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
The claim set submitted on 07 APRIL 2023 is acknowledged and considered. In the claim set, Claims 1-20 are presented.
Claim considered are Claims 1-20 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 JANUARY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered 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.
Claims 1, 3, 4, 10, 11, 13, 16, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WHEELER, US Publication No. 2020/0108389 A1.
Applicant’s invention is directed towards a system.
Regarding Claim 1, the WHEELER reference discloses a system, abstract, microfluidic system, Figure 1A, 1B, comprising:
a first layer comprising a first region configured to receive a sample, Figure 1A-2B, chip 110, [0023-0031];
a gasket disposed on the first layer such that the gasket surrounds the first region, Figure 1A-2B, gasket 120, [0023-0031];;
a housing layer, Figure 1A-2B, holder 150, [023-0031], wherein the first layer is disposed between the gasket and the housing layer, Figure 1A-2B; and
a clamp configured to apply a force on the gasket to form a liquid tight seal against the first layer, Figure 1A, 1B, manifold 140, [0025], Claim 14.
Additional Disclosures Included are: Claim 3: wherein the system of claim 1, wherein the clamp is configured to apply a mechanical force to the gasket and the housing layer, Figure 1A-2A, [0023-0031], protrusion or tab engaged/aligned and slots.; Claim 4: wherein the system of claim 1, wherein the clamp comprises a first piece configured to apply a first force on the gasket in a first direction and a second piece configured to apply a second force on the housing layer in a second direction opposite the first direction, [0031].; Claim 10: wherein the system of claim 1, further comprising a second layer positioned on the gasket to thereby form an enclosed flow cell, and wherein the clamp is configured to apply the force on the second layer, the gasket, and the first layer to thereby form a chamber, Figure 1B, see layer above the gasket 120. ; Claim 11: wherein the system of claim 10, further comprising an inlet and an outlet in fluid communication with the chamber, Figure 1A-2B, microfluidic chip has channel which have inlet/outlet, [0023].
Applicant’s invention is directed towards a system.
Regarding Claim 13, the reference WHEELER discloses a system, Figure 1A, 1B, comprising :
a first layer comprising a first region configured to receive a sample, Figure 1A-2B, chip 110, [0023-0031];
a wall extending around the first region, Figure 2B, well 114, has walls;
a second layer, Figure 1A-2B, holder 150, [023-0031];
a gasket disposed between the first layer and the second layer, wherein the gasket is positioned along an interior of the wall, Figure 1A-2B; and
a clamp configured to apply a force on the second layer to form a liquid tight seal between the first layer, the gasket, and the second layer thereby forming an enclosed flow cell having a chamber, Figure 1A, 1B, manifold 140, [0025], Claim 14.
Additional Disclosures Included are: Claim 16: wherein the system of claim 13, further comprising at least one inlet and at least one outlet in fluid communication with the chamber, Figure 1A-2B, microfluidic chip has channel which have inlet/outlet, [0023]. ; and Claim 17: wherein the system of claim 16, wherein the at least one inlet and/or the at least one outlet is in fluid communication with a reservoir, Figure 1A-2B, microfluidic chip has channel which have inlet/outlet and a well, [0023].
Applicant’s invention is directed towards a method
Regarding Claim 19, the WHEELER reference discloses a method, [0023], comprising:
providing a first layer comprising a first region configured to receive a sample, Figure 1A-2B, chip 110, [0033-0031];
positioning a gasket on the first layer such that the gasket surrounds the first region, Figure 1A-2B, gasket 120, [0023-0031]; and
positioning a housing layer on the first layer, Figure 1A-2B, holder 150, [0023-0031], wherein the first layer is disposed between the gasket and the housing layer, Figure 1A-2B; and
applying a force on the gasket with a clamp to form a liquid tight seal between the first layer and the gasket thereby forming an open flow cell, Figure 1A, 1B, manifold 140, [0025], Claim 14.
Applicant’s invention is directed towards a method
Regarding Claim 20, the WHEELER reference discloses a method comprising:
providing a first layer comprising a first region configured to receive a sample, Figure 1A-2B, chip 110 has wells 114, [0023-0031],
wherein the first layer comprises a wall extending around the first region, Figure 1A-2B, chip 110 has wells 114, [0023-0031];
positioning a second layer spaced at a distance from the first layer, Figure 1A-2B, holder 150, [0023-0031]; and
positioning a gasket between the first layer and the second layer, Figure 1A-2B; and
applying a force with a clamp on the second layer to form a liquid tight seal between the first layer and the second layer thereby forming an enclosed flow cell, Figure 1A, 1B, manifold 140, [0025], Claim 14.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over WHEELER, US Publication No. 2020/0108389 A1, and further in view of RENZI, US Publication No. 2004/0126279 A1.
Regarding Claim 2, the reference WHEELER discloses the claimed invention, but is silent in regards to wherein the clamp comprises a magnet.
The RENZI discloses a system, abstract, device, Figure 1, comprising:
a first layer comprising a first region configured to receive a sample, Figure 1, base 152 with depressions 153 acting as reservoirs, [0064];
a gasket disposed on the first layer such that the gasket surrounds the first region, [0048, 0058];
a housing layer, Figure 5-7, cover/housing, [0116],
wherein the first layer is disposed between the gasket and the housing layer, Figure 1-7, [0058]; and
a clamp configured to apply a force on the gasket to form a liquid tight seal against the first layer, [0053, 0058], wherein the clamp comprises a magnet, [0058].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the WHEELER with the clamp comprising a magnet as taught by RENZI, so that the components of the device can be compressed against each other creating a seal and held together without the addition of any other mechanical moving parts, such as screws and clips. With the use of magnet, the component will automatically attached and align with each other without when in close enough proximity to each other extra work done by the user/operator.
Claims 5-9, 12, 14, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WHEELER, US Publication No. 2020/0108389 A1.
Regarding Claim 5, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein the first piece and the second piece are integral with each other.
The WHEELER reference discloses the claimed invention, but is silent in regards to the pieces are integral.
However, it would obvious to one having ordinary skill in the art before the effective filing date to have the first piece and the second piece are integral with each other, since “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”, In reLarson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claim 6, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein the first piece and the second piece are separable.
However, it would obvious to one having ordinary skill in the art before the effective filing date to have the first piece and the second piece are separable to allow access to the interior of the system for cleaning or supplying samples to the chip, In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claim 7, the WHEELER reference discloses the claimed invention, including the gasket is a first gasket, wherein the first layer further comprises a second region configured to hold a second sample, Figure 1-5, wells 114, [0035], but it is silent in regards to wherein the device includes a second gasket disposed on the first layer such that the second gasket surrounds the second region.
However, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the WHEELER reference with a second gasket that surrounds the second region to tight seal between the manifold and the wells, [0008, 0025], and prevent any cross contamination between adjacent regions or wells within the device.
Regarding Claim 8, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein the first gasket and the second gasket are integral with each other.
The WHEELER reference discloses the claimed invention, but is silent in regards to the pieces are integral.
However, it would obvious to one having ordinary skill in the art before the effective filing date to have the first gasket and the second gasket are integral with each other, since “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”, In reLarson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claim 9, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein the first piece and the second piece are separable.
However, it would obvious to one having ordinary skill in the art before the effective filing date to have the first piece and the second piece are separable to allow access to the interior of the system for cleaning or supplying samples to the chip, In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claim 14, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein the first layer and the wall are integral with each other. .
However, it would obvious to one having ordinary skill in the art before the effective filing date to have the first layer and the wall are integral with each other, since “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”, In reLarson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claim 15, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein the first layer and the wall are separate.
However, it would obvious to one having ordinary skill in the art before the effective filing date to have the first layer and the wall are separate to allow access to the interior of the system for cleaning or supplying samples to the chip, In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claims 12 and 18, the WHEELER reference discloses the claimed invention, but is silent in regards to wherein a thickness of the first layer is from about 1 mm to about 1 mm.
WHEELER disclose the microfluidic chip 110 is configured for use with fluid samples of microliter, nanoliter, or picoliter volume sizes or less, for example, less than 10 microliters, less than 5 microliters, less than 1 microliter, less than 500 nanoliters, less than 100 nanoliters, less than 50 nanoliters, less than 10 nanoliters, or less than 1 nanoliter, [0023].
Since WHEELER discloses the chip, interpreted to be the first layer, to hold a small amount of liquid, to the nanoliter range, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the thickness of the first layer is from about 1 mm to about 1 mm so that it can be deep enough to use in continuous-flow microfluidics, genomic analysis, cell or particle sorting, purification, biological/biochemical assaying, lab-on-chip applications, optofluidics, fuel cells, etc., [0023].
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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797