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 .
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.
Priority
3. This application is a 371 of PCT/JP2022/004592 02/07/2022.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application JAPAN 2021-017807 02/05/2021 filed on 08/01/23.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 08/01/23, 12/24/24, 08/06/25, and 09/17/25 have been considered. Please refer to Applicant's copy of the 1449 submitted herewith.
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 1-9, 12-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US 5990202).
Regarding claims 1-8, 12-16, Nguyen discloses copolymer comprising A-B-C types such as (hexyl acrylate)20-(methyl methacrylate)60-(poly(ethylene glycol) methyl ether acrylate, mw=404)60 or (benzyl methacrylate)60-(methyl methacrylic acid)10-(triethylene glycol) methyl ether acrylate, mw=150)30 (column 6, lines 17-, column 13, lines -30, column 23, lines 15-23), meeting the requirements of claims 1-8, 12-16.
Regarding claim 9, Nguyen discloses monomer such as acrylic acid or methacrylic acid (column 15, lines 32-33; read on R6 is hydrogen).
Regarding claims 17-18, Nguyen discloses poly(ethylene glycol) methyl ether acrylate, mw=404 (PEGAc(404)) (16 g; monomer (1)), Hexyl acrylate (40 g; monomer (2)), and methyl methacrylate (MMA) (24 g; monomer (3)) (example 1), results in parts by mass ratio (1):(2):(3) =1:2.5:1.5, fall into instant claim 17 ratio of structural units (A), (B), and (C) is composed of 0.01 to 100 parts by mass of (B) and 0.1 to 100 parts by mass of (C) with respect to 1 part by mass of (A) or claim 18 0.01 to 100 parts by mass of monomer (2) and 0.1 to 100 parts by mass of monomer (3) are polymerized with respect to 1 part by mass of monomer (1).
Regarding claim 19, Nguyen discloses (benzyl methacrylate)60-(methyl methacrylic acid)10-(triethylene glycol) methyl ether acrylate, mw=150)30 (column 23, lines 22-23), results in Mn of 15,933, fall into claimed range of 5,000 to 150,000.
Regarding claims 20-21, since the composition requirement is met by Nguyen, such composition can be used for any future intended purpose such as in single chain nanoparticle and/or pharmaceutical composition.
Claims 1-14, 16, 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higgs (US 2016/0194424).
Regarding claims 1-14, 16, Higgs discloses a copolymers (para [0021], [0134], [0269]) from three or more monomers comprising monomers of methyl acrylate, ethyl acrylate, n-propyl acrylate, n-butyl acrylate, t-butyl acrylate, n-hexyl acrylate, cyclohexyl acrylate, ethoxyethyl acrylate, methoxyethyl acrylate, methyl methacrylate, ethyl methacrylate, n-propyl methacrylate, n-butyl methacrylate, n-hexyl methacrylate, cyclohexyl methacrylate, ethoxyethyl methacrylate, methoxyethyl methacrylate, isobornyl methacrylate, isobornyl acrylate, 2-phenylethyl methacrylate, 2-phenylethyl acrylate, and mixtures thereof (para [0082]); another monomers of 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, 2-hydroxypropyl methacrylate, 2-hydroxypropyl acrylate, 3-hydroxypropyl methacrylate, 3-hydroxypropyl acrylate, 4-hydroxybutyl methacrylate, 4-hydroxybutyl acrylate, methacrylic acid, acrylic acid, 2-hydroxy-3-phenoxypropyl acrylate, polyethylene glycol monomethacrylate (PEG chain M.sub.w=200-2,000), polyethylene glycol methyl ether methacrylate (PEG chain M.sub.w=200-2,000), polyethylene glycol monoacrylate (PEG chain M.sub.w=200-2,000), polyethylene glycol methyl ether acrylate (PEG chain M.sub.w=200-2,000) and N-(2-hydroxypropyl) methacrylamide and mixtures thereof (para [0115]), and 2-ethylhexylacrylate, 2-ethylhexylmethacrylate (para [0123]), meeting the requirements of claims 1-14, 16.
Regarding claims 20-21, since the composition requirement is met by Higgs, such composition can be used for any future intended purpose such as in single chain nanoparticle and/or pharmaceutical composition.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Higgs as applied to claim 1 above.
Higgs includes the features of claim 1 above.
Regarding claim 15, Higgs discloses polyethylene glycol monoacrylate (PEG chain M.sub.w=200-2,000) (para [0115]), overlapping the m is integer 4 to 22.
A prima facie case of obviousness exists for the polymer composition, wherein Higgs discloses polyethylene glycol monoacrylate (PEG chain M.sub.w=200-2,000), overlapping the requirement of claim 15. See In re Wertheim regarding prima facie cases with overlapping ranges (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) See MPEP § 2144.05).
Conclusion
References Tokyo Ohka Kogyo Co Ldt (JP 2017-198919), DNP Fine Chemicals Co Ltd (JP 2016-122174), Fujifilm Corp (JP 2012-108460), Toyo Ink Sc Holding Co Ltd (JP 2017-105722), and JSR Corp (JP 2003-231648) were cumulative in nature to the above rejection and thus not set forth.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KUMAR R BHUSHAN whose telephone number is (313)446-4807. The examiner can normally be reached 9.00 AM to 5.50 PM (EST).
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/KUMAR R BHUSHAN/Primary Examiner, Art Unit 1766