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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 in the reply filed on 8/1/25 and Species D of Fig 23-27B, Claims 1-3, 5-12, 20-22, 28-31 on 1/9/26 is acknowledged.
Claims 4, 13-19, 23-27, 32-33 are currently withdrawn.
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 10-11 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 10 recites multiple limitations as “optionally”. It is unclear exactly which limitations are optional and which are required limitations of the claim. As such the meets and bounds cannot be properly determined. Claim 11 depends form claim 10 and therefore includes the same deficiencies.
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, 5-6, 10, 12, 28 is/are rejected under 35 U.S.C. 102a1 as being anticipated by CAMPBELL (US 2003/0215941).
Regarding claim 1, CAMPBELL discloses a microwell plate system (Fig 3, 6, 7) comprising:
A standard 96 or 384 or 1536 well microtiter dish (plate with at least one well) (0114);
Each well comprising:
A filter membrane 107 (porous membrane);
A patterning membrane 103 with micro-through holes to define micro-scale culture wells (through pore microwell membrane) (0096, 0123) having a top and bottom, with the bottom above and on the porous membrane, a top opening at the top of the patterning membrane and bottom opening at the bottom of patterning membrane, the microwell membrane comprising a plurality of microwells each capable of holding a 3D cell culture, (0054, Fig 3, 5, 6);
A delivery device 102 placed in the chamber open top (an inlet passageway) in fluid communication with each top opening of the microwells and configured to deliver liquid medium to the microwells (Fig 3, 92-95);
An analyte removal device 105 in fluid communication with the space under the filter membrane (in communication with each bottom opening of the plurality of microwells) and configured to receive the liquid medium from the microwells (outlet passageway) (Fig 3);
A well above the patterning membrane that define a portion of the inlet passageway (see side walls of 101 in Fig 3 which contain the fluids and cells to the space above the membrane and therefore act as a culture well, Fig 7, 9).
Regarding claim 2, CAMPBELL discloses each well comprises a bottom outlet channel 106, 104 below the filter membrane and extending between a central portion of the well and an outer peripheral portion of the well, which defines at least a portion of the outlet passageway (Fig 3, 0054).
Regarding claim 5, CAMPBELL discloses the bottom outlet channel can be defined in the plate (Fig 9).
Regarding claim 6, CAMBELL discloses each well has an insert (body) comprising at least one layer that is on the microwell membrane (inner side of well walls is on membrane) and the culture well is defined in a central portion of the insert (body) (Fig 3).
Regarding claim 10, CAMPBELL discloses an outlet medium reservoir in fluid communication with and positioned above the bottom outlet channel, which defines at least a portion of the outlet passageway (Fig 3, 9).
Regarding claim 12, CAMPBELL discloses an inlet medium reservoir in fluid communication with and positioned above the culture well, which defines at least a portion of the inlet passageway (Fig 3, 9).
Regarding claim 28, CAMPBELL disclose the at least one well can be a plurality of wells (Fig. 7, 10, 0006, 0052).
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.
Claim(s) 3, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over CAMPBELL (US 2003/0215941) in view of FUJIYAMA (US 10301586).
Regarding claims 3, 11, CAMPBELL does not explicitly disclose the shapes of the outlet channel such that it widens from a central portion to the outer portion of the well nor that the outlet medium reservoir is arcuate and extends along a portion of the outer peripheral portion of the body. However, FUJIYAMA discloses a cell culturing device having a well with a porous membrane in which channels and reservoirs of the device can have a variety of shapes including widening and arcuate shapes (Fig 2). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of CAMPBELL to include the outlet channel and outlet medium reservoir having different shapes as were known from FUJIYAMA in order to allow for the preferred reservoir capacity and flow patterns desired in using the device. Furthermore, a change in shape is considered 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. MPEP 2144.04.
Claim(s) 7, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CAMPBELL (US 2003/0215941) in view of RENKEN (US 9186669).
Regarding claim 7, CAMPBELL does not explicitly disclose the filter insert is bonded to the plate. However, RENKEN discloses a filter device that includes a well having a filter which is an improvement over the insert style device (Fig 1a) in which the filter layer is connected to the substrate (plate) layers using adhesives (bonded). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of CAMPBELL to include the filter insert (body) adhered to the substrate (plate) as taught by RENKEN is useful when a permanent assembly is desired (Col 9, lines 4-25) to overcome the issues with the insert style devices (Col. 3, line 39-50).
Regarding claim 20, CAMPBELL does not explicitly disclose the body is monolithic. However, RENKEN discloses the filter device can be formed of a single piece design (body is monolithic) (Col 9, lines 4-25). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of CAMPBELL to include the body being monolithic as taught by RENKEN because it would allow for the system to be made by injection molding (Col 9, lines 4-25) and would simplify the preparation of the device in use.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over CAMPBELL (US 2003/0215941).
Regarding claim 8, CAMPBELL discloses it was known to select PMMA as the material to form various parts of the device including the analyte removal (outlet channel) (0095-96, 0105, 112, 183) but does not explicitly disclose the material that makes up the insert (body) or plate to comprise PMMA. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to choose PMMA to construct the body or plate of the device as the disclosure of CAMPBELL makes clear it was a material with known properties that make it ideal for use in instances where it will contact biological specimens and reagents. Furthermore, it would have been obvious to one having ordinary skill in the art to choose PMMA for the body and/or plate, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Regarding claim 9, CAMPBELL discloses the body is on a first side of the plate and a lower surface on the opposite side below the bottom channel (Fig 3, 9) and that use of glass as a surface in cell culture applications was known (0069-73, 0226-229) but does not explicitly disclose the second opposite side of the plate is formed by a glass coverslip. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to create the second side of the plate out of a glass coverslip to allow for optical observation of any process taking place in the plate. Furthermore, it would have been obvious to one having ordinary skill in the art to choose a glass coverslip for the opposite side of the plate, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over CAMPBELL (US 2003/0215941) in view of EDDINGTON (US 8501462).
Regarding claim 21, CAMPBELL does not explicitly disclose a lid to be installed over the plate. However, EDDINGTON discloses an insert device for a multiwell plate in which the insert has a membrane 30 on the bottom (Fig 2), the device has a planar top portion 13 (lid) configured to be selectively installed over the plate 14, the top portion 13 having a supply port 24, 25a/b and exhaust port 28, 27a/b, (inlet and outlet ports) for each well (Fig 2), the supply and exhaust orts of the lid being in fluid communication with an inlet and outlet port of the well (Fig 3, 4). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of CAMPBELL to include the lid with inlet and outlet ports as taught by EDDINGTON because they allow flow communication with a supply source to create a desired flow communication through each well (Col. 2, lines 1-67).
Regarding claim 22, EDDINGTON discloses the supply and exhaust ports of the lid are connected to conduits (tubes) at one end of each conduit, the connection of the ports to the conduits would inherently require couplers (Fig 2); the other end of the conduits is connected to a supply source 74 and exhaust manifold 78 (fig 7a/b, Col 8, lines 18-47) and that a pump could be connected to inlets and outlets to allow for perfusion (Col 18, lines 59-Col 19, line 21), but does not explicitly disclose the inlet and outlet tubes both connected to the pump. However, it would have been obvious to one of ordinary skill in the art to modify the device of EDDINGTON to include the pump attached to both inlet and outlet tubes to allow for a singular pump to provide both operations in order to simplify the construction or in order to create a recirculating perfusion loop.
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over CAMPBELL (US 2003/0215941) in view of HOHNEL (US 2018/0264465) as cited by applicant on the IDS.
Regarding claim 29-31, CAMPBELL does not explicitly disclose the shape of the microwell, its sidewalls or top and bottom openings. However, HOHNEL discloses a micro structured film having a cavity with a plurality of microwells for receiving at least one cell (Abs) in which the microwells have cavities of different sizes or shapes (0034, 0137 Fig 20), in which pyramidal shapes were known (sloped trapezoidal sidewalls, openings square) (0112, Fig 12) as were curved sidewalls with circular openings and hemispherical shapes (Fig 20, 0011). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of CAMPBELL to include the various shapes of microwells as disclosed by HOHNEL because they allows for reproducible formation of cellular aggregates (0054) for use in multiple applications (0137).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See additional references cited on the attached PTO 892 that disclose the current state of the art of applicant’s invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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