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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 27 January 2026 is acknowledged.
Claim 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 January 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "of the gas reservoir" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim as claims 6, 10, and 11 from which claim 12 depends on do not positively recite a gas reservoir, but instead a reservoir for containing an inert mechanical fluid (claim 6). Examiner recommends amending claim 12 to recite “the inert mechanical fluid reservoir” or to amend the dependency of the claim to rely on claim 9 which positively recites “a gas reservoir” or an equivalent thereof.
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, 3, 5-6, 9-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kayyem, et. al. (US 20180161769 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].
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].
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 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 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).
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem, et. al. (US 20180161769 A1) in view of claim 1 above in view of Lim, et. al. (KR 102033701 B1; citations made with respect to attached 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 Kayyem to instead be a non-Newtonian fluid as taught by Lim in order to efficiently separate biological mixtures without putting undue stress on the sample and still using simple microfluidic structures and construction. Because both microfluidic devices use simple injection methods (no pumps) and the purification/isolation/separation of part from a complicated biological mixture, substituting one inert mechanical fluid like oil to a non-Newtonian plugging fluid as provided Lim, provides likewise sought functionality wherein the substitution would yield predictable results. MPEP 2143(I)(B).
Regarding claim 4, 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).
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 Kayyem to instead be a non-Newtonian fluid as taught by Lim in order to efficiently separate biological mixtures without putting undue stress on the sample and still using simple microfluidic structures and construction. Because both microfluidic devices use simple injection methods (no pumps) and the purification/isolation/separation of part from a complicated biological mixture, substituting one inert mechanical fluid like oil to a non-Newtonian plugging fluid as provided Lim, provides likewise sought functionality wherein the substitution would yield predictable results. 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) in view of claim 6 above in 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 in order to efficiently separate biological mixtures without putting undue stress on the sample and still using simple microfluidic structures and construction. Because both microfluidic devices use simple injection methods (no pumps) and the purification/isolation/separation of part from a complicated biological mixture, substituting one inert mechanical fluid like oil to a non-Newtonian plugging fluid as provided Lim, provides likewise sought functionality wherein the substitution would yield predictable results. 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).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kayyem, et. al. (US 20180161769 A1) in view of claim 11 above in view of Kurowski, et. al. (US 20110186466 A1).
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 in order to have improved pressure and metering control of fluid into the microfluidic device upon actuation of the blister. Because both devices used sealed blister backs to meter fluid to a microfluidic device upon actuation, modifying the sealing layer to include a pre-formed hole as provided by Kurowski, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kayyem, et. al. (US 20180161769 A1) in view of claim 13 above in view of Kurowski, et. al. (US 20110186466 A1).
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 opening 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 in order to ensure a tight a tight seal between the blister pouch and attaching layers in order to prevent fluid loss during storage. Because both devices used sealed blister backs to meter fluid to a microfluidic device upon actuation, modifying the blister package to have an additional adhesive layer as provided by Kurowski, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wright, et. al. (US 20140261708 A1) teaches a container for sealing fluids in a blister that upon actuation is metered into a second device (Abstract).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758