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/JP2022/041017 11/02/2022.
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 2021-179722 11/02/2021 JAPAN 2021-179721 11/02/2021 filed on 04/30/24.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 12/22/25, 02/25/25, and 04/30/24 have been considered. Please refer to Applicant's copy of the 1449 submitted herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 4, the substituents R1, R2 and O in the structure (F) are not defined to ascertain the metes and bounds of the claim. Accordingly, the instant claim is rejected as failing to particularly point out and distinctly claim the invention.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hiroi by US 2023/0235141).
The applied reference has a common inventor and/or assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1, 5, 7-11, Hiroi discloses a composition and a process of forming a cured coating film on a substrate, wherein the process comprises a step of polymerizing a monomer mixtures containing claimed formula (A), (B), (C), (D) and polycarbodimide (para [0031]-[0046]) with examples formula (A): phosphoxypropylene glycol monomethacrylate (propylene oxide: 5; para [0116]); formula (B): dimethylaminoethyl (meth)acrylate, diethylaminoethyl (meth)acrylate, dimethylaminopropyl (meth)acrylate, 2-(t-butylamino)ethyl (meth)acrylate, methacryloylcholine chloride (para [0047]); formula (C): butyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, lauryl (meth)acrylate, stearyl (meth)acrylate, etc.; cyclic alkyl esters of (meth)acrylic acids such as cyclohexyl (meth)acrylate, isobornyl (meth)acrylate, etc.; aralkyl esters of (meth)acrylic acids such as benzyl (meth)acrylate, phenethyl (meth)acrylate (para [0048]), formula (D): ethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, propylene glycol di(meth)acrylate; and polycarbodiimide: Carbodilite V-02, Carbodilite V-02-L2, Carbodilite E-02 (para [0068]), wherein the ratio of formula (A) to (B) is 130 mol% (para [0116]; 6.02 g phosphoxypropylene glycol monomethacrylate (propylene oxide: 5, ~0.0127 mol); 2.54 g about 80% methacryloylcholine chloride, 0.00979 mol) fall into claimed range of 40 mol% or more, wherein the polymerized product is applied on the substrate to form coating film, drying the applied coating to form cured product, wherein the reaction of the phosphoric acid group with polycarbodiimide inherently form pyrophosphate structure, which further comprises washing the cured product after drying with water containing alcohol solvent (para [0072]-[0076], examples), meeting the requirements of claims 1, 7-11.
Regarding claims 3-4, Hiroi discloses polycarbodiimide (C) contains a hydrophilic group represented by the following formula (I):
R.sup.1—(O—CHR.sup.2—CH.sub.2).sub.m (I)
wherein R.sup.1 represents an alkyl group having 1 to 5 carbon atoms, R.sup.2 represents a hydrogen atom or a methyl group, when a plurality of R.sup.2s is present, the R.sup.2s may be the same or different from each other, and m represents an integer of 1 to 30) (para [0064]-[0065]).
Regarding claims 6, 12, Hiroi discloses the applied cured coating film has ability to suppress adhesion or aggregation of antibody biological substance (para [0080]-[0083]).
Regarding claim 13, Hiroi discloses the surface of the base material (read on storage container) on which the coating film of the present invention has been formed has an ability to suppress adhesion of antibody biological substance (para [0070]-[0074], [0081]-[0083])
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hiroi as applied to claim 1 above.
Hiroi includes the features of claim 1 above.
Regarding claim 2, Hiroi discloses ethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, or propylene glycol di(meth)acrylate in an amount of 0 to 50 mol% (para [0049]), encompassing claimed range of less than 30 mol%.
A prima facie case of obviousness exists for the coating composition, wherein Hiroi discloses ethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, or propylene glycol di(meth)acrylate in an amount of 0 to 50 mol%, encompassing the requirement of claim 2. It is well-settled that where claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 267 (CCPA 1976).
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hiroi (US 2017/0349777; hereinafter called “Hiroi-1”) in view of Takahashi (US 2006/0003085).
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Regarding claims 1, 3-12, Hiroi-1 discloses a composition and a process of forming a coating film on a substrate, wherein the process comprises a step of polymerizing a monomer mixtures containing claimed formula (A), (B), (C), and (D) of structures
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wherein T.sup.d represent a hydrogen atom or a linear or branched alkyl group having 1 to 5 carbon atoms; R.sup.d represent a linear or branched alkylene group having 1 to 10 carbon atoms which may be substituted by a halogen atom(s); and n represents an integer of 1 to 6 (para [0014]-[0016], [0040]), wherein in the copolymer according to the present invention is 3 mol % to 80 mol % of the formula (A) and 3 mol % to 80 mol % of the formula (B), overlapping claimed range of ratio of (A) and (B) is 40 mol% or more, wherein the polymerized product is applied on the substrate to form coating film, drying the applied coating, which further comprises washing after drying with water containing alcohol solvent, wherein the applied cured coating film has ability to suppress adhesion or aggregation of antibody biological substance (para [0023]-[0025], [0033]-[0036], [0091]). Hiroi-1 does not disclose the presence of polycarbodiimide to obtain the cured product.
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However, Takahashi discloses a process of producing cured acrylate and/or acrylamide type coating film on the substrate, wherein the curing is performed with the hydrophilic polycarbodiimide containing
to produce cured coating film having a sufficient strength in a shorter treating time than conventionally (para [0029]-[0034], [0038], [0063]).
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It would have been obvious to one with ordinary skill, in the art at the time of invention, to modify Hiroi-1 with hydrophilic polycarbodiimide containing
as taught by Takahashi. The rationale to do so would have been motivation provided by of Takahashi that to do so would produce cured coating film having a sufficient strength in a shorter treating time than conventionally. The reaction of the phosphoric acid group with polycarbodiimide would necessarily form pyrophosphate structure.
A prima facie case of obviousness exists for the coating composition, wherein Hiroi-1 discloses the copolymer according to the present invention is 3 mol % to 80 mol % of the formula (A) and 3 mol % to 80 mol % of the formula (B), overlapping the requirement of claims 1, 9, 11. It is well-settled that where claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 267 (CCPA 1976).
Regarding claim 2, Hiroi-1 discloses (D) in an amount of 0 to 50 mol% (para [0120]), encompassing claimed range of less than 30 mol%.
A prima facie case of obviousness exists for the coating composition, wherein Hiroi-1 discloses (D) in an amount of 0 to 50 mol%, encompassing the requirement of claim 2. It is well-settled that where claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 267 (CCPA 1976).
Regarding claim 13, Hiroi-1 discloses the surface of the base material (read on storage container) on which the coating film of the present invention has been formed has an ability to suppress adhesion of antibody biological substance (para [0080]-[0085], [0091]).
Conclusion
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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