DETAILED ACTION
This Office Action is in response to the Amendment filed on 7/16/2026. Claim 14 was added. Claims 1 – 14 are now pending in the application.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi, et al. (WO 2019/208669 as listed on the IDS dated 9/26/2023; English Machine Translation provided herewith) in view of Natori et al. (WO 2021/039982 listed on the IDS dated 9/26/2023; US 2022/0163535 used as English Translation).
The disclosure of Kobayashi in view of Natori et al. is adequately set forth on pages 3 – 5 of the Office Action dated 3/20/2026 and is incorporated herein by reference.
Regarding claims 1-2, Kobayashi et al. teach a particle comprising
a polymer having a polymerizable monomer wherein the monomer is a styrene monomer (Abstract, claim 4) thereby reading on the polymer with a repeating unit derived from vinyl based monomer as required by the instant claim 1, and the styrene based monomer of claim 2,
an organosilane compound (Abstract), wherein the organosilane compound is a radical polymerizable compound in which an alkyoxy group is bonded to a silicone atom (claim 14) thereby corresponding to the claimed Si-X of Formula (1),
and a water-soluble compound (Abstract) thereby reading on the surface of the particle contains a water-soluble polymer.
Kobayashi et al. do not particularly teach the organosilane compound Si-X being bonded to the rest of the structure as required by Formula (1).
However, Natori et al., in the same field of endeavor, teach a particle and a ligand on a surface of the particle, wherein the particle has a repeating unit represented by the formula (2-3):
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Wherein L1 represents an alkylene group having 1 to 15 carbon atoms [0017] thereby corresponding to the L2 in the claimed Formula (1), wherein R2 is a carboxy group or a hydrogen atom thereby corresponding to the R in the claimed Formula (1), wherein the carboxyl group reads on the claimed L1 when L1 is an oxyalkylene having one carbon, and wherein R1 is hydrogen. Natori et al. offer the motivation of using this structure as a ligand on a particle surface for surface layer modification such that the particle has affinity for a target substance in an in vitro diagnostic reagent and kit including the affinity particle [0012]. In light of this benefit, it would have been obvious to one of ordinary skill in the art to combine the ligand having the structure of Natori et al. with the organosilane compound of Kobayashi et al. in the particle of Kobayashi et al., thereby arriving at the claimed invention.
Regarding claim 3, Kobayashi et al. teach the polymer having repeating unit comprising styrene as set forth above, thereby reading on the claimed Formula (2) and further teach the an organosilane compound selected from 3-methacryloxypropyltrimethoxysilane (claim 7) thereby reading on the Formula (3).
Regarding claim 4, Kobayashi teach a particle comprising a radical polymerizable monomer consisting of styrene (claim 17) with a reactive functional group containing a mercapto group (claim 10).
Kobayashi et al. do not teach the exact structure as required by the claimed Formula (4).
However, Kobayashi teaches mercapto functional groups and styrene monomers with “sufficient specificity” that one of ordinary skill in the art would arrive at the claimed combination. Moreover, one of ordinary skill in the art at the time of the claimed invention would have found it “obvious to try” the mercapto group functional group together with the styrene monomer as the teaching represents a finite number of identified, predictable combinations. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
Regarding claim 5, Kobayashi et al. teach the particle diameter is 50 nm or more and 400 nm or less [0033] thereby reading on the claimed range of 50 nm or greater and 500 nm or less.
Regarding claim 6, Kobayashi et al. teach the water soluble polymer is selected from polyacrylamide, polyvinyl alcohol, polyethylene oxide and polyvinylpyrrolidone (claim 18).
Regarding claim 7, Kobayashi et al. teach the particle having a compound having a reactive functional group containing a silicon alkoxide group (claim 19) thereby reading on the siloxane bond.
Regarding claim 8, Kobayashi et al. teach a ligand bond [0040] to a reactive functional group wherein the reactive functional group contains a carboxy group (claim 10).
Regarding claim 9, Kobayashi et al. do not particularly teach the amount of ligand bound to the particle.
However, Kobayashi et al. teach the ligand is an antibody or antigen used to detect an antigen or antibodies in a sample [0044] and that the ligan isa compound that specifically binds to a receptor possessed by a particular target substance [0040]. Therefore the amount of ligand bound to the particle will affect the resulting detection of the antigen or antibodies in a sample. Therefore, the amount of ligand can be optimized to reach the desired detection required via a routine optimization. The case law has held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to adjust the relative amount of the compounds for the intended application via a routine optimization, thereby obtaining the present invention.
Regarding claim 10, Kobayashi et al. teach a test reagent for in vitro diagnosis comprising the particle and a dispersion medium [0043].
Regarding claim 11, Kobayashi et al. teach a test reagent wherein the ligand is an antibody or antigen and the test reagent is used for detecting the antigen or antibody in a specimen by latex agglutination [0044-0044].
Regarding claim 12, Kobayashi et al. teach a test kit for in vitro diagnosis [0045] comprising the test reagent and a housing.
Regarding claim 13, Kobayashi et al. teach a method of producing a particle, the method comprising mixing a radical polymerizable monomer, an organosilane compound, an aqueous solution, a radical polymerization initiator, and a water soluble polymer (Abstract), wherein the particle comprises the structure represented by Formula (1) as set forth in the rejection above for claim 1, wherein the organosilane compound reads on the coupling agent, wherein the compound contains a reactive functional group containing a glycidyl group, a compound containing a mercapto group and a carboxy group (claim 10).
Regarding claim 14, see the disclosure as set forth above for claims 1, 3, and 4 wherein Kobayashi in view of Natori teach or render obvious the claimed Formulae (1), (2), (3) and (4).
Response to Arguments
Applicant's arguments filed 7/16/2026 have been fully considered but they are not persuasive. Regarding the 103 rejection over Kobayashi in view of Natori, Applicant states that in the structure of the claimed formula (1), the L1 does not correspond to an ester bond. Therefore, formula (1) of the claim 1 does not have an ester bond in the structure adjacent to the hydroxyl group.
In response, attention is drawn to the language of instant claim 1, wherein L1 and L2 each independently represent an alkylene group having 1 or more and 15 or less carbon atoms or an oxyalkylene group having 1 or more and 15 or less carbon atoms (emphasis added).
The structure of Natori is best compared to the instant formula (1) when instant formula (1) is rotated 180 degrees:
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Natori (2-3)
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Instant Formula (1) rotated 180 degrees
Moving from left to right:
The COOH group of the instant formula (1) is met by the COOH of Natori (denoted by a carboxylic group and OH in Natori)
The L2 of formula (1) is met by the L1 of Natori
The R of formula (1) is met by the R2 of Natori
The S in the formula (1) is met by the S of Natori
The OH pendant group in formula (1) is met by the OH of Natori
The O in formula (1) is met by the O of Natori
The L1 of formula (1) can be an “oxyalkylene” having one carbon, which is met by the C=O (carboxylic group) of Natori.
Absent a specific definition of “oxyalkylene” the term is given its broadest reasonable interpretation. The term “oxyalkylene” is interpreted as any alkylene group with an oxygen. The oxyalkylene of L1 in instant formula (1) can have one carbon. As such, the carboxylic group of Natori reads on the oxyalkylene of L1 when one carbon is present. Therefore, the compound of Natori when combined with the Si-X of Kobayashi as set forth in the rejection above meets the instant Formula (1).
It is for these reasons that Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LANEE REUTHER whose telephone number is (571)270-7026. The examiner can normally be reached M-F 7:30-3:30.
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/ARRIE L REUTHER/Supervisory Primary Examiner, Art Unit 1764
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