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 .
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, 7, 9, 14 and 16 – 18 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mishra et al. (WO 2018/033609 A1; hereinafter “Mishra”).
Regarding claim 1, Mishra teaches a microfluidic differential extraction device (a microfluidic disk device; page 7, lines 6 – 9; figures 1 – 7) comprising:
a first fluidic layer (layers defined by B, C; figures 2 and 7);
a second fluidic layer (layers defined by F and G; figures 2 and 7);
a valving layer disposed between the first and second fluidic layers, the valving layer having multiple valves (layers defined by D and E (figures 2 and 7); layer E comprises valves (page 14, lines 6 – 7); layer E is provided that contains the first and second sacrificial membranes 4 and 13, and a membrane support layer D is provided on top of layer E (page 13, lines 5 and 6); a valve comprises a first sacrificial membrane 4 (page 13, lines 22 and 23); and a valve comprising sacrificial membrane 13);
a plurality of reagent chambers extending through the layers (a reagent chamber is defined as holding fluid between markings 4 and 7 in figure 4, and shown extending through layers C and D in figure 7);
a sample chamber extending through the layers (the sample chamber defined by lowermost chamber in figure 6, is shown extending through layers B, C, D, E, F and G in figure 7);
a plurality of recovery chambers extending through the layers (the chamber at 17 formed in layers C and D as shown in figures 2 and 7, wherein a plurality of chambers is disclosed); and
microfluidic channels formed in the first fluidic layer and the second fluidic layer that selectively couple the reagent chambers to the sample chamber and the sample chamber to the recovery chamber in response to actuation of the valves (the channels in the first layer as shown in layer B in figure 7; in the second flujdic layer as indicated in layer G as shown in figure 7, the channels connect the chambers as shown in figure 5, wherein the actuation of the valves 4 and 13 allow for fluid to flow between the channels).
Mishra teaches that the disclosed system can be used for point-of-care diagnostics for disease diagnosis and monitoring, which implicitly incorporate the use of PCR and DNA processing (page 1, lines 10 – 15).
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Regarding claim 2, Mishra teaches the device of claim 1, and further comprising top and bottom layers sandwiching the first and second fluidic layers and valving layers (e.g., layers A and H; figures 6 and 7).
Regarding claim 6, Mishra teaches the device of claim 1, wherein the layers are disc shaped about a central axis and wherein the chambers and microfluidic channels are configured to move fluid in response to spinning of the layers about the central axis (in an embodiment in which the microfluidic device is a disk, the device comprises a turn-table for spinning them microfluidic deice to generate centrifugal force (page 7, lines 6 – 9); a rotary drive for a turn-table is provided for moving fluid with centrifugal force (page 8, line 33 to page 9, line 32)).
Regarding claim 7, Mishra teaches the device of claim 1, and further comprising means for moving fluid between the chambers (in an embodiment in which the microfluidic device is a disk, the device comprises a turn-table for spinning them microfluidic deice to generate centrifugal force (page 7, lines 6 – 9); a rotary drive for a turn-table is provided for moving fluid with centrifugal force, and including micropumps (page 8, line 33 to page 9, line 32)).
Regarding claim 9, Mishra teaches the device of claim l, wherein the fluidic layers are transparent and the valves in the valve layer are capable of being actuatable via heat provided by a laser (these recited layer materials and functional capability are implicit wherein the various device layers can be made of light-transmitting PMMA (poly(methyl methacrylate)), which can therefore enable valve actuation via heat provided by a laser; page 17, lines 13 – 15).
Regarding claim 14, as discussed above for the rejection of claim 1, Mishra teaches all of the positively recited structure of the claimed system, wherein claim 14 merely recites the conventional operation of the disclosed system. Therefore, Mishra teaches a method of performing differential extraction of DNA from a sample, the method comprising:
placing the sample in a sample chamber (a sample chamber extending through the layers wherein the chamber is defined by lowermost chamber in figure 6, is shown extending through layers B, C, D, E, F and G in figure 7);
filling reagent chambers with reagent (a reagent chamber is defined as holding fluid between markings 4 and 7 in figure 4, and shown extending through layers C and D in figure 7);
and iteratively, for each reagent chamber and a corresponding recovery chamber (multiple chambers and interconnecting channels are shown and taught (reagent chambers 6; figures 1 and 6); a sample chamber defined by a chamber formed above and below film 4 (figures 1 and 5); recovery chambers defined by chambers connected to a chamber at 4 (figures 4 and 5); valves 4 and 13 can be actuated sequentially or iteratively in order to control fluid between chambers);
transferring reagent from the reagent chamber (a reagent chamber is defined as holding fluid between markings 4 and 7 in figure 4, and shown extending through layers C and D in figure 7) to the sample chamber to react with the sample (the sample chamber defined by lowermost chamber in figure 6, is shown extending through layers B, C, D, E, F and G in figure 7); and
transferring material from the sample chamber to the corresponding recovery chamber (a plurality of recovery chambers extending through the layers (the chamber at 17 formed in layers C and D as shown in figures 2 and 7, wherein a plurality of chambers is disclosed).
Regarding claim 16, Mishra teaches the method of claim 14, wherein transferring reagent or material comprises spinning the layers about a central axis of the layers (in an embodiment in which the microfluidic device is a disk, the device comprises a turn-table for spinning them microfluidic deice to generate centrifugal force (page 7, lines 6 – 9); a rotary drive for a turn-table is provided for moving fluid with centrifugal force (page 8, line 33 to page 9, line 32)).
Regarding claim 17, Mishra teaches the method of claim 14, and further comprising actuating a valve prior to transferring reagent or material (the disclosed system comprises a valving layer disposed between the first and second fluidic layers, the valving layer having multiple valves (layers defined by D and E (figures 2 and 7); layer E comprises valves (page 14, lines 6 – 7); layer E is provided that contains the first and second sacrificial membranes 4 and 13, and a membrane support layer D is provided on top of layer E (page 13, lines 5 and 6); a valve comprises a first sacrificial membrane 4 (page 13, lines 22 and 23); and a valve comprising sacrificial membrane 13).
Regarding claim 18, Mishra teaches the method of claim 17, wherein actuating the valve comprises heating the valve by a laser (the various device layers can be made of light-transmitting PMMA (poly(methyl methacrylate)), which can therefore enable valve actuation via heat provided by a laser; page 17, lines 13 – 15).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (WO 2018/033609 A1; hereinafter “Mishra”) in view of Kido (US 2007/0125942 A1; hereinafter “Kido”).
Regarding claim 8, Mishra does not specifically teach the device of claim l, and further comprising multiple separate sets of chambers, microfluidic channels, and valves disposed in the first and second fluidic and valve layers.
Mishra does teach that the disclosed system can comprise a disk comprising various chambers (page 7, lines 6 – 9; figure 6).
Kido further teaches a microfluidic disk system platform pattern comprising multiple sets of microfluidic channels and separation units (paragraphs 49; figure 5). Consequently, as shown by Kido, this type of microfluidic disk configuration would have been considered to be a suitable and predictable alternative to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide multiple separate sets of chambers, microfluidic channels, and valves disposed in the first and second fluidic and valve layers to allow for the efficient and effective processing of multiple samples.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (WO 2018/033609 A1; hereinafter “Mishra”) in view of Kulinsky et al. (US 2016/0167045 A1; hereinafter “Kulinsky”).
Regarding claim 15, Mishra teaches a system comprising:
an assembly including first and second fluidic layers (a first layer defined by layers B and C (figures 6 and 7); and a second layer defined by layers F and G) sandwiching a valve layer (a valve layer defined by layers D and E (figures 6 and 7); layer E comprises valves (page 14, lines 6 and 7); layer E is provided that that contains the first and second sacrificial membranes 4 and 13, and a membrane support layer D is provided on top of layer E (page 13, lines 5 and 6); a valve comprising a first sacrificial membrane 4 (page 13, lines 22 and 23); a valve having a second sacrificial membrane 13) and having multiple chambers and microfluidic channels positioned to sequentially control fluid flow between multiple reagent chambers and a sample chamber and between the sample chamber and multiple recovery chambers (multiple chambers and interconnecting channels are shown and taught (reagent chambers 6; figures 1 and 6); a sample chamber defined by a chamber formed above and below film 4 (figures 1 and 5); recovery chambers defined by chambers connected to a chamber at 4 (figures 4 and 5); valves 4 and 13 can be actuated sequentially in order to control fluid between chambers);
a laser positioned to project light onto the valve layer to actuate multiple valves disposed between the microfluidic channels (top layer A is formed from light transmitting PMMA which allows laser light to pass through layer A and onto film 13 to rupture the film and effect the movement of liquid; page 17, lines 13 – 15); and
a motor coupled to the assembly to rotate the assembly to move fluid within the assembly (the microfluidic disk device comprises a turn-table which comprises a rotary drive motor to rotate the turn-table; page 7, lines 6 – 9).
Mishra teaches that the disclosed system can be used for point-of-care diagnostics for disease diagnosis and monitoring, which implicitly incorporate the use of PCR and DNA processing (page 1, lines 10 – 15).
Mishra does not specifically teach a controller coupled to the laser and the motor to control movement of the fluid and provide centrifugal force to facilitate separation of DNA in the fluid.
Kulinsky teaches a controller that can be used to control rotation speed and other components in a microfluidic system comprising a computing device 66, wherein the computing device can be programmed the rotation and other rotational parameters of the disc drive 62 (paragraph 59). The computing device 66, and/ore disc drive 62 and other device components, can be separate components of the microfluidic system 60, or any one or more of the components can be integrated together. Consequently, as shown by Kulinsky, this type of microfluidic disk configuration comprising a controller would have been considered to be a suitable and predictable alternative to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a controller coupled to the laser and the motor to control movement of the fluid and provide centrifugal force to facilitate separation of DNA in the fluid so as to allow for the efficient and effective processing of samples for DNA analysis.
Allowable Subject Matter
Claim 3 – 5, 10 – 13, 19 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, Mishra and the additional cited prior art neither teach nor fairly suggest the device of claim 2, and further comprising accessory pieces to couple to the top layer and extend the reagent, sample, and recovery chamber volume.
Regarding claim 5, Mishra and the additional cited prior art neither teach nor fairly suggest the device of claim 1, wherein the microfluidic channels include main channels formed in arcs of increasing radius from a center axis of the device.
Regarding claim 10, Mishra and the additional cited prior art neither teach nor fairly suggest the device of claim l, wherein the valves in the valve layer are disposed between corresponding microfluidic channels extending in the first and second fluidic layers from the reagent chambers and recovery chambers.
Regarding claim 11, Mishra and the additional cited prior art neither teach nor fairly suggest the device of claim l, wherein the valves between the reagent chambers and the sample chamber are disposed to control fluid flow through feeder channels formed in the first and second fluidic layers.
Regarding claim 12, Mishra and the additional cited prior art neither teach nor fairly suggest the device of claim l, wherein the valves are controllable to sequentially fill the sample chamber and empty contents of the sample chamber into a corresponding recovery chamber.
Regarding claim 19, Mishra and the additional cited prior art neither teach nor fairly suggest the system of claim 15, wherein the valves in the valve layer are disposed to control fluid flow through feeder channels formed in the first and second fluidic layers.
Regarding claim 20, Mishra and the additional cited prior art neither teach nor fairly suggest the system of claim 15, wherein the valves are controllable to sequentially fill the sample chamber and empty contents of the sample chamber into a corresponding recovery chamber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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