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 .
Status of Claims
Claims 1-16 remain pending in the application.
Claim Objections
Claims 11, 13, 15 are objected to because of the following informalities:
Claim 11 recites “The device of claim 10, wherein: wherein the device is configured” where it is suggested that the second “wherein” be removed.
Claim 13 recites “wherein the plurality of branch channels for each stem channel having different dimensions.” where it is believed that changing “having” to “have” would help the claim read more smoothly.
Claim 15 recites “the plurality of branch channels for the each stem channel” on line 2 and “the first branch channel is disposed near a first end of the each stem channel” on line 5, and “at the second end of the each stem channel.” on lines 6-7, where the phrasing is awkward. It is suggested to amend the claim to recite:
“the plurality of branch channels for
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 1-16 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.
Claim 1 recites “a second layer having a second set of one or more inlets in fluid communication with stem channels and a plurality of chambers;” on lines 4-5, where it is unclear if these stem channels and plurality of chambers are the same or different from the ones described on lines 2-3.
[0032]-[0033] of the instant specification describes layer 110 having stem channels 130, 140, 150, 160, and 170, and second layer 210 having stem channels 230, 240, 250, 260, and 270.
Additionally, lines 7-8 of claim 1 describe chambers of the first layer and chambers of the second layer.
Therefore, for examination it will be interpreted that the first layer and second layer each have their own set of stem channels and plurality of chambers.
One suggested amendment to the claim is to recite “a second layer having a second set of one or more inlets in fluid communication with a second set stem channels and a second set of plurality of chambers;”
Lines 13-14 recites “wherein each branch channel of each layer is in direct fluid communication with a chamber of the each layer;” where it is unclear if the chamber described on lines 13-14 is the same or different from the plurality of chambers described prior.
For examination, it will be interpreted that they are the same.
One suggested amendment is “wherein each branch channel of each layer is in direct fluid communication with a chamber of the plurality of chambers of the each layer;” or “wherein each branch channel of each layer is in direct fluid communication with [[a chamber]] one of the chambers of the each layer;” where “the” has been removed per the objection supra.
Claims 2-16 are rejected by virtue of being dependent on a rejected claim.
Claim 3 recites “wherein the angle of each branch channel is about 30 to degrees.” where it is unclear if “to” should be deleted or if it was meant to be claiming a range of degrees.
From the instant specification [0038] it describes the angle being about 30-60 degrees.
For examination, it will be interpreted that the angle is about 30 degrees.
Claim 4 is rejected by virtue of being dependent on a rejected claim.
Claim 7 recites “each layer includes five stem channels;” on line 2, where it is unclear if the stem channels are the same or different from the ones described previously.
For examination, it will be interpreted that they are the same.
It is suggested to amend claim 7 to recite “each layer includes five of the stem channels;”
Claims 8-11 are rejected by virtue of being dependent on a rejected claim.
Claim 11 recites “four different agents.” on line 3, where it is unclear if the four different agents are the same or different from the first, second, third, and fourth agents described in claim 10.
For examination, it will be interpreted that they are the same.
Claim 12 recites “each branch channel of each layer is in direct fluid communication with a stem channel and a chamber.” on lines 5-6, where it is unclear if the stem channel and chamber are the same or different from the ones described in claim 1.
For examination, it will be interpreted that they are the same. Where the branch channel in the first layer is in direct fluid communication with the stem channel in the first layer and the chamber in the first layer, and similarly the branch channel in the second layer will be connected with the stem channel and chamber found in the second layer.
Claims 13-14 are rejected by virtue of being dependent on a rejected claim.
Claim 15 recites “the network of inlet channels” on lines 5-6 where there is insufficient antecedent basis for this limitation, as no network of inlet channels has been recited prior.
It is noted that claim 6 is the first instance where a network of inlet channels is referenced.
Therefore, for examination it will be interpreted that claim 15 is dependent on claim 6 rather than claim 2.
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) 1-2, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sandell (US-2014/0096625-A1).
Regarding claim 1, Sandell teaches a microfluidic device comprising:
a first layer (bottom member 210b) having a first set of one or more inlets (reservoir opening 218 and reservoir 214X) in fluid communication with stem channels (main channels 260) and a plurality of chambers (chambers 212) ([0056], Figures 6-7);
a second layer (top member 210a) having a second set of one or more inlets (reservoir opening 218 and reservoir 214Y) in fluid communication with stem channels (main channels 262) and a plurality of chambers (chambers 212) ([0056], Figures 6-7);
the second layer (210a) being disposed above the first layer (210b) so that the first set of inlets (218 and 214X) and the second set of inlets (218 and 214Y) are offset, and the plurality of chambers (212) of the first layer (210a) and the plurality of chambers (212) of the second layer (210a) align and overlap ([0056], Figures 6-7); and
a plurality of wells defined by the aligned the plurality of chambers (212) of the first layer (210b) and the plurality of chambers (212) of the second layer (210a) ([0058] see the chambers 212 in Figure 6 may be configured like the chambers described in Figures 5a-b, [0046] see sample chamber 112 is divided into chamber portions 112a and 112b. As such, there will be chambers in the bottom member 210b and chambers in top member 210a seen in Figure 6 that when put together will define a plurality of wells. Herein the structure formed by the chambers of the top and bottom member will be referred to as wells);
wherein each stem channel (260 and 262) of the first layer (210b) and the second layer (210a) has a plurality of branch channels (branch channels 260a and 262a) in direct fluid communication with each well ([0056], Figure 5b in particular where both branch channels are in direct fluid communication with the well);
wherein each branch channel (260a and 262a) of each layer (210a and 210b) is in direct fluid communication with a chamber (212) of the each layer (210a and 210b) ([0056]);
wherein each branch channel (260a and 262a) is disposed at an angle with respect to a respective stem channel (260 and 262) and a respective chamber (212) of the respective layer (210a and 210b) ([0056] see in particular branch channels 260a and 262a run diagonally off to the chamber 212, Figure 6); and
wherein each well is in direct fluid communication with a respective branch channel (260a) of the first layer (210b) and a respective branch channel (262a) of the second layer (210a) (see Figure 5b which show branch channels of each respective layer being in direct fluid communication with the well).
Regarding claim 2, Sandell teaches the device of claim 1. Sandell further teaches wherein the first layer (210b) and the second layer (210a) are disposed so that the first set of inlets (218 and 214X) of the first layer (210b) are perpendicular to the second set of inlets (218 and 214Y) of the second layer (210a) (Figures 6-7, [0056] see main channel 260 and branch channel 260a are disposed on the bottom part of the microcard hence the dotted lines).
Regarding claim 12, Sandell he device of claim 2, wherein each layer (210a and 210b) includes:
a number of the plurality of chambers (212) corresponds to a number of the plurality of branch channels (260a and 262a) (see Figure 6 where for each of the top and bottom members there are as many branch channels as there are chambers); and
each branch channel (260a and 262a) of each layer (210a and 210b) is in direct fluid communication with a stem channel (260 and 262) and a chamber (212) (Figures 6-7).
Claim Rejections - 35 USC § 103
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(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandell (US-2014/0096625-A1) in view of Bedingham (US-2006/0269451-A1).
Regarding claim 3, Sandell teaches the device of claim 2. While Sandell does teach that both branch channels 260a and 262a run diagonally off to the chambers 212, Sandell does not teach a specific angle.
In the same problem solving area of devices that include conduits that distribute sample materials to a group of process chambers that are located in fluid communication with main conduits, Bedingham teaches where feeder conduits 42 are angled off main conduits 40 to form a feeder conduit angle that is less than 90 degrees and more preferably about 45 degrees (Bedingham; [0008], [0078], Figure 1).
Sandell is silent with regards to specific angle that the branch channels run off to, therefore, it would have been necessary and thus obvious to look to the prior art for conventional angles. Bedingham provides this conventional teaching showing that it is known in the art to use feeder conduit angles of about 45 degrees. Therefore, it would have been obvious to one having ordinary skill in the art to make the angle that the branch channels run off to the chambers to be about 45 degrees because it is taught by Bedingham that this is an effective angle for channels that branch off a main channel to deliver sample to a chamber.
Regarding claim 4, modified Sandell teaches the device of claim 3. Bedingham further teaches wherein the angle is about 45 degrees, see claim 3 supra.
Claim(s) 5-11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandell (US-2014/0096625-A1) in view of Novo (EP-3417931-A1) and Pollack (US-2008/0038810-A1).
Regarding claim 5, Sandell teaches the device of claim 2. While Sandell does teach that there is a plurality of inlets, Sandell does not teach wherein:
the first set of inlets includes a first inlet and a second inlet; and
the second set of inlets includes a third inlet and a fourth inlet.
In the analogous art of microfluidic devices, Novo teaches a microfluidic device that generates a concentration gradient of a soluble out of at least two fluids of different concentration (Novo; [0001]).
Specifically, Novo teaches where a microfluidic device has first and second input lines 12 and 13 that are each connected to a micromixer unit 20, and each have their outlets connected to a common gradient rail (Novo; [0023], Figure 3). There are three mixing stages 10 shown in Figure 3, where in the first stage there are two micromixer units 20, then in the next stage there are three micromixer units 20, and in the following stage there are five micromixer units 20, and the final mixing stage 10 has nine micromixer units 20 that terminate with an output line 16. [0014] describes that the device comprises three or more consecutive mixing stages wherein an output line of the previous mixing stage is feeding into each individual input line of the following mixing sage, where each mixing stage has n input lines and at least n+1 output lines.
The microcard of Sandell is directed to performing nucleic acid amplification on samples of biological material (Sandell; [0022]), where it is taught by Pollack that in a device may perform PCR in several droplets in parallel in which the concentration of one or more buffer components is systematically varied in a series of droplets in order to improve or optimize the buffer for a specific reaction, where once the best of the tested buffer conditions is identified the PCR can proceed using the best buffer system or further optimization may be conducted around the best of the tested buffer systems (Pollack; [0073]).
It would have been obvious to one skilled in the art to modify the reservoirs and fill ports of both the top and bottom members of Sandell to be connected to the gradient tree as taught by Novo, because it is taught by Pollack that it is desirable to improve/optimize the concentration of one or more buffer components in a system (Pollack; [0073]), and therefore the inclusion of the gradient tree of Novo would allow for such optimization/improvement to occur.
The input lines of the gradient tree will now be the first and second set of inlets for the device.
Regarding claim 6, modified Sandell teaches the device of claim 5. Novo further teaches wherein each layer includes:
a network of inlet channels disposed between the respective set of inlets and the stem channels.
Sandell has been modified by Novo such that each of the reservoirs and fill ports of both the top and bottom member are connected to the output line of the gradient tree. Each mixing stage of Novo is a network of inlet channels.
Regarding claim 7, modified Sandell teaches the device of claim 5.
While Figure 6 of Sandell shows there being twenty four reservoirs 214X and sixteen reservoirs 214Y, [0027] states that the present teachings are suitable with any number of reservoirs and sample chambers. Therefore, one skilled in the art would find it obvious that a microcard may have five reservoirs 214X and five reservoirs 214Y.
Additionally, Sandell has been modified by Novo such that each of the reservoirs and fill ports are connected to the output line of the gradient tree, and as such the gradient tree will be in direct fluid communication with each of the main channels 260 and 262 (stem channels).
Regarding claim 8, modified Sandell teaches the device of claim 7. Novo further teaches wherein:
each network of inlet channels includes three generations of inlet channels.
As there are only five reservoirs and fill ports in each layer of Sandell, it is understood that the gradient tree that is connected to the reservoirs and fill ports will go from two micromixer units to three micromixer units to five micromixer units as seen in Figure 3 of Novo, and thus there will be three generations of inlet channels.
Regarding claim 9, modified Sandell teaches the device of claim 8. Novo further teaches wherein the inlet channels have a serpentine shape (Novo; [0011] see micromixer unit comprise a twisted fluid channel, Figure 3).
Regarding claim 10, modified Sandell teaches the device of claim 7.
The limitations of claim 10 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Sandell and the apparatus of modified Sandell is capable of providing five different concentrations of a first agent provided via the first inlet and/or a second agent provided via the second inlet to the stem channels and providing five different concentrations of a third agent provided via the third inlet and/or a fourth agent provided via the fourth inlet to the stem channels. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Sandell (see MPEP §2114).
Additionally, the first, second, third, and fourth agents have not been positively recited in the claim, and are therefore not a part of the claimed device.
Regarding claim 11, modified Sandell teaches the device of claim 10.
The limitations of claim 11 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Sandell and the apparatus of modified Sandell is capable of providing twenty-five different combinations and/or concentrations of four different agents. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Sandell (see MPEP §2114).
Additionally, the four different agents have not been positively recited in the claim and are therefore not a part of the claimed device.
Regarding claim 15, modified Sandell teaches the device of claim 2. Please see 112 section supra regarding claim 15 dependency and the interpretation that claim 15 will depend from claim 6.
Sandell further teaches wherein:
the plurality of branch channels (260a and 262a) for the each stem channel (260 and 262) includes a first branch channel, a second branch channel, a third branch channel, a fourth branch channel, and a fifth branch channel (Sandell; see Figure 7 in particular, where the first branch channel is the one closest to their respective reservoir 214X or 214Y);
Sandell has been modified with Novo such that the output lines of the gradient tree will be connected to each of the reservoirs and fill ports. As such, the first branch channel will be considered the one closest to the reservoir and fill port (thus closest to the gradient tree) and the fifth branch will be at the opposite end.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandell (US-2014/0096625-A1) in view of Sakamoto (US-2014/0311910-A1).
Regarding claim 13, Sandell teaches the device of claim 12. Sandell does not teach wherein the plurality of branch channels for each stem channel having different dimensions.
In the analogous art of microchips, Sakamoto teaches where the microchip is provided with a flow channel formed to supply a liquid to a plurality of analysis areas at the same time (Sakamoto; [0002]).
Specifically, Sakamoto teaches where a microchip 11 includes an inlet part 12, a plurality of analysis areas 13, and a flow channel 14 (Sakamoto; [0055], Figure 1). The flow channel 14 includes a main flow channel 15 connected to the inlet part 12 and a plurality of branch flow channels 16 that are branched from the main flow channel 15 and are connected to each analysis area 13 (Sakamoto; [0069], Figure 1). [0073] describes where the flow channel 14 is formed in a way such that the flow channel resistances in the main flow channel 15 and branch flow channels 16 from the inlet part 12 to each of the analysis areas 13 is substantially the same, where flow channel resistances can be the same by changing the lengths of the branch channels 16 for every branch flow channel 16 by adjusting the widths and depths of the branch flow channels 16. [0091] specifically describes where the width and/or depth of a branch flow channel 16 positioned in the downstream side in the vertical cross-section more than the width and/or depth of a branch flow channel 16 positioned in the upstream side in the vertical cross-section.
It would have been obvious to one skilled in the art to adjust the width and/or depth of the branch channels of Sandell such that they vary from one another as taught by Sakamoto because Sakamoto teaches that by adjusting the width and/or depth it allows liquid to be supplied to multiple analysis areas at the same time, where if liquid is not provided to each analysis area at the same time it causes a fluctuation in the completion time of filling the analysis areas which causes contamination between analysis areas or fluctuation in the amount of the liquid (Sakamoto; [0012], [0106]).
Regarding claim 14, modified Sandell teaches the device of claim 13. Sakamoto further teaches wherein the plurality of branch channels for each stem channel has a different width, see claim 13 supra.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandell (US-2014/0096625-A1), Novo (EP-3417931-A1), and Pollack (US-2008/0038810-A1), and in further view of Sakamoto (US-2014/0311910-A1).
Regarding claim 16, modified Sandell teaches the device of claim 15. Sandell further teaches wherein:
the first branch channel has a width w1;
the second branch channel has a width w2;
the third branch channel has a width w3;
the fourth branch channel has a width w4;
the fifth branch channel has a width w5; and
The branch channels seen in Figure 6 of Sandell will all have widths of some amount.
However, Sandell does not teach:
w1< w2< w3< w4< w5.
In the analogous art of microchips, Sakamoto teaches where the microchip is provided with a flow channel formed to supply a liquid to a plurality of analysis areas at the same time (Sakamoto; [0002]).
Specifically, Sakamoto teaches where a microchip 11 includes an inlet part 12, a plurality of analysis areas 13, and a flow channel 14 (Sakamoto; [0055], Figure 1). The flow channel 14 includes a main flow channel 15 connected to the inlet part 12 and a plurality of branch flow channels 16 that are branched from the main flow channel 15 and are connected to each analysis area 13 (Sakamoto; [0069], Figure 1). [0073] describes where the flow channel 14 is formed in a way such that the flow channel resistances in the main flow channel 15 and branch flow channels 16 from the inlet part 12 to each of the analysis areas 13 is substantially the same, where flow channel resistances can be the same by changing the lengths of the branch channels 16 for every branch flow channel 16 by adjusting the widths and depths of the branch flow channels 16. [0091] specifically describes where the width and/or depth of a branch flow channel 16 positioned in the downstream side in the vertical cross-section more than the width and/or depth of a branch flow channel 16 positioned in the upstream side in the vertical cross-section.
It would have been obvious to one skilled in the art to adjust the width and/or depth of the branch channels of Sandell such that they vary from one another, the width and/or depth being smaller at the inlet side and increase as it moves downstream from the inlet as taught by Sakamoto because Sakamoto teaches that by adjusting the width and/or depth it allows liquid to be supplied to multiple analysis areas at the same time, where if liquid is not provided to each analysis area at the same time it causes a fluctuation in the completion time of filling the analysis areas which causes contamination between analysis areas or fluctuation in the amount of the liquid (Sakamoto; [0012], [0106]).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yamana (US-20014/0272981-A1) teaches a microfluidic device 10 having an array of chambers 12, where each chamber is divided into corresponding cavities 102 and 112 (Yamana; [0074], Figures 1-3).
McBride (US-268219-B1) teaches where a main channel is connected to branches via apertures that progressively increase in diameter along the length of the main channel to allow fluid to more evenly be distributed to the branches (McBride; abstract).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759