DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 05/25/2023 has been entered. Claims 11-15 are new. Claims 1-15 are pending in this application. Claims 1-3, 8-11, and 15 are withdrawn. Claims 4-7 and 12-14 are currently under examination.
Priority
This application is a 371 of PCT/JP2021/042832 filed on 11/22/2021 and claims foreign priority of JAPAN 2020-196323 filed on 11/26/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Election/Restrictions
Applicant's election with traverse of Group II invention (claims 4-7 and 12-14) in the reply filed on 02/13/2026 is acknowledged. The traversal is on the ground(s) that “See MPEP §803 in which it is stated that "if the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits” (p. 1, para. 2). This is not found persuasive because "Groups I/II/III are directed to a technical feature: Formula (1):
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wherein R1 is a hydrogen atom or a methyl group, m is 1 to 2000, and n is 10 to 500,
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is a cyclodextrin in which at least one hydroxyl group is modified with a group represented by -X-Y, X is a divalent organic group, and Y is a hydroxyl group or a sulfo group. This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Arisaka et al. … Therefore, the common technical feature of Groups I/II/III cannot be a special technical feature over the prior art”, as set forth on page 6 of the Restriction/Election Requirement mailed on 12/17/2025. “Lack of unity of invention may be directly evident “ a priori ,” that is, before considering the claims in relation to any prior art, or may only become apparent “ a posteriori ,” that is, after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.“ (see MPEP § 1850 [R-01.2024], 37 CFR 1.475, II).
Claims 1-3, 8-11, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 4-7 and 12-14 are currently under examination.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Three information disclosure statements (IDS) filed on 06/29/2023, 07/14/2023, and 05/13/2024 have been considered.
Claim Objections
Claims 4-6 and 12 are objected to because of the following informalities: In claim 4, change the incorrect recitation “represented by” (lines 4 and 12), which means one of many, to “of”; delete the excessive recitations “[Chemical Formula 3]” (line 5) and “[Chemical Formula 4]” (line 9); and provide legible structure of Formula (1), which is blurry. In claim 5, insert the missing word “further” immediately before the recitation “comprising coating” (line 1) because the coating step is a further step; and replace the incorrect recitation “represented by” (line 2), which means one of many, with “of”. In claims 6 and 12, change the incorrect recitation “represented by” (line 3 of claim 6; line 2 of claim 12), which means one of many, to “of”. Appropriate correction is required.
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.
Claims 4-7 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajendran et al. (ACS Biomater. Sci. Eng. 5, 5652−5659, 2019, Published: February 28, 2019, hereinafter referred to as Rajendran ‘2019, also listed in IDS filed on 06/29/2023) as evidenced by Arisaka et al. (Journal of Biomaterials Science, Polymer Edition, 28(10–12), 974–985, 2017, hereinafter referred to as Arisaka ‘2017, also listed in IDS filed on 06/29/2023).
With regard to structural limitations “a method for promoting osteoblast differentiation, comprising: culturing mesenchymal stem cells (or somatic stem cells derived from mesoderm having self-renewal ability and pluripotency into mesenchymal tissues such as osteoblasts, see specification, p. 2 , [0004]) on a surface of a substrate coated with a composition comprising a polyrotaxane of Formula (1):
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wherein R1 is a methyl group, m is 1 to 2000, and n is 10 to 500 (or 3 to 220),
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is a cyclodextrin in which at least one (or 1 to 18) hydroxyl group is modified with a group of -X-Y, X is a divalent organic group, and Y is a sulfo group” (claims 4, 6, 7, and 12-15), and “further comprising coating the composition onto the surface of the substrate” (claim 5):
Rajendran ‘2019 disclosed that human mesenchymal stem cells (hMSCs) cultured on highly mobile PRX surfaces exhibited poor actin cytoskeletal organization and retention of the transcriptional regulator, yes-associated protein (YAP), in cytoplasm in contrast to the hMSCs on less mobile PRX surfaces. When the hMSCs that proliferated under these conditions were collected and subjected to osteogenic differentiation on tissue culture polystyrene (TCPS) surfaces, only the hMSCs cultured on highly mobile PRXs with FGF2 in both soluble and immobilized forms showed mineralization indicative of osteogenic differentiation.
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. Chemical formula of synthesized Sulfopropyl ether modified PRX triblock copolymer (SPE-PRX):
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. hMSCs were seeded onto the surface of either SPE−PRX5 with high molecular mobility or SPE−PRX86 with less molecular mobility (page 5652, Abstract; page 5653, Figure 1; page 5654, right col., para. 5). Sulfonated-PRX triblock copolymers composed of sulfopropyl ether-modified α-CDs threaded onto a PEG chain (Mn = 20 000) as a middle PRX segment and poly(benzyl methacrylate) (PBzMA) at both terminals of the PEG as anchoring segments (SPE-PRXs), as well as unsulfonated PRX triblock copolymers, were prepared as described previously (reference #29, Arisaka et al.). SPE−PRX was dissolved in DMSO at 0.05 w%. SPE−PRX was coated onto the 24-well tissue culture polystyrene plates by using the simple drop casting method (page 5654, left col., para. 2 to 3; page 5659, #29). Arisaka ‘2017 (cited as evidence only here) disclosed that the molecular weight (Mn) of PRX-PBzMA triblock copolymers with an α-CD threading number of 5.1 (PRX5-PBzMA) was 37,100 (Mn ratio of PRX/PBzMA segments: 2.04), whereas that of PRX-PBzMA triblock copolymers with an α-CD threading number of 86.1 (PRX86-PBzMA) was 103,700 (Mn
ratio of PRX/PBzMA segments: 2.15). The numbers of modified sulfopropyl groups in PRX5-PBzMA and PRX86-PBzMA determined by 1H-NMR measurement were 28.1 (SPE-PRX5-PBzMA) and 224.3 (SPE-PRX86-PBzMA) (page 979, para. 2).
Thus, these teachings of Rajendran ‘2019 evidenced by Arisaka ‘2017 anticipate Applicant’s claims 4-7 and 12-14.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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