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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-7, in the reply filed on 12/19/2025 is acknowledged.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
Status of Claims
Claims 1-15 remain pending in the application, with claims 1-7 being examined and claims 8-15 being withdrawn pursuant to the election filed 12/19/2025.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “an anti-fouling layer to be hydrated covering the inner wall surface and containing a hydration polymer;” on lines 3-4, where it is suggested to rephrase this so that it is more clear that the anti-fouling layer contains a hydration polymer. As it is recited, it could be read that the anti-fouling layer and hydration polymer are separate.
[0032] of the instant specification recites “Furthermore, the anti-fouling layer to be hydrated contains a hydration polymer”
As such, one suggested phrasing is “an anti-fouling layer to be hydrated containing a hydration polymer covering the inner wall surface
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minagawa (US-2020/0238201-A1).
Regarding claim 1, Minagawa teaches a blood container, comprising:
a container body (centrifugal container 11) having an inner wall surface ([0069], Figure 1A);
an anti-fouling layer (low protein adsorbing layer 18) to be hydrated covering the inner wall surface and containing a hydration polymer ([0043] see low protein adsorbing layer may have any layer having low protein adsorbing properties such as layers formed of low protein adsorbing polymers, and that examples of low protein adsorbing layers formed of low protein adsorbing polymers are produced by polymerizing low protein adsorbing monomers such as zwitterionic monomers, [0069], Figure 1);
wherein a covering rate of the hydration polymer on the inner wall surface is from 50% to 100% ([0053] see the low protein adsorbing layer is formed on the entire inner surface, Figure 1A).
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(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minagawa (US-2020/0238201-A1).
Regarding claim 2, Minagawa teaches the blood container according to claim 1. Minagawa further teaches wherein a thickness of the anti-fouling layer (18) to be hydrated ranges from 5 μm to 100 μm ([0053] see the low protein adsorbing layer preferably has a thickness of 20 to 10,000 nm (0.02 to 10 μm)).
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the thickness of the low protein adsorbing layer in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Claim(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minagawa (US-2020/0238201-A1) and as evidenced by Sigma Aldrich, see attached NPL for 2-methacryloloxyethyl phosphorylcholine.
Regarding claim 3, Minagawa teaches the blood container according to claim 2. Minagawa further teaches wherein the hydration polymer is a zwitterionic polymer, one molecular end of the zwitterionic polymer has an acrylate group, and another molecular end of the zwitterionic polymer has an anionic moiety or a cationic moiety ([0045] see examples of zwitterionic monomers include carboxybetaines, sulfobetaines, and phosphobetaines, [0047] see in the zwitterionic group the cation may be a quaternary ammonium and the anion may be a carboxylate, sulfonate, or phosphate, [0051] see examples of zwitterionic monomers include 2-(meth)acryloyloxyethyl phosphorylcholine (MPC)).
It is described on page 4 of Sigma Aldrich that 2-methacryloloxyethyl phosphorylcholine (MPC) is a zwitterionic phosphorylcholine group containing methacrylate monomer.
Regarding claim 4, Minagawa teaches the blood container according to claim 3.
While Minagawa does not address that the low protein adsorbing layer when hydrated has a hydrous layer formed, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the layers are different, the prior art is considered to have the same properties with respect to forming a hydrous layer as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 5, Minagawa teaches the blood container according to claim 3. Minagawa further teaches wherein a number average molecular weight of the zwitterionic polymer ranges from 5000 g/mol to 10000 g/mol ([0052]).
While Minagawa describes that the low protein adsorbing polymer has a number average molecular weight of 10,000 to 200,000 with no units, one skilled in the art would find it obvious that the conventional units for number average molecular weight is measured in grams per mole.
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the number average molecular weight in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Regarding claim 6, Minagawa teaches the blood container according to claim 3. Minagawa further teaches wherein the anionic moiety of the zwitterionic polymer is selected from the group consisting of a phosphate group, a sulfonic acid group, and a carboxylic acid group, and the cationic moiety of the zwitterionic polymer is a quaternary ammonium group ([0047], [0051] which lists more specific zwitterionic monomers that can be used including 2-(meth)acryloyloxyethyl phosphorylcholine, 2-(meth)acryloyloxyethyl carboxybetaine and 2-(meth)acryloyloxyethyl sulfobetaine which are understood to have either a phosphate group, sulfonic acid group, carboxylic acid group, and quaternary ammonium group ).
Regarding claim 7, Minagawa teaches the blood container according to claim 3. Minagawa further teaches wherein the zwitterionic polymer includes 2-methacryloyloxyethylphosphoric choline ([0051] where 2-(meth)acryloyloxyethyl phosphorylcholine is understood to be the same as the claimed polymer).
Please note that [0051] also describes 2-(meth)acryloyloxyethyl carboxybetaine and 2-(meth)acryloyloxyethyl sulfobetaine.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759