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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 filed on 06/25/2026.
Response to Amendment
The Amendment filed 06/10/2026 has been entered. Claims 1, and 3-8 and 10-15 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 03/10/2026. New grounds of rejections necessitated by amendments are discussed below.
Terminal Disclaimer
The terminal disclaimer filed on 06/10/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Application 18/471,397 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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, 3-8, and 10-14 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.
Regarding claim 1, claim 1 recites “flat abutting surface that applies the pressing force, without using any protrusions, by being pressed against the enclosing body due to operation of the pressing operation part” (emphasis added). The disclosure describes an abutting surface is a flat surface (specification, paragraphs [0008],[0157]; Figs. 2-4, 6, 9-15), however the disclosure fails to support the negative limitation of “without using any protrusions.” Note that any negative limitation or exclusionary proviso must have basis in the original disclosure and that the mere absence of a positive recitation is not basis for an exclusion (see MPEP 2173.05(I)). Thus, the claim 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. Claims 3-8, and 10-14 are rejected by virtue of their dependency on claim 1.
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 1, 3-4, 8, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wada et al. (US 20170307603 A1; cited in the IDS filed 12/21/2023) in view of Skerratt (EP 0504772 A2).
Regarding claim 1, Wada teaches an assay cartridge (Figs. 1-10) used for immunochromatographic assay (abstract; paragraphs [0013]-[0015]), comprising:
a carrier (Fig. 1, insoluble carrier 2) to which a sample and a reagent are supplied (interpreted as an intended use of the carrier, see MPEP 2114; paragraphs [0116]-[0118] teaches a specimen liquid and amplification liquid are supplied to the carrier 2);
an enclosing body (Fig. 1, second pot 50) in which the reagent to be supplied to the carrier is enclosed (paragraph [0087] teaches second pot encloses second amplification liquid 51), and which has a sealing portion (Figs. 4-5, interpreted as the portion of the breakable sheet member 53 of second pot 50) that opens earlier than other portions due to an internal pressure being increased due to an application of a pressing force (interpreted as an intended use, see MPEP 2114; Figs. 4-5 and paragraph [0106] teaches the sealing member opens earlier than other portions, e.g. the upper end of second pot 50, when pressure on the sheet member 53 is increased due to an application of a pressing force from movable member 24), the enclosing body (Figs. 4-5, second pot 50) being supported by a flat supporting surface (Figs. 1,4-5 teaches flat supporting sidewall surfaces 32 of middle member 30 functionally supporting at least the sides of the second pot 50; Figs. 4-5 teaches protrusion portion 33 includes at flat supporting surface towards the top left of the structure that supports the enclosing body in Fig. 4); and
a case (Fig. 1, case 9) accommodating the carrier (Fig. 1) and the enclosing body (Fig. 1) and having a pressing operation part (Figs. 1 and 4-5, movable member 24) that is operated to apply the pressing force to the enclosing body (Figs. 4-5; paragraph [0106]); and
a pressing part (Figs. 4-5, columnar portion 24a) that includes a flat abutting surface (Figs. 4-5 shows the bottom of the columnar portion 24a is a flat surface, i.e. flat abutting surface, that abuts on second pot 50) that applies the pressing force (interpreted as an intended use, see MPEP 2114; paragraphs [0106]-[0107]; Figs. 4-5), without using any protrusions, by being pressed against the enclosing body due to operation of the pressing operation part (interpreted as an intended use, see MPEP 2114; paragraphs [0106]-[0107] and Figs. 4-5 teach the bottom flat surface of columnar portion 24a does not have protrusions, i.e. without using any protrusions, and presses against second pot 50 due to pressing down on the columnar portion 24a).
Wada fails to teach: the sealing portion is a welded portion that opens by separating due to the increased internal pressure.
Skerratt teaches a microprocessor-based control unit for analysis of a fluid sample, the unit including a compartmentalized pouch containing chemicals and roller to break the rupturable seals of the compartment (abstract). Skerratt teaches an essential feature of the invention is a pouch that includes sealed walls by use of welding and in part of heat seals by use of conventional heat sealing; wherein the invention includes rupturable walls but no rupture of permanently sealed walls (column 5, line 49- column 6, line 8). Skerratt teaches a pressure-compressible compartment is defined by a wall portion suitably formed by welding, and by a relatively weaker or rupturable, wall portion, suitably formed by heat sealing (column 6, lines 38-51). Skerratt teaches compressing the pressure-compressible compartment and thereby breaking outflow-providing heat seal (column 9, lines 30-33; column 10, lines 11-19); and the force of fluid exiting the compartments under pressure causes them to mix very well and very quickly (column 10, lines 26-29).
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 sealing portion of Wada to incorporate the teachings of pressure rupturable pouches containing chemicals for fluid analysis, and the pouch includes portions that are heat sealed or welded of Skerratt (abstract; column 5, line 49- column 6, line 8; column 6, lines 38-51; column 9, lines 30-33; column 10, lines 11-19 and lines 26-29) to provide: the sealing portion is a welded portion that opens by separating due to the increased internal pressure. Doing so would have a reasonable expectation of successfully improving sealing of the enclosing body at desired locations and ensuring opening of the enclosing body at the desired locations due to increased internal pressure caused by the pressing part.
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. an enclosing body having a welded portion) by known methods with no change in their respective functions (i.e. enclosing a reagent; opening and directing the reagent to a direction after pressure is applied to break the welded portion), and the combinations yielded nothing more than predictable results (i.e. providing a welded portion for the enclosing body would yield nothing more than the obvious and predictable result of improving sealing of the enclosing body at desired locations and ensuring opening of the enclosing body at the desired locations). See MPEP 2143(A).
Regarding claim 3, Wada further teaches wherein an accommodating part accommodates the enclosing body (Figs. 1, 4-5, pot accommodation portion 32 accommodates second pot 50) and includes a supply port (Figs. 4-5 and 7, an amplification liquid-filling hole 34) for supplying the reagent discharged from the enclosing body to the carrier (Figs. 4-5 and 7 and paragraph [0061]), and
in the accommodating part, the sealing portion (Figs. 4-5, the portion of the breakable sheet member 53 of second pot 50) is disposed at the supply port (Figs. 4-5 shows the bottom portion of the breakable sheet member 53 is disposed at the supply port of the pot accommodation portion 32).
Regarding claim 4, Wada further teaches wherein a position of the sealing portion disposed at the supply port is fixed (Figs. 4-5 shows the bottom portion of the breakable sheet member 53 disposed at the supply port of the pot accommodation portion 32 is fixed or secured due to element 24).
Regarding claim 8, modified Wada fails to teach: wherein the enclosing body includes a plurality of sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion.
Skerratt teaches a microprocessor-based control unit for analysis of a fluid sample, the unit including a compartmentalized pouch containing chemicals and roller to break the rupturable seals of the compartment (abstract). Skerratt teaches an essential feature of the invention is a pouch that includes sealed walls by use of welding and in part of heat seals by use of conventional heat sealing; wherein the invention includes rupturable walls but no rupture of permanently sealed walls (column 5, line 49- column 6, line 8). Skerratt teaches a pressure-compressible compartment is defined by a wall portion suitably formed by welding, and by a relatively weaker or rupturable, wall portion, suitably formed by heat sealing (column 6, lines 38-51).
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 sealing portion of modified Wada to incorporate the teachings of rupturable pouches containing chemicals for fluid analysis, and the pouch includes portions that are heat sealed or welded to be permanently sealed or rupturable of Skerratt (abstract; column 5, line 49- column 6, line 8; column 6, lines 38-51) to provide: wherein the enclosing body includes a plurality of sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion. Doing so would have a reasonable expectation of successfully improving sealing of the enclosing body and ensuring rupturable opening of the enclosing body at desired portions, such as towards the supply port, and no rupturing of the other portions of the enclosing body.
Regarding claim 10, modified Wada further teaches wherein the sealing portion is heat-welded (see above claim 1; modified Wada teaches the sealing portion is a welded portion; note that “heat-welded” is interpreted as a product-by-process limitation; MPEP 2113 states that 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, i.e. heat-welded; and 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; therefore, since modified Wada teaches the “welded portion”, the product, i.e. sealing portion, is the same as claimed).
Regarding claim 11, Wada further teaches wherein an accommodating part accommodates the enclosing body (Figs. 1, 4-5, pot accommodation portion 32 accommodates second pot 50) and includes a supply port (Figs. 4-5 and 7, an amplification liquid-filling hole 34) for supplying the reagent discharged from the enclosing body to the carrier (Figs. 4-5 and 7 and paragraph [0061]), and
in the accommodating part, the sealing portion (Figs. 4-5, the portion of the breakable sheet member 53 of second pot 50) is disposed at the supply port (Figs. 4-5 shows the bottom portion of the breakable sheet member 53 is disposed at the supply port of the pot accommodation portion 32).
Modified Wada fails to teach: the enclosing body includes a plurality of sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and
the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion,
wherein sealing forces of the weak sealing portion and the other sealing portion are adjusted by controlling an applied thermal energy.
Skerratt teaches a microprocessor-based control unit for analysis of a fluid sample, the unit including a compartmentalized pouch containing chemicals and roller to break the rupturable seals of the compartment (abstract). Skerratt teaches an essential feature of the invention is a pouch that includes sealed walls by use of welding and in part of heat seals by use of conventional heat sealing; wherein the invention includes rupturable walls but no rupture of permanently sealed walls (column 5, line 49- column 6, line 8). Skerratt teaches a pressure-compressible compartment is defined by a wall portion suitably formed by welding, and by a relatively weaker or rupturable, wall portion, suitably formed by heat sealing (column 6, lines 38-51).
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 sealing portion of modified Wada to incorporate the teachings of rupturable pouches containing chemicals for fluid analysis, and the pouch includes portions that are heat sealed or welded to be permanently sealed or rupturable of Skerratt (abstract; column 5, line 49- column 6, line 8; column 6, lines 38-51) to provide: the enclosing body includes a plurality of sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion, wherein sealing forces of the weak sealing portion and the other sealing portion are adjusted by controlling an applied thermal energy. Doing so would have a reasonable expectation of successfully improving sealing of the enclosing body and ensuring rupturable opening of the enclosing body at desired portions, such as towards the supply port, and no rupturing of the other portions of the enclosing body.
Regarding claim 14, modified Wada fails to teach: wherein the enclosing body includes a plurality of welded sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion.
Skerratt teaches a microprocessor-based control unit for analysis of a fluid sample, the unit including a compartmentalized pouch containing chemicals and roller to break the rupturable seals of the compartment (abstract). Skerratt teaches an essential feature of the invention is a pouch that includes sealed walls by use of welding and in part of heat seals by use of conventional heat sealing; wherein the invention includes rupturable walls but no rupture of permanently sealed walls (column 5, line 49- column 6, line 8). Skerratt teaches a pressure-compressible compartment is defined by a wall portion suitably formed by welding, and by a relatively weaker or rupturable, wall portion, suitably formed by heat sealing (column 6, lines 38-51).
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 sealing portion of modified Wada to incorporate the teachings of rupturable pouches containing chemicals for fluid analysis, and the pouch includes portions that are heat sealed or welded to be permanently sealed or rupturable of Skerratt (abstract; column 5, line 49- column 6, line 8; column 6, lines 38-51) to provide: wherein the enclosing body includes a plurality of welded sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion. Doing so would have a reasonable expectation of successfully improving sealing of the enclosing body and ensuring rupturable opening of the enclosing body at desired portions, such as towards the supply port, and no rupturing of the other portions of the enclosing body.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Skerratt as applied to claim 1 above, and further in view of Weber et al. (US 20100308051 A1).
Regarding claim 5, Wada further teaches wherein an accommodating part accommodates the enclosing body (Figs. 1, 4-5, pot accommodation portion 32 accommodates second pot 50) and includes a supply port (Figs. 4-5 and 7, an amplification liquid-filling hole 34) for supplying the reagent discharged from the enclosing body to the carrier (Figs. 4-5 and 7 and paragraph [0061]).
Modified Wada fails to teach: in the accommodating part, the sealing portion (Figs. 4-5, the portion of the breakable sheet member 53 of second pot 50) is connected to the supply port through a connecting portion.
Weber teaches a microfluidic storage device having a supply chamber formed by bulging a film (abstract; Figs. 1-4). Weber teaches an enclosing body (Fig. 1, fluid supply chamber 5) that is sealed at a sealing portion (10) and a supply port (26). Weber teaches the sealing portion is connected to the supply port through a connecting portion (9). Weber teaches the connection potion (transport path 9) allows for no air bubbles to form in the fluid flow which could impair the processing and functioning of the fluid in the flow cell (paragraph [0038]). Weber teaches the device makes it possible to obtain a very precise metering of individual partial quantities of the fluid stored in the supply chamber (paragraph [0039]).
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 sealing portion of modified Wada to incorporate the teachings of a sealed fluid supply chamber connected to a supply port via a connecting portion of Weber (Figs. 1-6; paragraphs [0038]-[0039]) to provide: in the accommodating part, the sealing portion is connected to the supply port through a connecting portion. Doing so would have a reasonable expectation of successfully improving direction and metering of the reagent from the enclosing body to the supply port without air bubbles as taught by Weber.
Regarding claim 6, modified Wada fails to teach: wherein the connecting portion is a portion of the enclosing body and is a portion extended from the sealing portion toward the supply port.
Weber teaches a microfluidic storage device having a supply chamber formed by bulging a film (abstract; Figs. 1-4). Weber teaches an enclosing body (Fig. 1, fluid supply chamber 5) that is sealed at a sealing portion (10) and a supply port (26). Weber teaches the sealing portion is connected to the supply port through a connecting portion (9). Weber teaches the connecting portion (Fig. 4, transport path 9) is a portion of the enclosing body (5) and is a portion extended from the sealing portion (Fig. 1, element 10) towards the supply port (26). Weber teaches the connection potion (transport path 9) allows for no air bubbles to form in the fluid flow which could impair the processing and functioning of the fluid in the flow cell (paragraph [0038]). Weber teaches the device makes it possible to obtain a very precise metering of individual partial quantities of the fluid stored in the supply chamber (paragraph [0039]).
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 sealing portion of modified Wada to incorporate the teachings of a sealed fluid supply chamber connected to a supply port via a connecting portion of the enclosing body that extends to the supply port of Weber (Figs. 1-6; paragraphs [0038]-[0039]) to provide: wherein the connecting portion is a portion of the enclosing body and is a portion extended from the sealing portion toward the supply port. Doing so would have a reasonable expectation of successfully improving direction and metering of the reagent from the enclosing body to the supply port without air bubbles as taught by Weber.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Skerratt and Weber as applied to claim 5 above, and further in view of Gollob et al. (US 20210291182 A1; effectively filed 11/17/2016).
Regarding claim 7, modified Wada fails to teach: wherein the connecting portion is a tubular body separated from the enclosing body.
Gollob teaches a point-of-care system for analyte detection in a fluid (abstract). Gollob teaches fluid flows to lateral flow strips (paragraph [0011]). Gollob teaches flow regulation tubes are utilized to connect the components of the pressure driven component of the device, e.g., from the inlet chamber to first fluid flow pathway (paragraph [0031]). Gollob teaches the diameter of the flow regulation tubes are selected based upon the viscosity of fluid and the desired flow rate (paragraphs [0011],[0031]). Gollob teaches a channel is a passage directing flow of fluid; and the channel may be an enclosed hollow tube (paragraph [0053]). Gollob teaches flow regulation tubes refer to tubes that permit the flow of liquid from one chamber to another within a given fluid flow pathway and thereby control the rate of flow and reaction time (paragraph [0082]). Gollob teaches flow regulation tubes control volume and flow rate of liquids between chambers and delivery arrays (paragraph [0129]). Gollob teaches flow regulation tubes (Fig. 4, element 450) as separate components that connect various ports of chambers (Fig. 4).
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 connecting portion of modified Wada to incorporate the teachings of fluidic systems that incorporate hollow tubes as channels for flow regulation between chambers and arrays of Gollob to provide: wherein the connecting portion is a tubular body separated from the enclosing body. Doing so would have a reasonable expectation of successfully improving control of volume and flow rate between the enclosing body and the supply port.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Skerratt as applied to claim 1 above, and further in view of Schmidt et al. (US 20120214254 A1).
Regarding claim 12, Wada further teaches wherein an accommodating part accommodates the enclosing body (Figs. 1, 4-5, pot accommodation portion 32 accommodates second pot 50) and includes a supply port (Figs. 4-5 and 7, an amplification liquid-filling hole 34) for supplying the reagent discharged from the enclosing body to the carrier (Figs. 4-5 and 7 and paragraph [0061]), and
in the accommodating part, the sealing portion (Figs. 4-5, the portion of the breakable sheet member 53 of second pot 50) is disposed at the supply port (Figs. 4-5 shows the bottom portion of the breakable sheet member 53 is disposed at the supply port of the pot accommodation portion 32).
Modified Wada fails to teach: the enclosing body includes a plurality of sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and
the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion,
wherein the weak sealing portion has a smaller welding area than the other sealing portion.
Skerratt teaches a microprocessor-based control unit for analysis of a fluid sample, the unit including a compartmentalized pouch containing chemicals and roller to break the rupturable seals of the compartment (abstract). Skerratt teaches an essential feature of the invention is a pouch that includes sealed walls by use of welding and in part of heat seals by use of conventional heat sealing; wherein the invention includes rupturable walls but no rupture of permanently sealed walls (column 5, line 49- column 6, line 8). Skerratt teaches a pressure-compressible compartment is defined by a wall portion suitably formed by welding, and by a relatively weaker or rupturable, wall portion, suitably formed by heat sealing (column 6, lines 38-51).
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 sealing portion of modified Wada to incorporate the teachings of rupturable pouches containing chemicals for fluid analysis, and the pouch includes portions that are heat sealed or welded to be permanently sealed or rupturable of Skerratt (abstract; column 5, line 49- column 6, line 8; column 6, lines 38-51) to provide: the enclosing body includes a plurality of sealing portions, one of the plurality of the sealing portions being a weak sealing portion having a weaker sealing force than the other sealing portion, and the weak sealing portion is disposed at the supply port or is connected to the supply port through a connecting portion. Doing so would have a reasonable expectation of successfully improving sealing of the enclosing body and ensuring rupturable opening of the enclosing body at desired portions, such as towards the supply port, and no rupturing of the other portions of the enclosing body.
Modified Wada fails to teach: wherein the weak sealing portion has a smaller welding area than the other sealing portion.
Schmidt teaches a microfluidic system for fluidic applications (abstract). Schmidt teaches a substrate containing a recess for holding reagents and separated by a predetermined breaking point (paragraph [0006]), which breaks if a critical pressure is exceeded, which can be achieved by means of film welding by using specific welding parameters or by specific geometries of the joint seam or joint zone (paragraph [0007]). Schmidt teaches a predetermined breaking point can be obtained by applying weaker joining parameters than during the permanent joining of the membrane, e.g. a thinner weld seam, or by a shape of the weld seam bringing about the concentration of mechanical stresses at a point (paragraph [0039]).
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 weak sealing portions of modified Wada to incorporate the teachings of releasing reagents via a breakable point formed of a thinner welded seam of Schmidt (paragraphs [0006]-[0007],[0039]) to provide: wherein the weak sealing portion has a smaller welding area than the other sealing portion. Doing so would have a reasonable expectation of successfully improving opening of the enclosing body at a desired sealing portion due to the geometry of the sealing portions.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Skerratt as applied to claim 8 above, and further in view of Briman (US 20140138260 A1) and Ismagilov et al. (US 20160263577 A1).
Regarding claim 13, modified Wada fails to teach: wherein the enclosing body comprises a single sheet in a cylindrical shape, the enclosing body includes two sealing portions along a direction intersecting a cylinder axis direction of the sheet thereby defining the enclosing body in which the reagent is enclosed, and one of the two sealing portions is the weak sealing portion.
Briman teaches a cartridge for diagnostic assays (abstract) including at least one blister pack for on-board liquid storage (paragraph [0007]). Briman teaches the blister pack may be cylindrical in shape and may contain a deformable top layer that provides a cavity for liquid storage and a bottom layer that seals the liquid in (paragraph [0012]).
Ismagilov teaches a fluidic system for controlling fluids and reagents (abstract). Ismagilov teaches a resistant unit comprising a blister or blister pack connected to a channel and a pushing unit (paragraph [0191]), the pushing unit comprising pistons (paragraph [0195]). Ismagilov teaches the blister or blister pack can include one or more burstable seals to allow reagent to flow into a chamber or channel, the seals including a weakened heat seal (paragraph [0211]). Ismagilov teaches the blister or blister pack can be formed using any methods, such as laminating, folding, feeding, and/or cutting of one or more films, sheets, substrates, or layers (paragraph [0224]). Ismagilov teaches resistant units can be arranged in a cylindrical channel (paragraph [0201]). Ismagilov teaches the resistant units can have various shapes or geometries that allow the pushing unit to activate multiple barrier units sequentially, simultaneously, in parallel, or in combination (paragraph [0239]).
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 enclosing body of modified Wada to incorporate Briman’s teachings of cylindrical shaped blister packs (paragraph [0012]) and Ismagilov’s teachings of blister packs formed from one sheet, can be arranged in a cylindrical channel, and can have various shapes or geometries (paragraphs [0201], [0211], [0244], [0239]) and a blister pack connected to a channel and the blister pack including burstable weakened heat seals to allow reagent to flow into a chamber or channels (paragraphs [0191],[0211]) to provide: wherein the enclosing body comprises a single sheet in a cylindrical shape, the enclosing body includes two sealing portions along a direction intersecting a cylinder axis direction of the sheet thereby defining the enclosing body in which the reagent is enclosed, and one of the two sealing portions is the weak sealing portion. Doing so would have utilized known shapes (i.e. cylindrical) and structures (i.e. single sheet) for an enclosing body, e.g. blister pack, with a reasonable expectation of successfully improving and ensuring proper direction of reagent from the enclosing portion when opened, and optimizing the shape of the enclosing body in relation to the shape of the case.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wada et al. (US 20170307603 A1; cited in the IDS filed 12/21/2023) in view of Briman (US 20140138260 A1), Ismagilov et al. (US 20160263577 A1), and Samsoondar (US 20220091148 A1; effectively filed 09/18/2020).
Regarding claim 15, Wada teaches an assay cartridge (Figs. 1-10) used for immunochromatographic assay (abstract; paragraphs [0013]-[0015]), comprising:
a carrier (Fig. 1, insoluble carrier 2) to which a sample and a reagent are supplied (interpreted as an intended use of the carrier, see MPEP 2114; paragraphs [0116]-[0118] teaches a specimen liquid and amplification liquid are supplied to the carrier 2);
an enclosing body (Fig. 1, second pot 50) in which the reagent to be supplied to the carrier is enclosed (paragraph [0087] teaches second pot encloses second amplification liquid 51);
a case (Fig. 1, case 9) accommodating the carrier (Fig. 1) and the enclosing body (Fig. 1) and having a pressing operation part (Figs. 1 and 4-5, movable member 24) that is operated to apply pressing force to the enclosing body (Figs. 4-5; paragraph [0106]); and
an accommodating part that accommodates the enclosing body (Figs. 1, 4-5, pot accommodation portion 32 accommodates second pot 50) and includes a supply port (Figs. 4-5 and 7, an amplification liquid-filling hole 34) for supplying the reagent, the reagent being discharged from the enclosing body to the carrier (Figs. 4-5 and 7 and paragraph [0061]), and
the enclosing body is disposed in the accommodating part (Figs. 1, 4-5, second pot 50 is disposed in pot accommodation portion 32).
Wada fails to teach: wherein the enclosing body comprises a single sheet member in a cylindrical shape and having two welded sealing portions at both ends thereof, respectively, such that the two sealing portions are formed along a direction intersecting a cylinder axis direction of the sheet member, one of the two welded sealing portions is a weak sealing portion having a weaker sealing force than the other welded sealing portion, the weak sealing portion being configured to open earlier than other portions of the enclosing body due to an internal pressure being increased due to application of the pressing force; the enclosing body is disposed in the accommodating part such that the weak sealing portion is disposed closer to the supply port than the other welded sealing portion.
Briman teaches a cartridge for diagnostic assays (abstract) including at least one blister pack for on-board liquid storage (paragraph [0007]). Briman teaches the blister pack may be cylindrical in shape and may contain a deformable top layer that provides a cavity for liquid storage and a bottom layer that seals the liquid in (paragraph [0012]).
Ismagilov teaches a fluidic system for controlling fluids and reagents (abstract). Ismagilov teaches a resistant unit comprising a blister or blister pack connected to a channel and a pushing unit (paragraph [0191]), the pushing unit comprising pistons (paragraph [0195]). Ismagilov teaches the blister or blister pack can include one or more burstable seals to allow reagent to flow into a chamber or channel, the seals including a weakened heat seal (paragraph [0211]). Ismagilov teaches the blister or blister pack can be formed using any methods, such as laminating, folding, feeding, and/or cutting of one or more films, sheets, substrates, or layers (paragraph [0224]). Ismagilov teaches resistant units can be arranged in a cylindrical channel (paragraph [0201]). Ismagilov teaches the resistant units can have various shapes or geometries that allow the pushing unit to activate multiple barrier units sequentially, simultaneously, in parallel, or in combination (paragraph [0239]).
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 enclosing body of Wada to incorporate Briman’s teachings of cylindrical shaped blister packs (paragraph [0012]) and Ismagilov’s teachings of blister packs formed from one sheet, can be arranged in a cylindrical channel, and can have various shapes or geometries (paragraphs [0201], [0211], [0244], [0239]) and a blister pack connected to a channel and the blister pack including burstable weakened heat seals to allow reagent to flow into a chamber or channels (paragraphs [0191],[0211]) to provide: wherein the enclosing body comprises a single sheet member in a cylindrical shape and having two welded sealing portions at both ends thereof, respectively, such that the two sealing portions are formed along a direction intersecting a cylinder axis direction of the sheet member. Doing so would have utilized known shapes (i.e. cylindrical) and structures (i.e. single sheet) for an enclosing body, e.g. blister pack, with a reasonable expectation of successfully improving and ensuring sealing of the reagent, and optimizing the shape of the enclosing body in relation to the shape of the case.
Modified Wada fails to teach: one of the two welded sealing portions is a weak sealing portion having a weaker sealing force than the other welded sealing portion, the weak sealing portion being configured to open earlier than other portions of the enclosing body due to an internal pressure being increased due to application of the pressing force; the enclosing body is disposed in the accommodating part such that the weak sealing portion is disposed closer to the supply port than the other welded sealing portion.
Ismagilov teaches a fluidic system for controlling fluids and reagents (abstract). Ismagilov teaches a resistant unit comprising a blister or blister pack connected to a channel and a pushing unit (paragraph [0191]), the pushing unit comprising pistons (paragraph [0195]). Ismagilov teaches the blister or blister pack can include one or more burstable seals to allow reagent to flow into a chamber or channel, the seals including a weakened heat seal (paragraph [0211]).
Samsoondar teaches a point-of-care testing system comprising an analyzer (abstract). Samsoondar teaches a cartridge includes a preassembled calibration liquid blister and a spike for rupturing the blister to release the calibration liquid (paragraph [0014]), and pressure pushing the released liquid into a sensor chamber (paragraph [0016]). Samsoondar teaches in various embodiments, the means for releasing calibration liquid comprise: (a) at least one spike for rupturing the at least one sealed blister; or (b) a weakened portion of each of the at least one sealed blister for rupturing the at least one sealed blister, wherein when the calibration cartridge is installed with an associated analyzer, a force on the at least one sealed blister is provided by the associated analyzer (paragraph [0036]).
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 enclosing body of modified Wada to incorporate Ismagilov’s teachings of a blister pack connected to a channel and the blister pack including burstable weakened heat seals to allow reagent to flow into a chamber or channels (paragraphs [0191],[0211]) and Samsoondar’s teachings of a means for releasing liquid in a preassembled blister that includes a weakened portion of a sealed blister (paragraph [0036]) to provide: one of the two welded sealing portions is a weak sealing portion having a weaker sealing force than the other welded sealing portion, the weak sealing portion being configured to open earlier than other portions of the enclosing body due to an internal pressure being increased due to application of the pressing force; the enclosing body is disposed in the accommodating part such that the weak sealing portion is disposed closer to the supply port than the other welded sealing portion. Doing so would have a reasonable expectation of successfully improving and ensuring proper direction of reagent from the desired weak sealing portion of the enclosing portion to the supply port when opened.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 06/10/2026, 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 03/10/2026 have been withdrawn.
Applicant’s arguments, see pages 7-8, filed 06/10/2026, with respect to the rejection(s) of claims 1-4 under 35 U.S.C. 102(a)(1) and 101(a)(2) and claims 5-13 under 35 U.S.C. 103, specifically regarding amended claim 1 and the limitation of the “welded portion”, 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 Wada et al. (US 20170307603 A1; cited in the IDS filed 12/21/2023) in view of Skerratt (EP 0504772 A2).
In response to applicant’s arguments, see page 8, filed 06/10/2026, that Wada fails to teach: “the enclosing body is pressed and supported by flat surfaces without protrusions”, the examiner disagrees. Wada teaches: the enclosing body (Figs. 4-5, second pot 50) being supported by a flat supporting surface (Figs. 1,4-5 teaches flat supporting sidewall surfaces 32 of middle member 30 functionally supporting at least the sides of the second pot 50; Figs. 4-5 teaches protrusion portion 33 includes at flat supporting surface towards the top left of the structure that supports the enclosing body in Fig. 4) and a pressing part (Figs. 4-5, columnar portion 24a) that includes a flat abutting surface (Figs. 4-5 shows the bottom of the columnar portion 24a is a flat surface, i.e. flat abutting surface, that abuts on second pot 50) that applies the pressing force (interpreted as an intended use, see MPEP 2114; paragraphs [0106]-[0107]; Figs. 4-5), without using any protrusions, by being pressed against the enclosing body due to operation of the pressing operation part (interpreted as an intended use, see MPEP 2114; paragraphs [0106]-[0107] and Figs. 4-5 teach the bottom flat surface of columnar portion 24a does not have protrusions, i.e. without using any protrusions, and presses against second pot 50 due to pressing down on the columnar portion 24a). Note that the BRI of claim 1 does not exclude the assay cartridge including protrusions. Claim 1 merely recites an intended use of the pressing part, where the pressing part has a flat abutting surface that applies pressing force without any protrusions against the enclosing body, i.e. the flat abutting surface applies pressing force without any protrusions. As discussed above, Wada’s bottom flat surface of columnar portion 24a (Figs. 4-5) does not have protrusions.
Note that 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. See MPEP 2114.
Applicant’s arguments, see page 8, filed 06/10/2026, with respect to the double patenting rejection, specifically with respect to the submitted Terminal Disclaimer, have been fully considered and are persuasive. The double patenting rejection of 03/10/2026 has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Neuman et al. (US 20220178943 A1; effectively filed 02/06/2019) teaches a lateral flow assay device (abstract; Figs. 3,6) comprising a test strip (301) and a blister pack (314), with a housing (306) used to actuate to crush the blister pack to release fluid (Figs. 6a-6b; paragraph [0028]); wherein the blister pack is supported by a flat surface (Fig. 3, element 310).
Kelso et al. (US 20120107811 A1; cited in the IDS filed 12/21/2023 ) teaches systems for performing biological and chemical reactions including the use of a burstable liquid packaging for delivery of reagents to biological and chemical assays (abstract). Kelso teaches an enclosing body including reagent (Fig. 15, seal burst with reagent inside) supported on a flat supporting surface (Fig. 15, substrate below the seal burst), a pressing part having a flat abutting surface (plunger) that applies pressing force to the enclosing body without any protrusions (Fig. 15), therefore bursting a heat seal nearest to an input port to allow fluid to flow through a channel and into a chamber (Fig. 15; paragraph [0021]).
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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