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 .
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The new grounds of rejection set forth below are necessitated by applicant’s amendment filed on 9/23/2026. In particular, new claims 25 and 26 have been added. This presents the claims in a manner with a scope not previously examined. Thus, the following action is properly made FINAL.
Claim Rejections - 35 USC § 112
Claim 26 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 26 recites a bottlebrush unimolecular polymer comprising a backbone, a plurality of sidechains and a biological agent electrostatically bound to the unimolecular polymer.
This is indefinite because the claim requires a unimolecular polymer, which includes a biological agent electrostatically bound to the polymer. It is unclear whether the biological agent is intended to be part of the unimolecular polymer (as indicated by the claim) or whether it is intended to be part of the compound.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 recites that each side chain is covalently bonded to the backbone at a unique location along a length of the backbone. There is no literal support for this limitation in the specification. No other support was found for this limitation and the applicant has not cited to where support is present. Therefore, because no support was found, this limitation is new matter.
Claim Rejections - 35 USC § 102
Claim(s) 1-5, 8-9, 21-23, 25-26 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.
The rejection is adequately set forth in the office action mailed on 6/23/2026 and is incorporated here by reference.
Regarding claim 25, each sidechain is on the backbone at a different repeat unit on the backbone (Formula 3, ¶83) where each repeat unit corresponds to a unique location because it is different from the other repeat units and meets claim 25.
Regarding claim 26, Huang teaches the electrostatic interaction (¶6-7, 56) and specifically teaches electrostatic loading of photothermal agents (¶56) such as indocyanine green which is able to generate heat and photothermal effects acting as a drug in photothermal-chemotherapy (¶56). This meets the limitation of an electrostatically bound biological agent.
Claim(s) 1-5, 8, 21, 25 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.
The rejection is adequately set forth in the office action mailed on 6/23/2026 and is incorporated here by reference.
Regarding claim 25, each sidechain is on the backbone at a different repeat unit on the backbone ((¶ 155) where each repeat unit corresponds to a unique location because it is different from the other repeat units and meets claim 25.
Response to Arguments
Applicant's arguments filed 9/23/2026 have been fully considered but they are not persuasive.
Applicant argues that claim 1 recites a unimolecular polymer comprising a backbone where a unimolecular polymer is a single polymer while Huang relies on a nanocrystal matrix rather than a single polymer backbone.
This is not persuasive.
Huang teaches the structure
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(Formula 3, ¶83) which is a single molecule with one backbone (the cellulose backbone). This structure meets the ‘unimolecular’ (single polymer backbone) limitation.
It appears that Applicant’s position is that the nanocrystal matrix of Huang falls outside the scope of ‘unimolecular’. However, the rejection is not based on the ‘nanocrystal matrix’ of Huang, but of the polymer itself. A polymer is a molecule having repeat structures. As it is a molecule, each polymer itself is unimolecular. The presence of each polymer in a matrix, whether it is a nanocrystal or some other form, meets the claimed limitations of ‘compound’ and ‘unimolecular’.
Applicant argues that Kageyama requires a bottlebrush polymer comprising a backbone and a plurality of side-chains while Kageyama teaches microparticles havinga hydrophobic core surrounded by polymer chains which is not a bottlebrush polymer.
This is not persuasive.
The instant specification defines polymers with a well-defined unimolecular architectures made up of polymer side-chains that are covalently attached to and extend radially from a central polymer backbone. See instant specification, ¶54, pg. 8.
While Kageyama does not describe the polymers as bottlebrush, Kageyama teaches the structure
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(¶154-158) which has a central backbone of
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and polymeric side chains
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covalently attached to the backbone. The side chains extend from the central backbone and thus meet the definition in the instant specification of (1) unimolecular central polymer backbone, (2) covalently attached, (3) polymer side chains, and (4) extend radially from the backbone. The polymers of Kageyama have the same structural features as required by the specification and meet the claimed limitations regarding bottlebrush.
The examiner was unable to locate where Kageyama teaches crosslinking or aggregation. However, if Kageyama teaches crosslinking and/or aggregation, it is noted that the polymer taught by Kageyama would still meet the claimed limitations.
It is also noted that a polymer core surrounded by polymer chains appears to be the same structure as a bottlebrush where the unimolecular central polymer backbone is the core and the polymer side chains extending from the backbone surround the core.
Applicant appears to be distinguishing a micelle structure from a bottlebrush polymer. However, the claims do not exclude micelle structures, but rather require a bottlebrush polymer to be present. As previously described, the polymer of Kageyama meets the bottlebrush limitation.
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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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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT C BOYLE whose telephone number is (571)270-7347. The examiner can normally be reached Monday-Thursday, 10am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie (Lanee) Reuther can be reached at (571)270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT C BOYLE/Primary Examiner, Art Unit 1764
