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
This is an office action in response to Applicant’s arguments and remarks filed on 23 June 2026. Claims 1-18 are currently pending in this application. Claims 15-18 have been previously withdrawn. Claims 1-14 are being examined herein.
Response to Amendment
The rejection of Claim 12 under 35 U.S.C. § 112(b) is withdrawn in view of amendments.
The rejections of Claims 1, 3, 5-6, 9-11, and 13 under 35 U.S.C. § 102(a)(1) in view of Kayyem, et. al. (US 20180161769 A1) are withdrawn in view of amendments.
The rejections of Claims 2, 4, 7, and 8 under 35 U.S.C. § 103 in view of Kayyem, et. al. (US 20180161769 A1) in view of Lim, et. al. (KR 102033701 B1) are withdrawn in view of amendments.
The rejections of Claims 12 and 12 under 35 U.S.C. § 103 in view of Kayyem, et. al. (US 20180161769 A1) in view of Kurowski, et. al. (US 20110186466 A1) are maintained.
Response to Arguments
Applicant's arguments filed 23 June 2026 have been fully considered but they are not persuasive.
Applicant argues Kayyem alone does not teach the new limitations of the apparatus added to independent claims 1 and 6 [remarks, pg. 7, par. 03 – pg. 8, par. 03].
Examiner does agree that Kayyem alone does not teach all of the newly added limitations. However, Kayyem does teaches “the second reservoir comprising a concave shape to puncture a corresponding seal barrier layer of the second reservoir” (claim 1) and “the liquid reservoir comprising a concave shape to puncture a corresponding seal barrier layer of the liquid reservoir” (claim 6). Examiner notes the use of lance blisters 34b, 36b, 40b, 42b to be used with corresponding blisters 34a, 36a, 40a, 42a [Kayyem, Fig. 2, 5]. These lance blisters are fluidically connected to their respective (fluid) blisters and serve to puncture the sealing layer before actuating the larger fluid blister [Kayyem, par. 0123]. Further details below.
Applicant also argues neither Lim nor Kurowski do not cure the deficiencies of “the first reservoir comprising an opening configured to allow the inert mechanical fluid to be ejected without further rupturing a corresponding seal barrier layer of the first reservoir” (claim 1) and “the reservoir comprising an opening configured to allow the inert mechanical fluid to be ejected without further rupturing a corresponding seal barrier layer of the reservoir” (claim 6).
Examiner respectfully disagrees. Kurowski teaches a plastic strip 2 that forms a pouch 4 (reservoir) with an intermediate film 13 directly connected to plastic strip 2 wherein intermediate film 13 (sealing layer) has a hole/opening 6, such that when the pouch 4 is actuated, a channel forms for fluid to flow from blister 4, through hole 6, to an inlet region of a microfluidic device [Kurowski, Fig. 3; par. 0089-0090]. This hole/opening 6 is a pre-formed hole in the intermediate film 13 and therefore after actuation of blister 4, the hole 6 means film 13 is not further ruptured during actuation. Further details below.
Claim Objections
Examiner notes "a corresponding seal barrier layer" for the first and second reservoir means the portion of the seal barrier layer that is associated with that specific reservoir and blister. However, this phrasing could lead to confusion regarding the presence of a second seal barrier layer underneath and corresponding to said reservoirs. Examiner recommends amending the claim to recite "a corresponding area of the seal barrier layer" or an equivalent thereof.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-6, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem, et. al. (US 20180161769 A1) in view of Kurowski, et. al. (US 20110186466 A1).
Regarding claim 1, Kayyem teaches a fluid processing cartridge comprising deformable fluid chambers (Abstract). Kayyem teaches the cartridge utilizes a series of deformable fluid compartments 34a, 36a, 38a, 40a, 42a atop seal layer 56 (a plurality of reservoirs formed as blisters) wherein the compartments comprise an upper layer (see arrow pointing downward at dome-shape in provided Fig. 5 below) (having an actuatable barrier layer) and a lower layer (see arrow pointing upward ad dashed line in provided Fig. 5 below) (and a seal barrier layer) to hold a fluid between the two layers (with contents of the plurality of reservoirs situated between the actuatable barrier layer and the seal barrier layer) for a biochemical reaction [par. 0004, 0097, 0102] upon actuation [Fig. 4, 5; par. 0119-00123] (wherein the contents are adapted to facilitate isolation of a biological component from a biological sample).
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Kayyem teaches the blisters 34a, 36a, 38a, 40a, 42a collapse under suitable pressure at a predefined time in the assay process to release the fluid within the blister and the blisters can further be provided with a lance blister 34b,36b, 38b, 40b, 42b to ensure the lower, sealing layer is broken [Fig. 4, 5; par. 0120-0123] (wherein the individual reservoirs facilitate release of the contents through the seal barrier layer upon actuation of the actuatable barrier layer).
Provided Figure 3 below shows the portion of the cartridge comprising the deformable blisters outlined that has a defined length (as seen by the horizontal arrow) and width (vertical direction) with the deformable blisters primarily aligning along the length of the cartridge (wherein the sample preparation blister pack has a width and a length, with the plurality of reservoirs aligned along the length).
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Kayyem teaches the series of blisters can each contain a unique processing element with some blisters containing buffers (a second reservoir of the plurality of reservoirs contains a buffer) and another containing oil or another immiscible fluid (wherein a first reservoir of the plurality of reservoirs contains an inert mechanical fluid) [Fig. 3; par. 0120, 0196-0197].
Kayyem teaches the lance blisters 34b, 36b, 40b, 42b, each corresponding to their respective fluid blister [Fig. 2], are used to minimize the compressive force needed to actuate the blister and break the sealing layer [Fig. 5; par. 0123]. The lance blisters 34b, 36b, 40b, 42b take a concave shape in the upper layer and are fluidically connected to their respective blister 34a, 36a, 40a, 42a such that after initial actuation of the lance blister, the respective fluid blister can be actuated to dispense fluid with significantly less force [par. 0123] (and the second reservoir comprising a concave shape to puncture a corresponding seal barrier layer of the second reservoir).
Kayyem is silent to the first reservoir comprising an opening configured to allow the inert mechanical fluid to be ejected without further rupturing a corresponding seal barrier layer of the first reservoir.
Kurowski teaches a container for holding sealed volumes of fluid for metering into a microfluidic system (Abstract). Kurowski teaches wherein the container comprises a plastic strip 2 that forms a pouch 4 (reservoir) with an intermediate film 13 directly connected to plastic strip 2 wherein intermediate film 13 has a hole/opening 6, such that when the pouch 4 is actuated, a channel forms for fluid to flow from blister 4, through hole 6, to an inlet region of a microfluidic device [Fig. 3; par. 0089-0090] (the first reservoir comprising an opening configured to allow the inert mechanical fluid to be ejected without further rupturing a corresponding seal barrier layer of the first reservoir). Kurowski teaches this embodiment of a blister back wherein a hole is pre-formed in the layer sealing the fluid inside the blister prevents the abrupt release of fluid when pressure is applied meaning the release of fluid into the microfluidic device is more controlled [par. 004-0017, 0036-0037].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the seal barrier layer of Kayyem to further include a pre-formed hold as taught by Kurowski because a pre-formed opening in the seal barrier layer improves pressure and metering control of fluid into the microfluidic device upon actuation of the blister [Kurowski, par. 0004-0017] reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 3, Kayyem teaches at least one deformable blister 38a is used to hold an immiscible fluid that will interact with (but not react with) the sample fluid at a later point in the fluidic path of the cartridge after actuation [Fig. 3, 4; par. 0335]. Kayyem teaches the immiscible fluid can be a wide variety of oils or inert gases [par. 0196-0197] (wherein the inert mechanical fluid is a gas).
Regarding claim 5, Kayyem teaches the blisters 34a, 36a, 38a, 40a, 42a collapse under suitable pressure at a predefined time in the assay process to release the fluid within the blister and the blisters can further be provided with a lance blister 34b,36b, 38b, 40b, 42b to ensure the lower, sealing layer is broken with the help of opening device 46 (opening feature) that breaks the burstable seal [Fig. 4, 5; par. 0120-0123]. These align with inlet ports (like 136) (an opening) of seal layer 56 to which the lower, breakable layer is attached to be sent further along the fluidic pathway of the cartridge for processing [Fig. 4, 5; par. 0147] (wherein the seal barrier layer includes a plurality of opening features, wherein individual opening features are adapted to provide an opening to release contents of the individual reservoirs into a sample preparation cartridge channel upon actuation of the actuatable barrier adjacent to the respective individual reservoirs). Kayyem teaches these inlets under lance blisters 34b,36b, 38b, 40b, 42b align along the length of the of the cartridge beside their respective blisters 34a, 36a, 38a, 40a, 42a [Fig. 2] (wherein the plurality of opening features are lined up along the length of the sample preparation blister pack).
Regarding claim 6, Kayyem teaches a fluid processing cartridge comprising deformable fluid chambers (Abstract). Kayyem teaches the cartridge utilizes a series of deformable fluid compartments 34a, 36a, 38a, 40a, 42a atop seal layer 56 (a plurality of reservoirs formed as blisters) wherein the compartments comprise an upper layer (see arrow pointing downward at dome-shape in provided Fig. 5 below) (having an actuatable barrier layer) and a lower layer (see arrow pointing upward ad dashed line in provided Fig. 5 below) (and a seal barrier layer) to hold a fluid between the two layers for a biochemical reaction [par. 0004, 0097, 0102] upon actuation [Fig. 4, 5; par. 0119-00123] (wherein individual reservoirs contain a fluid between the actuatable barrier layer and the seal barrier layer, and wherein the individual reservoirs are adapted to release the fluid through the seal barrier layer upon actuation of the actuatable barrier layer). Kayyem teaches the blisters 34a, 36a, 38a, 40a, 42a collapse under suitable pressure at a predefined time in the assay process to release the fluid within the blister and the blisters can further be provided with a lance blister 34b,36b, 38b, 40b, 42b to ensure the lower, sealing layer is broken [Fig. 4, 5; par. 0120-0123].
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Kayyem teaches the series of blisters can each contain a unique processing element with some blisters containing buffers (a liquid reservoir containing a liquid comprising a buffer) and another containing oil or another immiscible fluid (a reservoir containing an inert mechanical fluid) [Fig. 3; par. 0120, 0196-0197].
Kayyem teaches the lance blisters 34b, 36b, 40b, 42b, each corresponding to their respective fluid blister [Fig. 2], are used to minimize the compressive force needed to actuate the blister and break the sealing layer [Fig. 5; par. 0123]. The lance blisters 34b, 36b, 40b, 42b take a concave shape in the upper layer and are fluidically connected to their respective blister 34a, 36a, 40a, 42a such that after initial actuation of the lance blister, the respective fluid blister can be actuated to dispense fluid with significantly less force [par. 0123] (and the liquid reservoir comprising a concave shape to puncture a corresponding seal barrier layer of the liquid reservoir).
Kayyem is silent to the reservoir comprising an opening configured to allow the inert mechanical fluid to be ejected without further rupturing a corresponding seal barrier layer of the reservoir.
Kurowski teaches a container for holding sealed volumes of fluid for metering into a microfluidic system (Abstract). Kurowski teaches wherein the container comprises a plastic strip 2 that forms a pouch 4 (reservoir) with an intermediate film 13 directly connected to plastic strip 2 wherein intermediate film 13 has a hole/opening 6, such that when the pouch 4 is actuated, a channel forms for fluid to flow from blister 4, through hole 6, to an inlet region of a microfluidic device [Fig. 3; par. 0089-0090] (to the reservoir comprising an opening configured to allow the inert mechanical fluid to be ejected without further rupturing a corresponding seal barrier layer of the reservoir). Kurowski teaches this embodiment of a blister back wherein a hole is pre-formed in the layer sealing the fluid inside the blister prevents the abrupt release of fluid when pressure is applied meaning the release of fluid into the microfluidic device is more controlled [par. 004-0017, 0036-0037].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the seal barrier layer of Kayyem to further include a pre-formed hold as taught by Kurowski because a pre-formed opening in the seal barrier layer improves pressure and metering control of fluid into the microfluidic device upon actuation of the blister [Kurowski, par. 0004-0017] reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 9, Kayyem teaches at least one deformable blister 38a is used to hold an immiscible fluid that will interact with (but not react with) the sample fluid at a later point in the fluidic path of the cartridge after actuation [Fig. 3, 4; par. 0335]. Kayyem teaches that the immiscible fluid can be a wide variety of oils or inert gases [par. 0196-0197] (wherein the reservoir containing the inert mechanical fluid is a gas reservoir containing a gas).
Regarding claim 10, Kayyem teaches wherein one deformable blister 42a holds a wash buffer [Fig. 3; par. 0144] (wherein the liquid reservoir is a wash buffer reservoir containing a wash buffer).
Regarding claim 11, Kayyem teaches an additional deformation blister 40a that holds an additional buffer solution [Fig. 3, 4; par. 0143] (wherein the plurality of reservoirs further comprises a reconstitution buffer reservoir containing a reconstitution buffer).
Examiner notes "for reconstituting a lyophilized master mix reagent" is drawn to a function limitation of the reconstitution buffer and any liquid buffer will have the ability to reconstitute a dried mix reagent when introduced to it.
Regarding claim 12, Kayyem teaches a barrier layer that covers an immiscible fluid blister wherein the immiscible fluid can be a gas [par. 0196-0197].
Kayyem is silent to wherein a hole is pre-formed in the seal barrier layer of the gas reservoir.
Kurowski teaches a container for holding sealed volumes of fluid for metering into a microfluidic system (Abstract). Kurowski teaches wherein the container comprises a plastic strip 2 that forms a pouch 4 (blister) with an intermediate film 13 directly connected to plastic strip 2 wherein intermediate film 13 has a hole/opening 6 [Fig. 3; par. 0089-0090] (wherein a hole is pre-formed in the seal barrier layer). Kurowski teaches this embodiment of a blister back wherein a hole is pre-formed in the layer sealing the fluid inside the blister prevents the abrupt release of fluid when pressure is applied meaning the release of fluid into the microfluidic device is more controlled [par. 004-0017, 0036-0037].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the seal barrier layer of Kayyem to further include a pre-formed hold as taught by Kurowski because a pre-formed opening in the seal barrier layer improves pressure and metering control of fluid into the microfluidic device upon actuation of the blister [Kurowski, par. 0004-0017] reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 13, Kayyem teaches the blisters 34a, 36a, 38a, 40a, 42a collapse under suitable pressure at a predefined time in the assay process to release the fluid within the blister and the blisters can further be provided with a lance blister 34b,36b, 38b, 40b, 42b to ensure the lower, sealing layer is broken with the help of opening device 46 that breaks the burstable seal [Fig. 4, 5; par. 0120-0123]. These align with inlet ports (like 136) of seal layer 56 to which the lower, breakable layer is attached to be sent further along the fluidic pathway of the cartridge for processing [Fig. 4, 5; par. 0147]. Kayyem teaches these inlets under lance blisters 34b,36b, 38b, 40b, 42b align along the length of the of the cartridge beside their respective blisters 34a, 36a, 38a, 40a, 42a [Fig. 2] (further comprising a label layer affixed on the seal barrier layer, wherein the label layer comprises individual openings at the individual reservoirs to admit fluids released from the individual reservoirs).
Regarding claim 14, Kayyem teaches below seal layer 56 is substrate 72 which comprises inlets aligning with holes of seal layer 56 that are connected to microfluidic channels; see corresponding inlet 136 connected to channel 150 on substrate 72 of Figure 15 wherein the inlet 136 width is wider than the channel 150 width [Fig. 4, 15; par. 0147-0148] (a supply channel connected to an individual opening having a width greater than a width of the supply channel). Examiner notes while the inlets/openings share the same label marker, there are separate openings on each distinct layer as seen in Figure 4, see layers 56 and 72.
Kayyem is silent to a pressure-sensitive adhesive layer on the label layer opposite from the seal barrier layer, wherein the pressure-sensitive adhesive layer comprises individual openings aligned with the individual openings of the label layer.
Kurowski teaches a container for holding sealed volumes of fluid for metering into a microfluidic system (Abstract). Kurowski teaches wherein the container comprises a plastic strip 2 that forms a pouch 4 (blister) with a sealing layer 3 (seal barrier layer) attached to an elastic film 7 with through-hole 10 (label layer) and finally a fastening layer 29 with a continuation of through-hole 10 that is adhesive and attaches elastic film 7 to platform 17 through inlet 18 [Fig. 8; par. 0125-0126] (a pressure-sensitive adhesive layer on the label layer opposite from the seal barrier layer, wherein the pressure-sensitive adhesive layer comprises individual openings aligned with the individual openings of the label layer). Kurowski teaches the addition of an adhesive layer prevents loss of fluid from the pouch/blister during long term storage [par. 0027, 0029].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the layers of Kayyem to further include an adhesive layer as taught by Kurowski because an additional adhesive layer ensures a tight seal between the blister pouch and attaching layers in order to prevent fluid loss during storage [Kurowski, par. 0027, 0029] with reasonable expectation of success. MPEP 2143(I)(G).
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem, et. al. (US 20180161769 A1) and Kurowski, et. al. (US 20110186466 A1) as applied to claim 1 above in further view of Lim, et. al. (KR 102033701 B1; citations made with respect to previously provided English machine translation and original copy).
Regarding claim 2, Kayyem teaches at least one deformable blister 38a is used to hold an immiscible fluid that will interact with (but not react with) the sample fluid at a later point in the fluidic path of the cartridge after actuation [Fig. 3, 4; par. 0335]. Kayyem teaches the immiscible fluid can be a wide variety of oils or inert gases [par. 0196-0197].
Kayyem is silent to the inert mechanical fluid specifically being a non-Newtonian plugging fluid.
Lim teaches a microfluidic for separating biological mixtures using non-Newtonian fluids [par. 0001]. Lim teaches non-Newtonian fluids, like a viscoelastic fluid, can be used in current microfluidic devices to separate parts of biological samples by simple injection to the system [par. 0017] to mix with the sample [par. 0065] (a non-Newtonian plugging fluid). Lim teaches using non-Newtonian fluids allows for microfluidic devices with simple channel structure to be used [par. 0009] while yielding high-efficiency separation [par. 0012] without potentially damaging the sample from stress [par. 0014].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to substitute the oil in a blister of modified Kayyem to instead be a non-Newtonian fluid as taught by Lim. One of ordinary skill in the art would be motivated to so because non-Newtonian fluids efficiently separate biological mixtures without putting undue stress on the sample and still using simple microfluidic structures and construction and this involves the simple substitution of one known element (an oil) for another (a non-Newtonian fluid) to obtain predictable results (separation of biological mixtures). MPEP 2143(I)(B).
Regarding claim 4, modified Kayyem teaches a plurality of deformable blisters, at least five, each able to hold a unique processing element [Fig. 3; par. 0120]. Kayyem teaches at least one deformable blister 38a is used to hold an immiscible fluid that will interact with (but not react with) the sample fluid at a later point in the fluidic path of the cartridge after actuation [Fig. 3, 4; par. 0335]. Kayyem teaches the immiscible fluid can be a wide variety of oils or inert gases [par. 0196-0197] (wherein the sample preparation blister pack further comprises a third reservoir containing a gas).
Modified Kayyem is silent to wherein the inert mechanical fluid is a non-Newtonian plugging fluid.
Lim teaches a microfluidic for separating biological mixtures using non-Newtonian fluids [par. 0001]. Lim teaches non-Newtonian fluids, like a viscoelastic fluid, can be used in current microfluidic devices to separate parts of biological samples by simple injection to the system [par. 0017] to mix with the sample [par. 0065] (wherein the inert mechanical fluid is a non-Newtonian plugging fluid). Lim teaches using non-Newtonian fluids allows for microfluidic devices with simple channel structure to be used [par. 0009] while yielding high-efficiency separation [par. 0012] without potentially damaging the sample from stress [par. 0014].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to substitute the buffer in a remaining blister of modified Kayyem to instead be a non-Newtonian fluid as taught by Lim. One of ordinary skill in the art would be motivated to so because non-Newtonian fluids efficiently separate biological mixtures without putting undue stress on the sample and still using simple microfluidic structures and construction and this involves the simple substitution of one known element (a buffer) for another (a non-Newtonian fluid) to obtain predictable results (separation of biological mixtures). MPEP 2143(I)(B).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem, et. al. (US 20180161769 A1) and Kurowski, et. al. (US 20110186466 A1) as applied to claim 6 above, in further view of Lim, et. al. (KR 102033701 B1; citations made with respect to attached English machine translation and original copy).
Regarding claim 7, Kayyem teaches at least one deformable blister 38a is used to hold an immiscible fluid that will interact with (but not react with) the sample fluid at a later point in the fluidic path of the cartridge after actuation [Fig. 3, 4; par. 0335]. Kayyem teaches the immiscible fluid can be a wide variety of oils or inert gases [par. 0196-0197].
Kayyem is silent to t the reservoir containing the inert mechanical fluid being a non-Newtonian plugging fluid reservoir containing a non-Newtonian plugging fluid.
Lim teaches a microfluidic for separating biological mixtures using non-Newtonian fluids [par. 0001]. Lim teaches non-Newtonian fluids, like a viscoelastic fluid, can be used in current microfluidic devices to separate parts of biological samples by simple injection to the system [par. 0017] to mix with the sample [par. 0065] (a non-Newtonian plugging fluid reservoir containing a non-Newtonian plugging fluid). Lim teaches using non-Newtonian fluids allows for microfluidic devices with simple channel structure to be used [par. 0009] while yielding high-efficiency separation [par. 0012] without potentially damaging the sample from stress [par. 0014].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to substitute the oil in a blister of Kayyem to instead be a non-Newtonian fluid as taught by Lim. One of ordinary skill in the art would be motivated to so because non-Newtonian fluids efficiently separate biological mixtures without putting undue stress on the sample and still using simple microfluidic structures and construction and this involves the simple substitution of one known element (an oil) for another (a non-Newtonian fluid) to obtain predictable results (separation of biological mixtures). MPEP 2143(I)(B).
Regarding claim 8, modified Kayyem in view of Lim teaches the non-Newtonian fluid is a viscoelastic fluid [Lim, par. 0065] (wherein the non-Newtonian plugging fluid is a viscoelastic).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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