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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 JUNE 2026 has been entered.
Status of Claims
The claim set submitted with the RCE is acknowledged. In the claim set, Claims 1, 16, 18 are ‘Currently Amended’; Claims 2-15, 17 and 19 are ‘Original’ or ‘Previously Presented’; Claims 20-23 are ‘New’.
Currently pending claims are Claims 1-23 and are considered on the merits below.
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 22 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by PANASONIC, JPWO 2017154349 A1 ( as previously cited in the prior Office Action).
Applicant’s invention is directed towards a device.
Regarding Claim 22, the PANASONIC reference discloses a nucleic acid extraction container, abstract, comprising:
a filter part, Figure 4, filter 41, page 5, comprising a hydrophilic filter for collecting biological materials containing a nucleic acid from a sample, Figure 4, filter 41 is made of polyethersulfone, page 5, a biological material collection area for collecting the biological materials on the hydrophilic filter, page 5, filter 41 is for capturing and holding nucleic acid, page 2, ‘Description’ , and a sample permeation area for allowing a passage of the sample having permeated through the hydrophilic filter, Figure 4, support 42 is eye plate, page 5; a sample injection port that communicates with the biological material collection area, Figure 4, inlet 21, page 4; an air communication port that communicates with the biological material collection area, Figure 6B, inlet 22, page 4-5; and a sample discharge port that communications with the sample permeation area, Figure 4, outlet 31, page 5, wherein the air communication port is configured so as to be outwardly openable and closable, and the biological material collection area is configured as a channel having an elongated shape in a direction of fluid flow which is substantially perpendicular to the normal of the hydrophilic filter, Figure 4, capturing unit 40 which comprises main body 41 and support 42 has elongated shape, page 4 and 5, wherein the filter part is formed on a lower surface of the substrate, the hydrophilic filter is fixed by a pressing plate in the sample permeation area, Figure 3 and 4, see plate on top of container portion 12:
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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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over PANASONIC, JPWO 2017154349 A1 ( as previously cited in the prior Office Action) and further in view of GLAZIER, US Publication No. 2010/0189603 A1.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the PANASONIC reference discloses a nucleic acid extraction container, abstract, comprising:
a filter part, Figure 4, filter 41, page 5, comprising a hydrophilic filter for collecting biological materials containing a nucleic acid from a sample, Figure 4, filter 41 is made of polyethersulfone, page 5, a biological material collection area for collecting the biological materials on the hydrophilic filter, page 5, filter 41 is for capturing and holding nucleic acid, page 2, ‘Description’ , and a sample permeation area for allowing a passage of the sample having permeated through the hydrophilic filter, Figure 4, support 42 is eye plate, page 5; a sample injection port that communicates with the biological material collection area, Figure 4, inlet 21, page 4; an air communication port that communicates with the biological material collection area, Figure 6B, inlet 22, page 4-5; and a sample discharge port that communications with the sample permeation area, Figure 4, outlet 31, page 5, wherein the air communication port is configured so as to be outwardly openable and closable, and the biological material collection area is configured as a channel having an elongated shape in a direction of fluid flow which is substantially perpendicular to the normal of the hydrophilic filter, Figure 4, capturing unit 40 which comprises main body 41 and support 42 has elongated shape, page 4 and 5.
The PANASONIC reference discloses the claimed invention, but is silent in regards to wherein the filter is fixed by placing silicone rubber on the sides of the long side of the filter.
GLAZIER discloses a container, Figure 12, comprising: a filter part comprising a filter, [099, 0100], filter 82, for collecting biological materials, [0005], a biological material collection area for collecting the biological materials on the filter, and a sample permeation area for allowing a passage of the sample having permeated through the filter, Figure 12, [0099, 0100]; a sample injection port that that communicates with the biological material collection area, Figure 12, entry point at 75a or 75b; a sample discharge port that communicates with the sample permeation area, Figure 12, ‘waste’, [0095], wherein the filter is fixed in place by placing two silicon rubbers on both side of the long side of the filter, Figure 12, [0100], filter 82 is sandwiched between opposing PDMS molds.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the invention of PANASONIC with the structure of the filter as taught by GLAZIER to create a tight seal under both thermal expansion or vibration.
Additional Disclosures Included are: Claim 2: wherein the nucleic acid extraction container according to claim 1,wherein the hydrophilic filter extends along the channel of the biological material collection area, Figure 4, see how main body/filter 41 extends along support 42 area. ; Claim 3: wherein the nucleic acid extraction container according to claim 1, wherein the sample injection port and the air communication port are arranged on opposite sides of each other across the biological material collection area, Figure 6B, port 22 and 21 are on opposite , left to right, sides of 40/41/42.; Claim 4: wherein the nucleic acid extraction container according to claim 1, further comprising: a first channel that communicates the sample injection port with the biological material collection area; a second channel that communicates the sample discharge port with the sample permeation area; and a third channel that communicates the air communication port with the biological material collection area, Figure 4 and 6B, ports 21/22/31, page 4-5.; Claim 5: wherein the nucleic acid extraction container according to claim 4, wherein the first channel and the third channel extend on opposite sides of each other across the biological material collection area, Figure 6B, port 22 and 21 are on opposite , left to right, sides of 40/41/42.; Claim 6: wherein the nucleic acid extraction container according to claim 1, wherein the air communication port serves as a nucleic acid extraction solution injection port, Figure 2, ports 21/22 are at the same location.; Claim 7: wherein the nucleic acid extraction container according to claim 4, further comprising: a nucleic acid extraction solution injection port; and a first branch channel that communicates with the nucleic acid extraction solution injection port, wherein the first branch channel is connected to the third channel, Figure 11, page 11, ports connected to containers 200/300. ; Claim 8: wherein the nucleic acid extraction container according to claim 4, further comprising: a nucleic acid extraction solution outlet; and a second branch channel that communicates with the nucleic acid extraction solution outlet, wherein the second branch channel is connected to the third channel, Figure 11, page 11, pipes 5b, 2b.; Claim 9: wherein the nucleic acid extraction container according to claim 8, further comprising: an air injection port; and a third branch channel that communicates with the air injection port, wherein the third branch channel is connected to the third channel, Figure 11.; Claim 10: wherein the nucleic acid extraction container according to claim 9, wherein a region of the third channel between a connection position of the second branch channel and the third channel and a connection position of the third branch channel and the third channel is formed so as to dispense a predetermined amount of an extraction solution, Figure 11, page 11, valve 600 controls flow.; Claim 11: wherein the nucleic acid extraction container according to claim 4, wherein a nucleic acid extraction solution is enclosed in the third channel, and air is enclosed between a region where the nucleic acid extraction solution is present and the filter part, Figure 4, pages 4-6.; Claim 12: wherein the nucleic acid extraction container according to claim 7, wherein a nucleic acid extraction solution is enclosed in the first branch channel, and air is enclosed between a region where the nucleic acid extraction solution is present and the filter part, enclosed between a region where the nucleic acid extraction solution is present and the filter part, Figure 4, pages 4-6.; Claim 13: wherein the nucleic acid extraction container according to claim 9, wherein a nucleic acid extraction solution is enclosed in the third branch channel, and air is enclosed between a region where the nucleic acid extraction solution is present and the filter part, Figure 6C.; and Claim 15: wherein the nucleic acid extraction container according to claim 1, wherein the filter part is formed such that the presence or absence of a sample on the hydrophilic filter is visible from the outside, Figure 9, page 10, container at least is made of transparent material.; Claim 20: wherein the nucleic acid extraction container of claim 1, further comprising a substrate, wherein the filter part is formed on an upper surface of the substrate, and the biological material collection area is positioned between the two silicone rubbers, PANASONIC Figure 4, container 12 is considered to be a substrate in which filter is formed on. ; and Claim 21: wherein the nucleic acid extraction container of claim 1, further comprising a substrate, wherein the filter part is formed on a lower surface of the substrate, and the sample permeation area is positioned between the two silicone rubbers, PANASONIC Figure 4, part 11 is considered to be a substrate.
Applicant’s invention is directed towards a method of using claim 1.
Regarding Claim 16, the PANASONIC reference discloses a nucleic acid extraction method, page 2, method for extracting nucleic acid, by using the nucleic acid extraction container of claim 1, see Rejection above of Claim 1, comprising:
passing a sample through a filter part provided with a hydrophilic filter, Figure 4, filter 41 is made of polyethersulfone, page 5, and a biological material collection area for collecting biological materials containing a nucleic acid on the hydrophilic filter, wherein the biological material collection area is configured as a channel having an elongated shape in a direction of fluid flow along a biological material collection surface of the hydrophilic filter, page 6, ‘Capture process’, Step S1, Figure 4, capturing unit 40 which comprises main body 41 and support 42 has elongated shape, page 4 and 5;
and collecting the biological materials containing a nucleic acid on the hydrophilic filter, page 6, ‘Capture process’ , ‘As shown in Figure 6A, the specimen 210 that has passed through…It is collected…’;
putting a nucleic acid extraction solution in the filter part biological material collection area, page 6, ‘Capture process’, Step S1, and extracting the nucleic acid on the hydrophilic filter; and collecting a solution containing the nucleic acid extracted on the hydrophilic filter, page 6-7, ‘Capture process’ and ‘Nucleic acid extraction step’ , ‘As shown in Figure 6A, the specimen 210 that has passed through…It is collected…’.
Additional Disclosure Included is: Claim 17: wherein the nucleic acid extraction method according to claim 16, wherein the extraction of the nucleic acid on the hydrophilic filter is performed by bringing the nucleic acid extraction solution into contact with a portion of the hydrophilic filter and moving the nucleic acid extraction solution in the channel of the biological material collection area that an entire surface of the hydrophilic filter comes into contact with the nucleic acid extraction solution, page 6-7, ‘Capture process’ and ‘Nucleic acid extraction step’.
Applicant’s invention is directed towards a method of using claim 1.
Regarding Claim 18, the reference PANASONIC discloses a nucleic acid extraction method, page 2, method for extracting nucleic acid, by using the nucleic acid extraction container of claim 1, see Rejection above of Claim 1, comprising:
passing a sample through a filter part , page 6-7, ‘Capture process’ , provided with a hydrophilic filter, , Figure 4, filter 41 is made of polyethersulfone, page 5, and a biological material collection area for collecting biological materials containing a nucleic acid on the hydrophilic filter, wherein the biological material collection area is configured as a channel having an elongated shape in a direction of fluid flow which along a biological material collection surface of the hydrophilic filter, page 6, ‘Capture process’, Step S1, Figure 4, capturing unit 40 which comprises main body 41 and support 42 has elongated shape, page 4 and 5, and
collecting the biological materials containing a nucleic acid on the hydrophilic filter, page 6, ‘Capture process’ , ‘As shown in Figure 6A, the specimen 210 that has passed through…It is collected…’;
putting a nucleic acid extraction solution in the filter part biological material collection area, page 6, ‘Capture process’, Step S1, and
extracting the nucleic acid on the hydrophilic filter, page 6-7, ‘Capture process’ and ‘Nucleic acid extraction step’ , ‘As shown in Figure 6A, the specimen 210 that has passed through…It is collected…’. ;
moving a solution containing the nucleic acid extracted on the hydrophilic filter into a channel communicating with the filter part, page 6-7, ‘Capture process’; and
dispensing the solution containing the nucleic acid by injecting air in the channel, page 7, ‘Nucleic acid extraction step’.
Additional Disclosure Included is: Claim 19: wherein the nucleic acid extraction method according to claim 18, wherein the extraction of the nucleic acid on the hydrophilic filter is performed by bringing the nucleic acid extraction solution into contact with a portion of the hydrophilic filter, page 7, ‘Nucleic acid extraction step’, and moving the nucleic acid extraction solution in the channel of the biological material collection area such that [[the]]an entire surface of the hydrophilic filter comes into contact with the nucleic acid extraction solution, page 7,’ ‘Nucleic acid extraction step’, vacuum pump 2 adjust pressure in the nucleic acid extraction reagent holding mode… .
Regarding Claim 14: wherein the nucleic acid extraction container according to claim 4, wherein an average cross-sectional area of the third channel is smaller than an average cross-sectional area of the first channel.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the average cross-sectional area of the third channel so that it is smaller than the average cross-sectional area of the first channel to control the flow rate of fluid through the channels of the device for specific flow rate of fluid onto the filter part for control reaction/filter/extraction of analytes in the device, and dimension of the channels are a result effective variable for controlling the amount and flow rate of fluids through the device. A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over PANASONIC, JPWO 2017154349 A1 ( as previously cited in the prior Office Action).
Applicant’s invention is directed towards a device.
Regarding Claim 23, the PANASONIC reference discloses a nucleic acid extraction container, abstract, comprising:
a filter part, Figure 4, filter 41, page 5, comprising a hydrophilic filter for collecting biological materials containing a nucleic acid from a sample, Figure 4, filter 41 is made of polyethersulfone, page 5, a biological material collection area for collecting the biological materials on the hydrophilic filter, page 5, filter 41 is for capturing and holding nucleic acid, page 2, ‘Description’ , and a sample permeation area for allowing a passage of the sample having permeated through the hydrophilic filter, Figure 4, support 42 is eye plate, page 5; a sample injection port that communicates with the biological material collection area, Figure 4, inlet 21, page 4; an air communication port that communicates with the biological material collection area, Figure 6B, inlet 22, page 4-5; and a sample discharge port that communications with the sample permeation area, Figure 4, outlet 31, page 5, wherein the air communication port is configured so as to be outwardly openable and closable, and the biological material collection area is configured as a channel having an elongated shape in a direction of fluid flow which is substantially perpendicular to the normal of the hydrophilic filter, Figure 4, capturing unit 40 which comprises main body 41 and support 42 has elongated shape, page 4 and 5.
The PANASONIC reference discloses the claimed invention, but is silent in regards to wherein the hydrophilic filter is glued or fused to a groove surface of a lower surface of the substrate.
However, PANASONIC discloses the support part 42, the first container part 11, and the second container part 12 are fixed by, for example, four screws, page 5, third to last paragraph, ‘The main body portion 41 includes…’.
While PANASONINC teaches a different mean for how the device is put together, such as for example by screws, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the way the device is put together or how the filter is assemble such as by glue or fused to a groove to create a permanent seal between part of the overall device, preventing any leak as the device is being used.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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