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 .
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 83 and 87 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.
Regarding claim 83: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 83 recites the broad recitation “a C1-C3 alkyl”, and the claim also recites (e.g., methyl or ethyl)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 87: The scope of claim 87 is indefinite. The claim requires E1 and E2 to be of the formula –(CH2)2-NR2-(CH2)2-NR22 or -(CH2)2-NR2-(CH2)2-NHR2, and requires R4 to be -C(O)-O-. However, R4 is not present in either of the two possibilities of E1 and E2, but is instead found in some of the alternative E1 and E2 moieties defined in claim 17. Therefore, it is unclear if the other possibilities of E1 and E2 found in claim 17 are potential alternatives in claim 87 or if E1 and E2 are required to be one of the two possibilities shown in line 2 of claim 87. Further, in line 4 of claim 87, the “and/or” leads one to reason that each of the limitations after “wherein” are potential alternatives to the first limitation defining E1 and E2, meaning that one of the other E1 and E2 definitions from claim 17 is possible when R4 is -C(O)-O-. However, the “and” is not clear since then E1 and E2 would be required to have divergent definitions, namely one of the formulas from line 2 of claim 87 AND one of the formulas from claim 17 that contains an R4 moiety. For the purpose of further examination, it is taken to mean that each limitation is an alternative to each other (meaning the “or” is present but not the “and”).
Further z is undefined in the structures of R5.
With the interpretation taken above, that each limitation is an alternative to each other, it is unclear if the limitation “wherein R2 is hydrogen, methyl, or ethyl” refers only to the previous limitation “wherein each of E1 and E2 is a group of the formula –(CH2)2-NR2-(CH2)2-NR22 or -(CH2)2-NR2-(CH2)2-NHR2” or if that is one of the alternative limitations and can refer to any of the R2 moieties in the E1 and E2 definitions given in claim 17.
Response to Arguments
Applicant's arguments filed November 20, 2025 have been fully considered but they are not persuasive.
A) Applicant’s argument that the Office has not pointed to any teaching or motivation to move the polyalkylene oxide group at the terminus to a side chain. However, the rejection below points out the teaching with citations provided. The motivation statement is also present in the rejection, namely: “would have been motivated to do so in order to encapsulate therapeutic drugs such as doxorubicin”. This teaching does come from the reference Uchegbu. The side chain structure of the polymer (see fig. 1) leads to the formation of vesicles, which are suitable the entrap the active agents (abstract). Further, rationale may be in a reference, or reasoned from common knowledge in the art, and can be different from applicant’s (MPEP 2144).
B) Applicant’s argument that there is no motivation in the references to prepare a polymer with the specific three monomers as claimed is not persuasive. The combination of references teaches all the claimed monomers and the motivation statement is provided as set forth above. Further, the number of side chains/monomers of each monomer is not claimed in claim 1. Therefore, a person having ordinary skill in the art could choose an H as a terminal group, and call the polyalkylene oxide of Kim et al. a “side chain” with an n of 1. That is why claim 27 contains allowable subject matter since neither reference teaches the number of monomer repeats claimed along with the other claimed limitations.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-7, 10, 16, 17, 19, 20, 28, 86, and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2021/0340322) in view of Uchegbu WO 99/61512).
Regarding claims 1 and 3: Kim et al. teaches a polymer with a hydrolysable polyamide polymer backbone (see structure below and pg. 7 chem.6, chem.7) having a monomer unit with a side chain comprising a hydrophobic group/R6a and R6b are unsubstituted aliphatic hydrocarbon groups having 7 to 12 carbon atoms (para. 56), a monomer unit with a side chain comprising a polyamine (para. 56, R7a and R7b), and a monomer unit comprising a polyalkylene oxide/ethylene glycol (chem.6, chem.7, para. 72):
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Kim et al. teaches R7a and R7b can be
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(para. 56), which overlaps the first claimed formula.
Kim et al. does not teach the polyalkylene oxide unit is a side chain. However, Uchegbu teaches a similar polymer
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(fig. 1), having a polyethylene glycol unit as a side chain. Kim et al. and Uchegbu are analogous art since they are both concerned with the same field of endeavor, namely therapeutic delivery polymers. Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to use the polyalkylene oxide side chains for Uchegbu in the polymer of Kim et al. and would have been motivated to do so in order to encapsulate therapeutic drugs such as doxorubicin.
Regarding claims 5 and 6: Kim et al. teaches R7a and R7b can be
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(para. 56), which overlaps the first claimed formula.
Regarding claim 7: Kim et al. teaches
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where m is 5 or more (para. 58) and n is 0 to m (para. 56), the units with (m-n) and (n) as the subscripts are the monomer units having a hydrophobic group since R6a and R6b can be alkyls. The number of units of the polyalkylene oxide group on one terminus of the polymer is 1. The x can be 2-250 (para. 58), while y is 0 to x and z is 0 to x (para. 56). The units with (x-y-z) and (y) and (z) are the polyamine units since R7a, R7b and R8 are polyamines. Therefore, there can be 1 monomer/mol% of the polyalkylene oxide unit, 5 or more monomers/mol% of the hydrophobic group, and 2-250 molecules/mol% of the polyamine monomer unit, which overlaps the claimed ranges.
Regarding claim 10: Kim et al. teaches the polymer comprises at least one polyethylene glycol group having 45-1000 ethylene glycol units (see chem.6 shown above and para. 72).
Regarding claim 16: Kim et al. teaches the structure show above (chem.6) which has an end group that is the “n3” monomer claimed, where n3 is 1. L1 may be -CH2- /methylene, claimed X3 would be a bond, and X4 is polyalkylene oxide.
Regarding claim 17: Kim et al. teaches
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claimed X1 and X3 can both be -C(O)NR13- since R5 can be -NH-. X2 can be a C7-12 linear alkyl, E1 and E2 are the claimed amine groups, which overlaps the claimed structure of formula 2 other than the polyalkylene oxide units being a side chain. However, Uchegbu teaches a similar polymer
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(fig. 1), having a polyethylene glycol unit as a side chain. Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to use the polyalkylene oxide side chains for Uchegbu in the polymer of Kim et al. and would have been motivated to do so in order to encapsulate therapeutic drugs such as doxorubicin.
Regarding claim 19: Kim et al. teaches ethylene glycol units (para. 72), which is the first structure claimed where R18 is hydrogen and p is 45-1000, which overlaps the claimed range.
Regarding claim 20: Kim et al. teaches R7a and R7b can be
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(para. 56), which overlaps the first claimed formula where R2 is hydrogen and p2 is 2, q1 is 2, and r1 is 1.
Regarding claim 28: Kim et al. teaches
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where R1 can be -NH-R1b and R1b is linear alkyl group having 1-12 carbon atoms (para. 56). The moieties the contain R7a and R7b read on the amine moieties in claimed polymer 72 (para. 56). The moieties with R6a and R6b read on the claimed hydrophobic units since R6a and R6b are aliphatic hydrocarbon groups having 7-12 carbon atoms. Kim et al. does not teach the polyalkylene oxide units being a side chain. However, Uchegbu teaches a similar polymer
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(fig. 1), having a polyethylene glycol unit as a side chain. Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to use the polyalkylene oxide side chains for Uchegbu in the polymer of Kim et al. and would have been motivated to do so in order to encapsulate therapeutic drugs such as doxorubicin.
Regarding claims 86 and 87: Kim et al. teaches
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claimed X1 and X3 can both be -C(O)NR13- since R5 can be -NH-. X2 can be a C7-12 linear alkyl, E1 and E2 are the claimed amine groups, which overlaps the claimed structure of formula 2 other than the polyalkylene oxide units being a side chain. Further, the claimed Q’ is the disclosed endgroup where the claimed c is the disclosed k and can be 20-20,000 (para. 68). The claimed R6 is the disclosed R10 and can be hydrogen (para. 68), and the claimed R17 is the disclosed R2 and can be hydrogen (para. 56), which meets one of the alternative limitations in claim 87 “wherein R17 is hydrogen”.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2021/0340322) in view of Uchegbu WO 99/61512) as applied to claim 17 set forth above and in view of Satchi-Fainaro et al. (US 2018/0318428).
Regarding claim 85: Kim et al. teaches the basic claimed composition as set forth above. Not disclosed is the R6a and R6b of the structure is a C3-C6 linear or branched alkyl group. However, Satchi-Fainaro et al. teaches a similar polymer having a C6 alkyl group:
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. Kim et al. and Satchi-Fainaro et al. are analogous art since they are both concerned with the same field of endeavor, namely polymers for active agent delivery. Before the effective filing date of the claimed invention a person having ordinary skill in the art would have found it obvious to have a C3-C6 alkyl group as in Satchi-Fainaro et al. and would have been motivated to do so since Satchi-Fainaro et al. teaches it is preferable for the alkyl to be at least three carbon atoms in length and preferably 5-10 (para. 263-265).
Allowable Subject Matter
Claim 27 is 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.
Claim 83 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Kim et al. is the closest prior art as set forth above. However, there is no teaching or suggestion found in the prior art to have each of m1 and m2 be 5-100, each of n1 and n2 to be 5-100, each of n3 and n4 to be 5-100, each instance of R3a and R3b be methylene, in combination with the other limitation requirements of the claim.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Megan McCulley whose telephone number is (571)270-3292. The examiner can normally be reached Monday - Friday 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached at 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN MCCULLEY/Primary Examiner, Art Unit 1767