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 09/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 2-3, 6, 8, 11, 18, 19, and 21 objected to because of the following informalities: “Claim” does not need to be capitalized in claims 2-3, 6, 8, 11, and 19. Further, for claim 21, it is recommended “Use” is removed from line 1 of said claim and applicant continues the same format as previously used in the claims. That is, “The cell culture well device in accordance…”. Appropriate correction is required.
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.
Claims 1-6, 10, 12-13, and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0194588 A1-Rao et al (hereinafter Rao).
Regarding claim 1, Rao discloses a multi-well plate compatible cell culture device (partitioning device is separately formed from and fits into a well of a standard cell culture well plate or other type of well structure, para. [0004], lines 7-10) comprising: an outer wall (side surface, 116, para. [0073], line 4, Fig. 1; and shown below in annotated Fig. 1); an inner wall within the outer wall and defining a volume within the inner wall (shown below in annotated Fig. 1), wherein the outer wall and the inner wall form a cavity therebetween (shown below in annotated Fig. 1);
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Rao discloses a base (bottom surface 112, para. [0073], lines 3-4, Fig. 1) connected to a bottom of the outer wall and a bottom of the inner wall (shown above in annotated Fig. 1, the bottom surface 112, is shown connected to a bottom of the outer wall 116, which is connected to bottom surface 112) and configured to position a cell culture sample below the volume within the inner wall (the platform includes a partitioning device that divides a volume of a well into multiple compartments for receiving different 3D cultures, para. [0004], lines 5-7);
Rao discloses and one or more partitions (a first wall portion 130, a second wall portion 140, and a third wall portion 150, para. [0074], lines 1-3, Fig. 1) connected to the base (bottom surface 112, Fig. 1) and connecting the inner wall to the outer wall (each of the first 130, second 140, and third wall portions 150 has an upper edge 132, 142, 152, a lower edge 133, 143, 153, a first side edge 134, 144, 154, a second side edge 135, 145, 155, a first divider surface 136, 146, 156, and a second divider surface 13 , 147, 157, respectively, para. [0074], lines 3-7, Fig. 1) wherein the one or more partitions segment the cavity into a plurality of voids (the first divider surface 136 of the first wall portion 130 and the second divider surface 157 of the third wall portion 150 define a third compartment 174, para. [0075], lines 17-19, Fig. 1; further, Rao discloses compartments 170, 171, and 174 are formed via the surfaces of the wall portions, 130, 140, and 150, shown in Fig. 1).
Rao discloses wherein openings in surfaces forming the voids allow fluid flow from a first one of the voids and below the volume within the inner wall to a second one of the voids, and wherein the fluid flow is configured to interact with the cell culture sample when flowing through a sample region within the inner wall, wherein the sample region has a depth defined by a height of the inner wall greater than a length defined by an inner distance across the volume defined within the inner wall (the wall portions of the partitioning device comprise one or more openings through which uptake materials flow between the compartment, para. [0021], lines 4-6. Further, Rao discloses the platform includes a partitioning device that divides a volume of a well into multiple compartments for receiving different 3D cultures, para. [0004], lines 5-7).
Regarding claim 2, Rao discloses wherein the outer wall is dimensioned to fit into a well of a cell culture dish or a cell culture plate (the partitioning device is separately formed from and fits into a well of a standard cell culture well plate or other type of well structure, para. [0004], lines 7-9).
Regarding claim 3, Rao discloses wherein the openings are formed in the base (the wall portions of the partitioning device comprise one or more openings through which uptake materials flow between the compartment, para. [0021], lines 4-6; further, Fig. 1 shows openings extending through the top opening of device 120 through the bottom of device 120).
Regarding claim 4, Rao discloses wherein the openings are formed in the inner wall (the wall portions of the partitioning device comprise one or more openings through which uptake materials flow between the compartment, para. [0021], lines 4-6).
Regarding claim 5, Rao discloses wherein the openings comprise netted openings (the wall portions can define holes or include a membrane, para. [0077], line 12, where a membrane can form netting via the various holes of the membrane).
Regarding claim 6, Rao discloses wherein, in operation, the cell culture sample present in the fluid flowing from the first one of the voids and below the volume within the inner wall to the second one of the voids is retained as the fluid flows through the netted openings (the wall portions can define holes or include a membrane; the holes or membrane are sized such that the culture substrate does not flow outside the respective compartment , but the uptake material inserted in the compartments is able to flow freely among each of the compartments through the holes or membrane, para. [0077], lines 12-17).
Regarding claim 10, Rao discloses wherein in operation, the fluid flowing from the first one of the voids and below the volume within the inner wall to the second one of the voids comprises a cell culture media (the wall portions of the partitioning device comprise one or more openings through which uptake materials flow between the compartment, para. [0021], lines 4-6; additionally, Rao discloses pourable culture substrates can include any substance that can take a liquid form and subsequently solidify or partially solidify, for example, solutions (para. [0080], lines 4-7).
Regarding claim 12, Rao discloses wherein the openings comprise netted openings, and wherein in operation, the cell culture sample present in the fluid flowing from the first one of the voids and below the volume within the inner wall to the second one of the voids is retained as the fluid flows through the netted openings (the wall portions of the partitioning device comprise one or more openings through which uptake materials flow between the compartment, para. [0021], lines 4-6; additionally, Rao discloses pourable culture substrates can include any substance that can take a liquid form and subsequently solidify or partially solidify, for example, solutions (para. [0080], lines 4-7).
Regarding claim 13, Rao discloses wherein the cell culture sample is selected from the group consisting of organoids, spheroids, tissue, biopsy samples, and cell culture cell lines (culture substrates can contain various types of cultures, including cell cultures, para. [0080], lines 8-9).
Regarding claim 17, Rao discloses wherein the one or more partitions connecting the inner wall to the outer wall comprise two or more partitions segmenting the cavity into two or more voids (annotated Fig. 1 above of Rao discloses one or more partitions connecting the inner wall to the outer wall, where the partitions segment the cavity into two or more voids, shown above in annotated Fig. 1).
Regarding claim 18, Rao discloses wherein the two or more partitions connecting the inner wall to the outer wall comprise two partitions segmenting the cavity into two voids (annotated Fig. 1 above shows two or more partitions connecting the inner wall to the outer wall, where the two partitions segment the cavity into two voids).
Regarding claim 20, Rao discloses further comprising a membrane or a laminate attached to an outer surface of the base for sealing the cell culture well insert (the wall portions of the partitioning device comprise a membrane that allow for the flow therethrough of an uptake substance between the compartments, para. [0040], lines 7-9).
Regarding claim 21, Use of the cell culture well device in accordance with claim 1 as an insert into a well of a multi-well cell culture dish or a multi-well cell culture plate (partitioning device is separately formed from and fits into a well of a standard cell culture well plate or other type of well structure, para. [0004], lines 7-10).
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over by US 2019/0194588 A1-Rao et al (hereinafter Rao) as applied to claim 1 above, and further in view of US 2024/0067911 A1-Nieh et al (hereinafter Nieh, has an earlier effective date as of the provisional application).
Regarding claim 7, Rao teaches the invention discussed above in claim 1. Further, Rao teaches openings of the device, also discussed above. However, Rao does not explicitly teach pillars.
For claim 7, Nieh teaches a multi-layer, multi-gel microfluidic device (para. [0007], lines 1-2) and Nieh teaches PDMS posts (para. [0125], line 6), which reads on the instant claim limitation of pillars.
It would have been obvious to one of ordinary skill, in the art at the time, to further include pillars as taught by Nieh, because Nieh teaches the function of these posts is to retain a viscous cell-gel solution during loading and to serve as lateral supports for the extracellular gel matrix (para. [0125], lines 6-10).
Regarding claim 8, Rao teaches the invention discussed above in claim 7. Further, Rao teaches openings of the device, also discussed above. Further, Rao teaches the holes or membrane are sized such that the culture substrate does not flow outside the respective compartment , but the uptake material inserted in the compartments is able to flow freely among each of the compartments through the holes or membrane, para. [0077], lines 12-17). However, Rao does not explicitly teach pillars.
For claim 8, Nieh teaches a multi-layer, multi-gel microfluidic device (para. [0007], lines 1-2) and Nieh teaches PDMS posts (para. [0125], line 6), which reads on the instant claim limitation of pillars.
It would have been obvious to one of ordinary skill, in the art at the time, to further include pillars as taught by Nieh, because Nieh teaches the function of these posts is to retain a viscous cell-gel solution during loading and to serve as lateral supports for the extracellular gel matrix (para. [0125], lines 6-10).
Claims 9 and 14-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0194588 A1-Rao et al (hereinafter Rao).
Regarding claim 9, Rao teaches the invention discussed above in claim 1. Rao teaches a cell culture sample (cell cultures, para. [0071], line 4) and a base of a device, also discussed above. However, Rao does not explicitly teach a cell culture sample enclosed in a hydrogel.
For claim 9, a different embodiment of Rao teaches pourable culture substrates can include any substance that can take a liquid form and subsequently solidify or partially solidify, for example, hydrogels (para. [0880], lines 4-7), which reads on the instant claim limitation of a cell culture sample enclosed in a hydrogel.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a cell culture sample enclosed in a hydrogel as taught by a different embodiment of Rao. Further, Rao teaches the different pourable culture substrates capable of setting as solids are inserted into each compartment, respectively, with each culture substrate and respective compartment containing a different culture (para. [0080], lines 1-4; suggesting structural support for the cell culture substrates and the providing for the different cell culture substrates to be retained within the device).
Regarding claim 14, Rao teaches the invention discussed above in claim 1. Further, Rao teaches partitions and an outer wall of the device. However, Rao does not explicitly teach partitions having a height less than the height of the outer wall.
For claim 14, a different embodiment of Rao teaches first, second, and third wall portions 430, 440, and 450 (partitions) of the partitioning device 420 (para. [0084], lines 4-5, Fig. 4), further, annotated Fig. 4 below, shows partitions (first, second, and third wall portions 430, 440, and 450, Fig. 4), having a height less than the height of the outer wall of device 420, which reads on the instant claim limitation of partitions having a height less than the height of the outer wall.
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It would have been obvious to one of ordinary skill, in the art at the time, to further include partitions having a height less than the height of the outer wall as taught by a different embodiment of Rao. Further, Rao teaches the partitioning device has a platform that can be easily adapted with standard culture substrates in a range of tissue-like environments and, thus, can be readily utilized by laboratories studying nanoparticle-cellular interactions (para. [0004], lines 20-23).
Regarding claim 15, Rao teaches the invention discussed above in claim 14. Further, Rao teaches partitions and an outer wall of the device. However, Rao does not explicitly teach the partitions having a height half the height of the outer.
For claim 15, a different embodiment of Rao teaches first, second, and third wall portions 430, 440, and 450 (partitions) of the partitioning device 420 (para. [0084], lines 4-5, Fig. 4), further, annotated Fig. 4 above, shows partitions (first, second, and third wall portions 430, 440, and 450, Fig. 4), having a height half the height of the outer wall of device 420, which reads on the instant claim limitation of partitions having a height half the height of the outer wall.
It would have been obvious to one of ordinary skill, in the art at the time, to further include partitions having a height half the height of the outer wall as taught by a different embodiment of Rao. Further, Rao teaches the partitioning device has a platform that can be easily adapted with standard culture substrates in a range of tissue-like environments and, thus, can be readily utilized by laboratories studying nanoparticle-cellular interactions (para. [0004], lines 20-23).
Regarding claim 16, Rao teaches the invention discussed above in claim 1. Further, Rao teaches cavities formed in the inner wall and the outer wall of the device, also discussed above. However, Rao does not teach wherein the cavities formed of the inner and outer wall are less deep than a height of the outer wall.
For claim 16, a different embodiment of Rao teaches first, second, and third wall portions 430, 440, and 450 (partitions) of the partitioning device 420 (para. [0084], lines 4-5, Fig. 4), further, annotated Fig. 4 above, shows partitions (first, second, and third wall portions 430, 440, and 450, Fig. 4), having a height half the height of the outer wall of device 420, thus, the spaces or cavities formed in the inner wall and the outer wall of device 420 (shown above in annotated Fig. 4), are less deep than the height of the outer wall, which reads on the instant claim limitation of wherein the cavities formed of the inner and outer wall are less deep than a height of the outer wall.
It would have been obvious to one of ordinary skill, in the art at the time, to further include wherein the cavities formed of the inner and outer wall are less deep than a height of the outer wall as taught by a different embodiment of Rao. Further, Rao teaches the partitioning device has a platform that can be easily adapted with standard culture substrates in a range of tissue-like environments and, thus, can be readily utilized by laboratories studying nanoparticle-cellular interactions (para. [0004], lines 20-23).
Regarding claim 19, Rao teaches the invention discussed above in claim 17. Further, Rao teaches two more partitions connecting the inner wall to the outer wall, also discussed above. However, Rao does not explicitly teach four partitions segmenting the cavity into four voids.
For claim 19, a different embodiment of Rao (referring to Fig. 2), teaches four partitions (first wall portion 230, second wall portion 240, third wall portion 250, and fourth wall portion 260, para. [0078], lines 1-8, Fig. 2), segmenting the cavity or space of device 200 into four compartments (first compartment 270, second compartment 272, third compartment 274, and fourth compartment 276, para. [0078], lines 20-28, Fig. 2), which reads on the instant claim limitation of four partitions segmenting the cavity into four voids.
It would have been obvious to one of ordinary skill, in the art at the time, to further include four partitions segmenting the cavity into four voids as taught by a different embodiment of Rao, because Rao teaches the partitioning device 220 of competitive assay platform permitted evaluation of selective nanoparticle uptake to test for competition; the compartments enabled incorporation of four different cell types, which were tested for selective nanoparticle uptake (para. [0088], lines 6-12).
Allowable Subject Matter
Claim 22 is 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 22, the prior art fails to teach or fairly suggest a cell culture device kit comprising: a cell culture well device in accordance claim 1; and a sample removal rod, wherein a shape of the sample removal rod is dimensioned to snugly fit within the volume defined within the inner wall of the cell culture well device, where the limitations are in combination with the claim as a whole.
The closest prior art is US 2019/0194588 A1-Rao et al (hereinafter Rao)., and of US 2024/0067911 A1-Nieh et al (hereinafter Nieh). Rao teaches various implementations of competitive assay plat forms can be used to study selective uptake of substances (e.g., nanoparticles, drugs, heavy metals, chemicals) in three dimensional (3D) cultures. Nieh teaches a multi-layer, multi-gel microfluidic device, comprising: a plurality of layers comprising a plurality of inlets, outlets, and channels in fluid communication, and a middle layer comprising a cell growing chamber in fluid communication with a culture medium channel, the cell growing chamber comprising a first cured hydrogel, wherein the first cured hydrogel provides a plurality of uncured spaces, the uncured space capable of being filled with a population of tumor cells encapsulated in a second cured hydrogel. However, Rao and Nieh do not teach or fairly suggest a cell culture device kit comprising: a cell culture well device in accordance claim 1; and a sample removal rod, wherein a shape of the sample removal rod is dimensioned to snugly fit within the volume defined within the inner wall of the cell culture well device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799