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 1-10, in the reply filed on 4/24/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/24/2026.
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 2 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.
Claim 2 recites the repeating cationic unit is 2-dimethylamino ethyl methacrylate. This is indefinite because 2-dimethylamino ethyl methacrylate is not cationic, but is a neutral monomer. It is suggested that claim 2 be amended to recite the cationic unit is derived from 2-dimethylamino ethyl methacrylate.
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.
Claim(s) 1-5, 8-9, 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (CN 110627978). As the CN document is not in English, citations are made to the attached translation.
Huang teaches brush polymers (¶ 10-11) where a block PCL and hydrophilic cationic block of PDMAEMA is grafted to a cellulose nanocrystal matrix (¶11) to give CNC-g-PCL-b-PDMAEMA (¶13). The CNC corresponds to the claimed backbone and the PDMAEMA corresponds to a side chain having plurality of repeating cationic units. Huang teaches dimethylaminoethyl methacrylate is a hydrophilic cationic monomer that forms the cationic block (¶ 7, 11) which meets claim 2.
Huang teaches the structure
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162
240
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(Formula 3, ¶83).
Huang teaches the degree of polymerization of n is 17, x is 5, and m is 300 (¶95). This corresponds to 5 repeating cationic units in each side chain and meets claim 3. This also corresponds to 300 side chains covalently attached to the backbone and meets claim 4. Huang does not provide any indication that a different amount of repeat units is present, and thus the chains have the same amount of repeat units present and meet claim 5.
Huang teaches the molecular weight of the polymer is 13024 (¶95) which is 13.024 kDa and meets claim 8.
Huang does not expressly recite the pKa of the brush polymer. However, the instant specification teaches that the DMAEMA has a pKa of 8.5 which lowers to around 6.9-7.0 when used in the bottlebrush polymer. See instant specification, pg. 14, ¶ 71, Table 2. Huang teaches using the same monomer, DMAEMA, in a brush polymer (as described above), and thus is expected to have the same pKa discussed by the instant specification, around 6.9-8.5. This meets claim 9.
Huang teaches the polymeric materials are used as drug carriers for entry into cells (¶4-6, 121) by using electrostatic interactions (¶ 56).
Claim(s) 1-5, 8, 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kageyama (JP 2012-241189). As the JP document is not in English, citations are made to the attached translation.
Kageyama teaches a polymer having the structure
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209
684
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where the molecular weight of the MATMAC polymer is 12,000 (¶ 155) where MATMAC is Methacryloyloxyethyltrimethylammonium chloride DMAEMA (¶ 153) which has a molecular weight of 207.70 g/mol. This gives about 57 repeat units of DMAEMA which meets claim 3. Kageyama teaches the moles of the macromonomer, DMAEMA and styrene to form the backbone is about 0.43:0.43:0.43 (¶156) and the amount of initiator is 0.015 mol (¶ 156) which would result in about 28 repeat units of each monomer and macromonomer. This meets the range of claim 4 and would also provide a molecular weight of about 339,000 which is 339 kDa and meets claim 8.
Kageyama does not provide any indication that a different amount of repeat units is present, and thus the chains have the same amount of repeat units present and meet claim 5.
While Kageyama does not explicitly state the polymer is configured to associate with a biological agent for delivery into a cell, Kageyama teaches the same polymeric structure of a backbone with a plurality of side chains having a plurality of cations as the instant claims. This feature provides the polymer with a configuration to associate with a biological agent for delivery.
Allowable Subject Matter
Claims 6-7, 10, 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 6-7 recite different number of side chain repeat units depending on where the side chains are located.
Claim 10 recites a zeta potential of about 25-40 mV.
Claim 24 recites the biological agent comprises DNA, RNP or mixtures thereof.
Relevant prior art includes Huang (CN 110627978), Huang (CN 110627978), and Hortz, Macromolecules 2015, 48, 2074-2086 (present on the IDS of 3/15/2024).
Huang teaches brush polymers (¶ 10-11) where a block PCL and hydrophilic cationic block of PDMAEMA is grafted to a cellulose nanocrystal matrix (¶11) to give CNC-g-PCL-b-PDMAEMA (¶13). The CNC corresponds to the claimed backbone and the PDMAEMA corresponds to a side chain having plurality of repeating cationic units. Huang teaches dimethylaminoethyl methacrylate is a hydrophilic cationic monomer that forms the cationic block (¶ 7, 11). Huang fails to teach the different number of side chain repeat units depending on where the side chains are located, the claimed zeta potential, or the biological agent comprises DNA, RNP or mixtures thereof.
Kageyama teaches a polymer having the structure
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209
684
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where the molecular weight of the MATMAC polymer is 12,000 (¶ 155) where MATMAC is Methacryloyloxyethyltrimethylammonium chloride DMAEMA (¶ 153) which has a molecular weight of 207.70 g/mol. Kageyama fails to teach the different number of side chain repeat units depending on where the side chains are located, the claimed zeta potential, or the biological agent comprises DNA, RNP or mixtures thereof.
Hortz teaches brush polymers having a polyaminohexylmethacrylamide backbone and polysarcosine side chains where the amino groups on the side chains are cationic (Scheme 1). Horst fails to teach a brush polymer having a repeating cationic units.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT C BOYLE whose telephone number is (571)270-7347. The examiner can normally be reached Monday-Thursday, 10am-4pm.
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/ROBERT C BOYLE/Primary Examiner, Art Unit 1764
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