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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/08/2026 has been entered.
Claim Status
Claims 1-7, 9-14, 16-17 and 19-20 are pending with claims 11-14, 16-17 and 19-20 being examined. Claims 1-7 and 9-10 are withdrawn. Claims 8, 15 and 18 are canceled.
Response to Amendment
As to the claim amendments and remarks filed on 06/08/2026, the previous 112(b) rejection is withdrawn.
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 11-14, 16-17 and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
As to claim 11, there is a lack of antecedent basis for the limitations “the liquid fraction having the same chemical hydrophilic or hydrophobic nature” and “the liquid fraction having the opposite chemical hydrophilic or hydrophobic nature”.
The limitations will be in interpreted as “a first liquid fraction having the same chemical hydrophilic or hydrophobic nature” and “a retention of a second liquid fraction having the opposite chemical hydrophilic or hydrophobic nature” for clarity.
Claims 12-14, 16-17 and 19-20 are rejected based on dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11, 13-14, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Aysta (US 5264184; hereinafter “Aysta” previous of record) in view of Werner et al. (US 20160168562 A1; hereinafter “Werner”), further in view of view of Shukla (US 7276158 B1; hereinafter “Shukla”).
Regarding claim 11, Aysta teaches a method of sample separation (Aysta; Title) in a liquid-liquid system (Aysta; Col. 2 lines 24-25) using a device comprising a first chamber having a container with a U- or V-shaped bottom (Aysta; fig. 1. 12, 26, 32 illustrates a first chamber 32 that has a container 12 with a V shaped bottom portion), wherein the device further comprises a second chamber surrounding the outside of the bottom of the first chamber (Aysta; fig. 1. 32).
Aysta fails to teach introducing immiscible liquids into the first chamber with the fluid sample.
However, in the analogous art of sample separation (Werner; [0087]), Werner teaches introducing immiscible liquids into a first chamber (Werner; [0096] and fig. 4. D-E L3, P3, P4).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Aysta’s sample preparation to by introducing immiscible liquids into the first chamber, as taught by Werner, to retain insoluble components of the sample while allowing the soluble components to be eluted (Werner; [0096] and fig. 4. D-E L3, P3, P4).
Aysta fails to teach the first chamber having at least one aperture with a diameter within the range of 1 to 100 pm, wherein each aperture surface is hydrophilized or hydrophobized;
applying a pressure force on the liquids in the first chamber causing a first liquid fraction having the same chemical hydrophilic or hydrophobic nature, respectively, as the hydrophilic or hydrophobic nature of the aperture surface, respectively, to pass through the aperture into a second chamber, and causing retention of a second liquid fraction having the opposite chemical hydrophilic or hydrophobic nature, respectively, than the hydrophilic or hydrophobic nature of the aperture surface, respectively.
However, in the analogous art of sample separation (Shukla; Abstract), Shukla teaches a separation container (Shukla; Title) that includes a first chamber (Shukla; fig. 3. 3), wherein the first chamber has at least one aperture with a diameter within the range of 1 to 100 pm (Shukla; Col. 5 lines 26-28) and the aperture surface is hydrophobized (Shukla; Col. 3 lines 36-41 “the pipette tip can made of polytetrafluoroethylene” (PTFE)). PTFE is a hydrophobic material;
applying a pressure force on the liquids in the first chamber to cause a first liquid fraction (Shukla; Col. 5 lines 38-39) having the same chemical hydrophilic or hydrophobic nature, respectively, to pass through the aperture into a second chamber as the hydrophilic or hydrophobic nature of the aperture surface, respectively (Shukla; Col. 5, lines 42-44; “50 percent isopropanol was eluted”), and cause retention of a second liquid fraction having the opposite chemical hydrophilic or hydrophobic nature, respectively, than the hydrophilic or hydrophobic nature of the aperture surface, respectively (Shukla; Col. 5 lines 39-40 “the peptide was retained”).
To one of ordinary skill in the art before the effective filing date of the invention, it would have been obvious to modify the method of the prior art combination above to provide an aperture with a diameter within the range of 1 to 100 µm in the first chamber, wherein aperture surface is hydrophobized; and applying a pressure force on the liquids in the first chamber to cause separation of hydrophilic/hydrophobic liquid fractions, causing the liquid fractions, as taught by Shukla, to allow retention of particles that are larger than the aperture (Shukla; Col. 1, lines 34-37) and fractionally separate and filtrate samples lines (Shukla; Col. 1 lines 37-38 and Col. 5 lines 38-42).
Regarding claim 13, modified Aysta (i.e., Aysta in view of Werner) teaches the method according to claim 11 (see above), wherein the bottom of the first chamber is at least the inner surface area of the first chamber in which the said at least one aperture is located (Aysta; fig. 3. 12, 20, 26 and Abstract “sample container 12 has bottom wall 20”) or the surface of the aperture and the inner surface of the first chamber are hydrophilized or hydrophobized.
As mentioned above, modified Aysta fails to teach the aperture surface and surface of at bottom of the first chamber are hydrophobized.
However, Shukla the analogous art of sample separation (Shukla; Abstract) that includes a separation container with an aperture (Shukla; fig. 3. 1, 4) wherein the surface of the aperture and the surface of the bottom of the first chamber are hydrophobized (Shukla Col 3 lines 36-41 teaches the separation container can be made of PTFE, PTFE is known in the art to be hydrophilic).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Aysta’s surface of the aperture and the bottom surface of the first chamber to be hydrophobized, as taught by Shukla, because Shukla teaches this allows to have a separation container made of one or more synthetic materials (Shukla; Col. 3 lines 36-39).
Regarding claim 14, modified Aysta teaches the method according to claim 11 (see above), wherein the material of the first chamber and the second chamber is a plastic (Aysta Col. 3 lines 45-47 teaches “the collecting container and the sample container are preferably designed as plastic tubes”) selected from a polycarbonate, a polyolefin, a polystyrene, a polyvinyl chloride, and a fluorinated polymer (Aysta; Col. 4 lines 25-31 teaches the collection container (second chamber) is made of blown polymeric fibers).
Regarding claim 16, modified Aysta teaches the method according to claim 11 (see above), wherein the device comprises a plurality of first chambers and a plurality of second chambers (Aysta; fig. 5. 58, 32), wherein each of the plurality of first chambers is arranged in a first holder (Aysta; fig. 5. 52) to form a first chamber system, wherein each of the plurality of second chambers is arranged in a second holder to form a second chamber system (Aysta; fig. 5. 32, 50), and wherein the first chamber system is inserted into the second chamber system (Aysta; fig. 5. 32, 50, 52, 54 and Col. 9 lines 2-5).
Regarding claim 20, modified Aysta teaches the method according to claim 16 (see above), wherein the first holder (Aysta; fig. 5. 52 and the second holder (Aysta; fig. 5. 50) are each a multi-well plate provided with apertures in the bottoms of the wells representing the plurality of first chambers (Aysta; fig. 5. 60), and wherein the multi-well plates are arranged so that the wells representing the second chambers surround the outside of the bottom of the wells representing the first chambers (Aysta; fig. 5. 32).
Claims 12, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Aysta (US 5264,184; hereinafter “Aysta” previous of record) in view of Werner et al (US 20160168562 A1; hereinafter (Werner”), and Shukla (US 7276158 B1; hereinafter “Shukla”) as applied to claim 11 above, and further in view of Jia (US 20080020446 A1; hereinafter “Jia” previous of record).
Regarding claim 12, modified Aysta teaches the method according to claim 11 (see above) to include a first chamber (see above).
Modified Aysta fails to teach the first chamber is closable by a lid, a membrane, or a foil.
However, Jia teaches the analogous art of a separation device (Jia; Title) that includes a first chamber (Jia; fig. 1. 2) that is closable by a lid, a membrane, or a foil (Jia; fig. 1. 1).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Aysta’s first chamber to include a lid as taught by Jia because Jia teaches a first chamber (Jia; fig. 1. 2) that is closable by a lid, a membrane, or a foil (Jia; fig. 1. 1).
Having a lid over the first chamber would prevent sample contamination.
Regarding claim 17, modified Aysta teaches the method according to claim 11 (see above), to include a first chamber and second chamber (see above).
Modified Aysta fails to teach wherein the device comprises one or more additional first chambers nested within the first chamber or within one another such that, in a series of N first chambers, each of N-1 first chambers surrounds an exterior bottom portion of a preceding first chamber in a direction of liquid flow through the device, and an exterior bottom portion of a last first chamber is surrounded by the second chamber, and wherein each additional first chamber comprises a U- shaped or V-shaped bottom and at least one aperture having a diameter in the range of 1 to 100µm.
However, Jia teaches the analogous art of a separation device (Jia; Title) wherein the device comprises one or more additional first chambers nested within the first chamber or within one another such that, in a series of N first chambers, each of N-1 first chambers surrounds an exterior bottom portion of a preceding first chamber in a direction of liquid flow through the device, and an exterior bottom portion of a last first chamber is surrounded by the second chamber (Jia; fig. 6. B, C).
Jia teaches isolating plasmid or similar DNA from bacteria (Jia; [0002]) and a filter (Jia; fig. 6. 7) that is in the filtration device (first chamber) U shaped bottom aperture (Jia; fig. 6. 2).
It would have been obvious to include at least one aperture having a diameter in
the range of 1 to 100µm in the (first chamber) U shaped bottom aperture in order to capture plasmid DNA. It is well known in the art that DNA plasmids depending on kilo based pairs can measure up to 1 micron in diameter.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Aysta’s first and second chambers to include one or more additional first chambers nested within the first chamber or within one another such that, in a series of N first chambers, each of N-1 first chambers surrounds an exterior bottom portion of a preceding first chamber in a direction of liquid flow through the device, and an exterior bottom portion of a last first chamber is surrounded by the second chamber, and wherein each additional first chamber comprises a U- shaped or V-shaped bottom as taught by Jia because Jia teaches a plurality of first chambers inserted into each other, so that in N first chambers, each of (N-1) first chambers surrounds the outside of the bottom of the preceding first chamber in the direction of the flow of liquids through the device, and the outside of the bottom of the last first chamber is surrounded by a second chamber (Jia; fig. 6. B,C).
The modification allows combining the lysate filtration device 2 with the DNA capture device 3 (Jia; [0046]) and a centrifuge tube to collect the lysate filtrate (Jia; [0040]).
Regarding claim 19, modified Aysta teaches the method according to claim 17 (see above), wherein the separating means are selected from antibodies, affinity agents, hydrophobic agents, hydrophilic agents, ionic agents, chelating agents, magnetic components, components based on imprinted polymers, and combinations thereof (Aysta; Col. 5 lines 1-6 teaches separation of nucleic acids which are known in the art to be hydrophilic).
Response to Arguments
Applicant’s arguments with respect to claims 11-12 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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