DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-20 are pending and are examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 2, 3, 6, 7, 8, 10, 11, 12, 15, 16, 17, 18, 19, and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Takeuchi (EP 2219032).
Regarding Claim 1, Takeuchi teaches the flow cell assembly (a planar lipid bilayer array. See Technical Field) for use in nanopore sequencing (Fig. 4 is a diagram showing a process of rapid decrease in the fluorescent intensity in the microchamber due to the diffusion of fluorescent material (Calcein) into the microchannel through nanopores formed by membrane protein (α-Hemolysin) illustrating the embodiment of the present invention. This is the standard for nanopore) comprising: an array of wells ([0008] Fig. 1 is a conceptual diagram of microchannels having microchambers of a PDMS.), said wells having an inner surface (the microchambers would inherently have an inner surface on the inside of the microchamber), the inner surface of the wells being indented with a plurality of indentations; said indentations extending around the inner recess of said well ([0012] Fig. 1 the microchambers having the apertures are alternately arranged on the both sides of the microchannel 2).
Regarding Claim 2, Takeuchi teaches the flow cell assembly of claim 1, wherein the volumes of polar medium contained in the wells have a convex surface and the membranes have a concave surface (the volumes are directed to intended use of the device).
Regarding Claim 3, Takeuchi teaches the flow cell assembly of claim 1, wherein the indentations have a depth-to-width aspect ratio of between or equal to 1:1 and 10:1 (Fig. 1, apertures have a depth-to-width ratio 1:1 and 10:1. [0007] see [5]).
Regarding Claim 6, Takeuchi teaches the flow cell assembly of claim 1, wherein the indentations extend along the entire length of the inner surface of the wells (see Fig. 1).
Regarding Claim 7, Takeuchi teaches the flow cell assembly of claim 1, wherein the indentations extend outwardly of the wells ([0014] the microchambers having the apertures are alternately arranged on the both sides of the microchannel 2, so that PDMS pillars 4 are aligned in the middle of the main microchannels, imparting a robust structure to the PDMS device 1 to prevent the microchannels from structurally collapsing.).
Regarding Claim 8, Takeuchi teaches the flow cell assembly of claim 1, wherein the wells have a non-circular profile as viewed from the openings of the wells (Fig. 1, microchambers).
Regarding Claim 10, Takeuchi teaches the flow cell assembly of claim 1, wherein the wells constrain volumes of polar medium contained in neighboring wells from contacting each other (the wells are capable of constraining volumes of polar medium).
Regarding Claim 11, Takeuchi teaches the flow cell assembly of claim 1, wherein the membranes comprise nanopores (the membranes are directed to intended use of the device).
Regarding Claim 12, Takeuchi teaches the flow cell assembly of claim 1, further comprising a layer of polar medium extending across the array of wells ([0007] section [9] Fig. 3(a), a phosphate buffer solution 16 containing membrane protein (α-Hemolysin) and fluorescent material (Calcein) is infused into microchannels 14 and microchambers 15 of the PDMS device 13 saturated with water.)
Regarding Claim 15, Takeuchi teaches the flow cell assembly of claim 1, wherein the membranes comprise a bilayer, a monolayer, triblock copolymers, lipids, polymer membranes, or combination thereof (the membranes are directed to intended use of the device).
Regarding Claim 16, Takeuchi teaches the flow cell assembly of claim 1, wherein the wells are capable of containing volumes of polar medium that have an average volume in the range from 0.4 pL to 400 nL (the wells are capable of containing volumes).
Regarding Claim 17, Takeuchi teaches the flow cell assembly of claim 12, wherein the layer of polar medium is in contact with the volumes of polar medium at an interface ([0007] section [9] Fig. 3(a), a phosphate buffer solution 16 containing membrane protein (α-Hemolysin) and fluorescent material (Calcein) is infused into microchannels 14 and microchambers 15 of the PDMS device 13 saturated with water.)
Regarding Claim 18, Takeuchi teaches the flow cell assembly of claim 17, wherein the membranes are present at the interface between the layer of polar medium and the volumes of polar medium ([0007] section [9] Fig. 3(a), a phosphate buffer solution 16 containing membrane protein (α-Hemolysin) and fluorescent material (Calcein) is infused into microchannels 14 and microchambers 15 of the PDMS device 13 saturated with water.)
Regarding Claim 19, Takeuchi teaches the flow cell assembly of claim 1, wherein the array has a regularly repeating pattern of wells (Fig. 1 array of microchambers).
Regarding Claim 20, Takeuchi teaches the flow cell assembly of claim 1, wherein the wells have the same size and shape as one another (see Fig. 1 microchambers are the same size)
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 4, 5, and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Takeuchi (EP 2219032).
Regarding Claims 4 and 5, Takeuchi teaches the flow cell assembly of claim 1.
Takeuchi is silent to the indentations have a width of between or equal to 20 microns and 5 microns and the indentations have a depth of 50 microns and a width of 5 microns.
Regarding the size of the indentations, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 IV. A.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have configured the indentations have a width of between or equal to 20 microns and 5 microns and the indentations have a depth of 50 microns and a width of 5 microns, in the device of Takeuchi to allow for a smaller and more portable device.
Regarding Claim 9, Takeuchi teaches the flow cell assembly of claim 1.
Takeuchi is silent the wells have a circular profile as viewed from the openings of the wells.
Regarding the shape of the profile as viewed from the openings of the wells, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 IVB.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have configured the profile as viewed from the openings of the wells to be circular, in the device of Takeuchi, to allow for a device with a standard circular shape of wells.
Claims 13 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Takeuchi (EP 2219032), in view of O’Connor (US Pub 2005/0003521).
Regarding Claims 13 and 14, Takeuchi teaches the flow cell assembly of claim 1.
Takeuchi is silent to an electrode provided within each well in electrical contact with the respective volumes of polar medium and a common electrode in electrical contact with the layer comprising polar medium.
O’Connor teaches in the related art of array of samples. See Abstract. [0043] an electrode is positioned in a cavity of a microwell.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have added an electrode within each well, as taught by O’Connor, to the array in the assembly as taught by Takeuchi, so that each microwell is capable of forming an "ion bridge" or pathway for the flow of ions between the two sides of the substrate, as taught by O’Connor, in [0043].
Response to Arguments
Applicant's arguments, see pages 4-8, filed 6/30/26 have been fully considered but they are not persuasive.
First, Applicant argues on page 6 that the flow cell assembly comprises indentations placed at the inner surface of the wells.
In response, the examiner notes that the prior art of Takeuchi teaches a microchannel with microchambers and apertures in the microchambers. In Fig. 1, reference numeral 1 denotes a PDMS (Polydimethylsiloxane) device, 2 denotes a microchannel formed in the PDMS device 1, and 3 denotes a microchamber having an aperture alternately arranged on both sides of the microchannel 2. Although the both sides of the microchannel 2 are exemplified as side walls of the microchannel herein, the both sides of the microchannel 2 may refer to top and bottom walls of the microchannel.
The examiner further notes that Takeuchi teaches as shown in Fig. 3(c), a lipid solution (organic solvent (hexadecane) containing phosphatidycoline (PC)) 17 is infused into the microchambers 15 loaded with the phosphate buffer solution 16. Next, as shown in Fig. 3(d), a buffer solution 18 containing no dissolved materials is infused into the microchannels 14. Thereby, as shown in Figs. 3(e) and (f), due to the flow of the buffer solution 18 and the absorption of the organic solvent into the PDMS device, the organic solvent covering the microchambers 15 thins down, and the aperture of the microchamber 15 is sealed with a planar lipid bilayer 19. Note that Fig. 3(d) also shows the broken planar lipid bilayers. The examiner notes that Taekuchi teaches different solutions are placed in the microchannel, microchambers and apertures distinguishing each of these structural elements. Therefore, the rejection is maintained.
Second, Applicant argues on page 7 regarding the 103 rejection that claims 4, 5, and 9 differ from Takeuchi by more than only a recitation of dimensions. Applicant argues that due to the functions provided by the indentations at the inner surface of the wells, a skilled person would expect the claimed flow assembly would perform differently from Takeuchi.
In response, the examiner notes that the function provided by the indentations is directed to intended use of the device. The applicant discusses in arguments regarding claims 4, 5, and 9 about preventing flow of the apolar medium from on the surface of electrode. However, the electrode is not part of the claimed invention for these claims. The prior art of Takeuchi teaches the function of controlled flow in a flow assembly. Takeuchi teaches in Fig. 3(a), a PDMS device 13 is saturated with water by immersing in water 12 in a petri dish 11 for 12 hours or more. This is for preventing water from absorbing into the PDMS device 13 during the operation. Next, as shown in Fig. 3(b), a phosphate buffer solution 16 containing membrane protein (α-Hemolysin) and fluorescent material (Calcein) is infused into microchannels 14 and microchambers 15 of the PDMS device 13 saturated with water. Next, as shown in Fig. 3(c), a lipid solution (organic solvent (hexadecane) containing phosphatidycoline (PC)) 17 is infused into the microchambers 15 loaded with the phosphate buffer solution 16. Next, as shown in Fig. 3(d), a buffer solution 18 containing no dissolved materials is infused into the microchannels 14. Thereby, as shown in Figs. 3(e) and (f), due to the flow of the buffer solution 18 and the absorption of the organic solvent into the PDMS device, the organic solvent covering the microchambers 15 thins down, and the aperture of the microchamber 15 is sealed with a planar lipid bilayer 19. Note that Fig. 3(d) also shows the broken planar lipid bilayers. Therefore, the rejection is maintained.
Applicant’s arguments, see pages bottom of page 7 and page 8, with respect to the rejection under pre-AIA 35 U.S.C. 103(a) in view of Christians have been fully considered. Applicant argues Christians is not available as prior art.
In response, a new ground of rejection is presented citing a new reference. The examiner notes the newly cited reference, O’Connor, US Pub 2005/0003521, teaches an electrode in a cavity of a microwell.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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