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 .
Response to Amendment
The Amendment filed 03/09/2026 has been entered. Claims 1-41 and 43-45 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 12/08/2025. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-41 and 43-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites “a major surface that is parallel to a surface upon which the cell culture article sits”. While the disclosure describes a major surface as a cell growth area defined by the microcavity substrate surface (Figs. 1-2; paragraph [0040]-[0041]), the disclosure is silent on “a major surface that is parallel to a surface upon which the cell culture article sits”. Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-41 and 43-45 are rejected by virtue of their dependency on claim 1.
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 1-41 and 43-45 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.
Regarding claim 1, claim 1 recites the limitation " the cell culture article" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Claims 2-41 and 43-45 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites the limitation " the interior space" in line 12. There is insufficient antecedent basis for this limitation in the claim. Claims 2-41 and 43-45 are rejected by virtue of their dependency on claim 1.
Regarding claim 36, the term “low-adhesion” is a relative term which renders the claim indefinite. The term “low-adhesion” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, the specification, paragraph [0069] merely restates that the open well comprises low-adhesion material. The specification does not provide a standard for ascertaining the requisite degree
Claim Rejections - 35 USC § 102
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 1-2, 21-23, 27-28, 30, 32-33, 35-38, 40-41, and 43-45 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Miwa et al. (US 20180201888 A1; cited in the IDS filed 06/16/2023).
Regarding claim 1, Miwa teaches a cell culture device (abstract; Figs. 1-2) comprising:
a frame (Figs. 1-2, frame of cell culture vessel 10) comprising:
an open well disposed therein (Figs. 1-2 shows an open well within the peripheral wall 11), the open well comprising:
a bottom plate (12) comprising a microcavity substrate (Fig. 2 and paragraphs [0042]-[0043] teaches wells 2 having micrometer sizes, i.e. microcavity substrate), the bottom plate defining a major surface (Fig. 2, surface of bottom 12) that is parallel to a surface upon which the cell culture article sits (Fig. 2, surface of bottom 12 is parallel to the surface of wells 2 upon which a cellular aggregate 5 sits, i.e. cell culture article),
a top opening across the microcavity substrate (Fig. 2, top opening 10a across the wells 2), and
one or more sidewalls (Fig. 2, peripheral wall 11) extending from the bottom plate to the top opening (Fig. 2) and in a plane perpendicular to the surface upon which the cell culture article sits (Fig. 2 teaches the peripheral wall 11 extends perpendicular from the surface upon which the cellular aggregate 5 sits); and
a fluid inlet area (Fig. 2, interpreted as the area of the face of peripheral sidewall 11) in communication with the interior space defined by the open well (Fig. 2 teaches the area of the face of peripheral sidewall 11 is in fluid communication with the interior space defined by the open well within the peripheral wall 11).
Regarding claim 2, Miwa further teaches wherein the fluid inlet area comprises a face of a sidewall of the one or more sidewalls (Fig. 2, interpreted as the area of the face of peripheral sidewall 11).
Regarding claim 21, Miwa further teaches wherein the fluid inlet area is a fluid outlet area (Fig. 2, interpreted as the area of the face of peripheral sidewall 11, which is structurally capable of functioning as a fluid inlet and fluid outlet).
Regarding claim 22, Miwa further teaches wherein the cell culture device further comprises a baffle (Figs. 1-2 and paragraph [0045], partition 15).
Regarding claim 23, Miwa further teaches wherein the baffle (Figs. 1-2 and paragraph [0045], partition 15) is disposed within the open well between the major surface and the top opening (Figs. 1-2 and paragraph [0045], teaches partition 15 is disposed within the cell culture vessel 10 between the bottom 12 and top opening 10a).
Regarding claim 27, Miwa further teaches wherein the microcavity substrate comprises a plurality of microcavities (Fig. 2 and paragraphs [0042]-[0043] teaches a plurality wells having micrometer sizes).
Regarding claim 28, Miwa further teaches wherein the plurality of microcavities are arranged in at least one row (Fig. 2 shows at least one row of wells 2).
Regarding claim 30, Miwa further teaches wherein each microcavity of the plurality of microcavities (Fig. 2 and paragraphs [0042]-[0043], well 2) comprises a top aperture (top opening of well 2), a bottom (bottom region of well 2), and a microcavity sidewall surface extending from the top aperture to the microcavity bottom (curved sidewall surface of well 2 that extends from the top opening to the bottom of the well).
Regarding claim 32, Miwa further teaches wherein each microcavity comprises a rounded bottom (Fig. 2; paragraph [0033], “curved surface”).
Regarding claim 33, Miwa further teaches wherein a width of the top aperture of each microcavity is 500 um to 5 mm (paragraph [0043] teaches a major axis of an opening surface in an elliptical shape of 500 um±20 um).
Regarding claim 35, Miwa further teaches wherein each microcavity is non- adherent to cells (paragraph [0044] teaches the wells includes a coating that prevents the cells from adhering to the surface).
Regarding claim 36, Miwa further teaches wherein an interior surface of each microcavity is coated with a low-adhesion material (paragraph [0044] teaches the wells includes a coating in the inner surfaces that prevents the cells from adhering to the surface).
Regarding claim 37, Miwa further teaches wherein each microcavity is configured such that cells cultured in the well form a spheroid (Fig. 2 and paragraph [0044]).
Regarding claim 38, Miwa further teaches wherein the one or more sidewalls (Fig. 2, wall 11) defines a reservoir above the microcavity substrate (Fig. 2 teaches a reservoir including culture medium 14 above the wells 2).
Regarding claim 40, Miwa further teaches wherein an inner surface of the open well (Fig. 2, interpreted as including the surfaces of the wells 2) is non-adherent to cells (paragraph [0044] teaches the wells includes a coating in the inner surfaces that prevents the cells from adhering to the surface).
Regarding claim 41, Miwa further teaches wherein the inner surface of the open well comprises a non-adherent surface coating comprising perfluorinated polymers, olefins, agarose, non-ionic hydrogels, polyethers, polyols, polymers that inhibit cell attachment, or a combination thereof (paragraph [0044] teaches at least polymers that inhibit cell attachment).
Regarding claim 43, Miwa further teaches wherein the frame, one or more sidewalls, or a combination thereof are formed from polystyrene, polypropylene, polyethylene, polyethylene terephthalate, polymethylpentene, polycarbonate, polymethyl methacrylate, styrene-ethylene-butadiene-styrene, a silicone rubber or copolymer, ethylene vinyl acetate, polysulfone, polytetrafluoroethylene, poly(styrene-butadiene-styrene), or a combination thereof (paragraph [0045] teaches the wall 11 is formed as the same material as partition 15 and bottom 12; paragraph [0031] teaches the bottom 12 having a culture surface 3 made of polystyrene; therefore, the frame or sidewall is interpreted as formed from polystyrene).
Regarding claim 44, Miwa further teaches wherein the microcavity substrate (Fig. 2, wells 2 that includes culture surface 3) is formed from polydimethylsiloxane (PDMS), polymethylpentene, (poly)4- methylpentene (PMP), polyethylene (PE), polystyrene (PS), polypropylene, polyethylene terephthalate, polycarbonate, polyrnethyl methacrylate, styrene-ethylene- butadiene-styrene, a silicone rubber or copolymer, ethylene vinyl acetate, polysulfone, polytetrafluoroethylene, poly(styrene-butadiene-styrene), or a combination thereof (paragraph [0031], teaches the culture surface 3 having a plurality of wells 2 is formed from polystyrene).
Regarding claim 45, Miwa further teaches wherein the cell culture device is a reservoir open well microcavity plate (Figs. 1-2 shows the cell culture vessel 10 is a reservoir open well microcavity plate since it has an opening 10a, has a microcavity plate 2, and forms a reservoir that includes culture medium 14).
Claim Rejections - 35 USC § 103
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 2 above, and further in view of Cecchi et al. (US 20170260499 A1).
Regarding claim 3, Miwa further teaches the face of the sidewall is from a top outer portion of the sidewall (Fig. 2, top portion of sidewall 11 opposite of element 12) to a bottom inner portion of the sidewall along the length of the sidewall (Fig. 2, bottom portion of sidewall 11 towards element 12).
Miwa fails to teach wherein the face of the sidewall is slanted from a top outer portion of the sidewall to a bottom inner portion of the sidewall along the length of the sidewall and is oblique to the bottom plate.
Cecchi teaches a culture dish (abstract; Figs. 1-4, dish 10) comprising sidewalls (26) and a bottom plate (24), wherein the bottom plate comprises wells (14). Cecchi teaches the face of the sidewall is slanted from a top outer portion of the sidewall to a bottom inner portion of the sidewall along the length of the sidewall and is oblique to the bottom plate (Figs. 1-4 teaches sidewall 26 is angled or slanted from the top to the bottom towards element 24). Cecchi teaches slanted walls can be used to allow embryos to settle at a lower point of a well (paragraph [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the face of the sidewall of Miwa to incorporate the teachings of culture dishes with slanted sidewalls of Cecchi (Figs. 1-4) to provide: wherein the face of the sidewall is slanted from a top outer portion of the sidewall to a bottom inner portion of the sidewall along the length of the sidewall and is oblique to the bottom plate. Doing so would have a reasonable expectation of successfully improving distribution of desired cells towards the wells. Additionally, doing so would have been an obvious change in shape, i.e. a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed sidewall was significant (MPEP 2144.04 (IV)(B); In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a cell culture device with the face of the sidewall is slanted from a top outer portion of the sidewall to a bottom inner portion of the sidewall along the length of the sidewall and is oblique to the bottom plate) by known methods with no change in their respective functions (i.e. containing a cell culture within the sidewalls while allowing for manipulation of contents within the device), and the combinations yielded nothing more than predictable results (i.e. providing the claimed sidewall being slanted and oblique would yield nothing more than the obvious and predictable result of enabling manipulation of contents within the device and desired distribution of cells in the device). See MPEP 2143(A).
Regarding claim 4, Miwa further teaches wherein the top outer portion is at a same level as the top opening (Fig. 2 teaches top portion of sidewall 11 opposite of element 12 is at the same level as opening 10a)
Regarding claim 5, Miwa further teaches wherein the bottom inner portion (. 2, bottom portion of sidewall 11 towards element 12) is at a same level as the major surface and in communication with the major surface (Fig. 2, bottom portion of sidewall 11 towards bottom 12 is at the same level and in communication with bottom 12).
Claims 6-7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 1 above, and further in view of Clark et al. (US 20160137961 A1).
Regarding claim 6, Miwa fails to teach wherein the fluid inlet area comprises a notch disposed in a sidewall of the one or more sidewalls.
Clark teaches a cell cultivating vessel or device comprising one or more cell growing trays (abstract; Figs. 1-5). Clark teaches the vessel (Fig. 3) comprises a fluid inlet area including a notch in the side wall (Fig. 3, interpreted as the notch, recess, or cavity, disposed in the vessel sidewall 54 that forms open area 41), which allows one to easily recover cells or exchange media or add new media or cells into the notch without disturbing the tray or requiring one to tip the flask vertically as is required by the prior art (paragraph [0053]). Clark teaches the vessel may have sidewalls (paragraph [0056]) and an embodiment (Fig. 5a; paragraph [0056]), where the vessel has sidewalls that form a triangular shaped flask (paragraph [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid inlet area of Miwa to incorporate the teachings of a notch or open area in a sidewall of a cell cultivating vessel and teachings of various shapes of sidewalls for cell cultivating vessels of Clark (paragraphs [0053],[0056]; Figs. 1-5) to provide: wherein the fluid inlet area comprises a notch disposed in a sidewall of the one or more sidewalls. Doing so would have a reasonable expectation of successfully allowing for improved recovery or exchange of cells or media of the cell culture device without disturbing the device or tipping the device as discussed by Clark (paragraph [0053]).
Regarding claim 7, modified Miwa fails to teach wherein the notch comprises a tetrahedron-shaped notch at a center of the sidewall.
Clark teaches a cell cultivating vessel or device comprising one or more cell growing trays (abstract; Figs. 1-5). Clark teaches the vessel (Fig. 3) comprises a fluid inlet area including a notch in the side wall (Fig. 3, interpreted as the notch, recess, or cavity, disposed in the vessel sidewall 54 that forms open area 41), which allows one to easily recover cells or exchange media or add new media or cells into the notch without disturbing the tray or requiring one to tip the flask vertically as is required by the prior art (paragraph [0053]). Clark teaches the vessel may have sidewalls (paragraph [0056]) and an embodiment (Fig. 5a; paragraph [0056]), where the vessel has sidewalls that form a triangular shaped flask (paragraph [0056]; Fig. 5a) or a design with five sidewalls (paragraph [0056]; Fig. 5d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the notch of modified Miwa to incorporate the teachings of various shapes of sidewalls for cell cultivating vessels of Clark (paragraph [0056]; Figs. 1-5) to provide: wherein the notch comprises a tetrahedron-shaped notch at a center of the sidewall. Doing so would have a reasonable expectation of successfully allowing for improved recovery or exchange of cells or media of the cell culture device without disturbing the device or tipping the device as discussed by Clark (paragraph [0053]). Additionally, doing so would have been an obvious change in shape of the notch (MPEP 2144.04(IV)(B); In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, providing the notch at a center of the sidewall would be an obvious rearrangement of parts (MPEP 2144.04(VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 11, Miwa fails to teach wherein the fluid inlet area comprises a notch disposed at a corner of the open well where a first sidewall of the one or more sidewalls joins a second sidewall of the one or more sidewalls at a right angle.
Clark teaches a cell cultivating vessel or device comprising one or more cell growing trays (abstract; Figs. 1-5). Clark teaches the vessel (Fig. 3) comprises a fluid inlet area including a notch in at least one corner of the side wall (Fig. 3, interpreted as the notch, recess, or cavity, disposed in the corners of the vessel sidewall 54 that forms open area 41), which allows one to easily recover cells or exchange media or add new media or cells into the notch without disturbing the tray or requiring one to tip the flask vertically as is required by the prior art (paragraph [0053]). Clark teaches the vessel may have sidewalls (paragraph [0056]) and an embodiment (Fig. 5a; paragraph [0056]), where the vessel has sidewalls that form rectangular shaped design (paragraph [0056]), i.e. right angles.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid inlet area of Miwa to incorporate the teachings of a notch or open area at a corner of a sidewall of a cell cultivating vessel and teachings of various shapes of sidewalls for cell cultivating vessels of Clark (paragraphs [0053],[0056]; Figs. 1-5) to provide: wherein the fluid inlet area comprises a notch disposed at a corner of the open well where a first sidewall of the one or more sidewalls joins a second sidewall of the one or more sidewalls at a right angle. Doing so would have a reasonable expectation of successfully allowing for improved recovery or exchange of cells or media of the cell culture device without disturbing the device or tipping the device as discussed by Clark (paragraph [0053]).
Regarding claim 12, modified Miwa fails to teach wherein the notch comprises a tetrahedron-shaped notch at the corner of the open well.
Clark teaches a cell cultivating vessel or device comprising one or more cell growing trays (abstract; Figs. 1-5). Clark teaches the vessel (Fig. 3) comprises a fluid inlet area including a notch in the side wall (Fig. 3, interpreted as the notch, recess, or cavity, disposed in the vessel sidewall 54 that forms open area 41), which allows one to easily recover cells or exchange media or add new media or cells into the notch without disturbing the tray or requiring one to tip the flask vertically as is required by the prior art (paragraph [0053]). Clark teaches the vessel may have sidewalls (paragraph [0056]) and an embodiment (Fig. 5a; paragraph [0056]), where the vessel has sidewalls that form a triangular shaped flask (paragraph [0056]; Fig. 5a) or a design with five sidewalls (paragraph [0056]; Fig. 5d).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the notch of modified Miwa to incorporate the teachings of various shapes of sidewalls for cell cultivating vessels of Clark (paragraph [0056]; Figs. 1-5) to provide: wherein the notch comprises a tetrahedron-shaped notch at the corner of the open well. Doing so would have a reasonable expectation of successfully allowing for improved recovery or exchange of cells or media of the cell culture device without disturbing the device or tipping the device as discussed by Clark (paragraph [0053]). Additionally, doing so would have been an obvious change in shape of the notch (MPEP 2144.04(IV)(B); In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, providing the notch at the corner of the open well would be an obvious rearrangement of parts (MPEP 2144.04(VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claims 8-10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Miwa in view of Clark as applied to claims 7 and 12 above, and further in view of Madsen et al. (US 20170044476 A1).
Regarding claim 8, Miwa further teaches a top outer portion of the sidewall (Fig. 2, top portion of sidewall 11 opposite of element 12) and a bottom inner portion of the sidewall (Fig. 2, bottom portion of sidewall 11 towards element 12).
Modified Miwa fails to teach wherein an edge of the tetrahedron-shaped notch is slanted from the top outer portion of the sidewall to the bottom inner portion of the sidewall.
Madsen teaches a culture dish (abstract). Madsen teaches an embodiment (Fig. 17) of a culture dish (122) comprising a fluid inlet area (154) comprising a ledge disposed in a sidewall, wherein the ledged is a grooved channel (Fig. 17 and paragraph [0114] teach the upper well section 154 as an elongate grooved channel in the trough 144, wherein the upper well section 154 is interpreted as a grooved channel), which can assist a user is seeking to manipulate objects within the well since a user's manipulation tool can approach from a shallower angle than would otherwise be the case (paragraph [0114]). Madsen teaches the ledge (Fig. 17, 154) slants from a top portion on a first end of a sidewall (the end towards element 144) to a bottom potion on a second end of the sidewall (the end towards element 156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ledge of modified Miwa to incorporate the teachings of a culture dish with a slanted ledge disposed in a sidewall (Fig. 17; paragraph [0114]) to provide: wherein an edge of the tetrahedron-shaped notch is slanted from the top outer portion of the sidewall to the bottom inner portion of the sidewall. Doing so would have a reasonable expectation of successfully improving the fluid inlet area for a user to manipulate the contents of the device as taught by Madsen.
Regarding claim 9, Miwa further teaches wherein the top outer portion is at a same level as the top opening (Fig. 2 teaches top portion of sidewall 11 opposite of element 12 is at the same level as opening 10a).
Regarding claim 10, Miwa further teaches wherein the bottom inner portion is at a same level as the major surface and in communication with the major surface (Fig. 2, bottom portion of sidewall 11 towards bottom 12 is at the same level and in communication with bottom 12).
Regarding claim 13, Miwa further teaches a top outer portion of the sidewall (Fig. 2, top portion of sidewall 11 opposite of element 12) and a bottom inner portion of the sidewall (Fig. 2, bottom portion of sidewall 11 towards element 12).
Modified Miwa fails to teach wherein an edge of the tetrahedron- shaped notch is slanted from a top outer portion of the corner to a bottom inner portion of the corner.
Madsen teaches a culture dish (abstract). Madsen teaches an embodiment (Fig. 17) of a culture dish (122) comprising a fluid inlet area (154) comprising a ledge disposed in a sidewall, wherein the ledged is a grooved channel (Fig. 17 and paragraph [0114] teach the upper well section 154 as an elongate grooved channel in the trough 144, wherein the upper well section 154 is interpreted as a grooved channel), which can assist a user is seeking to manipulate objects within the well since a user's manipulation tool can approach from a shallower angle than would otherwise be the case (paragraph [0114]). Madsen teaches the ledge (Fig. 17, 154) slants from a top portion on a first end of a sidewall (the end towards element 144) to a bottom potion on a second end of the sidewall (the end towards element 156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ledge of modified Miwa to incorporate the teachings of a culture dish with a slanted ledge disposed in a sidewall (Fig. 17; paragraph [0114]) to provide: wherein an edge of the tetrahedron- shaped notch is slanted from a top outer portion of the corner to a bottom inner portion of the corner. Doing so would have a reasonable expectation of successfully improving the fluid inlet area for a user to manipulate the contents of the device as taught by Madsen.
Regarding claim 14, modified Miwa fails to teach wherein the top outer portion of the corner is at a same level as the top opening.
Miwa further teaches wherein the top outer portion is at a same level as the top opening (Fig. 2 teaches top portion of sidewall 11 opposite of element 12 is at the same level as opening 10a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the top outer portion of the corner of modified Miwa to incorporate the teachings of a top outer portion being at a same level as the top opening of Miwa (Fig. 2) to provide wherein the top outer portion of the corner is at a same level as the top opening. Doing so would have been an obvious change in shape of the top outer portion (MPEP 2144.04(IV)(B); In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 15, modified Miwa fails to teach wherein the bottom inner portion of the corner is at a same level as the major surface and in communication with the major surface.
Miwa further teaches wherein the bottom inner portion is at a same level as the major surface and in communication with the major surface (Fig. 2, bottom portion of sidewall 11 towards bottom 12 is at the same level and in communication with bottom 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom inner portion of the corner of modified Miwa to incorporate the teachings of the bottom inner portion is at a same level as the major surface and in communication with the major surface of Miwa (Fig. 2) to provide wherein the bottom inner portion of the corner is at a same level as the major surface and in communication with the major surface. Doing so would have been an obvious change in shape of the bottom inner portion (MPEP 2144.04(IV)(B); In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 1 above, and further in view of Madsen et al. (US 20170044476 A1).
Regarding claim 16, Miwa fails to teach wherein the fluid inlet area comprises a ledge disposed in a sidewall of the one or more sidewalls.
Madsen teaches a culture dish (abstract). Madsen teaches an embodiment (Fig. 17) of a culture dish (122) comprising a fluid inlet area (154) comprising a ledge disposed in a sidewall, wherein the ledged is a grooved channel (Fig. 17 and paragraph [0114] teach the upper well section 154 as an elongate grooved channel in the trough 144, wherein the upper well section 154 is interpreted as a grooved channel), which can assist a user is seeking to manipulate objects within the well since a user's manipulation tool can approach from a shallower angle than would otherwise be the case (paragraph [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid inlet area of the fluid inlet area of Miwa to incorporate the teachings of a culture dish with a ledge disposed in a sidewall (Fig. 17; paragraph [0114]) to provide: wherein the fluid inlet area comprises a ledge disposed in a sidewall of the one or more sidewalls. Doing so would have a reasonable expectation of successfully improving the fluid inlet area for a user to manipulate the contents of the device as taught by Madsen.
Regarding claim 17, modified Miwa fails to teach wherein the ledge is a grooved channel.
Madsen teaches a culture dish (abstract). Madsen teaches an embodiment (Fig. 17) of a culture dish (122) comprising a fluid inlet area (154) comprising a ledge disposed in a sidewall, wherein the ledged is a grooved channel (Fig. 17 and paragraph [0114] teach the upper well section 154 as an elongate grooved channel in the trough 144, wherein the upper well section 154 is interpreted as a grooved channel), which can assist a user is seeking to manipulate objects within the well since a user's manipulation tool can approach from a shallower angle than would otherwise be the case (paragraph [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid inlet area of the fluid inlet area of Miwa to incorporate the teachings of a culture dish with a ledge disposed in a sidewall (Fig. 17; paragraph [0114]) to provide: wherein the ledge is a grooved channel. Doing so would have a reasonable expectation of successfully improving the fluid inlet area for a user to manipulate the contents of the device as taught by Madsen.
Regarding claim 18, Miwa further teaches a top portion of the sidewall (Fig. 2, top portion of sidewall 11 opposite of element 12) and a bottom portion of the sidewall (Fig. 2, bottom portion of sidewall 11 towards element 12).
Modified Miwa fails to teach wherein the ledge slants from a top portion on a first end of the sidewall to a bottom portion on a second end of the sidewall.
Madsen teaches a culture dish (abstract). Madsen teaches an embodiment (Fig. 17) of a culture dish (122) comprising a fluid inlet area (154) comprising a ledge disposed in a sidewall, wherein the ledged is a grooved channel (Fig. 17 and paragraph [0114] teach the upper well section 154 as an elongate grooved channel in the trough 144, wherein the upper well section 154 is interpreted as a grooved channel), which can assist a user is seeking to manipulate objects within the well since a user's manipulation tool can approach from a shallower angle than would otherwise be the case (paragraph [0114]). Madsen teaches the ledge (Fig. 17, 154) slants from a top portion on a first end of a sidewall (the end towards element 144) to a bottom potion on a second end of the sidewall (the end towards element 156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ledge of modified Miwa to incorporate the teachings of a culture dish with a slanted ledge disposed in a sidewall (Fig. 17; paragraph [0114]) to provide: wherein the ledge slants from a top portion on a first end of the sidewall to a bottom portion on a second end of the sidewall. Doing so would have a reasonable expectation of successfully improving the fluid inlet area for a user to manipulate the contents of the device as taught by Madsen.
Regarding claim 19, Miwa further teaches wherein the bottom portion is at a same level as the major surface and in communication with the major surface (Fig. 2, bottom portion of sidewall 11 towards bottom 12 is at the same level and in communication with bottom 12).
Regarding claim 20, Miwa further teaches wherein the top portion is at a same level as the top opening (Fig. 2 teaches top portion of sidewall 11 opposite of element 12 is at the same level as opening 10a).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 22 above.
Regarding claim 24, Miwa fails to teach: wherein the baffle comprises a plurality of baffle segments, each baffle segment stretching from one end of the open well to an opposite end of the open well.
Miwa teaches embodiments of a plurality of baffle segments (Figs. 4-5,9, 16 element 15, 75). Miwa teaches an embodiment (Fig. 9) comprising a plurality of baffle segments (partitions 75) that stretch from one end to an opposite end of the open well (11). Miwa teaches the baffle segments, i.e. partitions, can enhance the effect of suppressing the flowage of the culture medium in the cell culture vessel, therefore improving the function of preventing the jumping of cells and spheroids out of the wells, resulting in that spheroids more uniform in shape and size can be obtained (paragraph [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the baffle of Miwa to incorporate the teachings of embodiments of baffle segments stretching across the open well (Fig. 9; paragraph [0066]) to provide: wherein the baffle comprises a plurality of baffle segments, each baffle segment stretching from one end of the open well to an opposite end of the open well. Doing so would have a reasonable expectation of successfully improving the function of preventing the jumping of cells and spheroids out of the wells, resulting in that spheroids more uniform in shape and size can be obtained (Miwa, paragraph [0066]).
Regarding claim 25, modified Miwa fails to teach wherein at least one baffle segment of the plurality of baffle segments is perpendicular to other baffle segments.
Miwa teaches embodiments of a plurality of baffle segments (Figs. 4-5,9, 16 element 15, 75). Miwa teaches an embodiment (Fig. 9) comprising a plurality of baffle segments (partitions 75) that stretch from one end to an opposite end of the open well (11), and the baffle segments are perpendicular to each other (Fig. 9). Miwa teaches the baffle segments, i.e. partitions, can enhance the effect of suppressing the flowage of the culture medium in the cell culture vessel, therefore improving the function of preventing the jumping of cells and spheroids out of the wells, resulting in that spheroids more uniform in shape and size can be obtained (paragraph [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the baffle of Miwa to incorporate the teachings of embodiments of perpendicular baffle segments stretching across the open well (Fig. 9; paragraph [0066]) to provide: wherein at least one baffle segment of the plurality of baffle segments is perpendicular to other baffle segments. Doing so would have a reasonable expectation of successfully improving the function of preventing the jumping of cells and spheroids out of the wells, resulting in that spheroids more uniform in shape and size can be obtained (Miwa, paragraph [0066]).
Regarding claim 26, modified Miwa fails to teach wherein a first baffle segment is disposed in the open well along a length of a sidewall and adjacent to the fluid inlet area.
Miwa teaches embodiments of a plurality of baffle segments (Figs. 4-5,9, 16 element 15, 75). Miwa teaches an embodiment (Fig. 9) comprising a plurality of baffle segments (partitions 75) that stretch from one end to an opposite end of the open well (11), and baffle segments disposed in the open well along a length of sidewall (11) and adjacent to fluid inlet areas (Fig. 9). Miwa teaches the baffle segments, i.e. partitions, can enhance the effect of suppressing the flowage of the culture medium in the cell culture vessel, therefore improving the function of preventing the jumping of cells and spheroids out of the wells, resulting in that spheroids more uniform in shape and size can be obtained (paragraph [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the baffle of Miwa to incorporate the teachings of embodiments of baffle segments stretching across the open well and along the length of a sidewall adjacent to fluid inlet areas (Fig. 9; paragraph [0066]) to provide: wherein a first baffle segment is disposed in the open well along a length of a sidewall and adjacent to the fluid inlet area. Doing so would have a reasonable expectation of successfully improving the function of preventing the jumping of cells and spheroids out of the wells, resulting in that spheroids more uniform in shape and size can be obtained (Miwa, paragraph [0066]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 27 above, and further in view of Lacey et al. (WO 2019014621 A1; cited in the IDS filed 06/16/2023).
Regarding claim 29, Miwa fails to teach wherein the plurality of microcavities are arranged in a hexagonal close-pack pattern.
Lacey teaches a cell culture vessel comprising microcavities for culturing cells (abstract). Lacey teaches the plurality of microcavities can be arranged in an array including a linear array, a diagonal array, a rectangular array, a circular array, a radial array, a hexagonal close-packed arrangement, etc. (paragraph [0061]). Lacey teaches hexagonal close-packed arrangement of microcavities (Fig. 5).
Since Lacey teaches known patterns of microcavities including linear arrays or hexagonal close-packed arrangements (paragraph [0061]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of microcavities of Miwa to incorporate the teachings of a hexagonal close-packed arrangement of microcavities of Lacey (paragraph [0061]; Fig. 5) to provide wherein the plurality of microcavities are arranged in a hexagonal close-pack pattern. Doing so would be a simple substitution of one known material (Miwa’s linear microcavities) with another (Lacey’s hexagonal close-packed microcavities), which would have a reasonable expectation of successfully culturing cells as taught by Lacey (abstract; paragraph [0061]). MPEP 2143(I)(B).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 30 above, and further in view of Cecchi et al. (US 20170260499 A1).
Regarding claim 31, Miwa fails to teach wherein the top apertures of the microcavities are co-planar with the major surface and the bottom of the microcavities are positioned below the major surface.
Cecchi teaches a culture dish (abstract; Figs. 1-4, dish 10) comprising sidewalls (26) and a bottom plate (24), wherein the bottom plate comprises wells (14). Cecchi teaches the top apertures of the wells (Fig. 2, top apertures of wells 14) are co-planar with a major surface (24) and the bottom of the wells are positioned below the major surface (Fig. 2). Cecchi teaches slanted walls can be used to allow embryos to settle at a lower point of a well (paragraph [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microcavities of Miwa to incorporate the teachings of a culture dishes with an arrangement of microcavities below a major surface of Cecchi (Fig. 2) to provide: wherein the top apertures of the microcavities are co-planar with the major surface and the bottom of the microcavities are positioned below the major surface. Doing so would have a reasonable expectation of successfully improving settlement of cells towards the lower point of the microcavities as taught by Cecchi.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 30 above.
Regarding claim 34, Miwa fails to explicitly teach wherein a depth of each microcavity of the plurality of microcavities is 500 um to 6 mm.
Miwa teaches the depth of the microcavity ranges from 10um-1500um (paragraph [0042]).
Since Miwa teaches a depth of microcavities of 10um-1500um (paragraph [0042]), wherein the range of 10um-1500um overlaps with the claimed range of 500 um to 6 mm, i.e. 500-1500 um, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miwa to provide wherein a depth of each microcavity of the plurality of microcavities is 500 um to 6 mm. I.e., it would have been prima facia obvious to have selected the overlapping portion of the range (i.e. 500-1500 um) from the taught range of 10um-1500um (Miwa, paragraph [0042]) (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05 (I)).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Miwa as applied to claim 38 above.
Regarding claim 39, Miwa fails to explicitly teach wherein the one or more sidewalls have a height of 0.780 inches.
Miwa teaches the sidewall has a height of 20 mm, i.e. 0.787 inches (paragraph [0032]).
Since Miwa teaches a height of 20 mm, i.e. 0.787 inches (paragraph [0032]), wherein the height is merely close to the claimed height, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miwa to provide wherein the one or more sidewalls have a height of 0.780 inches. (Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); see MPEP 2144.05(I))
Response to Arguments
Applicant’s arguments, see page 8, filed 03/09/2026, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(b) of 12/08/2025 have been withdrawn.
Applicant’s arguments, see pages 8-12, filed 03/09/2026, with respect to the rejection(s) of claims 1-6, 11, 16-21, 27-28, 30-32, 35-38, 40, 45 under 35 U.S.C. 102 and dependent claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Miwa et al. (US 20180201888 A1; cited in the IDS filed 06/16/2023).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hotte-Lohmeier et al. (US 20200165556 A1) teaches a cover lid collector for a sample carrier for cell cultivation (abstract; Fig. 1), wherein the cover lid collector comprises a tetrahedron-shaped notch (Fig. 1 and paragraph [0023] teaches a cavity 14 that has a pyramidal shape).
Asthana (US 20230193179 A1; effectively filed 05/19/2020) teaches a cell culture apparatus (abstract; Fig. 1) comprising a plurality of microcavities (Fig. 1c; abstract).
Martin (US 20210062126 A1; cited in the IDS filed 06/16/2023) teaches a microcavity dish for cultivating cells (abstract; Figs. 1-2) comprising and array of microcavities (46) and a sidewall that includes a transition portion (30) that divides the sidewall into an upper portion and a lower portion that is offset inward relative to the upper portion defining a liquid medium delivery surface (26) that extends at least partially along an interior surface (28) of the sidewall and slopes toward the bottom (abstract).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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