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 with traverse of Group I, claims 1-12 in the reply filed on 2/19/2026 is acknowledged. The traversal is on the ground(s) that the common technical feature makes a contribution over the prior art and is a special technical feature. This is not found persuasive because the common technical feature does not make a contribution over new prior art of record.
The common technical feature appears to be:
A cell mass-forming member comprising a substrate, wherein on a surface of the substrate, at least one or more attachment-preventing regions and at least one or more cell attachment regions are formed,
in at least part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed.
This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Yokoyama et al. (JP 2012120443 A) (hereinafter referred to as Yokoyama, English machine translation provided, see PTO-892), in view of Tokuno et al. (JP 2019037220 A) (hereinafter referred to as Tokuno, English equivalent EP 3674390 A1 cited herein, presented in IDS dated 1/21/2026).
Yokoyama discloses a cell mass-forming member ([Overview]) comprising a substrate ([Overview]) wherein on a surface of the substrate, at least one or more attachment-preventing regions ([Overview], “cell adhesion inhibiting region”) and at least one or more cell attachment regions are formed ([Overview], “cell adhesion region”).
Yokoyama does not disclose wherein in at least part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed.
However, Tokuno discloses a cell sheet-forming member (title), i.e., a cell mass-forming member, wherein at least one or more cell attachment regions are formed (Fig. 1B, recession/protrusion portion 140), in at least a part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed (Fig. 1B). Tokuno teaches that such a structure is suitable for facilitating cell adhesion and can control the orientation and position of cultured cells ([0041] and Fig. 4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form at least a part of the at least one or more cell attachment regions of Yokoyama with a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed because Tokuno teaches that this modification would be suitable for facilitating cell adhesion and would introduce the capability to control the orientation and positions of cultured cells.
Examiner notes that independent claims 13 and 14 are phrased in the alternative. Therefore, the limitations “in both the at least one or more attachment-preventing regions and the at least one or more cell attachment regions, a hydrophilic coating layer is formed” in claim 1 and “in either the at least one or more attachment-preventing regions or the at least one or more cell attachment regions, a hydrophilic coating layer is formed in claim 2 are not considered to be common matter.
Examiner asserts that there is clear lack of unity of invention because the common matter of the independent claims is well known and that the remaining subject matter of each claim differs from that of the others without there being any unifying novel inventive concept common to all (MPEP § 1850 II).
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 8/15/2023 and 1/21/2026 are compliance with 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Tokuno.
Regarding claim 1, Yokoyama discloses a cell mass-forming member ([Overview]) comprising a substrate ([Overview]) wherein on a surface of the substrate, at least one or more attachment-preventing regions ([Overview], “cell adhesion inhibiting region”) and at least one or more cell attachment regions are formed ([Overview], “cell adhesion region”),
in both the at least one or more attachment-preventing regions and the at least one or more cell attachment regions, a hydrophilic coating layer is formed (second embodiment of Yokoyama – [0037], “cell adhesion layer is a layer formed of a hydrophilic film…and the cell adhesion-inhibiting layer is a layer formed of a hydrophilic film”).
Yokoyama does not disclose wherein in at least part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed.
However, Tokuno discloses a cell sheet-forming member (title), i.e., a cell mass-forming member, wherein at least one or more cell attachment regions are formed (Fig. 1B, recession/protrusion portion 140), in at least a part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed (Fig. 1B). Tokuno teaches that such a structure is suitable for facilitating cell adhesion and can control the orientation and position of cultured cells ([0041] and Fig. 4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form at least a part of the at least one or more cell attachment regions of Yokoyama with a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed because Tokuno suggests that this modification would be suitable for facilitating cell adhesion and would introduce the capability to control the orientation and positions of cultured cells.
Regarding claim 2, Yokoyama discloses a cell mass-forming member ([Overview]) comprising a substrate ([Overview]) wherein on a surface of the substrate, at least one or more attachment-preventing regions ([Overview], “cell adhesion inhibiting region”) and at least one or more cell attachment regions are formed ([Overview], “cell adhesion region”),
in either the at least one or more attachment-preventing regions and the at least one or more cell attachment regions, a hydrophilic coating layer is formed (first embodiment of Yokoyama – [0036], “a cell adhesion-inhibiting hydrophilic film is formed…a site where cell adhesion is desired is subjected to an oxidation treatment and/or a decomposition treatment”).
Yokoyama does not disclose wherein in at least part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed.
However, Tokuno discloses a cell sheet-forming member (title), i.e., a cell mass-forming member, wherein at least one or more cell attachment regions are formed (Fig. 1B, recession/protrusion portion 140), in at least a part of the at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed (Fig. 1B). Tokuno teaches that such a structure is suitable for facilitating cell adhesion and can control the orientation and position of cultured cells ([0041] and Fig. 4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form at least a part of the at least one or more cell attachment regions of Yokoyama with a fine uneven structure comprising a plurality of protrusions or a plurality of recesses is formed because Tokuno suggests that this modification would be suitable for facilitating cell adhesion and would introduce the capability to control the orientation and positions of cultured cells.
Regarding claim 3, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination discloses that a height of the protrusion portion is between 50 nm and 5 µm ([0027]).
Although Tokuno does not expressly disclose the claimed range, it would have been obvious to one of ordinary skill in the art to form the plurality of protrusions such that an average height of the plurality of protrusions is 250 nm or greater because it has been held that when claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05).
The limitation “an average depth of the plurality of recesses is 250 nm or greater" is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 4, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination discloses that the diameter of the protrusion portion is between 50% and 100% of the pitch of the protrusion portions, and that the pitch of the protrusion portions is between 100 nm and 10 µm. Thus, the diameter of the protrusion portion is between 50 nm to 10 µm. With the protrusion portion height discussed above, the aspect ratio of the protrusion portion height to the protrusion portion diameter is from 0.5 to 1.0. E.g., 5 µm height:10 µm diameter to 50 nm height:50 nm diameter.
Although Tokuno does not expressly disclose the claimed range, it would have been obvious to one of ordinary skill in the art to form the plurality of protrusions such that an aspect ratio of the average height of the plurality of protrusions to an average diameter of the plurality of protrusions is from 0.5 to 5.0 because it has been held that when claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05).
The limitation “an aspect ratio of the average depth of the plurality of recesses to an average diameter of the plurality of recesses is from 0.5 to 5.0” is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 5, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination discloses that the pitch of the protrusion portions is between 100 nm to 10 µm.
Although Tokuno does not expressly disclose the claimed range, it would have been obvious to one of ordinary skill in the art to form the plurality of protrusions such that an average pitch between the plurality of protrusions or between the plurality of recesses is from 50 nm to 1 µm because it has been held that when claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05).
Regarding claim 6, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination implicitly discloses wherein the at least one or more cell attachment regions are located at a position with a height difference relative to the at least one or more attachment-preventing regions in a thickness direction of the substrate ([0010], “in a thickness direction of the cell sheet-forming member, a difference between a height of a distal end surface of each of the plurality of recession/protrusion portions and a height of each of the plurality of flat portions may be 0.5 µm or less, preferably 0.3 µm or less”). The flat portions can be formed to prevent attachment, i.e., the flat portion is an attachment-preventing region ([0043] discusses preferential adherence to different portions; Fig. 4B shows no cells attached to flat portion).
Regarding claim 7, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination implicitly discloses wherein a height difference between the at least one or more cell attachment regions and the surface of the substrate is from 50 nm to 5 µm ([0027]; Fig. 2, base 160 and protrusion portions 141 with a height difference).
Although Tokuno does not expressly disclose the claimed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the prior art combination cell mass-forming member such that a height difference between the at least one or more cell attachment regions and the surface of the substrate is from 0 to 3 µm because it has been held that when claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05).
Regarding claim 8, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination implicitly discloses wherein a hydrophilic layer is formed in recesses between the plurality of protrusions of the fine uneven structure region or in bottoms of recesses between the plurality of protrusions of the fine uneven structure region ([0030] discloses surface coatings which are hydrophilic).
Regarding claim 9, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Yokoyama of the prior art combination discloses wherein the substrate comprises at least one or more resins selected from the group consisting of poly(ethylene terephthalate), triacetyl cellulose, polycarbonate, cycloolefin polymers, cycloolefin copolymers, acrylic resins, polystyrene, and dimethylpolysiloxane ([0033] discloses acrylic resin, polycarbonate resin, and polystyrene).
Regarding claim 10, the prior art combination the cell mass-forming member according to claim 1 or 2.
Yokoyama of the prior art combination teaches that a cell adhesion region, i.e., a cell attachment region, can have a shape and/or a size suitable for cell differentiation ([0025]; Fig. 2 shows different shapes of cell attachment regions).
The prior art combination is silent to a ratio of a major axis of an ellipse with a minimum area circumscribing the at least one or more cell attachment regions to a minor axis of the ellipse is from 1 to 3.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination cell mass-forming member such that a ratio of a major axis of an ellipse with a minimum area circumscribing the at least one or more cell attachment regions to a minor axis of the ellipse is from 1 to 3 as such a modification would merely amount to a change in shape and proportion of the prior art at least one or more cell attachment regions. It has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP § 2144.04 IV B) and that changes in proportion are not sufficient to patentably distinguish over the prior art (MPEP § 2144.04 IV A).
Regarding claim 11, the prior art combination teaches the cell mass-forming member according to claim 1.
Yokoyama of the prior art combination teaches that a cell adhesion region, i.e., a cell attachment region, can have a shape and/or a size suitable for cell differentiation ([0025]; Fig. 2 shows different shapes of cell attachment regions).
The prior art combination discloses at least one or more cell attachment regions, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses, and in both the at least one or more attachment-preventing regions and the at least one or more cell attachment regions, a hydrophilic coating layer is formed, as set forth above in the claim 1 rejection under 35 U.S.C. 103.
The prior art combination is silent to wherein in a plan view of the cell mass-forming member, the at least one or more cell attachment regions are formed in an annular region surrounded by an outer diameter circle and an inner diameter circle, the outer-diameter circle having a diameter from 10 to 100 µm, a difference between the diameter of the outer diameter circle and a diameter of the inner diameter circle being from 200 nm to 30 µm, and in at least a part of the annular region, a fine uneven structure comprising a plurality of protrusions or a plurality of recesses being formed.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination cell mass-forming member to meet the limitations of note as such a modification would merely amount to a change in shape and proportion of the prior art at least one or more cell attachment regions. It has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP § 2144.04 IV B) and that changes in proportion are not sufficient to patentably distinguish over the prior art (MPEP § 2144.04 IV A).
Regarding claim 12, the prior art combination teaches the cell mass-forming member according to claim 1 or 2.
Tokuno of the prior art combination teaches that it is known in the art for a culture vessel comprising a cell sheet-forming member (Figs. 1A-1B, sheet member placed in culture plate 110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form a culture vessel comprising the prior art combination cell mass-forming member as this technique for improving the similar cell sheet-forming member of Tokuno was known in the art. This would have improved the prior art combination cell mass-forming member by providing means of transporting and storing the cells cultured on the cell mass-forming member.
Regarding claim 16, the prior art combination teaches the cell mass-forming member according to claim 1.
Tokuno of the prior art combination further discloses wherein: the hydrophilic coating layer is a layer formed by a hydrophilic material ([0030], discloses hydrophilic organic materials as coatings); the hydrophilic material is a biocompatible polymer ([0030], collagen and gelatine); and the surface of the hydrophilic coating layer formed in the fine uneven structure region of the cell attachment regions conforms to the fine uneven structure region ([0030], implicitly discloses that the entirety of surface is coated).
Regarding claim 17, the prior art combination teaches the cell mass-forming member according to claim 2.
Tokuno of the prior art combination further discloses wherein: the hydrophilic coating layer is a layer formed by a hydrophilic material ([0030], discloses hydrophilic organic materials as coatings); the hydrophilic material is a biocompatible polymer ([0030], collagen and gelatine); a hydrophilic layer is formed in a plurality of recesses between a plurality of protrusions of the fine uneven structure region ([0030], implicitly discloses that the entirety of surface is coated); and the plurality of protrusions protrude from the hydrophilic layer ([0029], “the surface 111 of the cell sheet-forming member 100 includes the flat portions 130 and the recession/protrusion portions 140”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fjorback et al. (US 2015/0080906 A1) discloses a medical device with a plurality of protrusions and recesses for cell adhesion.
Wang et al. (US 2007/0128716 A1) discloses a plate for patterning biological and non-biological materials, the plate comprising cavities for cell attachment.
Lo et al. (US 2018/0264466 A1) discloses a device comprising different regions with differing cellular adherence preferences.
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/A.J.C./Examiner, Art Unit 1799
/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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