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 with traverse of group I in the reply filed on 11/06/2025 is acknowledged. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Applicant disagrees with the restriction requirement mailed 10/24/2025. Applicant traverses on grounds that the claims of groups I and II are directed to a permissible combination that require the same corresponding special technical feature.
Accordingly claims 18-20 all require the recited closure for a sample tube. The argument is not persuasive. Group I is drawn to a closure for a sample tube, and group II is drawn to a method of using the closure, therefore groups I-II lack unity with each other with no single general inventive concept.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20 are pending with claims 1-17 being examined, claims 18-20 are deemed withdrawn.
Claim Objections
Claim 2 is objected to because of the following informalities:
In line 2 “intermediate the inlet and outlet” should read –intermediate to the inlet and outlet--.
Claim 2 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 3 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 4 is objected to because of the following informalities:
In line 1, “a closure according to claim 2” should read –the closure according to claim 2--.
Claim 5 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 6 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 7 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 8 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 9 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 10 is objected to because of the following informalities:
In line 1, “a closure according to claim 9” should read –the closure according to claim 9--.
Claim 11 is objected to because of the following informalities:
In line 1, “a closure according to claim 9” should read –the closure according to claim 9--.
Claim 12 is objected to because of the following informalities:
In line 9, “a closure according to claim 1” should read –the closure according to claim 9--.
Claim 13 is objected to because of the following informalities:
In line 1, “a closure according to claim 9” should read –the closure according to claim 9--.
Claim 14 is objected to because of the following informalities:
In line 1, “a closure according to claim 9” should read –the closure according to claim 9--.
Claim 15 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 16 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Claim 17 is objected to because of the following informalities:
In line 1, “a closure according to claim 1” should read –the closure according to claim 1--.
Appropriate correction is required.
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 2-4 and 14 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.
Claims 2 and 4 each recite “the microfluidic channel”. There is lack of antecedent basis for this limitation in the claims since claim 1 previously recites “at least one microfluidic mixing channel”. The limitations will be interpreted as “the at least one microfluidic mixing channel” for consistency and clarity.
As to line 1 of claim 3, “the microfluidic mixing channel” lacks antecedent basis since claim 1 previously recites “at least one microfluidic mixing channel”. The limitation will be interpreted as “the at least one microfluidic mixing channel” for consistency and clarity.
As to claim 14, “the hydrophobic section has a contact angle between about 90 degrees and about 120 degrees” is unclear. The contact angle would depend on the liquid/sample which is in contact with the hydrophobic section as the contact angle varies significantly by liquid. Furthermore, Applicant has not defined what the liquid/sample is.
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.
Claim 1-2 and 5-17 is rejected under 35 U.S.C. 103 as being unpatentable over Godart (WO 2019092040 A1; hereinafter (Godart”).
Regarding claim 1, Godart teaches a closure for a sample tube (Godart; fig. 20) the closure comprising a reaction vessel (Godart; fig. 1. 10), the reaction vessel comprising:
at least one microfluidic mixing channel (Godart; fig. 1. 42 and [0060]). Godart teaches a microfluidic channel and what the microfluidic channel is used for is a matter of intended use, having an inlet (Godart; [0070] “inlet of the microchannel”) and an outlet (Godart; [0070] “the inlet of the microchannel opens to the outside of the microfluidic chip”);
at least one reaction chamber in fluid communication with the inlet (Godart; fig. 1. 41) and the outlet,
an inlet chamber proximate the inlet of the at least one microfluidic mixing channel for introducing a portion of a sample solution from the sample tube into the at least one reaction chamber under hydrostatic pressure (Godart; fig. 1. 44 and [0070]).
a diffusion-control feature for limiting egress of fluid from the outlet such that the portion of the sample solution introduced to the at least one reaction chamber is partitioned from the rest of the sample solution (Godart; fig. 1. 43 and [0063] “microchannel valve 43”).
Regarding claim 2, Godart teaches the closure according to claim 1 (see above), wherein the at least one reaction chamber forms a portion of the microfluidic channel intermediate the inlet and the outlet (Godart; fig. 1. 41, 42).
Regarding claim 5, Godart teaches the closure according to claim 1 (see above), wherein the at least one reaction chamber is separate from, and in fluid communication with, the at least one microfluidic channel (Godart; fig. 1. 41, 42).
Regarding claim 6, Godart teaches the closure according to claim 1 (see above), comprising one or more lyophilized reagents in the at least one reaction chamber for mixing with the sample solution. Godart teaches a closure for a sample tube (see claim 1 above) and what the closure is used for is a matter of intended use.
Regarding claim 7, Godart teaches the closure according to claim 1 (see above), wherein the diffusion control feature comprises an inwardly tapering portion of the at least one microfluidic channel at the inlet, and/or an inwardly tapering portion of the at least one microfluidic channel at the outlet. Godart teaches an inlet at the portion of the channels 42 (Godart; fig. 1. 42 and [0070], that appears to be tapered inward). Applicant discloses a portion of the inlet mas serve as a diffusion control feature.
Regarding claim 8, Godart teaches the closure according to claim 1 (see above), wherein the diffusion control feature comprises a tapered section of the inlet chamber that is in communication with the inlet of the at least one microfluidic mixing channel (Godart; fig. 1. 41, 42 teaches an inlet that is in communication with the inlet of the microfluidic channel).
Examiner notes that Applicant discloses [0054] a portion of the inlet may serve as a diffusion control feature, therefore Godart’s inlet meets the limitation until further clarification,
the tapered section being shaped to allow one or more glass beads in the sample solution to block the inlet. Godart teaches a diffusion control feature comprising a tapered section, what the diffusion control feature comprising a tapered section is used for is a matter of intended use.
Regarding claim 9, Godart teaches the closure according to claim 1 (see above), wherein the diffusion control feature comprises a hydrophobic section of the at least one microfluidic mixing channel (Godart; [0064] “the microfluidic chip can be made from cyclo-olefin copolymer (COC).” Cyclo-olefin copolymer material is known in the art to be hydrophobic.
Examiner notes that the microchannels 42 which include the diffusion control feature (see claim 1 above) are part of the microfluidic chip and therefore made from the same material.
Regarding claim 10, Godart teaches the closure according to claim 9 (see above), wherein the hydrophobic section extends along the entire length of the at least one microfluidic mixing channel (Godart; [0064] “the microfluidic chip can be made from cyclo-olefin copolymer (COC).” Cyclo-olefin copolymer material is known in the art to be hydrophobic.
Examiner notes that the microchannels 42 which include the diffusion control feature (see claim 1 above) are part of the microfluidic chip and therefore made from the same material.
Regarding claim 11, Godart teaches the closure according to claim 9 (see above), wherein the hydrophobic section is adjacent the outlet (Godart; [0064] “the microfluidic chip can be made from cyclo-olefin copolymer (COC).”
Examiner notes that the microchannels 42 are part of the microfluidic chip and therefore made from the same material.
(Godart; [0070) also teaches “the end of the microchannels 42 open to the outside (outlet) of the microfluidic chip”).
Regarding claim 12, Godart teaches the closure according to claim 9, wherein the hydrophobic section comprises a hydrophobic coating or surface treatment, and/or microtexturing of a surface of the at least one microfluidic mixing channel.
Godart teaches a microfluidic channel (see claim 9 above).
Godart does not teach the hydrophobic section comprises a hydrophobic coating or surface treatment, and/or microtexturing of a surface of the at least one microfluidic mixing channel, however. It would have been obvious to micro texture the hydrophobic section of the microfluidic mixing channel to enhance performance by controlling fluid behavior in the microfluidic mixing channel and reducing drag.
Regarding claim 13, Godart teaches the closure according to claim 9 (see above) to include a reaction vessel (see above).
Godart does not explicitly teach the entirety of the reaction vessel is formed from one or more hydrophobic materials.
Godart teaches the reaction vessel 1 includes an observation window made of transparent plastic.
It would have been obvious to manufacture the entirety of the reaction vessel of one or more hydrophobic materials such as plastic in order to have a 1 piece design that includes the transparent window.
Regarding claim 14, as mentioned above, Godart teaches the closure according to claim 1 (see above), wherein the diffusion control feature comprises a hydrophobic section of the at least one microfluidic mixing channel (Godart; [0064] “the microfluidic chip can be made from cyclo-olefin copolymer (COC).” Cyclo-olefin copolymer material is known in the art to be hydrophobic. Thus, Godard would be capable of meeting the limitation “wherein the hydrophobic section has a contact angle between about 90 degrees and about 120 degrees” since the claimed contact angle is capable of being achieved depending on the surface energy of the liquid in contact with cyclo-olefin copolymer (COC).
Regarding claim 15, Godart teaches the closure according to claim 1 (see above), wherein the reaction vessel is transparent or translucent in at least a region surrounding the at least one reaction chamber (Godart; [0070] “observation window 60 located opposite reaction chambers 41 which is formed by a material transparent to visible light”).
Regarding claim 16, Godart teaches the closure according to claim 1 see above), wherein the closure is a monolithic structure (Godart; fig. 1. 20 illustrates what appears to be a monolithic (1 piece) closure).
Regarding claim 17, Godart teaches the closure according to claim 1 (see above), wherein the inlet and the outlet of the at least one microfluidic mixing channel and the inlet chamber are located in a first part of the closure, and the, or each, reaction chamber is located in a second part of the closure that is attached to the first part (Godart; fig. 1. 20, 44 illustrates the reaction chamber is located in the second part of the closure that is attached to the first part).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Godart (WO 2019092040 A1; hereinafter (Godart”) in view of Dirckx et al. (US 20160207042 A1; hereinafter “Dirckx”).
Regarding claim 3, Godart teaches a closure according to claim 1 (see above) to include a microfluidic channel (see above).
Godart fails to teach the microfluidic mixing channel is J-shaped and comprises a short arm in communication with the inlet and a long arm in communication with the outlet.
However, Dirckx teaches the analogous art of a microfluidic device (Dirckx; fig. 5A. 320) that includes a microfluidic channel (Dirckx; fig. 5A. 325), wherein the microfluid channel is J-shaped (Dirckx; fig. 5A. 325 a part of the microfluidic channel comprises a J shape) and comprises a short arm in communication with the inlet (Dirckx; fig. 5A. 30. 325) and a long arm in communication with the outlet (Dirckx; fig. 5A. 35).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Godart’s microfluidic channel to be “J” shaped as taught by Dirckx because Dirckx teaches a microfluidic device (Dirckx; fig. 5A. 320) that includes a microfluidic channel (Dirckx; fig. 5A. 325), wherein the microfluid channel is J-shaped (Dirckx; fig. 5A. 325 a part of the microfluidic channel comprises a J shape) and comprises a short arm in communication with the inlet (Dirckx; fig. 5A. 30. 325) and a long arm in communication with the outlet (Dirckx; fig. 5A. 35).
This modification allows to provide a J trap or water seal.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Godart (WO 2019092040 A1; hereinafter (Godart”) in view of Wunderle et al. (US 20160367981 A1; hereinafter “Wunderle”).
Regarding claim 4, Godart teaches the closure according to claim 2 (see above) to include at least one reaction chamber (see above).
Godart fails to teach the at least one reaction chamber is a U-shaped portion of the microfluidic channel, the U-shaped portion having a larger diameter than that of the remainder of the microfluidic channel.
However, Wunderle teaches the analogous art of a fluidic device (Wunderle; [0065] “the fluidic device of the disclosure”) that includes microfluidic channels (Wunderle; fig. 3. 131) and at least one reaction chamber (Wunderle; fig. 3. 122) wherein the reaction chamber is a U-shaped portion of the microfluidic channel, the U-shaped portion having a larger diameter than that of the remainder of the microfluidic channel (Wunderle; fig. 3. 122, 131).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Godart’s at least one reaction chamber to have a U shaped portion as taught by Wunderle because Wunderle teaches a fluidic device (Wunderle; [0065] “the fluidic device of the disclosure”) that includes microfluidic channels (Wunderle; fig. 3. 131) and at least one reaction chamber (Wunderle; fig. 3. 122) wherein the reaction chamber is a U-shaped portion of the microfluidic channel, the U-shaped portion having a larger diameter than that of the remainder of the microfluidic channel (Wunderle; fig. 3. 122, 131).
This modification allows to create an expansion chamber to hold sample fluid.
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