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 of Group I, claims 1, 3, 6, 9, 10, 13, 16-18, 20, 21, 22, 27-29, 31, 33, 39, and 68, is acknowledged. Election was made without traverse in the reply filed on 6/27/2025.
Applicant’s election without traverse of Species A-F in the reply filed on 6/27/2025 is acknowledged. Claims 9, 18, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/27/2025.
Status of the Claims
Claims 1, 3, 6, 9, 10, 13, 16-18, 20-22, 27-29, 31, 33, 39, 57, and 68 are pending. Claim 57 is withdrawn from consideration. Claims 1, 3, 6, 9, 10, 13, 16-18, 20, 21, 22, 27-29, 31, 33, 39, and 68 are under current examination.
Withdrawn Claim Rejections
All rejections not reiterated have been withdrawn.
Claim Objections
Claims 9, 10, 13, 16, 18, 20, 21, 27-29, and 31 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art is free of any teaching or suggestion of the elected species comprising the nanoparticle of the instant claims.
Claim Rejections - 35 USC § 103
The Examiner searched the elected species and found them free of the art. However, the following rejections are made on the generic claims.
Applicant’s amendments to the claims filed 12/15/2025 have necessitated the new grounds of rejection.
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.
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, 17, 22, 33, 39, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Lynn (U.S. Patent Application No. 2021/0393523, PCT filing date: 10/2/2019, of record) in view of Yang (U.S. Patent No. 7,316,816, issue year: 2008).
Applicant’s Invention
Applicant’s claim 1 is drawn to a nanoparticle comprising:(a) an amphiphile of formula (I):A-B-C (I) wherein: A is an amphiphilic group; B is a hydrophilic linker; and C is a first hydrophobic group; and(b) a nanoparticle co-assembly agent of formula (II):X-(Y-Z)m (II) wherein: X is a functionalized hydrophilic polymer; Y is a co-assembly agent linker; Z is a second hydrophobic group; and m is an integer ranging from 1 to 500.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 3, Lynn teaches an amphiphilic block copolymer composed of a hydrophilic surface stabilizing group S, a spacer B, and a hydrophobic oligomer H with the formula S-B-H (Abstract) that forms a nanoparticle in aqueous solution [0075]. The surface stabilizing group may comprise a charged molecule C, which refers to any molecule that has one or more functional groups that are positively or negatively charged in aqueous buffer at a pH of about 7.5. The net charge may be positive, negative or neutral [0192]. In some embodiments, the surface stabilizing group comprises a charged molecule C comprised of both negatively and positively charged amino acids [0201]. The spacer B may impart hydrophobic or hydrophilic properties to modulate micelle or polymersome stability [0091] and may be composed of hydrophilic linear polymers [0129].
Regarding claim 17, Lynn teaches that the spacer B may comprise PEG and/or peptide molecules [0210].
Regarding claim 22, Lynn teaches the relevant limitations of claim 1 above.
Regarding claim 33, Lynn teaches that the amphiphilic block copolymer may self-aggregate into a nanoparticle in an aqueous PBS buffer at pH 7.4 [0360].
Regarding claim 39, Lynn teaches that an immunogenic composition comprising amphiphilic block copolymers may be provided to a subject by any effective route [0042].
Regarding claim 68, Lynn teaches that pharmaceutical compositions containing the amphiphilic block copolymer nanoparticles may also include minor amounts of non-toxic auxiliary substances, such as wetting or emulsifying agents, preservatives, and pH buffering agents and the like [0083].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 3, and 22, Lynn does not teach a nanoparticle co-assembly agent. However, this deficiency is cured by Yang.
Yang teaches a copolymer comprising co-polymerized monomers chosen from a temperature sensitive, a hydrophilic unit, and a hydrophobic unit (col. 7 lines 29-43). The copolymers may also contain heterobifunctional PEG as a spacer (col. 8 lines 29-42). The copolymers may also comprise a terminating group such as polysaccharides (col. 9 line 49). The terminating moiety Y can be adapted to be a functional group that can react with functional groups present in other chemical moieties (col. 9 line 57-61). The spacer may be positioned between the ligand, tag, radioimmunoconjugate, drug or chemical molecule and the terminating
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moiety, as in the formula (col. 11 line 55):
The copolymers can self-assemble into a core-shell nanoparticle comprising a hydrophobic core. The drug conjugated represented by Q may be a hydrophobic drug (col. 4 line 48 and col. 12 line 53). Drugs can be encapsulated by either physical entrapment or chemical conjugation within the core (col. 4 lines 47-57).
Regarding claim 33, Lynn does not teach a nanoparticle co-assembly agent or a method of making a nanoparticle comprised of an amphiphile and a nanoparticle co-assembly agent. However, this deficiency is cured by Yang.
Yang teaches that the copolymers can self-assemble into a core-shell nanoparticle comprising a hydrophobic core (col. 4 line 48). The nanoparticles may be formed by preparing samples in PBS (col. 16 line 36).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 3, and 22, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the amphiphilic nanoparticle of Lynn and the self-assembling copolymer of Yang for the purpose of forming a nanoparticle for drug delivery), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Regarding claim 33, it would have been prima facie obvious to one of ordinary skill in the art of filing that the nanoparticle comprising the amphiphilic block copolymer of Lynn and the copolymer of Yang may be formed in a salt solution. One would have understood that both the amphiphilic block copolymer of Lynn may self-aggregate in an aqueous PBS buffer and that the block copolymer of Yang may form nanoparticles in PBS buffer. It would have been obvious that the copolymers of Yang and the amphiphilic block copolymer nanoparticle may together form an encapsulated nanoparticle in aqueous PBS buffer. One of ordinary skill in the art would have been motivated to encapsulate the nanoparticle of Lynn in a PBS buffer at pH 7.4 because Yang teaches that the nanoparticles are able to liberate the drug encapsulated within the hydrophobic core of the nanoparticle in response to a narrow change in environmental pH (col. 4 lines 57-61). This property can be harnessed for use in targeting organs or tumor tissues where the environment is characteristically acidic (col. 5 lines 1-2). The artisan of ordinary skill would have had reasonable expectation of success because Yang teaches that the nanocarrier may be used to encapsulate drugs in a hydrophobic core (col. 4 line 52).
Response to Arguments
Applicant’s arguments, see pg. 9-10, filed 12/15/2025, with respect to the rejection of claims 1, 3, 17, 22, 23, 33, 39, and 68 under 35 U.S.C. 103 over Lynn in view of Rutenberg et. al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made over Lynn in view of Yang.
Conclusion
Claims 1, 3, 17, 22, 33, 39, and 68 are rejected. Claims 9, 10, 13, 16, 18, 20, 21, 27-29, and 31 are objected to.
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 ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614