DETAILED ACTION
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Maejima (US 20190194376) in view of Im (US 20190233788).
With respect to claim 1, Maejima discloses a surface treatment agent comprising a block copolymer. The block copolymer includes a temperature-responsive polymer, which is designated in the reference as the (A) block. See paragraphs [0061]-[0069]. The block copolymer additionally includes a (B) block and a (C) block, wherein the (B) block has cell-adhesive qualities and may include a functional group exhibiting acidity. See paragraphs [0029], [0033] and [0072] (“Examples of the hydrophilic moieties in the repeating unit of each block include…carboxyl group moieties (—COOH)…[and] hydroxyl group moieties (—OH))”. The (C) block is also characterized by cell-adhesive qualities and may include a monomer having a HLB value in a range of 0 to 5.0. For example, Maejima identifies in paragraphs [0097] and [0100] that the monomer in the (C) block may be styrene. It is unclear, however, if the monomers that comprise the (B) and (C) blocks of Maejima may be properly construed to read on the (A) and (B) monomers of the claimed cell-adhesive polymer.
Im discloses a surface treatment agent comprising a block copolymer. Im states that the polymer may include (A) a monomer having a functional group exhibiting acidity, and (B) a monomer having a HLB value in a range of 0 to 5.0. See paragraph [0024] (“the first monomer may be a monomer selected from the group consisting of aromatic vinyl-based monomers (e.g., divinylbenzene, vinyl benzoate, styrene, etc.”, emphasis added) and paragraph [0025] (“the second monomer may be a monomer…having an acidic functional group”).
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Maejima surface treatment agent includes a cell-adhesive polymer including (A) a monomer having a functional group exhibiting acidity, and (B) a monomer having a HLB value in a range of 0 to 5.0. Maejima already teaches blocks of monomers having acidic functional groups and blocks of monomers (e.g., styrene) having a HLB value of 0 to 5.0. Im is further evidence that one of ordinary skill would know to combine these monomer blocks to form a block copolymer (in the event Maejima already does not teach this). Im teaches that such a configuration produces a surface treatment agent suitable for growing cell aggregates and releasing developed cell sheets from a support substrate.
As for the “consisting of” language, it is noted that Maejima teaches in at least paragraphs [0047], [0108], [0125] and [0154] that the (A), (B) and (C) blocks may exist as partial copolymers, such that a copolymer of any two blocks may exist in combination with a separate polymer of the remaining block (“In the present description, the term “partial copolymer” means a copolymer lacking any one of the essential blocks (A), (B) and (C). Examples thereof include (A)-(B), (A)-(C), (A)-(B)-(X), (A)-(X)-(C), etc.”). Accordingly, Maejima contemplates configurations in which the surface treatment agent includes a polymer of (A) associated with a partial copolymer of (B) and (C). Such an example satisfies the “consisting of” closed group language set forth in independent claim 1. Furthermore, Im discloses a polymer consisting of (A) a monomer having a functional group exhibiting acidity, and (B) a monomer having a HLB value in a range of 0 to 5.0. It would have been obvious to ensure that the partial block copolymer of Maejima consists of such monomers.
With respect to claims 2 and 7, Maejima and Im disclose the combination as described above. Maejima teaches in paragraphs [0038]-[0041] and [0109]-[0111] that the relative amounts of each block are wide ranging, and that the amount of cell-adhesive polymer may be 1 to 50 wt% with respect to the amount of temperature-responsive polymer. Along similar lines, the concentration of temperature-responsive polymer may be 0.1 to 5.0 wt% (“The ratio of block (A) to the total amount of block (A), block (B), and block (C) constituting the block copolymer of the present invention is not particularly limited as long as it is 1 to 90 mol %”).
With respect to claim 3, Maejima and Im disclose the combination as described above. Maejima expressly states that the temperature-responsive polymer exhibits a lower critical solution temperature with respect to water in a range of 0°C to 50°C. See the Abstract.
With respect to claim 4, Maejima and Im disclose the combination as described above. Maejima states in paragraph [0074] that each block, such as the temperature-responsive polymer of the (A) block, may include repeating units of three or more monomers (“each block constituting the block copolymer of the present invention is a copolymer comprising different monomers (monomer 1, monomer 2, etc.)”).
With respect to claims 5 and 6, Maejima and Im disclose the combination as described above. Maejima teaches in paragraphs [0029], [0033] and [0072] that the functional group exhibiting acidity may be a hydroxy group or a carobxy group having a pKa of -5.0 to 6.0.
With respect to claims 8 and 9, Maejima and Im disclose the combination as described above. Maejima states that the surface treatment agent is applied as a film having a thickness of 1 to 1,000 nm. See paragraphs [0134]-[0135].
With respect to claims 10-12, Maejima and Im disclose the combination as described above. Maejima further states in paragraphs [0012] and [0053] and throughout the reference that a film produced using the surface treatment agent is applied to a cell culture substrate.
Response to Arguments
Applicant's arguments filed 12 June 2026 have been fully considered but they are not persuasive.
In response to the amendment introducing “consisting of” language, it is noted that Maejima teaches in paragraphs [0047], [0108], [0125] and [0154] that the (A), (B) and (C) blocks may exist as partial copolymers, such that a copolymer of any two blocks may exist in combination with a separate polymer of the remaining block (“In the present description, the term “partial copolymer” means a copolymer lacking any one of the essential blocks (A), (B) and (C). Examples thereof include (A)-(B), (A)-(C), (A)-(B)-(X), (A)-(X)-(C), etc.”). Accordingly, Maejima contemplates configurations in which the surface treatment agent includes a polymer of (A) associated with a partial copolymer of (B) and (C). Such an example satisfies the “consisting of” closed group language set forth in independent claim 1. Furthermore, Im discloses a polymer consisting of (A) a monomer having a functional group exhibiting acidity, and (B) a monomer having a HLB value in a range of 0 to 5.0. It would have been obvious to ensure that the partial block copolymer of Maejima consists of such monomers. Im states that this specific, closed group combination of monomers produces a cell adhesive polymer that facilitates cell sheet formation and stacking.
Conclusion
THIS ACTION IS MADE FINAL. 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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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