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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Status
Claims 1-20 are pending with claims 11-20 being examined with claims 1-10 deemed withdrawn.
Response to Amendment
As to the claim amendments and remarks filed on 12/09/2025, the previous 112(b) rejection is withdrawn. Applicant addressed the issues.
The previous drawing objection is withdrawn. Applicant filed replacement drawings that identify the elements and amended the specification to include the elements.
The previous claim objection is withdrawn. Applicant addressed the issues.
As to the claim amendments and remarks, the examiner has found applicants arguments not persuasive. Therefore, the previous rejection has been modified to address the claim amendments.
Claim Rejections - 35 USC § 112
Claims 11-20 are 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.
When the phrase "consisting of" appears in a clause of the body of a claim, rather than immediately following the preamble, there is an "exceptionally strong presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements (see MPEP 2111.03(II)).
The phrase “consisting of” recited in claim 11 renders the scope of the invention unclear since claims 11-20 recite additional structural components for the claimed first chamber (e.g., the lid, membrane, foil in claim 12), and therefore it is unclear whether open or closed claim language is intended. For the purpose of examination, the recitation “consisting of” has been interpreted as “comprising” in accordance with the additional components and structural features recited in claims 11-20.
Claim Rejections - 35 USC § 103
Claims 11, 13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Aysta (US 5264184; hereinafter “Aysta” previous of record) in view of Dawud (Meltblown fibers, 2010).
The phrase “consisting of” appears in the clause “a device comprising a first chamber consisting of a container with a U- or V-shaped bottom” would limit the first container to that only feature (i.e., a U- or V-shaped bottom). In other words, the first chamber would be considered closed to further elements such as contents therein (the hydrophilized/hydrophobized aperture surface, the fluid sample), the lid, etc.
As mentioned above, the limitation will be interpreted as including the additional elements associated with the first chamber for consistency and in light of applicant’s specification.
Regarding claim 11, Aysta teaches a method of sample separation (Aysta) in a liquid-liquid system (Aysta; Col. 2 lines 24-25) using a device comprising a first chamber as a a container with a U- or V-shaped bottom (Aysta; fig. 1. 12, 26, 32 illustrates a first chamber 32 consisting of a container 12 with a V shaped bottom portion). Aysta’s device includes a sample container 12 with a V shaped bottom and collection chamber 32 both arranged in a parallel arrangements, wherein at least one aperture with a diameter within the range of 1 to 100 pm is provided in the first chamber. Aysta teaches a first chamber with an aperture (Aysta; fig. 3. 22, 26) and wherein at least the surface of each aperture is hydrophilized or hydrophobized (Aysta; Col. 2 lines 24-31). Examiner will interpret the separation layer having selective adsorption properties as being hydrophobic/hydrophilic
The container 12 of Aysta is considered to meet the limitation of the claim since the container 12 is designed with a “V shaped bottom”.
Aysta and the claim differs in that Aysta does not teach the exact same aperture dimensions as recited in claim 11, Aysta teaches aperture dimensions in the range of 0.3 to 2.0 mm which translates to 300-2000.mu.m.300-2000.mu.m that taper towards its free end (Aysta; Col. 6 lines 54-58 “outlet spout 24”).
It would have been obvious to choose an aperture with a diameter within the range of 1 to 100 m.um because Aysta’s aperture diameter encompasses the claimed aperture diameter of 1-100 .m.um. which would allow separating smaller components in the sample, and
wherein the device further comprises a second chamber surrounding the outside of the bottom of the first chamber (Aysta; fig. 1. 32), the method comprising:
introducing a system containing immiscible liquids into the first chamber (Aysta; Col. 2 lines 23-27),
introducing a fluid sample into the first chamber (Aysta; Col. 2 lines 23-27); and
applying a pressure force on the system in the first chamber (Aysta; Col. 3 lines 33-34) causing the 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 the second chamber (Aysta; Col. 3 lines 33-34 “liquid is pressed through the separation layer 28) and (Aysta Col.2. 30-31 ”material with selective adsorption properties”), and causing the retention of the liquid fraction having the opposite chemical hydrophilic or hydrophobic nature, respectively, than the hydrophilic of hydrophobic nature of the aperture surface (Aysta; fig. 3. 26 illustrates the aperture, and Col. 3 lines 34-35 “the liquid entering the collection container) respectively.
Aysta further teaches the sample container on the device includes a separation layer (Aysta; fig. 3. 28) that includes a selectively absorbing material that is made of a membrane with absorption properties (Aysta; Col. 6 lines 58-61). Examiner will interpret the separation layer having selective adsorption properties as being hydrophobic/hydrophilic.
Regarding claim 13, Aysta teaches the method according to claim 11 (see above), wherein the surface of the aperture and the surface of the bottom of the first chamber are hydrophilized or hydrophobized (Aysta; Col. 2 lines 24-31). Examiner will interpret the separation layer having selective adsorption properties as being hydrophobic/hydrophilic,
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”).
Regarding claim 14, 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). Polystyrene is known in the art to be a blown polymeric fiber (Dawud; Abstract).
It would have been obvious to manufacture the first and second chamber using a blown polymeric fiber for cost efficiency.
Regarding claim 15, Aysta teaches the method according to claim 11 (see above), which is provided with at least one ventilation opening located in the first chamber or the second chamber of the device. Aysta teaches rim 38 of opening 36 does not form an airtight seal with the bottom wall 20; rather an exchange of air between the interior of collecting container 32 and the environment is possible (Aysta teaches Col. 7 lines 13-17).
Examiner will interpret the air exchange between the collecting container and the environment through the non-airtight seal of rim 38 as a ventilation opening.
Regarding claim 16, 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 18, Aysta teaches the method according to claim 17 (see above), wherein one of the plurality of first chambers has an aperture with a hydrophilized or hydrophobized surface (Aysta Col.2. 30-31 ”material with selective adsorption properties”). Examiner will interpret the separation layer having selective adsorption properties as being hydrophobic/hydrophilic, and another of the plurality of first chambers has a V-shaped or U-shaped bottom containing at least one aperture with a diameter in the range of 1 to 100 pm (Aysta; fig. 5. 50).
Aysta and the claim differs in that Aysta does not teach the exact same aperture dimensions as recited in claim 11, Aysta teaches aperture dimensions in the range of 0.3 to 2.0 mm which translates to 300-2000.mu.m.300-2000.mu.m that taper towards its free end (Aysta; Col. 6 lines 54-58 “outlet spout 24”).
It would have been obvious to choose an aperture with a diameter within the range of 1 to 100 m.um because Aysta’s aperture diameter encompasses the claimed aperture diameter of 1-100 .m.um. which would allow separating smaller components in the sample.
Regarding claim 19, Aysta teaches the method according to claim 18 (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).
Regarding claim 20, 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 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Aysta (US 5264,184; hereinafter “Aysta” previous of record) and Dawud (Meltblown fibers, 2010) in view of Jia (US 20080020446 A1; hereinafter “Jia” previous of record).
Regarding claim 12, Aysta teaches the method according to claim 11 (see above) to include a first chamber (see above).
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, Aysta teaches the method according to claim 11 (see above) to include a plurality of first chambers and a second chamber (see above).
Aysta fails to teach the device contains 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.
However, Jia teaches the analogous art of a separation device (Jia; Title) wherein the device includes a plurality of first chambers (Jia; fig. 1. 2, 3) wherein the device contains 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).
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 plurality of first chambers and a second chamber wherein the 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 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).
This would allow for a serial liquid-liquid separation.
Response to Arguments
Applicant’s arguments, filed on 12/09/2025, with respect to the prior art rejections over Aysta in view of Dawud and Jia have been fully considered and are not persuasive. The rejections have been modified in accord with the amendment.
With respect to claim 11 Applicant argues Aysta does not teach any portion of the liquid is retained due to chemical mismatch between the liquid and the surface of an opening.
Examiner disagrees. Aysta Col. 2 lines 24-31 teaches the liquids can be separated using a material with selected adsorption properties.
Applicant also argues Aysta alone or in combination fails to teach a micro-aperture of 1-100 pm, a hydrophilic/hydrophobic surface.
Examiner disagrees. Aysta teaches aperture dimensions in the range of 0.3 to 2.0 mm which translates to 300-2000.mu.m.300-2000.mu.m that taper towards its free end (Aysta; Col. 6 lines 54-58 “outlet spout 24”).
It would have been obvious to choose an aperture with a diameter within the range of 1 to 100 m.um because Aysta’s aperture diameter encompasses the claimed aperture diameter of 1-100 .m.um. which would allow separating smaller components in the sample.
With respect to claim 14, Applicant argues Aysta’s containers made of blown polymeric fibers would not be air tight or pressure resistant.
Examiner disagrees. Aysta teaches extracting the liquid the sample into their individual components by applying vacuum (Aysta; Col. 2 lines 23-42).
Applicant argues Aysta’s first chamber requires a separation layer in order for the system to function and therefore cannot meet the requirements of the amended claim since claim 11 recite “consisting of” and excludes additional components.
In response, the examiner notes the phrase “consisting of” excludes additional components of the invention. As mentioned above, the phrase has been interpreted as “comprising” for consistency with the additional components recited in the claims.
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.
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/A.R./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798