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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/28/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The Brief Description should be separated into a “Brief Description of the Drawings” and the “Detailed Description” in order to conform to current U.S. practice.
Appropriate correction is required.
Claim Interpretation
For purposes of examination, the term “sealed connected” has been defined in light of the specification to be a sealant connection, a welding connection, a detachable thread connection, a snap connection, a tension connection or a Luer taper connection. In light of the specification, the term “fixed connection” is defined as a piece that is injection molded. The specification does not provide an additional description or definition for this term and any part or structure that is injected molded or a solid piece will read on this limitation.
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, 10, 11 and 17-19 are rejected under 35 U.S.C. 102a1 as being anticipated by Zohar et al. (US 2017/0355950 A1 – hereafter ‘950).
‘950 discloses a system for processing biological samples (Abstract) that includes the following limitations for claim 1:
“A cell clump dispersing device for dispersing cells”: ‘950 discloses a system for breaking up or dispersing cells such as cell clumps ([0038]).
“a dispersion structure module that includes at least one structure for providing fluid flow shear force”: ‘950 discloses a structure such as an orifice (Fig. 2D; [0037]) that provides a fluid flow shear force.
“wherein each structure for providing liquid flow shear force comprises an inlet for cell clumps to be dispersed to enter the structure”: ‘950 discloses that the device includes fluidic structures such as an inlet ([0060]) that provides the cell clumps to be dispersed.
“at least one outlet for dispersed cell clumps to flow out of the structure”: 950 discloses an orifice for the cells to leave the chamber, i.e. an outlet ([0037]; Fig. 2D) and an outlet for the chip ([0081]).
“a diameter of the at least one outlet is smaller than that of the inlet”: ‘950 discloses that the orifice has a smaller diameter (Fig. 2D; [0037]) than the inlet.
“each structure has a first end and a second end opposite the first end, the first end of at least one of the structures is capable of being connected to the second end of another of the structure directly.”: ‘950 discloses that the chamber has a first end and a second end (Fig. 2A; Fig. 2D; [0037]) that is fully capable of being connected to the second end of another structure.
For claim 10, ‘950 discloses that the flow structures can be in series (Fig. 3; [0038]) that includes two adjacent chambers where the first chamber would be a first structure and the second in series would be the second chamber and would therefore be labeled as such. Furthermore, both chambers are fixed in such a way as the second chamber would provide shear force flow away from the outlet of the first chamber.
For claim 11, ‘950 discloses that the dimensions of the orifices decrease with each chamber ([0038]; Fig. 3).
For claim 17, ‘950 discloses that the device is used in a closed-loop system ([0026]) that is being interpreted as the closed tube system of the instant application. ‘950 discloses supplying a fluid flow with the cell clusters to the microfluidic system ([0027]).
For claim 18, ‘950 discloses an embodiment that collects the output of the cells ([0032]) where this is being interpreted as the open tubing of the instant application since the cells and output are not kept within the system.
For claim 19, ‘950 discloses that the device is used in a closed-loop system ([0026]) that is being interpreted as the closed tube system of the instant application. ‘950 discloses supplying a fluid flow with the cell clusters to the microfluidic system ([0027]).
Therefore, ‘950 meets the limitations of claims 1, 10, 11 and 17-19.
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) 2-6, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zohar et al. (US 2017/0355950 A1 – hereafter ‘950) in view of Sharei et al. (US 2014/0287509 A1 – hereafter ‘509).
‘950 discloses the following limitations for claim 2:
“each structure for providing liquid flow shear force comprises a channel part with a relative constant cross-sectional area in the structure for providing liquid flow shear force and with proximal end and a distal end respectively located opposite ends along a length extension direction”: ‘950 discloses that each structure includes a channel ([0008])with a portion of the channel having a constant cross-sectional area ([0038]; Fig. 2D).
“a narrowed part with a gradually decreased cross-sectional area in the structure for providing liquid flow shear force and with a first end and a second end respectively located at opposite ends along a length extension direction”: ‘950 discloses a narrowed part where the channel width decreases gradually across the length to the orifice (Fig. 2D; [0021]) from the first end to a second end opposite the first.
“in a same structure for providing liquid flow shear force, the distal end of the channel part is connected to the first end of the narrowed part”: The distal end of the channel part is connected to the first end of the narrowed part (Fig. 2D).
“the proximal end of the channel part is the inlet, the second end of the narrowed part is the outlet, and an inner diameter of the narrowed part gradually decreases from the first end to the second end.”: The proximal end of the channel is the inlet ([0037]; Fig. 2D) and the second end, i.e. the orifice, is the outlet the inner diameter of the narrowed part gradually decreases to the orifice (Fig. 2D).
For claim 2, ‘950 does not specify that the channel is circular, however, this would merely be a change in shape as circular channels are a known structure within the microfluidic arts. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include a circular flow channel within ‘950 in order to move the cell clusters through the channels and orifice. See MPEP §2144.04 IV B.
‘509 (Sharei) discloses a microfluidic system (Abstract) that for claim 2 includes a constriction ([0023]) which allows delivery material to enter the cell. These channels can have a cross-section that is circular, elliptical, an elongated slit, square, hexagonal and triangular. Therefore, ‘509 demonstrates that a circular cross-sectional area was a common and known structure within the art.
For claim 3, ‘950 does not specify that the channel is circular, however, this would merely be a change in shape as circular channels are a known structure within the microfluidic arts. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include a circular flow channel within ‘950 in order to move the cell clusters through the channels and orifice. See MPEP §2144.04 IV B.
‘509 (Sharei) discloses a microfluidic system (Abstract) that for claim 3 includes a constriction ([0023]) which allows delivery material to enter the cell. These channels can have a cross-section that is circular, elliptical, an elongated slit, square, hexagonal and triangular. Therefore, ‘509 demonstrates that a circular cross-sectional area was a common and known structure within the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the circular channel of ‘509 within ‘950 in order to supply cell clusters to an orifice or constriction. See MPEP §2144.04 IV B.
Regarding the limitation of claim 4 where “the structure for providing liquid flow shear force further comprises a protective cover for protecting the outlet, the protective cover has a cavity in which the narrowed part is at least partially located, and the protective cover and the channel part are fixed connected or integrally injection molded”, this appears to be drawn to the substrate of the device and it should be noted that ‘950 discloses a substrate layer ([0073]) that reads on the protective cover that covers the outlet of the orifice and would thereby be fixed connected or integrally part of the device by injection molding ([0061]).
For claim 5, ‘950 does not specify that the channel is circular or that the top of the substrate narrows to the orifice, however, this would merely be a change in shape as circular channels which would narrow are a known structure within the microfluidic arts. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include a circular flow channel within ‘950 in order to move the cell clusters through the channels and orifice. See MPEP §2144.04 IV B.
‘509 (Sharei) discloses a microfluidic system (Abstract) that for claim 5 includes a constriction ([0023]) which allows delivery material to enter the cell. These channels can have a cross-section that is circular, elliptical, an elongated slit, square, hexagonal and triangular and would have a diameter that decreases gradually toward a constriction or orifice. Therefore, ‘509 demonstrates that a circular cross-sectional area was a common and known structure within the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the circular channel that narrows to a constriction of ‘509 within ‘950 in order to supply cell clusters to an orifice or constriction. See MPEP §2144.04 IV B.
For claim 6, the narrowed part of ‘950 is being interpreted as a funnel-shape (Fig. 2D) and the orifice has a polygonal shape such as a rectangular shape (Fig. 2C).
‘950 discloses the following limitations for claim 13:
“each structure for providing liquid flow shear force comprises a channel part with a relative constant cross-sectional area in the structure for providing liquid flow shear force and with proximal end and a distal end respectively located opposite ends along a length extension direction”: ‘950 discloses that each structure includes a channel ([0008])with a portion of the channel having a constant cross-sectional area ([0038]; Fig. 2D).
“a narrowed part with a gradually decreased cross-sectional area in the structure for providing liquid flow shear force and with a first end and a second end respectively located at opposite ends along a length extension direction”: ‘950 discloses a narrowed part where the channel width decreases gradually across the length to the orifice (Fig. 2D; [0021]) from the first end to a second end opposite the first.
“in a same structure for providing liquid flow shear force, the distal end of the channel part is connected to the first end of the narrowed part”: The distal end of the channel part is connected to the first end of the narrowed part (Fig. 2D).
“the proximal end of the channel part is the inlet, the second end of the narrowed part is the outlet, and an inner diameter of the narrowed part gradually decreases from the first end to the second end.”: The proximal end of the channel is the inlet ([0037]; Fig. 2D) and the second end, i.e. the orifice, is the outlet the inner diameter of the narrowed part gradually decreases to the orifice (Fig. 2D).
Furthermore, as the different chambers/structures are connected (Fig. 3) where this is being interpreted as fixed connected. Regarding the limitation of claim 13 of the protective cover, this appears to be drawn to the substrate of the device and it should be noted that ‘950 discloses a substrate layer ([0073]) that reads on the protective cover that covers the outlet of the orifice and would thereby be fixed connected or integrally part of the device by injection molding ([0061]).
For claim 13, ‘950 does not specify that the channel is circular, however, this would merely be a change in shape as circular channels are a known structure within the microfluidic arts. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include a circular flow channel within ‘950 in order to move the cell clusters through the channels and orifice. See MPEP §2144.04 IV B.
‘509 (Sharei) discloses a microfluidic system (Abstract) that for claim 13 includes a constriction ([0023]) which allows delivery material to enter the cell. These channels can have a cross-section that is circular, elliptical, an elongated slit, square, hexagonal and triangular and would have a diameter that decreases gradually toward a constriction or orifice. Therefore, ‘509 demonstrates that a circular cross-sectional area was a common and known structure within the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the circular channel that narrows to a constriction of ‘509 within ‘950 in order to supply cell clusters to an orifice or constriction. See MPEP §2144.04 IV B.
‘950 discloses the following limitations for claim 14:
“each structure for providing liquid flow shear force comprises a channel part with a relative constant cross-sectional area in the structure for providing liquid flow shear force and with proximal end and a distal end respectively located opposite ends along a length extension direction”: ‘950 discloses that each structure includes a channel ([0008])with a portion of the channel having a constant cross-sectional area ([0038]; Fig. 2D).
“a narrowed part with a gradually decreased cross-sectional area in the structure for providing liquid flow shear force and with a first end and a second end respectively located at opposite ends along a length extension direction”: ‘950 discloses a narrowed part where the channel width decreases gradually across the length to the orifice (Fig. 2D; [0021]) from the first end to a second end opposite the first.
“in a same structure for providing liquid flow shear force, the distal end of the channel part is connected to the first end of the narrowed part”: The distal end of the channel part is connected to the first end of the narrowed part (Fig. 2D).
“the proximal end of the channel part is the inlet, the second end of the narrowed part is the outlet, and an inner diameter of the narrowed part gradually decreases from the first end to the second end.”: The proximal end of the channel is the inlet ([0037]; Fig. 2D) and the second end, i.e. the orifice, is the outlet the inner diameter of the narrowed part gradually decreases to the orifice (Fig. 2D).
Furthermore, as the different chambers/structures are connected (Fig. 3) where this is being interpreted as fixed connected.
For claim 14, ‘950 does not specify that the channel is circular, however, this would merely be a change in shape as circular channels are a known structure within the microfluidic arts. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include a circular flow channel within ‘950 in order to move the cell clusters through the channels and orifice. See MPEP §2144.04 IV B.
‘509 (Sharei) discloses a microfluidic system (Abstract) that for claim 14 includes a constriction ([0023]) which allows delivery material to enter the cell. These channels can have a cross-section that is circular, elliptical, an elongated slit, square, hexagonal and triangular and would have a diameter that decreases gradually toward a constriction or orifice. Therefore, ‘509 demonstrates that a circular cross-sectional area was a common and known structure within the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the circular channel that narrows to a constriction of ‘509 within ‘950 in order to supply cell clusters to an orifice or constriction. See MPEP §2144.04 IV B.
Allowable Subject Matter
Claims 7-9, 12, 15 and 16 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: For claim 7, the prior art does not teach or fairly suggest where the side wall of the narrowed part close to the second end is provided with one or more structural weak portions.
Claim 8 would be allowable for the same reasons as claim 7.
For claim 9, the prior art does not teach or fairly suggest where the dispersion structure module further comprises a diverting device with at least one diverting inlet and at least two diverting outlets, and each of the diverting outlets is connected to the inlet of the structure for providing fluid flow shear force.
For claim 12, the prior art fails to teach or fairly suggest wherein along the flow direction of cell clumps to be dispersed, two adjacent structures of the plurality of series-connected structures for providing liquid flow shear force are sealed connected.
For claim 15, he prior art does not teach or suggest where the diameter of the inlet of the structure for providing liquid flow shear force ranges between 2-10 mm, the diameter of the outlet of the structure for providing liquid flow shear force ranges between 5 mm-2 mm, and an axial length of the structure for providing liquid flow shear force ranges between 5-50 mm.
Claim 16 would be allowable for the same reasons as claim 15.
The closest prior art is Zohar et al. (US 2017/0355950 A1 – hereafter ‘950) that discloses a microfluidic device that enables the controlled exposure of tissue to a flow-induced stress field, however, Zohar does not teach or fairly suggest the weak portions of the side wall, the diversion structure, the sealed connection or the diameters of the inlets, channel and outlet.
The next closest prior art is Sharei et al. (US 2014/0287509 A1 – hereafter ‘509) discloses a system for causing perturbations in cell membranes that includes a constriction within the microfluidic channel, however, Sharei does not teach or fairly suggest the weak portions of the side wall, the diversion structure, the sealed connection or the diameters of the inlets, channel and outlet.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aidun et al. (US 2012/0258536 A1) that disperses assemblies of biological material such as plant embryogenic mass, plant tissue, cultured plant cells, animal tissue and cultured animal cells.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799