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/JP2022/029659 08/02/2022.
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 2021-126893 08/02/2021 filed on 01/31/24.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 07/31/25, 03/04/24, and 02/09/24 have been considered. Please refer to Applicant's copy of the 1449 submitted herewith.
Election/Restrictions
Applicant’s election of claims 1, 3-15 and species polycarbonate in the reply filed on 08/14/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-19 are pending. Claims 2, 16-19 are directed to non-elected invention. Accordingly, claims 2, 16-19 are withdrawn from further consideration by Examiner, 37 CFR 1.142(b), as being drawn to non-election invention. Claims 1, 3-15 are examined in this Office action.
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, 7-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gen (WO 2020262602).
Regarding claims 1, 7-9, 11-14, Gen discloses a porous body comprising a polypeptide derivative, wherein the polypeptide derivative contains a block copolymer containing hydrophobic recombinant polypeptide such as modified spider silk fibroin bonded to plasticizer such as polyhydric alcohols and terminal carboxyl group oligo-alkylene glycols (terminal carboxyl group poly (ethylene glycol), e.g. polyalkylene glycol of molecular weight 200 to 600 (para [0064], [0065], [0085], [0103]-[0106], [0201]-[0203]), meeting the requirements of claims 1, 7-9, 11-14.
Regarding claim 10, Gen discloses hydrophobicity index 2.6 or more (para [0206]), fall into claimed 0.22 or more.
Regarding claim 15, Gen discloses plasticizer such as polyalkylene glycol and spider silk fibroin such as MaSp1 MiSp1 AcSp are bonded by thiol or amino groups (para [0085], [0103]-[0106], [0131]).
Claims 1, 3-8, 11-12, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rizzi (S. C. Rizzi et al, Recombinant Protein-co-PEG Networks as Cell-Adhesive and Proteolytically Degradable Hydrogel Matrixes. Part I: Developmental and Physiochemical Characteristics, Biomacromolecules 2005, 6, 1226-1238).
Regarding claims 1, 3-8, 11-12, 15, Rizzi discloses in charts 1,2 , experimental procedure, a porous body (hydrogel disks, p.1230, col2 §2 , hydrogel formation) comprising a polypeptide derivative, wherein the polypeptide derivative (recombinant protein have a thrombin-cleavable hexahistidine-tag (His-tag) at their N-termini provided by the PET 14b expression vector, fibrinogen fragment contains a block copolymer containing a first segment containing a polypeptide skeleton, and one or a plurality of second segments that are bonded to the first segment (PEG divinyl sulfone), the polypeptide skeleton is a recombinant polypeptide skeleton, and the second segment contains a molecular group having a plasticizing function for the polypeptide skeleton (PEG). PEG has a Mw of 6000 g/mol and protein (Mw between 11K-30K), read on claim 3 feature a molecular weight of the molecular group having the plasticizing function for the polypeptide skeleton is 10 or more when a molecular weight of the polypeptide skeleton is 100 or claim 4 feature the molecular weight of the molecular group having the plasticizing function for the polypeptide skeleton is 100 or less when the molecular
weight of the polypeptide skeleton is 100 or claim 5 feature a total molecular
weight of the second segment is 10 or more based on a molecular weight of the first segment being 100 or claim 6 feature the total molecular weight of the
second segment is 2,000 or less based on the molecular weight of the first segment being 100, wherein the first segment is bonded to the second segment by a thiol group, in the polypeptide skeleton (chart 1).
Conclusion
References Encordia (WO 2020/198264), Spiber (WO 2014/175178), Sumitomo (JP 2006-275769), Agency for Science Technology & research (JP 2014-064572), Hanmi Pharm (JP 2019-187440), and Spiber (WO 2017/188430) 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RANDY P GULAKOWSKI can be reached at (571)272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KUMAR R BHUSHAN/Primary Examiner, Art Unit 1766
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