environment).
Barbedette fails to teach: the lid assembly is made of at least two layers, one of said layers comprising at least a moisture-proof layer.
Audino teaches an apparatus, i.e. lid assembly, for sealing fluid containing vessels comprising a sheet of elastomer forming a sealing member disposed on a plate containing a plurality of wells; wherein the apparatus seals the wells of a multiwell plate, and has aspects of being vapor resistant, heat sealable, and able to be manipulated by automated analytical equipment (abstract). Audino teaches a need for chambers (i.e. wells) to be properly sealed to avoid contamination ([0006]), and known problems of sealing tapes and mats of not being designed for use in automated assay processes ([0009]). Audino teaches a need for a cover capable of effectively sealing wells ([0009]). Audino teaches an embodiment where the apparatus comprises a laminate of multiple layers comprising an elastomer sheet 10, a first polymer binder 21, a metallic foil 18, and a second polymer layer 22 ([0024]; Fig. 3), i.e. at least two layers. Audino teaches a metal foil acts as an effective vapor barrier to avoid gas diffusion into or out of the well ([0023]), and an elastomer-foil laminate can keep reagents in the well while keeping water out ([0023]). Audino teaches the embodiment (Fig. 3) allows for proper bonding of the layers and welding of the laminated structure to the plate ([0024]). Audino teaches an additional layer can be included to improve binding and sealing of the apparatus while avoiding deformation of the plate ([0025]). Audino teaches a metallic foil layer could also be sandwiched between the elastomer and thermoplastic layers to provide possibly a better vapor barrier ([0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lid assembly of Barbedette to incorporate Audino’s teachings of lid assembly comprising a laminate of multiple layers and layers to keep water out ([0006],[0009],[0023]-[0025],[0028]; Fig. 3) to provide: the lid assembly is made of at least two layers, one of said layers comprising at least a moisture-proof layer. Doing so would have a reasonable expectation of successfully improving hermetic sealing of the chambers and improving binding and sealing of the lid assembly to the chambers while avoiding deformation of the chambers (Audino, [0023]-[0025],[0028]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Barbedette and List as applied to claim 2 above, and further in view of Audino et al. (US 20020083686 A1).
Regarding claim 9, Barbedette further teaches wherein: the carrier assembly is made of at least two layers (Figs. 8-13,19, 24-28, 30 and [179]-[185]; interpreted as the layers of the housing 54 and cover 72), one of said layers being a moisture-proof layer ([179] teaches the cover hermetically isolates the test strips of each housing from the external environment; therefore, the cover is interpreted as being a moisture-proof layer since it hermetically seals the housings); and the closed chamber is moisture proof ([179] teaches the cover hermetically isolates the test strips of each housing from the external environment; therefore, the closed housings are moisture proof from the external environment).
Modified Barbedette fails to teach: the lid assembly is made of at least two layers, one of said layers comprising at least a moisture-proof layer; and wherein the carrier assembly comprises a first additional liaison layer and the closing assembly comprises a second additional liaison layer, the first and the second additional liaison layers facing each other.
Audino teaches an apparatus, i.e. lid assembly, for sealing fluid containing vessels comprising a sheet of elastomer forming a sealing member disposed on a plate containing a plurality of wells; wherein the apparatus seals the wells of a multiwell plate, and has aspects of being vapor resistant, heat sealable, and able to be manipulated by automated analytical equipment (abstract). Audino teaches a need for chambers (i.e. wells) to be properly sealed to avoid contamination ([0006]), and known problems of sealing tapes and mats of not being designed for use in automated assay processes ([0009]). Audino teaches a need for a cover capable of effectively sealing wells ([0009]). Audino teaches an embodiment where the apparatus comprises a laminate of multiple layers comprising an elastomer sheet 10, a first polymer binder 21, a metallic foil 18, and a second polymer layer 22 ([0024]; Fig. 3), i.e. at least two layers. Audino teaches a metal foil acts as an effective vapor barrier to avoid gas diffusion into or out of the well ([0023]), and an elastomer-foil laminate can keep reagents in the well while keeping water out ([0023]). Audino teaches the embodiment (Fig. 3) allows for proper bonding of the layers and welding of the laminated structure to the plate ([0024]). Audino teaches an additional layer can be included to improve binding and sealing of the apparatus while avoiding deformation of the plate ([0025]). Audino teaches a metallic foil layer could also be sandwiched between the elastomer and thermoplastic layers to provide possibly a better vapor barrier ([0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lid assembly of modified Barbedette to incorporate Audino’s teachings of lid assembly comprising a laminate of multiple layers and layers to keep water out ([0006],[0009],[0023]-[0025],[0028]; Fig. 3) to provide: the lid assembly is made of at least two layers, one of said layers comprising at least a moisture-proof layer. Doing so would have a reasonable expectation of successfully improving hermetic sealing of the chambers and improving binding and sealing of the lid assembly to the chambers while avoiding deformation of the chambers (Audino, [0023]-[0025],[0028]).
Modified Barbedette fails to teach: wherein the carrier assembly comprises a first additional liaison layer and the closing assembly comprises a second additional liaison layer, the first and the second additional liaison layers facing each other.
Audino teaches an apparatus, i.e. lid assembly, for sealing fluid containing vessels comprising a sheet of elastomer forming a sealing member disposed on a plate containing a plurality of wells; wherein the apparatus seals the wells of a multiwell plate, and has aspects of being vapor resistant, heat sealable, and able to be manipulated by automated analytical equipment (abstract). Audino teaches a need for chambers (i.e. wells) to be properly sealed to avoid contamination ([0006]), and known problems of sealing tapes and mats of not being designed for use in automated assay processes ([0009]). Audino teaches a need for a cover capable of effectively sealing wells ([0009]). Audino teaches an embodiment where the apparatus comprises a laminate of multiple layers comprising an elastomer sheet 10, a first polymer binder 21, a metallic foil 18, and a second polymer layer 22 ([0024]; Fig. 3), wherein the layers face each other (Fig. 3), and wherein the layers are interpreted as liaison layers. Audino teaches a metal foil acts as an effective vapor barrier to avoid gas diffusion into or out of the well ([0023]), and an elastomer-foil laminate can keep reagents in the well while keeping water out ([0023]). Audino teaches the embodiment (Fig. 3) allows for proper bonding of the layers and welding of the laminated structure to the plate ([0024]). Audino teaches an additional layer can be included to improve binding and sealing of the apparatus while avoiding deformation of the plate ([0025]). Audino teaches a metallic foil layer could also be sandwiched between the elastomer and thermoplastic layers to provide possibly a better vapor barrier ([0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier assembly and the lid assembly of modified Barbedette to incorporate Audino’s teachings of lid assembly comprising a laminate of multiple layers and layers to keep water out ([0006],[0009],[0023]-[0025],[0028]; Fig. 3) to provide: wherein the carrier assembly comprises a first additional liaison layer and the closing assembly comprises a second additional liaison layer, the first and the second additional liaison layers facing each other. Doing so would have a reasonable expectation of successfully improving hermetic sealing of the chambers and improving binding and sealing of the lid assembly to the chambers while avoiding deformation of the chambers (Audino, [0023]-[0025],[0028]).
Regarding claim 10, Barbedette further teaches wherein the lid assemblies are formed by a single lid assembly sheet (Figs. 9,11,24 and [179]-[180], teaches cover 72 is a continuous film that covers at least two housing 54).
Barbedette fails to teach: wherein the carrier assembly comprises a first liaison layer and the lid assembly sheet comprises a second liaison layer, the first and second liaison layers facing each other, and wherein the carrier assembly comprises a first additional liaison layer and the closing assembly comprises a second additional liaison layer, the first and the second additional liaison layers facing each other.
Audino teaches an apparatus, i.e. lid assembly, for sealing fluid containing vessels comprising a sheet of elastomer forming a sealing member disposed on a plate containing a plurality of wells; wherein the apparatus seals the wells of a multiwell plate, and has aspects of being vapor resistant, heat sealable, and able to be manipulated by automated analytical equipment (abstract). Audino teaches a need for chambers (i.e. wells) to be properly sealed to avoid contamination ([0006]), and known problems of sealing tapes and mats of not being designed for use in automated assay processes ([0009]). Audino teaches a need for a cover capable of effectively sealing wells ([0009]). Audino teaches an embodiment where the apparatus comprises a laminate of multiple layers comprising an elastomer sheet 10, a first polymer binder 21, a metallic foil 18, and a second polymer layer 22 ([0024]; Fig. 3), wherein the layers face each other (Fig. 3); wherein either layers 10,18,21,22 are interpreted as a first liaison layer, second liaison layer, first additional liaison layer, and second additional liaison layer non-respectively. Audino teaches a metal foil acts as an effective vapor barrier to avoid gas diffusion into or out of the well ([0023]), and an elastomer-foil laminate can keep reagents in the well while keeping water out ([0023]). Audino teaches the embodiment (Fig. 3) allows for proper bonding of the layers and welding of the laminated structure to the plate ([0024]). Audino teaches an additional layer can be included to improve binding and sealing of the apparatus while avoiding deformation of the plate ([0025]). Audino teaches a metallic foil layer could also be sandwiched between the elastomer and thermoplastic layers to provide possibly a better vapor barrier ([0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier assembly and the lid assembly of modified Barbedette to incorporate Audino’s teachings of lid assembly comprising a laminate of four multiple layers and layers to keep water out ([0006],[0009],[0023]-[0025],[0028]; Fig. 3) to provide: wherein the carrier assembly comprises a first liaison layer and the lid assembly sheet comprises a second liaison layer, the first and second liaison layers facing each other, and wherein the carrier assembly comprises a first additional liaison layer and the closing assembly comprises a second additional liaison layer, the first and the second additional liaison layers facing each other. Doing so would have a reasonable expectation of successfully improving hermetic sealing of the chambers and improving binding and sealing of the lid assembly to the chambers while avoiding deformation of the chambers (Audino, [0023]-[0025],[0028]).
In an alternative interpretation, claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Barbedette as applied to claim 1 above.
Regarding claim 14, if it is determined that Barbedette fails to teach the urine reagent containing device of claim 1, comprising between 50 and 100 closed chambers with sufficient specificity, Barbedette teaches the separator including at least 50 strips ([54]).
Since Barbedette teaches the separator including at least 50 strips in housings ([54]), wherein the range of at least 50 overlaps with the claimed range of between 50 and 100, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barbedette to provide the urine reagent containing device of claim 1, comprising between 50 and 100 closed chambers. I.e., it would have been prima facia obvious to have selected the overlapping portion of the range (i.e. between 50-100 closed chambers) from the taught range of at least 50 ([54]) in order to provide the desired number of closed chambers to contain each test strip (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05 (I)).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Barbedette as applied to claim 1 above, and further in view of Tian (US 20180141263 A1)
Regarding claim 20, the closest prior art of Barbedette et al. (WO 2021175909 A2; cited in the IDS filed 09/14/2023; see machine translation) further teaches wherein the carrier assembly is a single integral sheet formed to define the plurality of open chambers, the rim portions and the bridge portion (Figs. 25-27).
Barbedette fails to teach: the single integral sheet having a thickness of less than 0.5 mm, and wherein the gap extends along an entire width of the carrier assembly transverse to a longitudinal axis along which the plurality of open chambers are spaced.
Tian teaches microplates having wells that can be made by thermoforming processes to heat a sheet prior to molding (abstract). Tian teaches the microplate, i.e. carrier assembly (Figs. 1A-1B) define a plurality of open chambers spaced next to one another (wells 102) and are attached to one another at a rim portion by a bridge portion (Figs. 1A-1B), wherein the bridge portion and the adjacent chambers define therebetween a gap that is free of material of the carrier assembly and that is delimited at least in part by the bridge portion and by mutually facing walls of the two adjacent open chambers (Figs. 1A-1B shows a gap between wells 102 delimited by the top bridge portion of the microplate and the facing walls of the wells 102); and wherein the gap extends along an entire width of the carrier assembly transverse to a longitudinal axis along which the plurality of open chambers are spaced (Figs. 1A-1B, shows the wells 102 are separated below the bridge portion by a gap, therefore the gap extends along an entire width along the microplate transverse to a longitudinal axis, i.e. axis from left to right of Figs. 1A-1B, along which the wells are spaced). Tian teaches known problems of non-uniform wall thickness, which can lead to uneven heating of the sample contained in the well and thus, increased variability in reaction conditions ([0004]). Tian teaches microplates comprise thin-walled wells useful for decreasing the resistance to heat transfer to samples within the wells; and the microplates are generally made by thermoforming, and thus, the starting material can be a very thin polymer sheet or film ([0021]). Tian teaches microplates are made by a thermo-embossing process where an extruded polymer substrate (e.g., a polymer sheet, film, or layer) is first heated to soften the polymer, and then embossed to form any suitable number of wells in the substrate, e.g., one well or multiple wells can be formed ([0030]). Tian teaches the film thickness may range from 50 microns to 1000 microns; in one variation, the film thickness is 50 to 100 microns or 100 to 200 microns, i.e. less than 0.5 mm ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the single integral sheet of Barbedette to incorporate Tian’s teachings of making a carrier substrate with a plurality of chambers with gaps with a sheet of a thickness less than 0.5mm (Figs. 1A-1B; [0004],[0021],[0030],[0033]) to provide: the single integral sheet having a thickness of less than 0.5 mm, and wherein the gap extends along an entire width of the carrier assembly transverse to a longitudinal axis along which the plurality of open chambers are spaced. Doing so would have a reasonable expectation of successfully improving manufacturing the carrier assembly with uniform thicknesses of the chambers and gaps as taught by Tian.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed single integral sheet having a thickness of less than 0.5 mm, and wherein the gap extends along an entire width of the carrier assembly transverse to a longitudinal axis along which the plurality of open chambers are spaced) by known methods with no change in their respective functions (i.e. providing open chambers that are spaced apart by a gap), and the combinations yielded nothing more than predictable results (i.e. providing the claimed sheet thickness and gap shape would yield nothing more than the obvious and predictable result of enabling manufacturing of the carrier assembly with desired thickness of the chambers and gaps that separate the chambers). See MPEP 2143(A).
Response to Arguments
Applicant’s arguments, see page 7, filed 08/07/2026, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(b) of 05/15/2026 have been withdrawn.
Applicant’s arguments, see pages 7-13, filed 08/07/2026, with respect to the rejection(s) of claims 1, 4-6, and 11-17 under 35 U.S.C. 103 and the dependent claims under 35 U.S.C. 103, specifically regarding amended claim 1, 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 Barbedette et al. (WO 2021175909 A2; cited in the IDS filed 09/14/2023; see machine translation) with a different interpretation of the open chambers, bridge portion, and gap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mirasol et al. (US 3582283 A) teaches a chemical package, i.e. carrier assembly, (Figs. 1-3) comprising a plurality of chambers (16) that are sealed by a top membrane (18) and are pierceable (Fig. 2). Mirasol teaches the plurality of chambers are attached to one another at a rim portion of each chamber by a bridge (Fig. 1B, portion 52), and the bridge portion and two adjacent chambers define therebetween a gap (Fig. 1B shows a cap between chambers 16), wherein the gap extends along an entire width of the carrier assembly transverse to a longitudinal axis along which the plurality of open chambers are spaced (Figs. 1A-B shows the chambers 16 are separated below portion 52, i.e. gap, therefore the gap extends along an entire width along the chemical package transverse to a longitudinal axis, i.e. axis from left to right of Fig. 1B, along which the chambers are spaced).
O’caoimh et al. (US 20100184235 A1) teaches a carrier assembly (Figs. 1-2) including open chambers (3, 4) attached at a rim portion by a bridge (8), the bridge portion and two adjacent chambers define therebetween a gap (Fig. 2, gap between chambers 3,4), wherein the gap extends along an entire width of the carrier assembly transverse to a longitudinal axis along which the plurality of open chambers are spaced (Figs. 1-2). O’caoimh teaches well plates may comprise an elongated strip plate which may be of flexible, semi-rigid or rigid material having a plurality of wells located therein arranged in a single column extending longitudinally along the strip plate ([0002]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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