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 with traverse of claims 1-8 in the reply filed on 04/24/2026 is acknowledged. The traversal is on the ground(s) that unity of invention does exist between Groups I-III because there is a technical relationship that involves the same special technical feature. This is not found persuasive because the lack of unity is made a posteriori, so the shared technical feature applicant argues is acknowledged but it does not make a contribution over the prior art. Additionally, group I can be classified as B01J 20/3217, group II can be classified as B01J 20/3092, and group III can be classified as B01J 2220/52 proving there is a search burden for the examiner
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 5 is objected to because of the following informalities: “as 100%” in line 6 should be removed. Appropriate correction is required.
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.
Claims 3, 4, 5, and 8 are 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.
Claim 3 recites the limitation "ligand has been immobilized" in line 8. This does not match “ligand has not ben immobilized” in line 4. The examiner interprets this as the ligand not being immobilized because claim 2 already has the ligand immobilized.
Claim 5 recites the limitation "the particle size" in page 5 last line to page 6 first line. There is insufficient antecedent basis for this limitation in the claim. The examiner is interpreting the reference of the second sieve as the same reference of the first sieve which is a mean volume diameter of the solid phase support before sieve classification.
Claim 8 recites “during the providing” in line 4. The language describing what step suspension polymerization happens could be improved to particularly point and distinctly claim what step this is happening in. For example: “The method of claim 1, wherein the solid phase support is obtained by dispersing a monomer composition…”. The examiner interprets this as limiting the suspension polymerization to the first step of the method.
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.
(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, 2, and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tokunaga et al. (JP2017037069A).
Regarding claims 1 and 2, Tokunaga et al. discloses a separation agent suitably used as packing material for a chromatography column (paragraph 0001). The separating agent comprises porous particles made of a crosslinked synthetic polymer and an affinity-adsorbing ligand covalently bonded and immobilized to the porous particles (paragraph 0011). A sieve classification is done where the porous particles larger than 32 micrometers are collected using a sieve with a 32-micrometer opening and then passed through a sieve with a 53-micrometer mesh opening (paragraph 0082). The final particles are between 32-53 micrometers (paragraph 0082).
Tokunaga et al. is silent on coefficient of variation and ratio of volume cumulative 1% particle size to volume cumulative 50% particle size (d1/d50). In Example 1 of the specification, the sieve classification is done with 32 and 77 micrometer sieves. Looking at Table 1 in the specification, Example 1 has a coefficient of variation of 20% and d1/d50 of 0.56. Since the sieve classification in Tokunaga et al. is done with a smaller size range (32-53 micrometer), the distribution of porous particles would be narrower than those of Example 1. A narrower distribution would decrease the coefficient of variation and increase d1/d50 which has a maximum of 1.0. Therefore, it is inherent that the coefficient of variation of a volume particle size distribution is between 1% to 22% and d1/d50 is between 0.55 and 1.0.
Regarding claim 5, Tokunaga et al. discloses sieve classification with two sieves with different openings (32-53 micrometers) (paragraph 0082). The desired particles are collected over the top of a 32-micrometer opening sieve, and then passed through a sieve with a 53-micrometer opening (paragraph 0082).
Tokunaga et al. does not disclose a mean volume diameter of the porous particles before sieve classification, but one would expect for the mean volume diameter to inherently allow the sieves to satisfy the claimed range for a sufficient number of porous particles pass through the mentioned sieves of 32-53 micrometers.
If it is interpreted that the average particle size disclosed by Tokunaga et al. is 1-1000 micrometer before sieve classification (paragraph 0028), one could choose a size within the range. For example, if the mean volume diameter of the porous particle is 40 micrometers, a first 32-micrometer sieve is 80% with respect to a mean volume diameter and the second 53-micrometer sieve is 133% which is bigger than the first sieve.
Regarding claim 6, Tokunaga et al. discloses the sieve classification is done with porous particles in a water-wet state (paragraph 0082).
Tokunaga et al. is silent on coefficient of variation and ratio of volume cumulative 1% particle size to volume cumulative 50% particle size (d1/d50). In Example 1 of the specification, the sieve classification is done with 32 and 77 micrometer sieves. Looking at Table 1 in the specification, Example 1 has a coefficient of variation of 20% and d1/d50 of 0.56. Since the sieve classification in Tokunaga et al. is done with a smaller size range (32-53 micrometer), the distribution of porous particles would be narrower than those of Example 1. A narrower distribution would decrease the coefficient of variation and increase d1/d50 which has a maximum of 1.0. Therefore, it is inherent that the coefficient of variation of a volume particle size distribution is between 1% to 22% and d1/d50 is between 0.55 and 1.0.
Regarding claim 7, Tokunaga et al. is silent on coefficient of variation and ratio of volume cumulative 1% particle size to volume cumulative 50% particle size (d1/d50). In Example 1 of the specification, the sieve classification is done with 32 and 77 micrometer sieves. Looking at Table 1 in the specification, Example 1 has a coefficient of variation of 20% and d1/d50 of 0.56. Example 1 d1/d50 falls just outside the claimed range. Example 2 has a sieve classification is done with 34 and 77 micrometer sieves and has a d1/d50 of 0.62; within the claimed range. The sieve classification in Tokunaga et al. is done with a smaller size range (32-53 micrometer) than Examples 1 and 2, so the distribution of porous particles is narrower than Examples 1 and 2. A narrower distribution would decrease the coefficient of variation and increase d1/d50. Therefore, it is inherent that the coefficient of variation of a volume particle size distribution is between 5% and 20% and d1/d50 is between 0.60 and 0.95.
Regarding claim 8, Tokunaga et al. discloses it is preferable to manufacture the material by a suspension polymerization method (paragraph 0049). The monomers used in suspension polymerization are in aqueous solutions (paragraph 0007).
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.
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tokunaga et al. as applied to claims 1, 2, and 5-8 above, and further in view of Norinobu (US20200360894).
Regarding claim 3 Tokunaga et al. discloses a separation agent suitably used as packing material for a chromatography column (paragraph 0001). The separating agent comprises porous particles made of a crosslinked synthetic polymer and an affinity-adsorbing ligand covalently bonded and immobilized to the porous particles (paragraph 0011). A sieve classification is done where the porous particles larger than 32 micrometers are collected using a sieve with a 32-micrometer opening and then passed through a sieve with a 53-micrometer mesh opening (paragraph 0082). The final particles are between 32-53 micrometers (paragraph 0082).
Tokunaga et al. is silent on coefficient of variation and ratio of volume cumulative 1% particle size to volume cumulative 50% particle size (d1/d50). In Example 1 of the specification, the sieve classification is done with 32 and 77 micrometer sieves. Looking at Table 1 in the specification, Example 1 has a coefficient of variation of 20% and d1/d50 of 0.56. Since the sieve classification in Tokunaga et al. is done with a smaller size range (32-53 micrometer), the distribution of porous particles would be narrower than those of Example 1. A narrower distribution would decrease the coefficient of variation and increase d1/d50 which has a maximum of 1.0. Therefore, it is inherent that the coefficient of variation of a volume particle size distribution is between 1% to 22% and d1/d50 is between 0.55 and 1.0.
Tokunaga et al. does not disclose a porous particle on which a ligand has not been immobilized.
Norinobu discloses a chromatography carrier having a ligand immobilized thereto (paragraph 0001). The carrier is a porous particle (paragraph 0034 and 0035). The porous particle can have monomers that have no functional group capable of immobilizing a ligand (paragraph 0135).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to produce the carrier with ligand that has not been immobilized because even without the ligand, the particle can satisfy the desired effects of the present invention such as antifouling properties (paragraph 0135). Furthermore, a ligand may not be needed if the porous particle is used for size-exclusion chromatography because the carrier’s porous network separates the molecules based on size.
Regarding claim 4, Tokunaga does not disclose immobilizing a ligand on a porous particle that has gone through the sieve classification.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to try immobilizing after sieving as there are a finite number of ways a chromatography carrier with a ligand immobilized can be produced. Furthermore, one having ordinary skill in the art would have a reasonable expectation of success to have a particle that is capable of passing through the same sieves whether a ligand or has not been immobilized because Tokunaga et al. discloses the particle size of the separation agent is determined by the porous particle and not the ligand attached (paragraph 0028).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A CALDERON whose telephone number is (571)272-9866. The examiner can normally be reached Monday-Friday 8-5PM.
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/DAVID ANDREW CALDERON/Examiner, Art Unit 1742 /CHRISTINA A JOHNSON/Supervisory Patent Examiner, Art Unit 1742
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