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 .
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 1-19 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.
The metes and bounds of the sought microfluidic device are indefinitely defined by way of the recitation “…further wherein waste reservoirs larger than any one of the terminating chambers are excluded from the closed system.”
The sought feature(s) to the microfluidic device is not clearly understood from this recitation which is drawn to a prospective comparison with an element not positively claimed herein (waste chambers of particular volume). Examiner further notes that the claims are couched in open-ended “comprising” language.
Does Applicant intend to positively claim waste chambers of particular relative volume to that of a number of the terminating chambers?
Further, the recitation “the combined volume” in claim 1 and claims 16-18 lacks proper antecedent basis in the claims. Does Applicant intend to recite “a combined volume”?
Claims 2 and 5 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.
The metes and bounds of the sought arrangement of microfluidic device are indefinitely defined herein by the recitation in claim 2 to “…between a linear conduit and a microchamber.” By this recitation, it is unclear if the referenced linear conduit and microchamber are drawn to separate and distinct linear conduit/microchamber from the prior-claimed pluralities thereof in claim 1, or if Applicant intends to single out a particular one of those linear conduits/microchambers of their respective plurality (akin to the recitation to “a siphon conduit of the plurality of siphon conduits.”
Clarification is required.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1 and 3, as best understood, is/are rejected under 35 U.S.C. 102a as being anticipated by Kwang (US 2016/0310949).
With regard to claim 1, Kwang discloses a microfluidic device 200 comprising an inlet port 211 and a closed system fluidically coupled to the inlet port wherein the closed system comprises a plurality of linear loading conduits 226, a plurality of terminating chambers 222, a terminating chamber of the plurality of terminating chambers fluidically coupled to a linear loading conduit of the plurality of linear loading conduits, and pluralities of microchambers 214 (i.e. given by groups thereof, see fig. 2 and the individual lanes) for receiving the sample, a plurality of microchambers of the pluralities of microchambers fluidically coupled to a linear loading conduit of the plurality of linear loading conduits (pars.[0043-0045]; figs. 2B-F, for example). Kwang further discloses wherein, with respect to a first plurality of microchambers 214 and a first terminating chamber 222 fluidically coupled to a same proximate linear loading conduit, a volume of the first terminating chamber is equal to or less than that the combined volume of the first plurality of microchambers (i.e. the volume is less as chambers 50 are of a same volume and the terminating chamber thereof thereby has a lesser volume than a combined volume of a first plurality of microchambers) and further wherein waste reservoirs larger than any one of the terminating chambers are excluded from the closed system (see fig. 2B,C, for example).
With regard to claim 3, Kwang discloses a volume of the terminating chamber is larger than a volume of a microchamber of the plurality of microchambers (as seen through fig. 2B, and wherein the terminating chamber is provided for collecting the prior fluid partitions; see pars.[0041,0043]).
Claim(s) 1 and 7-10 as best understood, is/are rejected under 35 U.S.C. 102a as being anticipated by Dufresne et al. (US 2013/010980), hereafter Dufresne.
With regard to claim 1, Dufresne discloses a microfluidic device 10 comprising an inlet port 32 and a closed system fluidically coupled to the inlet port wherein the closed system comprises a plurality of linear loading conduits 40, a plurality of terminating chambers 50 (those at the distal end from that of the inlet 32 in fig. 1), a terminating chamber of the plurality of terminating chambers 50 fluidically coupled to a linear loading conduit 40 of the plurality of linear loading conduits, and pluralities of microchambers 50 (those chambers, and being in multiple groups thereof, proximal to the inlet port and proximal the distal terminating chambers) for receiving the sample, a plurality of microchambers of the pluralities of microchambers fluidically coupled to a linear loading conduit of the plurality of linear loading conduits (pars.[0032-0048], fig. 1, for example). Dufresne further discloses wherein, with respect to a first plurality of microchambers and a first terminating chamber fluidically coupled to a same proximate linear loading conduit, a volume of the first terminating chamber is equal to or less than that the combined volume of the first plurality of microchambers (i.e. the volume is less as chambers 50 are of a same volume and the terminating chamber thereof thereby has a lesser volume than a combined volume of a first plurality of microchambers) and further wherein waste reservoirs larger than any one of the terminating chambers are excluded from the closed system (see fig. 1, for example).
With regard to claims 7-10, Dufresne discloses wherein the device further comprises a thin film (deformable seal 16) applied to the device and wherein the thin film forms a surface of the closed system, and the surface of the thin film provides an outer surface of the pluralities of microchambers, and an outer surface of the plurality of linear loading conduits (par.[0044], fig. 3, for example).
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.
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.
Claim(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwang in view of Chiu et al. (WO 2017/008954), hereafter Chiu.
Kwang has been discussed above.
With regards to claims 2 and 5, Kwang does not specifically disclose a plurality of siphon conduits, a siphon conduit of the plurality of siphon conduits fluidically coupled between a linear loading conduit and a microchamber, and that a first dimension of the linear loading conduit and of the siphon conduit is less than about 10 microns.
Chiu discloses devices for self-digitization of samples (abstract). Chiu discloses a plurality of siphon channels 206, a siphon channel 206 of the plurality fluidically coupled between a linear loading conduit 200 and a chamber 202, wherein the siphon channel controls filling rate of the chamber and/or the completeness of filling (par.[0039,0054], fig. 2, for example). Chiu further discloses that a first dimension of the linear loading conduit and of the siphon conduit is less than about 10 microns (par.[0064] to the range of approximately 10 microns to 200 microns that overlaps concordantly).
It would have been obvious to one of ordinary skill in the art to modify Kwang to provide a plurality of siphon conduits, a siphon conduit of the plurality of siphon conduits fluidically coupled between a linear loading conduit and a microchamber, and that a first dimension of the linear loading conduit and of the siphon conduit is less than about 10 microns such as suggested by Chiu in order to provide conduits that afford the ability to control filling rate of the chamber(s) and/or the completeness of the filling, and wherein a first dimension of the linear loading conduit and siphon channel being less than about 10 microns represents an obvious dimensioning for providing a likewise-desired microfluidic fluid digitization device as in Kwang that would have a reasonable expectation of success therein.
Claim(s) 4, 6, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwang in view of Chiu.
Kwang has been discussed above.
With regards to claims 4 and 6, Kwang does not specifically disclose that the volume of the terminating chamber is at least about 4 times the volume of the microchamber, and a microchamber of the plurality of microchambers has a first dimension of at least about 100 microns. With regards to claims 16-18, Kwang does not specifically disclose the volume of the first terminating chamber is equal to or less than fifty percent of the combined volume of the first plurality of microchambers, and likewise with respect to twenty five percent and ten percent as particularly recited in cls. 17 and 18.
Kwang discloses that the skilled artisan will appreciate that the relative size and shape of the device can be varied based upon user requirements, and regardless of dimensioning, the device is configured to enable on board processes as in sample concentration adjustment, partition preparation for PRC, partition generation, and the like (par.[0070]).
Chiu discloses devices for self-digitization and discretizing of samples (abstract; par.[0003]). Chiu discloses a plurality of terminating chambers 314, a terminating chamber 314 being fluidically coupled to a linear loading conduit 304 (pars.[0067-0069], fig. 3A,B, for example), and wherein the showing in fig. 3A appears to reasonably show the terminating chamber having a volume at least about 4 times the volume of the microchamber 306 (therein, four microchambers 306 approximately align to an individual terminating chamber 314), and fig. 3A also reasonably provides to show a volume of the first terminating chamber is equal to or less than 10% the combined volume of the first plurality of microchambers (10% or less encompassing that of 50% or less and 25% or less as in cls. 16&17) wherein twelve rows of four microchambers are provided per terminating chamber (i.e. the first terminating chamber reasonably representing 4/48 of combined volume, as in about 8% of the combined volume of a first plurality), and wherein Chiu discloses dimensioning of the fluidic elements to increase flow resistance so as to improve control and consistency in the flow and filling (par.[0050]). Chi further discloses that a depth, as in a first dimension, of features of the microfluidic device (e.g. channels and compartments/chambers) may be of at least 100 microns (pars.[0067,0068]).
It would have been obvious to one of ordinary skill to modify Kwang to provide a volume of the terminating chamber is at least about 4 times the volume of the microchamber, a volume of the first terminating chamber is equal to or less than fifty percent of the combined volume of the first plurality of microchambers, and likewise with respect to twenty five percent and ten percent such as suggested by the analogous prior art of Chiu to devices for self-digitization and discretizing samples through routine optimization and engineering of the channel and chamber dimensions in which it seen through Kwang and Chiu that the terminating chamber(s) is to be larger than the upstream microchambers, and Chiu teaches toward and reasonably conveys a terminating chamber is at least about 4 times the volume of the microchamber so as to optimize for a desired collection reservoir sufficient for collecting a totality of the volume processed therethrough and desired to be held for further processing, and a volume of the first terminating chamber is equal to or less than 10% the combined volume of the first plurality of microchambers so as to optimize for flow control to the collection end by having a relatively higher resistance to flow given by the 10% or less volume terminating chamber. And further, it would have been obvious to one of ordinary skill in the art to modify Kwang to provide a microchamber of the plurality of microchambers has a first dimension, as in a depth, of at least about 100 microns such as suggested by the analogous prior art of Chiu in providing an obvious engineering design choice to a likewise desired microchamber for microfluidic sample processing and would have a reasonable expectation of success therein.
Further, see MPEP 2144.05 II, A – and “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore to the above, the choosing of the claimed dimensioning and relative sizing is said to be drawn to obvious engineering for the reasons discussed above and having a reasonable expectation of success in Kwang and further, wherein outside a showing of a criticality or unexpected results arising otherwise.
Claim(s) 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwang in view of Clime et al. (US 2022/0333181), hereafter Clime.
Kwang has been discussed above.
With regards to claims 7-10, Kwang does not specifically disclose a thin film applied to the device and wherein the thin film forms a surface of the closed system, and the surface of the thin film provides an outer surface of the pluralities of microchambers, and an outer surface of the plurality of linear loading conduits. With regards to claims 11 and 12, Kwang does not specifically disclose that the thin film has a thickness between about 70 and 90 microns, or as in 80 microns.
Clime discloses a microfluidic chip kit for displacing independent reaction volumes of an emulsion (abstract). Clime discloses that the substrate and its network of chambers and interconnecting channels is provided in a relief pattern that is sealed with a covering film, and having a thickness between about 70 to 90 microns, and as in 80 microns, and discloses providing visual or optical investigation of the channels/chambers (pars.[0030,0031,0072], for example).
It would have been obvious to one of ordinary skill in the art to modify Kwang to provide a thin film applied to the device and wherein the thin film forms a surface of the closed system, and the surface of the thin film provides an outer surface of the pluralities of microchambers, and an outer surface of the plurality of linear loading conduits, and the thin film has a thickness between about 70 and 90 microns, or as in 80 microns such as suggested by the analogous art of Clime to a microfluidic chip for displacing independent reaction volumes so as to suitably provide a protective cover that is also particularly thin to afford optical and visual detection of the channels and chambers that would be appreciated by Kwang (see par.[0041]).
Claim(s) 13-14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwang in view of Clime, as applied to claims 7-12 above, and in further view of Lin et al. (US 2020/0384471), hereafter Lin.
With regards to claims 13 and 14, Kwang/Clime does not specifically disclose that the thin-film comprises a gas-permeable thermoplastic material that is not permeable to the sample. With regard to claim 19, Kwang/Clime does not specifically disclose the microfluidic device comprising an injection-molded thermoplastic material.
Lin discloses a microfluidic array for sample digitization (abstract). Lin discloses a microfluidic device formed from a thermoplastic that allows for inexpensive and highly scalable injection molding processes, and including a thin, gas permeable membrane film (i.e. within the likewise, prior claimed 70-90 and 80microns) that provides the ability to outgas and avoiding fouling problems that covers the fluid flow path, channel, and chamber, and is not permeable to the sample which is impermeable to the liquid sample (pars.[0008,0052,0069]).
It would have been obvious to one of ordinary skill in the art to modify Kwang/Clime to provide a thin-film comprising a gas-permeable thermoplastic material that is not permeable to the sample and the microfluidic device comprising an injection-molded thermoplastic material such as suggested by the analogous art of Lin to a microfluidic array for sample digitization so as to provide a thin film that affords outgassing and avoiding fouling problems in the microfluidic device and being impermeable to the sample so as to avoid undesired sample loss, and wherein the microfluidic device comprises an injection molded thermoplastic affords an inexpensive and highly scalable material for manufacturing.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwang in view of Clime and Lin, as applied to claims 13-14, and 19 above, and in further view of Linder et al. (US 2011/0256551), hereafter Linder.
With regard to claim 15, Kwang/Clime/Lim does not specifically disclose that the gas-permeable thermoplastic material comprises a cyclic olefin copolymer.
Linder discloses microfluidic systems and devices for sample handling and analysis (abstract). Linder discloses that the cassette may include a cover in the form of a biocompatible adhesive that can be made of cyclic olefin copolymer (par.[0059]).
It would have been obvious to one of ordinary skill in the art to modify Kwang/Clime/Lim to utilize a gas-permeable thermoplastic material as a cyclic olefin copolymer such as suggested by the analogous prior art of Linder to microfluidic systems and devices for sample handling and analysis in order to provide an obvious particular one of a thermoplastic material that suitably provides a biocompatible cover as likewise desired in Kwang/Clime/Lim and would have a reasonable expectation of success therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798
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